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    • National Cancer Institute - Central IRB
    • 81 Trials Available
    • CONTACT US

    TRIAL NUMBER: EA2176

    Title: A Randomized Phase III Study of Immune Checkpoint Inhibition with Chemotherapy in Treatment-Naïve Metastatic Anal Cancer Patients

    Purpose:

    Primary Outcome Measures :
    1. Progression-free survival [ Time Frame: Up to 2 years ]
      Defined as the first of progressive disease or death due to any cause. Analyzed using a stratified two-sided overall 0.05 level log-rank test. Will utilize standard Eastern Cooperative Oncology Group -American College of Radiology Imaging Network interim monitoring for efficacy evaluation.


    Secondary Outcome Measures :
    1. Objective response rate (ORR) [ Time Frame: Up to 2 years ]
      ORR is the ratio of the number of patients with a complete response or partial response, as defined by Response Evaluation Criteria in Solid Tumors version 1.1, to the total number of treated patients.

    2. Overall survival [ Time Frame: Time between treatment randomization and death by any cause, assessed up to 2 years ]
      Evaluated by a stratified log-rank test, and using a two-sided 0.05 level Cochran Mantel-Haenzel.

    3. Incidence of adverse events [ Time Frame: Up to 2 years ]
      Analyses of toxicity will be via frequency tabulations and percentages by worst degree of toxicity and comparisons will be done via chi-square or Fisher's exact tests as appropriate.

    TRIAL NUMBER: A031701

    Title: A031701:A Phase II Study of Dose-Dense Gemcitabine Plus Cisplatin (ddGC) in Patients with Muscle-Invasive Bladder Cancer with Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations

    Purpose: This phase II trial studies how well gemcitabine hydrochloride and cisplatin work in treating participants with invasive bladder urothelial cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

    TRIAL NUMBER: A031803

    Title: PHASE II TRIAL OF INTRAVESICAL GEMCITABINE AND MK-3475 (PEMBROLIZUMAB) IN THE TREATMENT OF PATIENTS WITH BCG- NRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER

    Purpose:

    Primary Outcome Measures :
    1. Complete response rate in the carcinoma in situ (CIS) subpopulation [ Time Frame: At 6 months ]
      A complete response, only for patients with a CIS component, is a cystoscopy without evidence of bladder tumor, negative biopsy (including directed biopsies to any suspicious areas and in addition random bladder biopsies including trigone, left lateral wall, right lateral wall, posterior bladder, dome of bladder, and the prostatic urethra in men) and negative cytology for high grade disease at 6 months (end of cycle 8, week 25).

    2. Event-free survival at 18 months [ Time Frame: From the date of study registration to the first documentation of an event or death whichever comes first, assessed up to 18 months ]
      EFS will be measure from the date of study registration to the first documentation of an event or death whichever comes first. For patients without a documented event and who are still alive, they will be censored at last disease assessment. For patients who start any subsequent ant-cancer therapy without any reported events will be censored at their last disease assessment. will be obtained with a Kaplan-Meier estimator (using the Greenwood formula to estimate the variance) for the entire 155 patient group consisting of patients with CIS, CIS with Ta/T1 or Ta or T1 disease. A 90% confidence interval will be generated for the 18-month EFS estimate.


    Secondary Outcome Measures :
    1. Incidence of adverse events [ Time Frame: Up to 5 years post treatment ]
      Adverse events will be assessed based on the National Cancer Institute (NCI) common toxicity criteria (Common Terminology Criteria for Adverse Events [CTACAE] version [v] 5.0).

    2. Duration of response (DOR) [ Time Frame: From the time a patient had a documented response that had been confirmed (the time would start at the time a response was first noted) until disease-progression, assessed up to 5 years ]
      Analysis will only include those patients with a confirmed response. Patients who are alive and without a documented progression at the time of analysis will be censored at the time of the last disease status evaluation. The Kaplan-Meier product-limit estimator will be used to estimate DOR, medians and 95% confidence intervals (CI).

    3. Progression-free survival (PFS) [ Time Frame: From the date of study registration to the date of progression or death due to any cause, whichever occurs first, assessed up to 5 years ]
      Surviving patients without any documented progressions will be censored at the date of last known contact. Progression will be defined as the development of muscle invasive bladder cancer or metastatic urothelial cancer (nodal and/or distant). The Kaplan-Meier product-limit estimator will be used to estimate PFS, medians and 95% CI.

    4. Overall survival (OS) [ Time Frame: From the date of study registration to date of death due to any cause, assessed up to 5 years ]
      Surviving patients will be censored at the date of last known contact. The Kaplan-Meier product-limit estimator will be used to estimate OS, medians and 95% CI.

    5. Cystectomy-free survival [ Time Frame: From the date of study registration to the date of cystectomy for all patients ]
      The Kaplan-Meier product-limit estimator will be used to estimate cystectomy-free survival, medians and 95% CI.

    6. Recurrence free survival (RFS) [ Time Frame: From the date of study registration to the first documentation of recurrence or death due to any cause, assessed up to 5 years ]
      Surviving patients without any documented recurrence will be censored at the date of last known contact. Recurrence will be defined as the development of high-grade bladder cancer for patients with a CIS component only and those without a CIS component. The Kaplan-Meier product-limit estimator will be used to estimate RFS, medians and 95% CI.

    TRIAL NUMBER: EA8185

    Title: Phase 2 Study of Bladder-SparIng ChemoradiatioN with MEDI4736 (Durvalumab) in clinical Stage 3, Node PosItive bladdeR cancEr (INSPIRE)

    Purpose:

    Primary Outcome Measures :
    1. Clinical complete response (CR) [ Time Frame: Up to 6 years ]

    Secondary Outcome Measures :
    1. Metastasis-free survival [ Time Frame: From randomization to first evidence of metastatic disease or death from any cause, assessed up to 6 years ]
      Will be estimated by the Kaplan-Meier method.

    2. Bladder-intact event-free survival (BI-EFS) [ Time Frame: From randomization to the first BI-EFS event, assessed up to 6 years ]
      Will be estimated by the Kaplan-Meier method.

    3. Bladder cancer specific survival [ Time Frame: From randomization to death from bladder cancer, assessed up to 6 years ]
      Will be estimated by the Kaplan-Meier method.

    4. Overall survival [ Time Frame: From randomization to death from any cause, assessed up to 6 years ]
      Will be estimated by the Kaplan-Meier method.

    5. Progression-free survival [ Time Frame: From randomization to first of local progression, nodal or distant metastasis, or death from any cause, assessed up to 6 years ]
      Will be estimated by the Kaplan-Meier method.

    6. Complete response duration [ Time Frame: From the date of the biopsy documenting the complete response to the time of muscle invasive recurrence, local progression, evidence of metastatic disease or death due to any cause, assessed up to 6 years ]
      Stratified Cox proportional hazards models will be used to estimate hazard ratios in all eligible patients.

    7. Salvage cystectomy rate [ Time Frame: Up to 6 years ]
      Rate will be reported as a proportion of patients who do not experience clinical benefit after chemoradiotherapy (chemoRT) +/- MEDI4736 (durvalumab) along with a 90% confidence interval. Stratified Cox proportional hazards models will be used to estimate hazard ratios in all eligible patients.

    8. Incidence of adverse events [ Time Frame: Up to 1 year ]
      Assessed using the Common Terminology Criteria for Adverse Events (CTCAE). Toxicity will be evaluated in all treated patients, regardless of eligibility.

    TRIAL NUMBER: S1600

    Title: A Randomized Phase III Double-Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes

    Purpose: This randomized phase III trial studies how well nutrition therapy works in improving immune system in patients with bladder cancer that can be removed by surgery. Improving nutrition before and after surgery may reduce the infections and other problems that sometimes occur after surgery.

    TRIAL NUMBER: S1806

    Title: S1806: Phase III Randomized Trial of Concurrent Chemoradiotherapy with or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer

    Purpose: This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab.

    TRIAL NUMBER: A071401

    Title: PHASE II TRIAL OF SMO/AKT/NF2 INHIBITORS IN PROGRESSIVE MENINGIOMAS WITH SMO/AKT/NF2 MUTATIONS

    Purpose: Each arm is a prospective, one-stage phase 2 study evaluating the efficacy of smoothened receptor SMO or FAK inhibitors in patients with SMO-mutated or neurofibromin 2 (NF2)-mutated meningiomas, respectively. There will be a separate phase 2 arm for each of the two tumor mutation groups and each tumor grade cohort. Patients with recurrent or progressive Grade I-III meningiomas will be eligible for this trial. Samples will undergo central pathology review. Patient's tumor samples will be tested for the presence of SMO or NF2 mutations. Patients harboring SMO or NF2 mutations and who meet eligibility criteria will be enrolled. Within each arm, there will be two different patient cohorts based on histology: grade I versus II/III meningiomas.
    The primary and secondary objectives are described below.
    Primary objectives: 1.To determine the activity of a SMO inhibitor in patients with meningiomas harboring SMO mutations as measured by 6-month progression free survival (PFS) and response rate. 2.To determine the activity of a FAK inhibitor in patients with meningiomas harboring NF2 mutations as measured by 6-month PFS and response rate.
    Secondary objectives: 1.To determine overall survival and progression-free survival of SMO and FAK inhibitors in patients with meningioma. 2.To determine adverse event rates of SMO and FAK inhibitors in patients with meningioma.
    NOTE: Afuresertib, the agent identified for patients with AKT1 mutation is not currently available. Testing for the AKT1 mutation will commence once afuresertib becomes available and sites are notified via a protocol amendment. Tumor samples will only be tested for SMO and NF2 mutations until further notice.
    Patients will be followed for 2 years after completion of treatment.

    TRIAL NUMBER: A071701

    Title: Genomically-Guided Treatment Trial in Brain Metastases

    Purpose:

    Primary Outcome Measures :
    1. Objective response rate in the brain [ Time Frame: Up to 5 years ]
      Assessed per Response Assessment in Neuro-Oncology (RANO) criteria for brain metastases. The response rate is defined as the number of patients who have achieved complete response (CR) or partial response (PR) per RANO for brain metastases criteria during treatment with CDK, PI3K, or NTRK/ROS inhibitors divided by total number of evaluable patients. The response rate and associated exact confidence interval will be estimated within each cohort defined by the targeted agent and histology.


    Secondary Outcome Measures :
    1. Systemic response for extracranial disease [ Time Frame: Up to 5 years ]
      Assessed with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Will be estimated using the systemic response rate (SRR) - where SRR is defined as the number of evaluable patients achieving a response (PR or CR per RECIST 1.1) during treatment with study therapy divided by the total number of evaluable patients. Point estimates will be generated for systemic response rates within each cohort with corresponding 95% binomial confidence intervals.

    2. Clinical benefit rate for central nervous system (CNS) [ Time Frame: Up to 5 years ]
      Evaluated by Response Assessment in Neuro-Oncology (RANO) criteria. Will be estimated as the number of evaluable patients achieving stable disease (SD), partial response (PR), or complete response (CR) as their best objective response during treatment with protocol therapy divided by the total number of evaluable patients. Point estimates will be generated for clinical benefit rates within each cohort with corresponding 95% binomial confidence intervals.

    3. Clinical benefit rate for extracranial disease [ Time Frame: Up to 5 years ]
      Assessed by Response Evaluation Criteria in Solid Tumors (RECIST). Will be estimated as the number of evaluable patients achieving stable disease (SD), partial response (PR), or complete response (CR) as their best objective response (per RECIST for extracranial disease) during treatment with protocol therapy divided by the total number of evaluable patients. Point estimates will be generated for clinical benefit rates within each cohort with corresponding 95% binomial confidence intervals.

    4. Duration of response for brain metastases [ Time Frame: From the time measurement criteria are met for CR or PR for brain metastases until the first date that progressive CNS disease or death is documented, assessed up to 5 years ]
      Duration of response for brain metastases is defined for all evaluable patients who have achieved a confirmed response as the time from the date at which the patient's objective status for brain metastases is first noted to be a CR or PR (per Response Assessment in Neuro-Oncology [RANO] for brain metastases) to the date of the earliest progressive CNS disease is documented or death. The median and 95% confidence intervals will be estimated using the Kaplan-Meier estimator. No formal comparison will be made among the cohorts.

    5. Duration of response for extracranial disease [ Time Frame: From the time measurement criteria are met for CR or PR for extracranial disease until the first date that progressive disease for extracranial disease or death is documented, assessed up to 5 years ]
      Duration of response for extracranial disease is defined for all evaluable patients who have achieved a confirmed response as the time from the date at which the patient's objective status for extranial disease is first noted to be a CR or PR (per RECIST1.1) to the date of the earliest progression (PD) for extracranial disease is documented or death. The median and 95% confidence intervals will be estimated using the Kaplan-Meier estimator. No formal comparison will be made among the cohorts.

    6. Progression-free survival (PFS) - intracranial [ Time Frame: From first day of study treatment to the earliest date documentation of intracranial disease progression or death from any cause, assessed up to 5 years ]
      Intracranial PFS is defined as the time from the first day of study treatment to the earliest date of intracranial disease progression (per RANO for brain metastases) or death from any cause, whichever comes first. The median and 95% confidence intervals will be estimated using the Kaplan-Meier estimator. No formal comparison will be made among the cohorts.

    7. Progression-free survival (PFS) - extracranial [ Time Frame: From the first day of study treatment to the earliest date of documentation of extracranial disease progression or death from any cause, assessed up to 5 years ]
      Extracranial PFS is defined as the time from the first day of study treatment to the earliest date of extracranial disease progression (per RECIST1.1) or death from any cause, whichever comes first. The median and 95% confidence intervals will be estimated using the Kaplan-Meier estimator. No formal comparison will be made among the cohorts.

    8. Site of first progression [ Time Frame: Up to 24 months ]
      The site of first progression will be estimated descriptively within each cohort within 12 and 24 months after starting protocol treatment. The first progression is defined as the first documented central nervous system (CNS) progression per Response Assessment in Neuro-Oncology (RANO) or extracranial progression per Response Evaluation Criteria in Solid Tumors (RECIST), whichever occurs first. The percentage of extracranial progression at first progression within 12 and 24 months after starting protocol treatment will be estimated as number of patients who experience the first progression which is extracranial progression divided by number of patients who are still at risk up to 12 and 24 months, respectively.

    9. Overall survival [ Time Frame: From the first day of study treatment to death due to any cause, assessed up to 5 years ]
      Overall survival is defined as the time from the first day of study treatment to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. No formal comparison will be made among the cohorts.

    10. Incidence of adverse events [ Time Frame: Up to 5 years ]
      Assessed per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, toxicity is defined as adverse events that are classified as possibly, probably, or definitely related to study treatment. Toxicities will be evaluated via the ordinal CTCAE standard toxicity grading. Overall toxicity incidence as well as toxicity profiles by patient and treatment cohort will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of the analysis. No formal comparison will be made among the cohorts.

    TRIAL NUMBER: CG01 GBM

    Title: Standard Chemotherapy versus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients with Recurrent Glioblastoma Multiforme (GBM)

    Purpose:

    The purpose of this clinical study is to confirm the utility of chemosensitivity tumor testing on cancer stem cells (ChemoID) as a predictor of clinical response in poor prognosis malignant brain tumors such as recurrent glioblastoma (GBM).

    This study is designed as a parallel group randomized controlled clinical trial to determine if recurrent Glioblastoma (GBM) patients treated with drugs predicted by the ChemoID assay will have better outcomes than patients treated with standard-of-care control therapy chosen by the Physician.

    Upon obtaining informed consent, all eligible participants affected by recurrent GBM will have a tumor biopsy to undergo ChemoID drug response testing with multiple FDA-approved chemotherapeutic agents.

    Eligible participants will be randomized to a standard treatment arm with control treatment (chemotherapy chosen by the Physician from a provided list), or to a study arm of FDA-approved drugs selected by the ChemoID drug response assay.

    TRIAL NUMBER: N0577

    Title: N0577 (CODEL): Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

    Purpose: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.

    TRIAL NUMBER: NRG-BN003

    Title: PHASE III TRIAL OF OBSERVATION VERSUS IRRADIATION FOR A GROSS TOTALLY RESECTED GRADE II MENINGIOMA

    Purpose: Primary Outcome Measures: Progression-Free Survival (PFS) [ Time Frame: From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed up to 10 years. ] Kaplan-Meier method will be used to calculate the PFS rates for each of the two arms (Kaplan 1958). Hazard ratio (HR) on the treatment effect will be calculated using the Cox proportional hazard model (Cox 1972). A one-sided log-rank test will be used to test the difference in PFS between the two arms (Peto 1972).

    Secondary Outcome Measures: Overall Survival (OS) [ Time Frame: From randomization to death due to any cause, assessed up to 10 years ] Kaplan-Meier method will be used to calculate the OS rates for each of the two arms (Kaplan 1958). Hazard ratio (HR) on the treatment effect will be calculated using the Cox proportional hazard model (Cox 1972). A one-sided log-rank test will be used to test the difference in OS between the two arms (Peto 1972). Cox proportional hazard model will be used to determine the adjusted treatment effect on OS, with patient pretreatment characteristics as covariates.
    5 Year Overall Survival (OS) [ Time Frame: At 5 years after randomization ] Will be calculated based on the Kaplan-Meier curve.
    Disease-Specific Survival (DSS) [ Time Frame: From randomization to disease-related death, assessed up to 10 years ] Will be calculated using the cumulative incidence function for each arm. The HR for the treatment effect on DSS will be calculated using Gray's method under the competing risk approach, with death due to non-disease related cause treated as the competing risk (Gray 1988). Multivariate analysis on DSS will be performed using the Fine-Gray model, with patient pretreatment characteristics as covariates (Fine 1999).
    3 Year Disease-Specific Survival (DSS) [ Time Frame: At 3 years after randomization ] Will be calculated using the cumulative incidence function for each arm.
    5 Year Disease-Specific Survival (DSS) [ Time Frame: At 5 years after randomization ] Will be calculated using the cumulative incidence function for each arm.
    3 Year Progression-Free Survival (PFS) [ Time Frame: From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed at 3 years after randomization. ] Will be calculated based on the Kaplan-Meier curve.
    5 Year Progression-Free Survival (PFS) [ Time Frame: From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed up to 5 years after randomization. ] Will be calculated based on the Kaplan-Meier curve.
    Neurocognitive Function (NCF) [ Time Frame: Baseline up to 60 months after randomization ] Longitudinal analysis will be performed to compare NCF over time between the 2 arms, using the NCF Clinical Trial Battery (CTB) composite score. Early change from baseline in CTB composite score will be evaluated and compared between the 2 arms using 2-sample t tests.
    Patient Reported Outcomes (PRO) as assessed by MDASI-BT [ Time Frame: Baseline up to 60 months after randomization ] Longitudinal analysis will be performed to compare symptom burden over time between the 2 arms, using the MDASI-BT. Early change from baseline in symptom burden will be evaluated and compared between the 2 arms using 2-sample t tests.
    Assessment of pHH3 mitotic index [ Time Frame: Up to 10 years after randomization ] The Kaplan-Meier method will be used to estimate the PFS and OS rates by pHH3 category. The HRs on the effect of pHH3 on PFS and OS, respectively will be calculated using the Cox proportional hazard model and will be tested using the log-rank test. Multivariate analyses will be conducted with patient pretreatment characteristics, such as age and Simpson resection grade, included as covariates.
    Incidence of adverse events as measured by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4 (exclusive of alopecia) [ Time Frame: Up to 3 years after randomization ] The number of adverse events will be measured using the CTCAE, version 4

    Estimated Enrollment: 148 Actual Study Start Date: June 14, 2017 Estimated Study Completion Date: August 31, 2027 Estimated Primary Completion Date: June 15, 2027 (Final data collection date for primary outcome measure)

    TRIAL NUMBER: NRG-BN005

    Title: A Phase II Randomized Trial of Proton Vs. Photon Therapy (IMRT) for Cognitive Preservation in Patients With IDH Mutant, Low to Intermediate Grade Gliomas

    Purpose: This randomized phase II clinical trial studies the side effects and how well proton beam or intensity-modulated radiation therapy works in preserving brain function in patients with IDH mutant grade II or III glioma. Proton beam radiation therapy uses tiny charged particles to deliver radiation directly to the tumor and may cause less damage to normal tissue. Intensity-modulated or photon beam radiation therapy uses high-energy x-ray beams shaped to treat the tumor and may also cause less damage to normal tissue. Patients will be more likely to be randomized to proton beam radiation therapy. It is not yet known if proton beam radiation therapy is more effective than photon-based beam intensity-modulated radiation therapy in treating patients with glioma.

    TRIAL NUMBER: NRG-BN007

    Title: A RANDOMIZED PHASE II/III OPEN-LABEL STUDY OF IPILIMUMAB AND NIVOLUMAB VERSUS TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MGMT (TUMOR O-6-METHYLGUANINE DNA METHYLTRANSFERASE) UNMETHYLATED GLIOBLASTOMA

    Purpose:

    Primary Outcome Measures :
    1. Progression-free survival (PFS) (Phase II) [ Time Frame: From randomization to disease progress or death, assessed up to 4 years ]
      Analysis will be performed on the intent-to-treat basis. PFS distributions for each treatment group will be estimated via the Kaplan-Meier survival function. Will utilize the "PFS resolution" guidance provided in the ALLIANCE A071102 (NCT02152982) study, the updated Response Assessment in Neuro-Oncology Criteria (RANO) criteria.

    2. Overall survival (OS) (Phase III) [ Time Frame: From randomization to death from any cause, assessed up to 4 years ]
      Analysis will be performed on the intent-to-treat basis. Overall survival distributions for each treatment group will be estimated via the Kaplan-Meier survival function.


    Secondary Outcome Measures :
    1. PFS for the entire cohort (Phase II/III) [ Time Frame: Up to 4 years ]
      PFS curves will be estimated via the Kaplan-Meier method and a stratified log-rank test.

    2. OS proportion [ Time Frame: At 2 years ]
      2-year OS will be compared between treatment arms, to determine whether the proportion surviving to this landmark is increased in the experimental (ipilimumab [ipi] + nivolumab [nivo]) arm. Estimates will be obtained from the Kaplan Meier curves, and a test comparing the proportion surviving with an appropriate variance term that accounts for censoring (Greenwood's formula) will be used.

    3. Comparative frequency of specific adverse events of interest [ Time Frame: Up to 4 years ]
      Adverse events (AEs) will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 and Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE).

    4. Frequency summaries for all adverse event types [ Time Frame: Up to 4 years ]
      Adverse events will be graded according to CTCAE v5.0 and PRO-CTCAE. Comprehensive summaries of all AEs by treatment arm will be generated and examined. Counts and frequencies of worst (highest score) AE per patient will be presented overall and by AE type category, separately by assigned treatment group. Complementing physician-assessed AEs will be selected PRO-CTCAE symptom items that have demonstrated sensitivity to immunotherapy-related toxicities but do not overlap with MDASI-BT. The following PRO-CTCAE symptom items will be monitored: rash, itching, muscle pain, joint pain, headache, chills, mouth/throat sores, skin dryness, hair loss, cough, taste changes, dizziness, swelling, hot flashes.

    5. Patient reported symptom burden [ Time Frame: Up to 4 years ]
      Will be assessed using the MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)-modified. The MDASI-BT consists of 23 symptoms rated on an 11-point ordinal scale (0 to 10) to indicate the presence and severity of the symptom in the last 24 hours, with 0 being "not present" and 10 being "as bad as you can imagine." These interference items include: general activity, mood, work (includes both work outside the home and housework), relations with other people, walking, and enjoyment of life. Complementing MDASI-BT will be selected PRO-CTCAE symptom items that have demonstrated sensitivity to immunotherapy-related toxicities but do not overlap with MDASI-BT.

    6. Neurocognitive function (NCF) [ Time Frame: Up to 4 years ]
    7. Patient-reported toxicity outcomes [ Time Frame: Up to 4 years ]
      Will utilize the PRO-CTCAE to assess the following items: abdominal pain, rash, itching, muscle pain, joint pain, pain and swelling at injection site, headache, chills, mouth/throat sores, skin dryness, hair loss, cough, taste changes, dizziness, swelling, and hot flashes.


    Other Outcome Measures:
    1. OS (if the study discontinues in phase II) [ Time Frame: At the end of phase II of study ]
    2. Tumor biomarker analyses [ Time Frame: Up to 4 years ]
      Will assess PD-L1 expression and mutational burden expression specifically.

    3. MGMT protein expression [ Time Frame: Up to 4 years ]
      Will assess the prognostic value of MGMT protein expression (in terms of predicting clinical outcomes such as PFS, OS, and 2-year OS rate) in the two treatment arms, separately. In addition, will evaluate if MGMT protein expression may be predictive of differential treatment effects between the two treatment arms. Correlation methods and survival modeling will be used to address these questions

    TRIAL NUMBER: WF-1801

    Title: A Single Arm, Pilot Study of Ramipril for Preventing Radiation-Induced Cognitive Decline in Glioblastoma (GBM) Patients Receiving Brain Radiotherapy

    Purpose: This study is to determine if an oral drug called Ramipril can lower the chance of memory loss in patients with glioblastoma getting chemoradiation. Patients will take Ramipril during chemoradiation and continue until 4 months post-treatment. Memory loss will be assessed using several neurocognitive tests throughout the duration of the study.

    TRIAL NUMBER: A011202

    Title: A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (CT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy

    Purpose: Study Outline: All patients will undergo surgery to identify sentinel lymph node(s). If a lymph node (sentinel or non-sentinel) is determined to be positive on intra-operative pathology the patient will be registered/randomized intra-operatively. Patients who do not have a sentinel lymph node identified will not be registered/randomized to the study. Patients whose sentinel lymph node status is cannot be/is not determined intra- operatively, and have not undergone ALND, but had at least one lymph node (sentinel or non-sentinel) found to be positive on final pathology review will be registered/randomized post-operatively. Patients whose sentinel lymph node status is found to be negative intra-operatively and have not undergone ALND, but had at least one lymph node (sentinel or non-sentinel) found to be positive on final pathology review will be registered/randomized post-operatively. ALND is not to be performed prior to registration/randomization. Patients who are determined to have negative lymph nodes on final pathology will not be registered/randomized, but can be offered participation in another cooperative group trial. The primary and secondary objectives of the study are described below. Please see the "Arms" section for a detailed description of the treatment regimens. Primary Objective: To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive SLN(s) after completion of neoadjuvant chemotherapy Secondary Objectives: To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of the incidence of invasive loco-regional recurrences in patients with a positive SLN(s) after completion of neoadjuvant chemotherapy To obtain an estimate of the distribution of residual disease burden scores for each treatment arm To estimate the distribution of overall survival for each treatment arm Patients may receive adjuvant and ancillary therapy as appropriate per the protocol. Adjuvant Therapy: Adjuvant endocrine therapy: Patients with hormone receptor (ER and/or PR) positive disease should receive a minimum of 5 years of standard endocrine therapy (experimental agents/regimens are not permitted). Endocrine therapy should begin following completion of neoadjuvant chemotherapy and surgery, either before, during or after radiation therapy at the discretion of the oncologist. Selection of the agents is at the treating physician's discretion. Patients with HER 2 positive disease should complete a total of one year of trastuzumab therapy (over the neoadjuvant and adjuvant period). Chemotherapy, biologic therapy or vaccine therapy in the adjuvant setting is not allowed. Patients who wish to receive any of these therapies after surgery must go off study at the time of their initiation. Ancillary Therapy: Patients should receive full supportive care, including transfusions of blood and blood products, erythropoetin (unless otherwise specified in the protocol), antibiotics, antiemetics, etc. when appropriate. Patients are followed up for 5 years after completion of radiation therapy.

    TRIAL NUMBER: A011801

    Title: T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial

    Purpose: This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.

    TRIAL NUMBER: A211601

    Title: EVALUATION OF MAMMOGRAPHIC BREAST DENSITY EFFECT OF ASPIRIN: A COMPANION STUDY TO ALLIANCE STUDY A011502

    Purpose: Primary Outcome Measures : Mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms [ Time Frame: At 1 year post-registration to A011502 ] The 1-year mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms will be compared. Analysis of covariance (ANCOVA) adjusting for baseline MPD will be used to compare MPD at 1 year between the arms. After adjusting for the baseline MPD, it will be concluded that the 1-year MPD is statistically different between the two arms if the corresponding two-sided p-value is less than 0.05. If normality of the primary variable is questionable, then variable transformation or nonparametric Wilcoxon rank-sum test on simple change MPD values may be considered as alternative approaches. A subsequent exploratory analysis will include all patients with an MPD computed at baseline (regardless of that baseline value) and at 1-year post-baseline.

    Secondary Outcome Measures : Mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms [ Time Frame: At 2 years post-registration to A011502 ] The 2-year mammographic breast density in the contralateral (unaffected) breast between the two arms for those patients with a baseline mammographic percent density (MPD) >= 25% and a 2-year post-baseline MPD will be compared. ANCOVA will be used to compare MPD between the arms. The corresponding test for the between-arm difference in MPD at 2-years will also be carried out at the 0.05 significance level.

    TRIAL NUMBER: CCTG-MA.39

    Title: TAILOR RT: A RANDOMIZED TRIAL OF REGIONAL RADIOTHERAPY IN BIOMARKER LOW RISK NODE POSITIVE BREAST CANCER

    Purpose: The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.
    Women with node positive breast cancer normally will receive endocrine therapy and some may receive chemotherapy to help prevent the cancer from coming back. Many women will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). No one really knows whether patients with low risk breast cancer need to receive regional radiotherapy. Some women may be getting regional radiotherapy who do not need it. These women may be exposed to the side effects of their treatment without benefit.

    TRIAL NUMBER: EA1151

    Title: Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer

    Purpose: This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.

    TRIAL NUMBER: EA1181

    Title: CompassHER2-pCR: PREOPERATIVE THP AND POSTOPERATIVE HP IN PATIENTS WHO ACHIEVE A PATHOLOGIC COMPLETE RESPONSE PART 1 COMPONENT OF: THE CompassHER2 TRIALS (COMPREHENSIVE USE OF PATHOLOGIC RESPONSE ASSESSMENT TO OPTIMIZE THERAPY IN HER2-POSITIVE BREAST CANCER)

    Purpose:

    Primary Outcome Measures :
    1. Recurrence-free survival (RFS) [ Time Frame: Up to 3 years after end of treatment ]
      Events include recurrence of ipsilateral invasive breast tumor, recurrence of locoregional invasive breast tumor, and distant recurrence. Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and estrogen receptor (ER) status. Greenwood method will be used to estimate the 95% confidence interval for 3-year rate.


    Secondary Outcome Measures :
    1. Invasive disease-free survival (IDFS) [ Time Frame: Up to 3 years after the end of treatment ]
      Events include recurrence of ipsilateral invasive breast tumor, recurrence of locoregional invasive breast tumor, distant recurrence, contralateral invasive breast cancer, and second primary non-breast invasive cancer (other than squamous or basal cell skin cancer). Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and ER status. The analysis will be descriptive and there will be no statistical test.

    2. Distant disease-free survival (DDFS) [ Time Frame: Up to 3 years after the end of treatment ]
      Events include distant recurrence and second primary non-breast invasive cancer (other than squamous or basal cell skin cancer). Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and ER status. The analysis will be descriptive and there will be no statistical test.

    3. Distant relapse-free survival (DRFS) [ Time Frame: U to 3 years after the end of treatment ]
      Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and ER status. The analysis will be descriptive and there will be no statistical test.

    4. Recurrence-free interval (RFI) [ Time Frame: Up to 3 years after the end of treatment ]
      Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and ER status. The analysis will be descriptive and there will be no statistical test.

    5. Overall survival (OS) [ Time Frame: From date of surgery until the date of death from any cause, assessed up to 3 years after the end of treatment ]
      Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and ER status. The analysis will be descriptive and there will be no statistical test.

    6. Event-free survival (EFS) [ Time Frame: Up to 3 years after the end of treatment ]
      Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and ER status. The analysis will be descriptive and there will be no statistical test.

    7. Incidence of adverse events (AEs) [ Time Frame: Up to 1 week after cycle 4 (all patients) and/or up to cycle 13 post-surgery (Arm A only) (each cycle is 21 days) ]
      Will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. All treatment-emergent and baseline adverse events and hematological/biochemical toxicities based on laboratory measurements, as well as drug related AEs, will be summarized by NCI CTCAE v5.0 worst grade. The incidence of deaths and treatment-emergent serious adverse events (defined as number of patients experiencing the AE divided by all treated patients) will be summarized using binominal proportions and binomial exact 95% confidence intervals. The incidence of adverse events leading to discontinuation of protocol therapy will be summarized and listed as well.

    TRIAL NUMBER: NRG-BR003

    Title: A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel With or Without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

    Purpose: This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.

    TRIAL NUMBER: NRG-BR007

    Title: NRG-BR007: A PHASE III CLINICAL TRIAL EVALUATING DE-ESCALATION OF BREAST RADIATION FOR CONSERVATIVE TREATMENT OF STAGE I, HORMONE SENSITIVE, HER2-NEGATIVE, ONCOTYPE RECURRENCE SCORE ? 18 BREAST CANCER (DEBRA*) * DE-escalation of Breast RAdiation (DEBRA)

    Purpose:

    Primary Outcome Measures :
    1. Time to invasive or noninvasive IBTR. [ Time Frame: 5 years ]
      Time from randomization to any invasive or noninvasive IBTR or last follow-up (expressed as % IBTR-free)


    Secondary Outcome Measures :
    1. Percent of women with an intact index breast at report of the primary endpoint inclusive of salvage second breast conservation procedures. [ Time Frame: Through study completion, an average of 15 years. ]
      Time from randomization to any breast procedure after the initial surgery or last follow-up (expressed as % with intact index breast)

    2. Time from randomization to the first occurrence of invasive ipsilateral breast tumor recurrence. [ Time Frame: 5 years ]
      Time from randomization to any invasive IBTR or last follow-up (expressed as percentage of invasive IBTR-free

    3. Time from randomization to diagnosis of a local, regional or distant recurrence as a first cancer event. [ Time Frame: 5 years ]
      Time from randomization to any breast cancer recurrence at a local, regional or distant site or last follow-up (expressed as percentage of recurrence-free)

    4. Time from randomization to the first distant cancer event (either a recurrence or a secondary primary cancer). [ Time Frame: 5 years ]
      Time from randomization to any cancer occurring at a distant site or last follow-up (expressed as percentage of distant disease-free)

    5. Time from randomization to any death. [ Time Frame: 5 years ]
      Time from randomization to any death or last follow-up (expressed as percent surviving)

    TRIAL NUMBER: S1703

    Title: S1703; Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored with Serum Tumor Marker Directed Disease Monitoring (STMDDM) versus Usual Care in Patients with Metastatic Hormone Receptor Positive Breast Cancer

    Purpose: To assess whether patients with HER-2 negative, hormone receptor positive, metastatic breast cancer who are monitored with serum tumor marker directed disease monitoring (STMDDM) have non-inferior overall survival compared to patients monitored with usual care.

    TRIAL NUMBER: S1706

    Title: A PHASE II RANDOMIZED TRIAL OF OLAPARIB (NSC-747856) ADMINISTERED CONCURRENTLY WITH RADIOTHERAPY VERSUS RADIOTHERAPY ALONE FOR INFLAMMATORY BREAST CANCER

    Purpose: Primary Outcome Measures : Invasive Disease-Free Survival (IDFS) [ Time Frame: Up to 8 years ] Time from date of registration to date of first invasive recurrence (local, regional or distant), second invasive primary cancer (breast or not), or death due to any cause. Patients last known to be alive who have not experienced recurrence or second primary cancer are censored at their last contact date. Analysis will be on an intent-to-treat basis and will estimate the survival endpoints using the product-limit method of Kaplan and Meier and will compare the time-to-event distributions using log-rank test statistics. Hazard ratios will be calculated from Cox regression analyses. Effect modification by the stratification variables will be tested as interactions with treatment and separate hazard ratios with 95% confidence intervals by major subgroups will be displayed in a forest plot to examine for consistency of the treatment effect over these subgroups. Secondary Outcome Measures : Locoregional Recurrence-Free Interval (Local Disease-Free Interval (LDFI)) [ Time Frame: Up to 8 years ] Time from date of registration to date of invasive local or regional recurrence. Patients last known to be alive without recurrence are censored at their last contact date. Patients with distant recurrence, second primary cancer or death are censored at the time of that event. A competing risk framework will be conducted separating out the event types of locoregional recurrence from distant recurrence and death. Hazard ratios will be calculated from Cox regression analyses. Effect modification by the stratification variables will be tested as interactions with treatment and separate hazard ratios with 95% confidence intervals by major subgroups will be displayed in a forest plot to examine for consistency of the treatment effect over these subgroups. Distant Relapse-Free Survival (Distant Recurrence-Free Survival) [ Time Frame: Up to 8 years ] Time from date of registration to date of invasive distant disease recurrence, second invasive primary cancer (breast or not) or death due to any cause. Patients last known to be alive who have not experienced disease recurrence, or second primary cancer are censored at their last contact date. Overall Survival [ Time Frame: Up to 8 years ] Time from date of registration to date of death due to any cause. Patients last known to be alive are censored at their last contact date.

    TRIAL NUMBER: DCP-001

    Title: DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)

    Purpose: The protocol is not a scientific study; rather, a method to implement the screening tool and allow the collection and analyses of expanded data with informed consent. Investigators also enroll patients into NCI-treatment trials. The tool, based on a screening log successfully used within the NCI Community Cancer Centers Program (NCCCP), has been streamlined and integrated into the sites’ workflow by using OPEN. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. Also missing from the existing data is the context of care, within the communities themselves where most cancer and at risk of cancer patients receive care which is the focus of NCORP. The profile of patients accrued to NCI-sponsored clinical trials lacks both racial/ethnic and socioeconomic diversity. Accrued patients tend to be insured, highly educated and of higher socioeconomic means. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. NCORP's clinical trials portfolio includes cancer control, prevention, screening, symptom science, and cancer care delivery research.

    TRIAL NUMBER: DCP-002

    Title: DCP-002 Early Onset Malignancies Initiative (EOMI): Molecular profiling of Breast, Prostate, Colorectal, Liver, Kidney, and Multiple Myeloma among Racially and Ethnically Diverse Populations

    Purpose: The primary objective of the EOMI (Early Onset Malignancy Initiative) is to acquire tissue and blood, and other biospecimens for research purposes from tests performed for clinical care or for research indications on other research protocols to accelerate our understanding of the molecular basis of early onset cancers occurring in racial and/or ethnic minority populations through the application of genome analysis technologies, including large-scale genome sequencing and clinical data analysis.

    TRIAL NUMBER: A021502

    Title: Randomized Trial of Standard Chemotherapy Alone or Combined With Atezolizumab as Adjuvant Therapy for Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair

    Purpose: This randomized phase III trial studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy with atezolizumab may work better than combination chemotherapy alone in treating patients with colon cancer.

    TRIAL NUMBER: NRG-GI005

    Title: PHASE II/III STUDY OF CIRCULATING TUMOR DNA AS A PREDICTIVE BIOMARKER IN ADJUVANT CHEMOTHERAPY IN PATIENTS WITH STAGE IIA COLON CANCER (COBRA)

    Purpose:

    1.1 Primary Objectives

    1.1.1 Primary Objectives Phase II

    To compare the rate of ctDNA clearance in the ?ctDNA detected? patients treated with or without adjuvant chemotherapy following resection of stage IIA colon cancer.

    1.1.2 Primary Objective Phase III

    To compare recurrence-free survival (RFS) in ?ctDNA detected? patients treated with or without adjuvant chemotherapy following resection of state IIA colon cancer.

    1.2 Secondary Objectives

    1.2.1 To describe the prevalence of detectable ctDNA in patients with stage IIA colon cancer following surgical resection.

    1.2.2 To estimate time-to-event outcomes (overall survival [OS], recurrence-free survival {RFS], and time to recurrence [TTR] by ctDNA marker status and treatment for patients with resected stage IIA colon cancer.

    1.2.3 To estimate the rate of compliance with adjuvant chemotherapy and/or active surveillance for patients with resected stage IIA colon cancer.

    1.3 Exploratory Objectives

    1.3.1 To describe the association of quantitative ctDNA levels with time to event outcomes {RFS, OS, and TTR).

    1.3.2 To characterize genomics profiles associate with recurrence using a ctDNA assay in patients with resected stage IIA colon cancer.

    1.3.3 To model the cost effectiveness of the use of ctDNA versus standard of care in this setting.

    1.3.4 To evaluate performance of a ctDNA assay after incorporation of patient tumor and peripheral blood mononuclear cells.

    TRIAL NUMBER: NRG-GI008

    Title: Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease

    Purpose:
    This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

    TRIAL NUMBER: S2012

    Title: Randomized Phase II/III Trial of First Line Platinum/Etoposide With or Without Atezolizumab (NSC#783608) in Patients With Poorly Differentiated Extrapulmonary Small Cell Neuroendocrine Carcinomas (NEC)

    Purpose: This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) small cell neuroendocrine cancer. The other aim of this trial is to compare using atezolizumab just at the beginning of treatment versus continuing it beyond the initial treatment. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin and carboplatin are in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. Giving atezolizumab in combination with a platinum drug (cisplatin or carboplatin) and etoposide may work better in treating patients with poorly differentiated extrapulmonary small cell neuroendocrine cancer compared to standard therapy with a platinum drug (cisplatin or carboplatin) and etoposide alone.

    TRIAL NUMBER: S1823

    Title: A PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS miRNA 371 FOR OUTCOME PREDICTION IN PATIENTS WITH NEWLY DIAGNOSED GERM CELL TUMORS

    Purpose:

    Primary Outcome Measures :
    1. Relapse rate of active germ cell malignancy for those undergoing active surveillance of clinical stage I (CSI)/stage IIA germ cell malignancy [ Time Frame: Up to 3 years ]
    2. Positive predictive value [ Time Frame: Up to 3 years ]

    Biospecimen Retention:   Samples With DNA
    Blood

    TRIAL NUMBER: NRG-GY006

    Title: A Randomized Phase II Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer

    Purpose: This randomized phase II trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal cancer.

    TRIAL NUMBER: NRG-GY018

    Title: A PHASE III RANDOMIZED, PLACEBO-CONTROLLED STUDY OF PEMBROLIZUMAB (MK-3475, NSC #776864) IN ADDITION TO PACLITAXEL AND CARBOPLATIN FOR MEASURABLE STAGE III OR IVA, STAGE IVB OR RECURRENT ENDOMETRIAL CANCER

    Purpose:

    Primary Outcome Measures :
    1. Progression-free survival (PFS) [ Time Frame: Duration of time from study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 5 years ]
      Will be tested with a stratified log-rank statistic.


    Secondary Outcome Measures :
    1. Incidence of adverse events [ Time Frame: 5 years ]
      Assessed by Common Terminology Criteria for Adverse Events (CTCAE). Toxicities will be screened for differences between treatments by using an exact method or a Chi-Square test. For a given adverse event, each patient will be graded according to the worse grade experienced while on therapy (and within 30 days of treatment). These toxicities will then be divided into two or three categories such as mild, moderate, and severe or mild to moderate versus severe. The rates of severe toxicities may be characterized by risk ratios or odds ratios with confidence intervals (unadjusted for multiplicity). The number of toxicities examined is usually fairly large, so these analyses will be considered exploratory and may be inspected in light of other studies.

    2. Objective tumor response [ Time Frame: 5 years ]
      Assessed by Response Evaluation Criteria for Solid Tumors (RECIST) 1.1.

    3. Duration of objective response [ Time Frame: 5 years ]
      The time difference between the dates of first response and first progression; patients who do not progress are considered censored.

    4. Overall survival (OS) [ Time Frame: Time from study entry to time of death or the date of last contact, assessed up to 5 years ]
    5. Quality of life (QoL) and patient-reported outcomes (PROs) [ Time Frame: 5 years ]
      Measured by the Function Assessment of Cancer Therapy (FACT)-Endometrial Trial Outcome Index (En-TOI), the FACT/Gynecologic Oncology Group (GOG)-Neurotoxicity (Ntx) subscale (short), Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue (short form),the PROMIS-physical function (short form) and a single-item measuring bother from side effects of cancer therapy. A linear mixed model for repeated measures will be used to estimate and compare the mean differences between the treatment groups. Model covariates will include the patients' randomly assigned study treatment, age at enrollment onto the study, pre-treatment quality of life/patient reported outcome score, assessment time and treatment-by-time interaction. The stratification factors will be the same factors included in the clinical primary analysis. Hochberg's step-up multiple testing procedure (Hochberg, 1988) will be used to adjust p-values for each assessment time points estimated from the fitted model.

    6. Incidence of pembrolizumab treatment and self-reported neurotoxicity [ Time Frame: 5 years ]
      Assessed with FACT/GOG-Ntx.

    7. Concordance between Institutional Mismatch repair (MMR) immunohistochemistry (IHC) testing and centralized MMR IHC [ Time Frame: 5 years ]
      Concordance between institutional MMR IHC testing and centralized MMR IHC. The patient's MMR status will be assessed for prognostic value by conducting stratified log-rank tests or Cox Proportional Hazards (PH) modeling when assessing the impact on PFS or OS. When assessing the impact on the probability of response, a logistic regression model will be considered and include other pertinent variables that may influence response. A Cox PH model will be used to assess predictive value of MMR status for regimen efficacy through an interaction term. A similar type of analysis may be attempted with response using logistic regression. The concordance of institutional MMR IHC testing and centralized MMR IHC will be characterized by agreement statistics such as kappa statistics (e.g. Cohen's kappa coefficient).

    8. Effect of pembrolizumab on PFS and OS by PD-L1 IHC [ Time Frame: 5 years ]
      Will assess the effect of pembrolizumab on PFS and OS by PD-L1 IHC (combined positive score [CPS]) within proficient MMR (pMMR) and deficient MMR (dMMR) populations. The effectiveness of pembrolizumab will be compared by PD-L1 status (CPS). A formal test will be conducted by examining the interaction term between pembrolizumab treatment (yes or no) with PD-L1 status. The association between PD-L1 CPS status and MMR status will be assessed with odds ratios. A test may be conducted with a Fisher's Exact Test, and confidence intervals will be provided.

    9. Association between Program Death Ligand 1 (PD-L1) IHC and MMR status [ Time Frame: 5 years ]
      Measures of association between PD-L1 IHC (CPS) and MMR status. The concordance of institutional MMR IHC testing and centralized MMR IHC will be characterized by agreement statistics such as kappa statistics (e.g. Cohen's kappa coefficient).

    TRIAL NUMBER: NRG-GY019

    Title: A RANDOMIZED PHASE III, TWO-ARM TRIAL OF PACLITAXEL/CARBOPLATIN/MAINTENANCE LETROZOLE VERSUS LETROZOLE MONOTHERAPY IN PATIENTS WITH STAGE II-IV, PRIMARY LOW-GRADE SEROUS CARCINOMA OF THE OVARY OR PERITONEUM

    Purpose:

    Primary Outcome Measures :
    1. Progression-free survival (PFS) [ Time Frame: Time from the randomized treatment assignment to documentation of disease progression (Response Evaluation Criteria in Solid Tumors 1.1) or death from any cause, whichever comes first, assessed up to 8 years ]
      The PFS comparison will be assessed at the second interim and final analyses using a logrank test stratified by country and residual disease status. Estimates for the letrozole/letrozole (L/L) vs paclitaxel/carboplatin/letrozole (CT/L) hazard ratio and its confidence interval will be obtained using a stratified Cox proportional hazards model. Potential confounding factors, including the stratification factors, performance status and self-declared racial designation will be considered in a final exploratory model. A forest plot of treatment hazard ratios with confidence intervals within subgroups will also be reported. PFS will be characterized by treatment group with Kaplan-Meier plots and estimates of the median PFS.


    Secondary Outcome Measures :
    1. Incidence of adverse events (AE) [ Time Frame: Up to 8 years ]
      The nature, frequency and degree of toxicity will be tabulated at the System Organ Class and AE Term levels using Common Terminology Criteria for Adverse Events version 5.0. Each patient will be represented according the maximum grade observed for each term, within randomized treatment assignment. Tabulations will show the number and percentage of patients by maximum grade, within their randomized treatment assignment.

    2. Objective response rate (ORR) [ Time Frame: Up to 8 years ]
      Will be estimated as the binomial proportion of patients with best overall response of complete response (CR) or partial response (PR) among patients with measurable disease after cytoreductive surgery. Response rates and their 95% Wilson-Score confidence intervals will be estimated for each treatment arm, using the randomized treatment assignment. The odds-ratio for ORR in the L/L vs CT/L arms will be estimated from the multivariable logistic regression model adjusted for stratification factors.

    3. Duration of response [ Time Frame: Time from documentation of response under documentation of progression or death, which is observed first, assessed up to 8 years ]
      Will be defined among patients with best overall response of CR or PR. Comparison of response duration between the randomized treatment arms will be supported by Kaplan Meier methods, and the corresponding estimates for median duration and its 95% confidence intervals.

    4. Overall survival (OS) [ Time Frame: Time between randomization and death from any cause, assessed up to 8 years ]
      Differences in OS across the randomized treatment groups will be assessed using Kaplan Meier methods, with median time to death estimates and the corresponding 95% confidence intervals. The L/L vs CT/L hazard ratio will be estimated by a proportional hazards model stratified by the randomization stratification factors.

    5. Adherence to letrozole maintenance therapy [ Time Frame: At cycles 1, 6, and 12 ]
      Will be quantified as the mean rate of adherence (MRA), calculated as the proportion of product not returned divided by the number of days since the previous visit at which study products were dispensed. Currently, the letrozole is delivered in a 2.5 mg pill, and the recommended dose is 2.5 mg per day. This outcome will be computed for each treatment cycle (generally 21 days). The mean MRA will be compared between the randomized treatment groups using linear mixed model methods. The model will be specified with a random patient effect, and fixed effects for randomized treatment indicator, time (cycle number) and the interaction, with an adjustment for the protocol stratification factors. Primary interest is in the difference in mean (MRA) at cycles 1, 6 and 12 between the treatment group. The results will be reported as the estimated mean (MRA) and 95% confidence intervals for each treatment/time combination. Treatment differences within stratification factors may also be considered.

    TRIAL NUMBER: NRG-GY020

    Title: A Phase III Randomized Trial of Radiation +/- MK-3475 (Pembrolizumab) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer

    Purpose: This phase III trial compares whether the addition of pembrolizumab to radiation therapy is more effective than radiation therapy alone in reducing the risk of cancer coming back (recurrence) in patients with newly diagnosed stage I-II endometrial cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The addition of pembrolizumab to radiation treatment may be more effective than radiation treatment alone in reducing cancer recurrence.

    TRIAL NUMBER: NRG-GY023

    Title: A Randomized Phase II Trial of Triplet Therapy (a PD-L1 Inhibitor (Durvalumab) MEDI4736 in Combination With Olaparib and Cediranib) Compared to Olaparib and Cediranib or (Durvalumab) MEDI4736 and Cediranib or Standard of Care Chemotherapy in Women With Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Primary Peritoneal or Fallopian Cancer Who Have Received Prior Bevacizumab

    Purpose: This phase II trial studies the possible benefits of treatment with different combinations of the drugs durvalumab, olaparib and cediranib vs. the usual treatment in patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of improvement with platinum therapy (recurrent platinum resistant). Usual treatment is the type of treatment most patients with this condition receive if they are not part of a clinical study. Combination therapies studied in this trial include MEDI4736 (durvalumab) plus olaparib and cediranib, durvalumab and cediranib, or olaparib and cediranib. Monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumors cells to grow and spread. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Cediranib may stop the growth of tumor cells by blocking VEGF (an enzyme). needed for cell growth. Giving different combinations of durvalumab, olaparib and cediranib may work better in increasing the duration of time that the cancer does not progress compared to the usual treatment.

    TRIAL NUMBER: A041701

    Title: A Randomized Phase II/III Study of Conventional Chemotherapy +/- Uproleselan (GMI-1271) in Older Adults With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy

    Purpose: This phase II/III trial studies how well daunorubicin and cytarabine with or without uproleselan works in treating older adult patients with acute myeloid leukemia receiving intensive induction chemotherapy. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Uproleselan may prevent cancer from returning or getting worse. Giving daunorubicin and cytarabine with uproleselan may work better in treating patients with acute myeloid leukemia compared to daunorubicin and cytarabine alone.

    TRIAL NUMBER: EA3132

    Title: EA3132:Phase II Randomized Trial of Radiotherapy with or Without Cisplatin for Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) with TP53 Sequencing

    Purpose: This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known if radiation therapy is more effective with or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.

    TRIAL NUMBER: NRG-HN005

    Title: A RANDOMIZED PHASE II/III TRIAL OF DE-INTENSIFIED RADIATION THERAPY FOR PATIENTS WITH EARLY-STAGE, P16-POSITIVE, NON-SMOKING ASSOCIATED OROPHARYNGEAL CANCER

    Purpose:

    Primary Outcome Measures :
    1. Progression-free survival (PFS) (Phase II) [ Time Frame: Up to 6 years ]
      Will be estimated for all treatment arms using the Kaplan-Meier method (1958). The primary phase IIR endpoint will be tested using a confidence interval (CI) approach.

    2. PFS (Phase III) [ Time Frame: Up to 6 years ]
      Will be estimated for all treatment arms using the Kaplan-Meier method (1958). The co-primary phase III endpoint will be tested using a confidence interval (CI) approach.

    3. Quality of life [ Time Frame: Baseline up to 6 years ]
      Measured by the MD Anderson Dysphagia Inventory (MDADI) global quality of life (QOL) score. Will be compared between arms using a two-sample independent t-test at a one-sided significance level of 0.05 for each experimental arm comparison. MDADI global score and change from baseline will be summarized using mean and standard deviation at each time point for each arm.


    Secondary Outcome Measures :
    1. Locoregional failure [ Time Frame: From the time of randomization to the date of failure, date of precluding event, or last known follow-up date, assessed up to 6 years ]
      The cumulative incidence estimator will be used to estimate time to event distributions for locoregional failure between arm differences tested using cause-specific log-rank test.

    2. Distant failure [ Time Frame: Up to 6 years ]
    3. Overall survival [ Time Frame: From the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, assessed up to 6 years ]
      Will be estimated using the Kaplan-Meier method and treatment arms compared using the log-rank test (Kaplan 1958).

    4. Incidence of adverse events [ Time Frame: Up to 6 years ]
      Measured by the Common Terminology Criteria for Adverse Events (CTCAE). Adverse events (AEs) will be graded using CTCAE version (v)5.0. Counts of all AEs by grade will be provided by treatment arm. Counts and frequencies will be provided for the worst grade AE experienced by the patient by treatment arm. The number of patients with at least 1 grade 3 or higher AE will be compared between the treatment arms. A comparison between treatment arms of grade 3 and higher AEs related to treatment will also be tested. A comparison of grade 3 and higher events will be compared between treatment arms. All comparisons will be tested using a Chi-Square test, or Fisher's exact test if cell frequencies are < 5, with a significance level of 0.05.

    5. Hearing [ Time Frame: Baseline up to 24 months from end of radiation therapy (RT) ]
      Measured as Hearing Handicap Inventory for Adults-Screening (HHIA-S).

    6. Quality of life [ Time Frame: Baseline up to 24 months from end of RT ]
      Measured by the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ)30.

    7. Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) locoregional control [ Time Frame: Up to 6 years ]
      Will be associated with PFS.

    8. Negative predictive value of post-RT FDG-PET/CT for locoregional control [ Time Frame: At 1 and 2 years ]
      The negative predictive value of FDG-PET/CT for locoregional control will be estimated using binomial proportions and confidence intervals based on normal approximation.

    9. Negative predictive value of post-RT FDG-PET/CT for PFS [ Time Frame: At 1 and 2 years ]
      The negative predictive value of FDG-PET/CT PFS will be estimated using binomial proportions and confidence intervals based on normal approximation.

    10. Incidence of adverse events [ Time Frame: Up to 6 years ]
      Measured using Patient-Reported Outcomes (PRO)-CTCAE. For each symptom, counts and frequencies will be provided for the worst score experienced by the patient by treatment arm. The proportion of patients with scores >= 1 and >= 3 will be compared between groups using a Chi-square test, or Fisher's exact test if cell frequencies are < 5, using a significance level of 0.05. Analysis of changes in patient reported outcomes over time will analyzed by fitting generalized estimating equations (GEE) models using a logit link (dichotomizing the symptom scores as 0 vs. > 1 and 0-2 vs. 3-4) with time of assessment, treatment arm, and treatment-by-time interaction terms in the model.


    Other Outcome Measures:
    1. Quality of life [ Time Frame: Baseline up to 24 months from end of RT ]
      Measured by EuroQol-5 Dimensional- 5 Level (EQ-5D-5L).

    2. Swallowing physiology [ Time Frame: Up to 6 years ]
      Measured by a Modified Barium Swallow (MBS) test. The proportion of aspiration for each arm will be estimated assuming a binomial distribution and between arm comparison will be performed using a Fisher's exact test.

    3. Locoregional control for patients with post-RT FDG-PET/CT [ Time Frame: At 12-14 weeks post-RT ]
      Locoregional control rates will be compared between negative and positive/undetermined patients. Cox proportional hazards models will be used to determine whether there are differences between these two groups, while adjusting for treatment arm and other covariates (cause-specific Cox models for locoregional failure).

    4. PFS for patients with post-RT FDG-PET/CT [ Time Frame: At 12-14 weeks post-RT ]
      PFS rates will be compared between negative and positive/undetermined patients. Cox proportional hazards models will be used to determine whether there are differences between these two groups, while adjusting for treatment arm and other covariates (cause-specific Cox models for locoregional failure).

    TRIAL NUMBER: NRG-HN009

    Title: RANDOMIZED PHASE II/III TRIAL OF RADIATION WITH HIGH-DOSE CISPLATIN (100 MG/M2) EVERY THREE WEEKS VERSUS RADIATION WITH LOW-DOSE WEEKLY CISPLATIN (40 MG/M2) FOR PATIENTS WITH LOCOREGIONALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN)

    Purpose:

    Primary Outcome Measures :
    1. Incidence of acute toxicity (Phase II) [ Time Frame: Up to 180 days post-treatment ]
      Measured by the T-scores.

    2. Overall Survival (OS) (Phase III) [ Time Frame: From randomization to death of any cause, assessed up to 9 years ]
      OS rates will be estimated using the Kaplan-Meier method.

    3. Incidence of acute toxicity (Phase III) [ Time Frame: Up to 180 days post-treatment ]
      Measured by the T-scores.


    Secondary Outcome Measures :
    1. Locoregional Failure Rates [ Time Frame: Up to 9 years ]
    2. Progression-free survival (PFS) [ Time Frame: From randomization to locoregional failure, distant metastasis or death due to any cause, whichever occurs first, assessed up to 9 years ]
      PFS rates will be estimated using the Kaplan-Meier method and between-arm differences compared using the log-rank test with a two-sided alpha of 0.05 (Kaplan 1958).

    3. Incidence of acute toxicity [ Time Frame: Up to 180 days post-treatment ]
      Measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

    4. Incidence of late toxicity [ Time Frame: Up to 9 years ]
      Measured by CTCAE v5.0.

    5. Hearing loss [ Time Frame: At 6 months post-radiation therapy ]
      Measured by Hearing Handicap Inventory for Adults-Screening.

    TRIAL NUMBER: A031704

    Title: PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab Vs. VEGF TKI Cabozantinib with Nivolumab: A Phase III Trial in Metastatic Untreated REnal Cell CancEr [PDIGREE]

    Purpose: This phase III trial studies how well nivolumab and ipilimumab, followed by nivolumab versus cabozantinib and nivolumab, work in treating patients with renal cell cancer that is untreated and has spread to other parts of the body. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cabozantinib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known how well cabozantinib and nivolumab work in treating patients with untreated renal cell cancer that has spread to other parts of the body.

    TRIAL NUMBER: EA9181

    Title: A Phase III Randomized Trial of Steroids +Tyrosine Kinase Inhibitor Induction with Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-positive Acute Lymphoblastic Leukemia in Adults

    Purpose: This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.

    TRIAL NUMBER: A081801

    Title: INTEGRATION OF IMMUNOTHERAPY INTO ADJUVANT THERAPY FOR RESECTED NSCLC: ALCHEMIST CHEMO-IO

    Purpose:

    Primary Outcome Measures :
    1. Disease free survival (DFS) [ Time Frame: From randomization to the first of either disease recurrence or death from any cause, assessed up to 5 years after accrual completion ]
      Will be estimated using the Kaplan-Meier method, where the stratified log-rank test will be used to compare the distributions across the treatment arms. DFS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals.

    2. Overall survival (OS) [ Time Frame: From randomization to death from any cause, assessed up to 8 years after accrual completion ]
      Will be estimated using the Kaplan-Meier method, where the stratified log-rank test will be used to compare the distributions across the treatment arms. OS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals.


    Secondary Outcome Measures :
    1. DFS between combination pembrolizumab with standard of care vs. sequential pembrolizumab [ Time Frame: From randomization to the first of either disease recurrence or death from any cause, assessed up to 5 years after accrual completion ]
    2. OS between combination pembrolizumab with standard of care vs. sequential pembrolizumab [ Time Frame: From randomization to death from any cause, assessed up to 8 years after accrual completion ]
    3. Incidence of adverse events [ Time Frame: Up to 10 years ]
      The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5. The frequency and percentage of grade 3+ adverse events will be compared between the 2 experimental treatment arms and the control as well as between the two experimental arms. We will also compare the rate of drug discontinuation due to adverse events between the experimental treatment arms and control, and between the two experimental arms. Comparisons between arms will be made by using the Chi-square test. Analysis of the overall adverse event rates, as well as specific events of interest will involve Chi-square tests or Fisher's exact tests.

    4. DFS between each experimental pembrolizumab plus standard of care arms vs. standard of care by PD-L1 expression status [ Time Frame: From randomization to the first of either disease recurrence or death from any cause, assessed up to 5 years after accrual completion ]
      Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be used as the primary analytical method, where all baseline covariates will be considered in the univariable models and subsequently in the multivariable models based on the criteria for selection for the multivariable models.

    5. OS between each experimental pembrolizumab plus standard of care arms vs. standard of care by PD-L1 expression status [ Time Frame: From randomization to death from any cause, assessed up to 8 years after accrual completion ]
      Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be used as the primary analytical method, where all baseline covariates will be considered in the univariable models and subsequently in the multivariable models based on the criteria for selection for the multivariable models.

    TRIAL NUMBER: A151216

    Title: Genetic Testing For Patients with Resectable or Resected Lung Cancer: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

    Purpose: PRIMARY OBJECTIVES:
    I. To centrally genotype resected lung adenocarcinomas for epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma receptor tyrosine kinase (ALK) rearrangements to facilitate accrual to randomized adjuvant studies.
    II. To obtain clinically annotated tumor tissue and patient-matched non-malignant deoxyribonucleic acid (DNA) from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow clinically annotated advanced genomic analyses in concert with the National Cancer Institute (NCI) Center for Cancer Genomics (CCG).
    SECONDARY OBJECTIVES:
    I. To characterize the natural history of EGFR and ALK wild-type lung cancers to allow subsequent development of targeted therapies against genotype-defined sub-populations in the adjuvant and recurrent settings.
    II. To cross-validate local genotyping assays for EGFR and ALK with a central reference standard.
    TERTIARY OBJECTIVES:
    I. To study the genomic evolution of lung cancers by comparing genomic characteristics at resection and at recurrence.
    OUTLINE:
    Patients undergo collection of blood and tissue samples for EGFR and ALK testing via direct sequencing and fluorescence in situ hybridization (FISH). Patients that have had surgery prior to pre-registration will submit samples from the previous surgery for testing.
    After completion of study, patients that are not enrolled on either A081105 or E4512 are followed up every 6 months for 5 years.

    TRIAL NUMBER: A171901

    Title: Older Non-Small Cell Lung Cancer Patients (>/= 70 Years of Age) Treated With First-Line MK-3475 (Pembrolizumab)+/- Chemotherapy (Oncologist's/Patient's Choice)

    Purpose: This trial studies the side effects of pembrolizumab with or without chemotherapy in treating patients with stage IV non-small cell lung cancer that has come back (recurrent) and has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with or without chemotherapy may shrink the tumor in older patients with non-small cell lung cancer.

    TRIAL NUMBER: E4512

    Title: A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

    Purpose: PRIMARY OBJECTIVES:
    I. To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) over placebo for patients with stage IB >= 4 cm, II and IIIA, anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following surgical resection.
    SECONDARY OBJECTIVES:
    I. To evaluate and compare disease-free survival (DFS) associated with crizotinib and placebo.
    II. To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting.
    III. To collect tumor tissue and blood specimens for future research.
    OUTLINE: Patients are randomized to 1 of 2 treatment arms.
    ARM A: Patients receive crizotinib orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    ARM B: Patients receive placebo PO BID on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for 5 years.

    TRIAL NUMBER: EA5163

    Title: EA5163/S1709 INSIGNA : A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-Driven Analysis

    Purpose: Primary Outcome Measures : Overall survival (OS) [ Time Frame: From randomization to death from any cause, assessed up to 5 years post treatment ] OS distributions will be estimated using the Kaplan-Meier method.

    Secondary Outcome Measures : Progression-free survival (PFS) [ Time Frame: From randomization to documented disease progression or death from any cause, assessed up to 5 years post treatment ] PFS distributions will be estimated using the Kaplan-Meier method.
    Best objective response [ Time Frame: Up to 5 years post treatment ] Best objective response will be evaluated via Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
    Incidence of adverse events [ Time Frame: Up to 30 days post treatment ] Toxicities will be reported via the Common Terminology Criteria for Adverse Events (CTCAE) criteria version 5.0. Toxicity rates between arms in the overall population will be compared using Fisher's exact tests with a one-sided type I error rate of 1.25%; multivariable logistic regression modeling will be used to adjust for the effect of any covariates that are associated with these categorical outcomes.
    PD-L1 positivity [ Time Frame: At baseline ] PD-L1 positivity will be defined as >= 1% Tumor Proportion Score (TPS) for the purpose of enrollment onto the trial. Strongly PD-L1 positive is defined as >= 50% TPS; weakly positive is defined as 1% - 49% TPS.

    TRIAL NUMBER: LungMAP

    Title: LungMAP: A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)

    Purpose: 1.1 Primary Objective of the Master Protocol (LungMAP) The primary objective of this screening study is to test patient specimens to determine eligibility for participation in the biomarker-driven and non-matched sub-studies included within the Lung-MAP umbrella protocol. 1.2 Secondary Objectives a. Screening Success Rate Objective To evaluate the screen success rate defined as the percentage of screened patients that register for a therapeutic sub-study. Screen success rates will be evaluated for the total screened population and by the subset of patients screened following progression on previous therapy or pre-screened on current therapy. b. Translational Medicine Objectives 1. To evaluate circulating tumor DNA (ctDNA) and compare to the FMI Foundation tissue molecular profiling results in patients who submit a new biopsy for screening. 2. To establish a tissue/blood repository

    TRIAL NUMBER: RTOG-1308

    Title: RTOG-1308:PHASE III RANDOMIZED TRIAL COMPARING OVERALL SURVIVAL AFTER PHOTON VERSUS PROTON CHEMORADIOTHERAPY FOR INOPERABLE STAGE II-IIIB NSCLC

    Purpose: This randomized phase III trial studies proton chemoradiotherapy to see how well it works compared to photon chemoradiotherapy in treating patients with stage II-III non-small cell lung cancer that cannot be removed by surgery. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor, such as photon or proton beam radiation therapy, may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether proton chemoradiotherapy is more effective than photon chemoradiotherapy in treating non-small cell lung cancer.

    TRIAL NUMBER: S1827

    Title: A RANDOMIZED PHASE III TRIAL OF MRI SURVEILLANCE WITH OR WITHOUT PROPHYLACTIC CRANIAL IRRADIATION (PCI) IN SMALL-CELL LUNG CANCER

    Purpose:

    Primary Outcome Measures :
    1. Overall survival (OS) [ Time Frame: From the date of registration to date of death due to any cause, assessed up to 2 years after randomization ]
      Will evaluate OS with magnetic resonance imaging (MRI) surveillance alone and MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC).


    Secondary Outcome Measures :
    1. Cognitive failure-free survival (CFFS) [ Time Frame: Baseline to first neurocognitive failure CF or death due to any cause, assessed up to 12 months after randomization ]
      The comparison of CFFS up to 12 months between the arms will be done using a 1-sided 5% level log-rank test.

    2. CFFS rate [ Time Frame: Baseline to first neurocognitive failure CF or death due to any cause, assessed at 90, 180, 270, 360, 540, and 720 days after randomization ]
      There will be a comparison of the CFFS rates between the arms at each of the assessment times and the cumulative incidence of cognitive failure, evaluating death as a competing risk. The CFFS rates at the landmark times will be estimated using the method of Kaplan-Meier and the difference in rates will be evaluated using a 90% confidence interval using Greenwood?s formula.

    3. Cumulative incidence of cognitive failure [ Time Frame: Neurocognitive function test will be assessed at 90, 180, 270, 360, 540, and 720 days after randomization ]
      The cumulative incidence of cognitive failure in the presence of the competing risk of death will be estimated used the method of Fine and Gray.

    4. OS in an "as-treated" analysis [ Time Frame: From the date of registration to date of death due to any cause, assessed up to 2 years after randomization. Patients will be seen at day 90, 180, 270, 360, 540, and 720 ]
      The comparison of OS in the ?as-treated? analysis will be done as described for the primary analysis, however patients will be categorized per treatment received (patients who do not accept their randomized assignment will be analyzed per treatment received). The number of patients not accepting the randomized assignment will also be summarized.

    5. Brain metastases-free survival (BMFS) [ Time Frame: Up to 2 years after randomization. Patients will have MRI on day 90, 180, 270, 360, 540, and 720 ]
      This will be estimated using the method of Kaplan-Meier and comparisons will be done using a log-rank test at the 1-sided 0.05 level. Hazard ratios and associated confidence intervals will be estimated using a Cox Proportional hazards model. Confidence intervals for medians will be estimated using the method of Brookmeyer-Crowley.

    6. Incidence of adverse events [ Time Frame: Up to 2 years after randomization. Patients will be assessed for adverse event after PCI (for patients on PCI + MRI arm) and at month 3 (all patients) ]
      Binary proportions and associated confidence intervals will be estimated.

    TRIAL NUMBER: EA4181

    Title: A RANDOMIZED 3-ARM PHASE II STUDY COMPARING 1.) BENDAMUSTINE, RITUXIMAB AND HIGH DOSE CYTARABINE (BR/CR) 2.) BENDAMUSTINE, RITUXIMABM HIGH DOSE CYTARABINE AND ACALABRUTINIB (BR/CR-A), AND 3.) BENDUMUSTINEM RITUXIMAB AND ACALABRUTINIB (BR0A) IN PATIENT

    Purpose:

    Primary Outcome Measures :
    1. Composite of positron emission tomography (PET)/computed tomography (CT) complete response (CR) and peripheral blood (PB) minimal residual disease (MRD) negative rate [ Time Frame: Up to 8 weeks post treatment ]
      MRD status is defined as positive, negative, or indeterminate as measured from PB specimens following completion of treatment. Measures of frequencies and proportion, and location and dispersion will be used to describe categorical, and continuous variables respectively; 90% confidence intervals around these estimates will be computed. Kaplan-Meier method will be used to describe time-to-event endpoints and log-rank test to assess difference in time-to-event endpoints by levels of a categorical predictor. Cox proportional hazards (PH) regression model would be used to model the impact of baseline and other relevant variables on time-to-event endpoints.


    Secondary Outcome Measures :
    1. Progression-free survival (PFS) [ Time Frame: From randomization to earliest of disease progression or death, assessed at 36 months ]
    2. Incidence of adverse events [ Time Frame: Up to 10 years post randomization ]
      Assessed by Common Terminology Criteria for Adverse Events (CTCAE). The cumulative dose of high dose cytarabine and proportion of patients that discontinued treatment due to toxicity will be assessed.

    3. Objective response rate (ORR) [ Time Frame: Up to 10 years post randomization ]
      ORR is defined as the proportion of patients achieving a best response to treatment of complete response (CR) or partial response (PR). ORR and PET/CT CR will be estimated in each treatment arm in the efficacy population, as well as among all treated patients, regardless of informative tissue status.

    4. Overall survival (OS) [ Time Frame: From randomization to death, assessed at 36 months ]
      Patients that are alive will be censored at the time of last follow-up. OS will be described using the Kaplan-Meier method and log-rank test will be used to compare survival by treatment arm.

    5. Mobilization failure rate [ Time Frame: Up to 10 years post randomization ]
      Defined as a yield < 2 x10^6 CD34+ stem cells/kg with a maximum of 4 course of apheresis will be summarized as a categorical variable, and compared, between treatment arms using Z- test.


    Other Outcome Measures:
    1. PET/CT negative rate between the three arms [ Time Frame: Up to 10 years post randomization ]
    2. PET quantitative assessment (qPET) [ Time Frame: At end of treatment (within 6 months after the "8 weeks post treatment" timeframe) ]
      Will evaluate the association between baseline qPET and MRD status.

    3. Change of qPET parameters [ Time Frame: Baseline to end of treatment (within 6 months after the "8 weeks post treatment" timeframe) ]
      Will evaluate the association between the change of qPET parameters and MRD and compare this association across all 3 arms.

    4. Incremental prognostic value of baseline qPET to standard risk markers (Mantle Cell Lymphoma International Prognostic Index [MIPI]) [ Time Frame: At end of treatment (within 6 months after the "8 weeks post treatment" timeframe) ]
      Will assess the incremental prognostic value of baseline to standard risk markers (MIPI) in predicting MRD status.

    5. Interim PET status [ Time Frame: At end of treatment (within 6 months after the "8 weeks post treatment" timeframe) ]
      Interim PET status both qualitatively (Deauville) and quantitatively will be correlated with MRD status. Will fit a logistic regression model to evaluate this aim with binary MRD status at end of treatment (EOT) as the response variable and interim PET status as the predictor.

    6. Incremental prognostic value of interim qPET to standard risk markers (MIPI) [ Time Frame: At end of treatment (within 6 months after the "8 weeks post treatment" timeframe) ]
      Will assess the incremental prognostic value of interim qPET to standard risk markers (MIPI) in predicting MRD status.

    7. Incremental prognostic value of interim qPET to Ki67 [ Time Frame: At end of treatment (within 6 months after the "8 weeks post treatment" timeframe) ]
      Will assess the incremental prognostic value of interim qPET to Ki67 in predicting MRD status.

    8. Incremental prognostic value of baseline qPET to Ki67 [ Time Frame: At end of treatment (within 6 months after the "8 weeks post treatment" timeframe) ]
      Will assess the incremental prognostic value of baseline qPET to Ki67 in predicting MRD status.

    TRIAL NUMBER: S1826

    Title: A PHASE III, RANDOMIZED STUDY OF NIVOLUMAB (OPDIVO) PLUS AVD OR BRENTUXIMAB VEDOTIN (ADCETRIS) PLUS AVD IN PATIENTS (AGE >/= 12 YEARS) WITH NEWLY DIAGNOSED ADVANCED STAGE CLASSICAL HODGKIN LYMPHOMA

    Purpose:

    Primary Outcome Measures :
    1. Progression free survival (PFS) [ Time Frame: From date of registration to date of first observation of progressive disease according to the 2014 Lugano classification, or death due to any cause, assessed at 2 years ]
      Will test the null hypothesis (HR=1) for PFS using stratified log-rank test with a one-sided alpha of 0.021. The analysis will be based on modified intent-to-treat and will include all eligible patients as randomized regardless of treatment received. The one-sided alpha of .021 will control of the overall type-one error of the study (including the 2 interim superiority analyses) to be less than .025.


    Secondary Outcome Measures :
    1. Overall survival [ Time Frame: 2 years ]
    2. Event-free survival (EFS) [ Time Frame: From date of registration to date of first occurrence of EFS event, assessed at 2 years ]
      Will be estimated using Kaplan-Meier method and compared between treatment arms using cox regression model.

    3. Metabolic complete response rate [ Time Frame: Up to 10 years ]
      Defined using 2014 Lugano classification.

    4. Incidence of adverse events [ Time Frame: Up to 10 years ]
      Toxicity will be evaluated using Common Terminology Criteria of Adverse Events (CTCAE) version 5 items. Treatment-related toxicities between arms will be compared using Fisher's exact test stratified by age groups. Targeted patient-reported toxicities also will be collected at each time point using the Patient Reported Outcome (PRO)-CTCAE for patients 18 years and older and from youth 12-17 years, using the Pediatric (Ped) PRO-CTCAE

    TRIAL NUMBER: S1918

    Title: A Phase II/III Randomized Study of R-MiniCHOP With or Without CC-486 (Oral Azacitidine) in Participants Age 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma, Grade IIIB Follicular Lymphoma, Transformed Lymphoma, and High-Grade B-Cell Lymphomas With MYC and BCL2 and/or BCL6 Rearrangements

    Purpose: This phase II/III trial compares the side effects and activity of oral azacitidine in combination with the standard drug therapy (reduced dose rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone [R-miniCHOP]) versus R-miniCHOP alone in treating patients 75 years or older with newly diagnosed diffuse large B cell lymphoma. R-miniCHOP includes a monoclonal antibody (a type of protein), called rituximab, which attaches to the lymphoma cells and may help the immune system kill these cells. R-miniCHOP also includes prednisone which is an anti-inflammatory medication and a combination of 3 chemotherapy drugs, cyclophosphamide, doxorubicin, and vincristine. These 3 chemotherapy drugs, as well as oral azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Combining oral azacitidine with R-miniCHOP may shrink the cancer or extend the time without disease symptoms coming back or extend patient's survival when compared to R-miniCHOP alone.

    TRIAL NUMBER: S1801

    Title: A PHASE II RANDOMIZED STUDY OF ADJUVANT VERSUS NEOADJUVANT MK-3475 (PEMBROLIZUMAB) FOR CLINICALLY DETECTABLE STAGE III-IV HIGH RISK MELANOMA

    Purpose: Primary Outcome Measures : Event-free survival (EFS) in patients with high-risk resectable melanoma randomized to neoadjuvant pembrolizumab with patients randomized to adjuvant pembrolizumab [ Time Frame: Date of randomization to date of first progression or death assessed up to 10 years ] We will use exponential-mixture cure models to describe EFS patterns in the arms.

    Secondary Outcome Measures : Overall survival (OS) [ Time Frame: Up to 10 years ] Will be estimated using the Kaplan-Meier method and compared between arms using log-rank tests and Cox regression models.
    Disease control [ Time Frame: At 24 weeks ] Will be estimated using the Kaplan-Meier method and compared between arms using log-rank tests and Cox regression models.
    Local/regional control in the surgical site(s) [ Time Frame: Up to 10 years ] Will be estimated using the Kaplan-Meier method and compared between arms using log-rank tests and Cox regression models.
    Total number of pembrolizumab doses [ Time Frame: Up to 10 years ] Will use Fisher's exact test to compare the number of pembrolizumab doses received by patients on each treatment arm.
    Pathologic response rate [ Time Frame: Up to 10 years ] Will be tabulated for the neoadjuvant arm and exact 95% confidence intervals will be constructed.
    Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 response rate [ Time Frame: Up to 10 years ] Will be tabulated for the neoadjuvant arm and exact 95% confidence intervals will be constructed.
    Immune-related (i)RECIST response rate [ Time Frame: Up to 10 years ] Will be tabulated for the neoadjuvant arm and exact 95% confidence intervals will be constructed.

    TRIAL NUMBER: A231601CD

    Title: A231601CD: Improving Surgical Care and Outcomes in Older Cancer Patients Through Implementation of an Efficient Pre-Surgical Toolkit (OPTI-Surg)

    Purpose: This trial studies how well the use of a pre-surgical toolkit (OPTI-Surg) works in improving surgical care and outcomes in older participants with cancer. In many elderly patients, surgery can greatly affect physical condition and the ability to return to pre-surgery levels of physical functioning. Providing pre-surgical recommendations may help improve participants' recovery rate and functioning after surgery.

    TRIAL NUMBER: S1714

    Title: A PROSPECTIVE OBSERVATIONAL COHORT STUDY TO DEVELOP A PREDICTIVE MODEL OF TAXANE-INDUCED PERIPHERAL NEUROPATHY IN CANCER PATIENTS

    Purpose: 1.1 Primary Objective a. To develop and validate a clinical risk prediction model using clinical factors for the development of peripheral neuropathy in patients receiving taxane-based chemotherapy regimens. 1.2 Secondary Objectives a. To examine patient-reported outcomes (PROs) and objective measures of chemotherapy induced peripheral neuropathy (CIPN) to better define the phenotype of peripheral neuropathy in this patient population. b. To assess the incidence of CIPN within one year in this patient population. c. To identify predictors of treatment dose reductions, delays, and discontinuations associated with CIPN symptoms in this patient population. 1.3 Other Objectives a. To collect serum and plasma samples for future testing for biomarker and mechanistic studies of CIPN.

    TRIAL NUMBER: A151804

    Title: Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

    Purpose: This trial collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects.

    TRIAL NUMBER: EAA173

    Title: DARATUMUMAB TO ENHANCE THERAPEUTIC EFFECTIVENESS OF REVLIMID IN SMOLDERING MYELOMA (DETER-SMM)

    Purpose: Primary Outcome Measures :
    Overall survival (OS) [ Time Frame: From randomization to death due to any cause, or censored at date last known alive, assessed up to 15 years ] Will be estimated using the Kaplan-Meier (KM) method and compared using a stratified log-rank test. Stratified cox proportional hazards regression will produce a treatment hazard ratio estimate.
    Functional Assessment of Cancer Therapy-General (FACT-G) score [ Time Frame: Baseline to 24 cycles of treatment (each cycle is 28 days) ] A general effect size measure of half standard deviation will be used to establish the minimally important difference. Descriptive statistics (mean, standard deviation [SD], median, range) will be used to evaluate the distribution of levels and changes for the set of health-related quality of life (QOL) evaluations. Levels and changes will also be assessed graphically. Changes from baseline will be analyzed using linear mixed models based on restricted maximum likelihood estimation with covariance matrix maximizing Akaike information criteria. Models with treatment, assessment time, and treatment by assessment time interaction with and without other predictors will be fit. If there is substantial missingness, will analyze the data according to the methods described in Schluchter and Schluchter, Greene and Beck.

    Secondary Outcome Measures :
    Progression-free survival (PFS) [ Time Frame: From randomization until disease progression or death due to any cause, or censored at date of last disease evaluation, assessed up to 15 years ] Will be estimated using the KM method and compared using a stratified log-rank test. Stratified cox proportional hazards regression will produce a treatment hazard ratio estimate.
    Best response on treatment based on International Myeloma Working Group (IMWG) criteria [ Time Frame: At 12 and 24 months ] Response will be tabulated by category. Response rates of very good partial response (VGPR) or better and partial response (PR) or better will be compared using the Fisher's exact test. Ineligible patients are excluded from the analysis and unevaluable patients are counted in the denominator.
    Incidence of adverse events by worst grade and type for treated patients determined using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: Up to 28 days post-treatment ] Will monitor the toxicities experienced by all treated patients. Will compare rates of worst grade 3 or higher non-hematologic treatment-related events using the Fisher's exact test.
    Incidence of grade 3 or higher infusion-related reactions over course 1 determined based on CTCAE [ Time Frame: During cycle 1 of treatment (each cycle is 28 days) ] Will monitor the toxicities experienced by all treated patients. Will compare rates of worst grade 3 or higher non-hematologic treatment-related events using the Fisher's exact test.
    Stem cell (SC) mobilization failure [ Time Frame: After 4 to 6 cycles of treatment (each cycle is 28 days) ] Defined as not collecting a minimum of 5x10^6 CD34 cells per kilogram weight. SC mobilization and type of growth factor support will be summarized overall and by treatment arm with descriptive statistics.
    Early SC mobilization feasibility [ Time Frame: Up to 6 cycles of treatment (each cycle is 28 days) ] Defined as the proportion of patients less than 65 years of age treated for 6 courses who opt for SC mobilization. SC mobilization and type of growth factor support will be summarized overall and by treatment arm with descriptive statistics.
    Type of growth factor support [ Time Frame: During 4 to 6 cycles of treatment (each cycle is 28 days) ] SC mobilization and type of growth factor support will be summarized overall and by treatment arm with descriptive statistics.
    Change in FACT-G score [ Time Frame: From treatment end to 6 months post-treatment ] A general effect size measure of half standard deviation will be used to establish the minimally important difference. Descriptive statistics (mean, SD, median, range) will be used to evaluate the distribution of levels and changes for the set of health-related QOL evaluations. Levels and changes will also be assessed graphically. Changes from baseline will be analyzed using linear mixed models based on restricted maximum likelihood estimation with covariance matrix maximizing Akaike information criteria. Models with treatment, assessment time, and treatment by assessment time interaction with and without other predictors will be fit. If there is substantial missingness, will analyze the data according to the methods described in Schluchter and Schluchter, Greene and Beck.
    Levels of FACT-G score at each assessment time point [ Time Frame: From baseline, at 3, f7, 13, 19 cycles of treatment, and early discontinuation of treatment, assessed up to 24 cycles of treatment (each cycle is 28 days) ] A general effect size measure of half standard deviation will be used to establish the minimally important difference. Descriptive statistics (mean, SD, median, range) will be used to evaluate the distribution of levels and changes for the set of health-related QOL evaluations. Levels and changes will also be assessed graphically. Changes from baseline will be analyzed using linear mixed models based on restricted maximum likelihood estimation with covariance matrix maximizing Akaike information criteria. Models with treatment, assessment time, and treatment by assessment time interaction with and without other predictors will be fit. If there is substantial missingness, will analyze the data according to the methods described in Schluchter and Schluchter, Greene and Beck.
    Time to worsening of FACT-G [ Time Frame: From baseline until a decrease of 9 points, or censored at date of last assessment, assessed up to 6 months post-treatment ] Will be analyzed with Kaplan-Meier methods and Cox regression with the related treatment arm as the only factor. Correlation between time to worsening of symptoms with PFS and OS will be assessed with Kendall's Tau adjusted for censored observations.

    Other Outcome Measures:
    Cumulative dose calculated as the sum of all doses taken across all cycles [ Time Frame: Up to 24 months ] Cumulative dose will be calculated overall and by cycle. Data will be summarized by treatment arm with descriptive statistics and graphically over time. Patients will be classified into dichotomous groups based on a 75% relative dose intensity cutoff (< 75% versus [vs] >= 75% represents poor vs good treatment adherence). The proportion of patients with poor lenalidomide treatment adherence will be compared between arms using the Fisher's exact test. In addition, multi-variable logistic regression analysis will be conducted to identify the baseline factors associated with calculated good treatment adherence.
    Dose intensity calculated as cumulative dose received divided by treatment duration [ Time Frame: Up to 24 months ] Dose intensity will be calculated overall and by cycle. Data will be summarized by treatment arm with descriptive statistics and graphically over time. Patients will be classified into dichotomous groups based on a 75% relative dose intensity cutoff (< 75% vs >= 75% represents poor vs good treatment adherence). The proportion of patients with poor lenalidomide treatment adherence will be compared between arms using the Fisher's exact test. In addition, multi-variable logistic regression analysis will be conducted to identify the baseline factors associated with calculated good treatment adherence.
    Relative dose intensity calculated as the dose intensity divided by planned dose intensity [ Time Frame: Up to 24 months ] Dose intensity will be calculated overall and by cycle. Data will be summarized by treatment arm with descriptive statistics and graphically over time. Patients will be classified into dichotomous groups based on a 75% relative dose intensity cutoff (< 75% vs >= 75% represents poor vs good treatment adherence). The proportion of patients with poor lenalidomide treatment adherence will be compared between arms using the Fisher's exact test. In addition, multi-variable logistic regression analysis will be conducted to identify the baseline factors associated with calculated good treatment adherence.
    Duration of treatment [ Time Frame: From randomization to date off treatment, or censored at the date of last treatment, assessed up to 24 months ] Treatment duration in each arm will be estimated using Kaplan-Meier methods and compared between arms with the log-rank test.
    Time to progression [ Time Frame: From randomization to progression, or censored at date of last disease evaluation, assessed up to 15 years ] Will be estimated using the Kaplan-Meier method.
    Presence, frequency, interference, amount and/or severity of select patient reported outcomes (PRO)-CTCAEs [ Time Frame: Assessed at each treatment cycle, from cycle 1 of treatment to end of treatment, up to 24 cycles of treatment (each cycle is 28 days) ] Descriptive statistics (mean, standard deviation, median, range) will be used to summarize selected PRO-CTCAEs tabulated at each cycle overall and by arm. Will map PRO-CTCAEs with provider reported adverse events (AEs) and evaluate differences in incidence and worst severity. Items correspond to 5 attributes measured [frequency (F), severity (S), interference (I), presence/absence (P) and amount (A)] based on multiple choice questions. Response for each attribute except P which is binary is on a 5-point Likert scale with 5 indicating 'almost constantly' frequency, 'very severe' severity, 'very much' amount or 'very much' interference. An overall PRO-CTCAE score will be calculated at each time point.
    Overall PRO-CTCAE score [ Time Frame: Up to 15 years ] Defined as the sum of item scores on all symptomatic adverse events (AEs). Descriptive statistics will be used to summarize selected PRO-CTCAEs tabulated at each cycle overall and by arm. Will map PRO-CTCAEs with provider reported AEs and evaluate differences in incidence and worst severity. An overall PRO-CTCAE score will be calculated at each time point.
    Adherence Starts with Knowledge (ASK)-12 scores [ Time Frame: At 7, 13, and 19 cycles of treatment (each cycle is 28 days) ] Descriptive statistics will be used to summarize ASK-12 scores tabulated at cycles 7, 13 and 19 overall and by arm. Differences between arms will be evaluated based a t-test (or Wilcoxon rank sum test). Patients will also be classified into high versus low likelihood of medication adherence groups according to tertile distributions (lowest tertile vs second and top). Association between likelihood of medication adherence and calculated treatment adherence dichotomous groups will be evaluated in patients with both ASK-12 and treatment data at cycles 7, 13 and 19 post randomization. In addition, multivariable logistic regression analysis will be conducted to identify the baseline factors associated with low likelihood of medication adherence.
    PRO compliance rate [ Time Frame: Up to 15 years ] Defined as the proportion of patients who submit the given PRO instrument among those eligible at each time point which excludes those missing by design (due to death or disease progression, early treatment discontinuation).
    PRO completion rate [ Time Frame: Up to 15 years ] Defined as the proportion of patients who complete given PRO instrument based on the instrument's scoring system among those eligible at each time point.

    TRIAL NUMBER: S1803

    Title: S1803; Phase III Study of Daratumumab/rHuPH20 (NSC- 810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)

    Purpose: Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years.

    TRIAL NUMBER: URCC-19085

    Title: WIRELESS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) FOR CHEMOTHERAPY-INDUCED PERIPHERAL NEUROPATHY: A PHASE II CLINICAL TRIAL

    Purpose: Primary Aim. Obtain efficacy estimates of daily TENS on CIPN (European Organisation for Research and Treatment of Cancer-CIPN20 (EORTC-CIPN20)) to inform the design of a phase III confirmatory trial.
    2.2 Secondary Aim 1. Obtain efficacy estimates of TENS on individual CIPN symptoms (i.e.,  hot/burning pain, sharp/shooting pain, tingling, numbness, cramping (measured daily via 0 ? 10 Numeric Rating Scale (NRS)).
    2.3 Secondary Aim 2. Evaluate the feasibility of conducting, within the URCC NCORP network, a multisite, modified double-blind RCT of TENS for CIPN with physiologic assessments of descending inhibition (i.e., conditioned pain modulation (CPM) test) by assessing the proportions of (a) screened patients who enroll, (b) randomized participants who adhere to the treatment and complete the primary assessment, and (c) randomized participants who complete the CPM test.
    2.4 Exploratory Aim 1 Investigate the potential effects of TENS on balance, physical function, descending inhibition, lower limb sensation, and anxiety and depression.
    2.5 Exploratory Aim 2 Establish data to support the construct validity of the Treatment-Induced Neuropathy Assessment Scale (TNAS) and CIPN symptom inventory daily diary by comparison to the EORTC-CIPN20, which is the most commonly used measure of CIPN.

    TRIAL NUMBER: COVID-19 Biospecimen

    Title: COVID-19 Biospecimen Collection

    Purpose:

    TRIAL NUMBER: EAQ202

    Title: Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials

    Purpose: The purpose of this study is to evaluate feasibility and acceptability of completing PROs among AYAs randomized to Choice PRO vs Fixed PRO.


    TRIAL NUMBER: S1912CD

    Title: A Randomized Trial Addressing Cancer-Related Financial Hardship Through Delivery of a Proactive Financial Navigation Intervention (CREDIT)

    Purpose: This clinical trial examines a financial navigation program in helping patients and their spouses understand and better manage the financial aspects of cancer care. Cancer patients and their spouses may be at high risk for financial problems because of the cost of cancer treatment. A financial navigator is a person or team who work with patients and their families to help them reduce stress or hardship related to the cost of cancer treatment. Financial navigators help patients understand their out-of-pocket expenses and what their health insurance plans may cover. Financial navigation may also help patients set up payment plans, find cost-saving methods for treatments, and improve access to healthcare services that the patient needs. Providing financial navigation to patients may help reduce financial worries and improve quality of life.

    TRIAL NUMBER: URCC-21038

    Title: Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated with anti-PD-1/anti-PD-L1 Immunotherapy in a Community Oncology Setting

    Purpose:

    This is a Prospective Observational Cohort Study, designed specifically to investigate racial differences in toxicities and treatment outcomes of cancer patients treated with immune checkpoint inhibitors (ICIs).

    TRIAL NUMBER: NRG-HN006

    Title: RANDOMIZED PHASE II/III TRIAL OF SENTINEL LYMPH NODE BIOPSY VERSUS ELECTIVE NECK DISSECTION FOR EARLY-STAGE ORAL CAVITY CANCER

    Purpose:

    Primary Outcome Measures :
    1. Patient-reported neck and shoulder function (Phase II/III) [ Time Frame: From Baseline (Before surgery) to 6 months post-surgery ]
      Will be evaluated and compared using the Neck Dissection Impairment Index (NDII), a 10-item tool between the two treatment arms. It is assumed that a 7.5-point (change from Baseline to 6 months) between arm difference is clinically meaningful. The hypothesis of no between-arm difference in 6-month NDII scores will be tested using the ANCOVA model at one-sided significance level of 0.10. Point estimates and 95% confidence intervals (CIs) for the mean NDII scores at 6 months for each treatment arm and for the between-arm difference at 6-months based on the proposed model will be provided.

    2. Disease-Free Survival [ Time Frame: From randomization to local/regional recurrence, distant metastasis, or death due to any cause, whichever comes first, assessed up to 11 years ]
      An event for disease-free survival is local recurrence, regional recurrence, distant metastasis, or death due to any cause. Disease-free survival time is randomization date to the date of event or last known follow-up (censoring). Rates will be estimated using the Kaplan-Meier method and between-arm differences compared using the log-rank test.


    Secondary Outcome Measures :
    1. Overall Survival [ Time Frame: From randomization to death due to any cause, assessed up to 11 years ]
      An event for overall survival is death due to any cause. Overall survival time is randomization date to date of event or last known follow-up (censoring). Rates will be estimated using the Kaplan-Meier method and between-arm differences compared using the log-rank test.

    2. Loco-regional Failure [ Time Frame: From the time of randomization to the date of failure, date of precluding event, or last known follow-up date, assessed up to 11 years ]
      An event for local-regional failure is local or regional recurrence. Local-regional failure time is randomization date to date of event, precluding event, or last known follow-up (censoring). Rates will be estimated using the cumulative incidence method and between arm differences compared using cause-specific log-rank test.

    3. Distant metastasis [ Time Frame: From the time of randomization to the date of distant metastasis, date of precluding event, or last known follow-up date, assessed up to 11 years ]
      An event is the occurrence of distant metastasis. Distant metastasis time is randomization to date of event, precluding event, or last known follow-up (censoring). Rates will be estimated using the cumulative incidence method and between-arm differences compared using cause-specific log-rank test.

    4. Patient-reported shoulder-related QOL, function impairment and disability [ Time Frame: Baseline, 3 weeks, 3, 6, 12 months post-surgery. Analysis occurs at the same time as the primary endpoint. ]
      Patient reported using Abbreviated Disabilities of the Arm, Shoulder, and Hand (QuickDASH) with scores of 0-100. A higher score indicates greater disability.

    5. General quality of life [ Time Frame: Baseline, 3 weeks, 3, 6, 12 months post-surgery. Analysis occurs at the same time as the primary endpoint. ]
      Will be measured using the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) to measure Functional Assessment of Cancer Therapy-Head and Neck-Trial Outcome Index (FACT-TOI) scores on a scale from 0-96. A higher score indicates better quality of life.

    6. Nodal metastasis detection rate [ Time Frame: During surgery. Analysis occurs at the same time as the primary endpoint. ]
      Defined as the proportion of patients with pathologic positive nodes using the pathology results.

    7. Pathologic false omission rate [ Time Frame: During surgery. Analysis occurs at the same time as the primary endpoint. ]
      Measured within the sentinel lymph node biopsy (SLN) arm only. Defined as the proportion of patients with false negative results among negative SLN patients.

    8. Post-surgery patient-reported outcome [ Time Frame: At 6 months post-surgery. Analysis occurs at the same time as the primary endpoint. ]
      Measured by NDII in low-risk oral cavity squamous cell carcinoma patients using ANCOVA comparison model.

    TRIAL NUMBER: EA8171

    Title: EA8171:Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer

    Purpose: This phase II trial studies how well multiparametric magnetic resonance imaging (MRI) works in evaluating cancer stage and helping treatment planning in patients with prostate cancer. Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive disease.

    TRIAL NUMBER: NRG-GU002

    Title: NRG-GU002: PHASE II-III TRIAL OF ADJUVANT RADIOTHERAPY AND ANDROGEN DEPRIVATION FOLLOWING RADICAL PROSTATECTOMY WITH OR WITHOUT ADJUVANT DOCETAXEL

    Purpose: This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.

    TRIAL NUMBER: NRG-GU008

    Title: RANDOMIZED PHASE III TRIAL INCORPORATING ABIRATERONE ACETATE WITH PREDNISONE AND APALUTAMIDE AND ADVANCED IMAGING INTO SALVAGE TREATMENT FOR PATIENTS WITH NODE-POSITIVE PROSTATE CANCER AFTER RADICAL PROSTATECTOMY

    Purpose:

    TRIAL NUMBER: NRG-GU009

    Title: PARALLEL PHASE III RANDOMIZED TRIALS FOR HIGH RISK PROSTATE CANCER EVALUATING DE-INTENSIFICATION FOR LOWER GENOMIC RISK AND INTENSIFICATION OF CONCURRENT THERAPY FOR HIGHER GENOMIC RISK WITH RADIATION (PREDICT-RT*)

    Purpose:

    Primary Outcome Measures :
    1. Metastasis-Free Survival (MFS) [ Time Frame: From randomization to the date of detection of distant metastasis on standard imaging or date of death from any cause, assessed up to 13 years ]
      Assessed based on conventional imaging. MFS will be estimated using the Kaplan-Meier method (Kaplan 1958).


    Secondary Outcome Measures :
    1. Overall Survival (OS) [ Time Frame: From the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, assessed up to 13 years ]
      Will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test (Kaplan 1958).

    2. Prostate Specific Antigen (PSA) failure-free survival with non-castrate testosterone and no additional therapies [ Time Frame: From the date of randomization to the date event, or death or censored at the last known follow-up date, assessed up to 13 years ]
      PSA failure-free survival will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test (Kaplan 1958).

    3. Prostate Cancer Specific Mortality (PCSM) [ Time Frame: From the date of randomization to the date of prostate cancer death, assessed up to 13 years ]
    4. Time to testosterone recovery [ Time Frame: Up to 13 years ]
      Defined as testosterone that is non-castrate.

    5. Time to PSA failure or salvage therapy [ Time Frame: Up to 13 years ]
    6. Testosterone levels at the time of PSA failure and metastases [ Time Frame: Up to 13 years ]
    7. Incidence of Adverse Events [ Time Frame: Up to 13 years ]
      Measured by the Common Terminology Criteria for Adverse Events (CTCAE ) version (v) 5.0 and Patient Reported Outcomes (PRO)-CTCAE.

    TRIAL NUMBER: NRG-GU010

    Title: PARALLEL PHASE III RANDOMIZED TRIALS OF GENOMIC-RISK STRATIFIED UNFAVORABLE INTERMEDIATE RISK PROSTATE CANCER: DE-INTENSIFICATION AND INTENSIFICATION CLINICAL TRIAL EVALUATION (GUIDANCE)

    Purpose:

    Primary Outcome Measures  :
    1. Distant Metastasis (DM) (De-intensification study) [ Time Frame: From randomization to the detection of distant metastasis by conventional imaging, assessed up to 5 years ]
      Will be analyzed using competing-risk methods (Gooley 1999) where, in each case, death prior to occurrence of the event in question will be a competing risk.

    2. Metastasis-Free Survival (MFS) (Intensification study) [ Time Frame: From randomization until the occurrence of distant metastasis by conventional imaging or death from any cause, assessed up to 5 years ]
      MFS will be estimated by the Kaplan-Meier (1958) method and compared between the two treatment arms using a stratified log-rank test (stratified by the randomization stratification factors) at one-sided alpha level of 0.025.


    Secondary Outcome Measures :
    1. Overall Survival [ Time Frame: From randomization to death from any cause, assessed up to 5 years ]
      Will be estimated by the Kaplan-Meier method and compared between treatments arms by stratified log-rank test. Cox regression models will also be fit, adjusted for the stratification factors, to estimate hazard ratios, together with 95% confidence intervals.

    2. Time to Prostate Specific Antigen (PSA) failure [ Time Frame: Up to 5 years ]
      Defined as PSA > 2 ng/ml above the nadir post randomization. Will be analyzed using competing-risk methods (Gooley 1999) where, in each case, death prior to occurrence of the event in question will be a competing risk.

    3. MFS (De-intensification study) [ Time Frame: From randomization until the occurrence of distant metastasis by conventional imaging or death from any cause, assessed up to 5 years ]
      Will be estimated by the Kaplan-Meier method and compared between treatments arms by stratified log-rank test. Cox regression models will also be fit, adjusted for the stratification factors, to estimate hazard ratios, together with 95% confidence intervals.

    4. MFS including positron emission tomography (PET) imaging [ Time Frame: From randomization until the occurrence of distant metastasis by conventional and/or molecular imaging or death from any cause, assessed up to 5 years ]
      Will be estimated by the Kaplan-Meier method and compared between treatments arms by stratified log-rank test.

    5. Locoregional failure (LRF) [ Time Frame: From randomization until local or regional recurrence based upon conventional imaging or biopsy, assessed up to 5 years ]
      Will compare cumulative incidence between arms.

    6. DM including PET imaging [ Time Frame: From randomization to the detection of distant metastasis by conventional and/or molecular imaging, assessed up to 5 years ]
      Will be analyzed using competing-risk methods (Gooley 1999) where, in each case, death prior to occurrence of the event in question will be a competing risk.

    7. Prostate cancer-specific mortality [ Time Frame: From randomization until death from prostate cancer, assessed up to 5 years ]
      Will be analyzed using competing-risk methods (Gooley 1999) where, in each case death from causes other than prostate cancer as the competing risk.

    8. Sexual and hormonal function related quality of life [ Time Frame: Up to 5 years ]
      Measured by the Expanded Prostate Cancer Index Composite-26 (EPIC-26).

    9. Fatigue [ Time Frame: Up to 5 years ]
      Measured by the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue instrument.

    10. Cognition [ Time Frame: Up to 5 years ]
      Measured by the Functional Assessment of Chronic illness Therapy-Cognitive (FACT-Cog).

    11. DM (Intensification study) [ Time Frame: From randomization to the detection of distant metastasis by conventional imaging, assessed up to 5 years ]
      Will be analyzed using competing-risk methods (Gooley 1999) where, in each case, death prior to occurrence of the event in question will be a competing risk.

    12. Locoregional progression [ Time Frame: Up to 5 years ]
      Defined as defined as recurrence within the pelvis including lymph nodes below the iliac bifurcation, or prostate. Will be analyzed using competing-risk methods (Gooley 1999) where, in each case, death prior to occurrence of the event in question will be a competing risk.


    Other Outcome Measures:
    1. Castrate-resistant prostate cancer (CRPC) [ Time Frame: Up to 5 years ]
      CRPC is defined as PSA increase > 25% and more than 2 ng/mL above nadir on study in conjunction with a serum testosterone (T) < 50 ng/mL, confirmed by repeat measurements at least 2 weeks apart. Will be analyzed using competing-risk methods (Gooley 1999) where, in each case, death prior to occurrence of the event in question will be a competing risk.

    2. Bowel and urinary function related quality of life [ Time Frame: Up to 5 years ]
      Measured EPIC-26. Mixed effect regression models will be fit to compare the changes over time in the domain scores. Covariates will include treatment, time, and treatment-by-time treatment interaction terms.

    3. Cardio-metabolic markers [ Time Frame: Up to 5 years ]
      Will include body mass index, lipids, blood glucose, complete blood count, comprehensive metabolic panel, and hemoglobin A1c. Mixed effect regression models will be fit to compare the changes over time in the cardio-metabolic markers between treatment groups. Covariates will include treatment, time, and treatment-by-time treatment interaction terms.

    4. PSA failure-free survival with non-castrate testosterone and no additional therapies [ Time Frame: Up to 5 years ]
    5. Locoregional failure based upon either conventional or molecular imaging [ Time Frame: Up to 5 years ]
    6. Health utilities [ Time Frame: Up to 5 years ]
      Measured by the European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L). ). The bootstrap (Efron 1980) will be performed to obtain standard errors, test for significant differences, and generate 95% confidence intervals.

    7. Time to testosterone recovery [ Time Frame: From randomization until T > 200 ng/dL, assessed up to 5 years ]
      Will be analyzed using competing-risk methods (Gooley 1999) where, in each case, death prior to occurrence of the event in question will be a competing risk. Changes in quality of life measures will be correlated with changes in testosterone levels.

    TRIAL NUMBER: NRG-GU011

    Title: A Phase II Double-Blinded, Placebo-Controlled Trial of PROstate OligoMETastatic RadiotHErapy With or Without ANdrogen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG Promethean)

    Purpose: This phase II trial tests whether relugolix and radiation therapy works to shrink tumors in patients with prostate cancer that has spread in a limited way to 1 to 5 other parts of the body (oligometastatic). Testosterone can cause the growth of prostate cancer cells. Relugolix lowers the amount of testosterone made by the body. This may help stop the growth of tumor cells that need testosterone to grow. Giving relugolix with radiation therapy may help lower the chance of prostate cancer growing or spreading.

    TRIAL NUMBER: RTOG-3506

    Title: RTOG 3506; A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery (STEEL)

    Purpose: Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive disease features will receive salvage radiation therapy and standard androgen deprivation therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free survival when enhanced ADT is used compared to standard ADT.

    TRIAL NUMBER: S1802

    Title: S1802: Phase III Randomized Trial of Standard Systemic Therapy (SST) versus Standard Systemic Therapy plus Definitive treatment (surgery or radiation) of the primary tumor in Metastatic Prostate Cancer

    Purpose: This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

    TRIAL NUMBER: A031801

    Title: A PHASE II RANDOMIZED TRIAL OF RADIUM-223 DICHLORIDE AND CABOZANTINIB IN PATIENTS WITH ADVANCED RENAL CELL CARCINOMA WITH BONE METASTASIS (RADICAL)

    Purpose:

    Primary Outcome Measures :
    1. Symptomatic skeletal event (SSE)-free survival (FS) [ Time Frame: From the date of randomization to the date of the earliest occurrence of SSE or death from any cause, assessed up to 5 years ]
      SSE-FS distribution will be estimated using the method of Kaplan-Meier by treatment arm. Comparison between the two arms will be performed using a one-sided log-rank test and one-sided p-value less than 0.025 will indicate that the experimental arm is superior to the control arm. SSE-FS will be censored at the date of last SSE assessment for those alive and SSE free. Hazard ratio (experimental over control arm) as well as two-sided 90% confidence interval (CI) for treatment will be estimated using the stratified Cox proportional hazard model with a single treatment covariate.


    Secondary Outcome Measures :
    1. Incidence of adverse events [ Time Frame: Up to 5 years ]
      Will be determined using Common Terminology Criteria for Adverse Events version 5.0. Adverse events will be summarized and compared between arms using chi-square or fisher exact tests as appropriate.

    2. SSE-FS [ Time Frame: From randomization to the date of SSE or death due to any cause, whichever comes first, assessed up to 5 years ]
      Will be estimated with the Kaplan Meier methodology. Comparison between arms or between predefined groups will be conducted using the log-rank test.

    3. Progression-free survival [ Time Frame: From randomization to time of radiographic progression or death due to any cause, whichever occurs first, assessed up to 5 years ]
      Radiographic progression will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Will be estimated with the Kaplan Meier methodology. Comparison between arms or between predefined groups will be conducted using the log-rank test.

    4. Overall survival [ Time Frame: From randomization to the date of death due to any cause, assessed up to 5 years ]
      Will be estimated with the Kaplan Meier methodology. Comparison between arms or between predefined groups will be conducted using the log-rank test. Patients who are alive will be censored at last follow up date.

    5. Time to first SSE [ Time Frame: From randomization to the date of first SSE or death due to any cause, assessed up to 5 years ]
      Will be determined in each treatment. The median estimate to first SSE-FS will be calculated.

    6. Overall response rate (ORR) [ Time Frame: Up to 5 years ]
      Will be defined by RECIST version 1.1. Number and proportion of patients achieving ORR (by RECIST) will be summarized with two-sided 90% CI by treatment arm; comparison between arms will be conducted using chi-square or Fisher's exact test as appropriate.

    TRIAL NUMBER: S1931

    Title: Phase III Trial of Immunotherapy-Based Combination Therapy With or Without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (PROBE Trial)

    Purpose: This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer.

    TRIAL NUMBER: S2013

    Title: S2013, IMMUNE CHECKPOINT INHIBITOR TOXICITY (I-CHECKIT): A PROSPECTIVE OBSERVATIONAL STUDY

    Purpose:

    Primary Outcome Measures :
    1. Occurrence of severe or worse non-hematological immune-related adverse event (irAE) [ Time Frame: 52 weeks ]
      Adverse events will be recorded according to the physician rated Common Terminology Criteria for Adverse Events (CTCAE) scoring system.


    Secondary Outcome Measures :
    1. Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 [ Time Frame: Baseline to 52 weeks ]
      PROMIS-29 Includes 4 questions to evaluate each of 7 domains (physical function, anxiety, depression, fatigue, sleep disturbance, social functioning, and pain interference) using a 5- point Likert scale, as well as a single item to assess pain severity on a 0-10 scale. The PROMIS-29 assesses severity levels of symptoms and their effect on the patient's functioning, assessed over the preceding 7 day period.

    2. Change in PRO-CTCAE scores [ Time Frame: Baseline to 52 weeks ]
      Patients report severity, frequency, and/or interference of toxicities; for this protocol the following 11 items will be assessed: fatigue interference, neuropathy severity and interference, nausea frequency and severity, shortness of breath severity and interference, presence of rash, itching severity, and diarrhea severity and interference over the preceding 7 days.

    3. Change in PROMIS Cognitive Function- Short Form 4a version 2.0 scores [ Time Frame: Baseline to 52 weeks ]
      Assesses patient-perceived cognitive deficits over the past 7 days. Facets include mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in these cognitive functions. The extent to which cognitive impairments interfere with daily functioning, whether other people observe cognitive impairments, and the impact of cognitive dysfunction on quality of life are also assessed. The PROMIS Short Form Cognitive Function 4a is a questionnaire composed of 4 items rated on a 5 level scale, ranging from Never to Very often (Several times a day), with raw scores ranging from 5 to 20, with higher scores representing better cognitive function. In combination with the PROMIS-29, the use of this questionnaire allows the calculation of the PROMIS-Preference score, which quantifies the value participants place on different health states.

    4. Change in toxicity over time (ToxT) [ Time Frame: Baseline to 52 weeks ]
      ToxT is a collection of statistical codes in Statistical Analysis Software that generate plots depicting summary statistics or individual patient data over discrete timepoints, combined with longitudinal statistical analyses (repeated measures modelling, and time-to-event and AUC analyses).


    Other Outcome Measures:
    1. Change in cytokine toxicity (CYTOX) score [ Time Frame: Baseline to 1 cycle after ICI-therapy ]
      The relationship between the CYTOX score and the occurrence of irAE will be evaluated using area under the curve (AUC). Separate evaluations will be conducted using both cytokine levels determined both prior to ICI-based therapy and after 1 cycle of ICI-based therapy.


    Biospecimen Retention:   Samples With DNA
    Tissue, blood, plasma, buffy coat

    TRIAL NUMBER: EA6174

    Title: STAMP: Surgically Treated Adjuvant Merkel cell Carcinoma with Pembrolizumab, a Phase III Trial

    Purpose:

    Primary Outcome Measures :
    1. Recurrence free survival (RFS) [ Time Frame: From randomization until disease recurrence or death from any cause; assessed up to 4.5 years ]
      An intention-to-treat (ITT) analysis using the stratified log-rank test will be performed to compare overall survival (OS) and RFS between the two arms.

    2. OS [ Time Frame: From randomization until death, assessed up to 4.5 years ]
      An ITT analysis using the stratified log-rank test will be performed to compare OS and RFS between the two arms.


    Secondary Outcome Measures :
    1. Impact of radiation therapy on RFS [ Time Frame: Up to 4.5 years ]
      RFS in each arm will be evaluated by radiation treatment status (radiation versus [vs.] no radiation therapy). The analysis will be a planned post-hoc analysis with primary goal of examining whether use of post-operative radiation therapy is associated with RFS. Cox multivariate models for RFS will be developed to evaluate the impact of radiation therapy while adjusting for pembrolizumab treatment and clinical/ pathological factors. The treatment fields and dose data will also be included in the Cox model as covariates. Secondary analyses for radiation therapy (RT) will examine factors associated with use of post-operative RT. Multivariate logistic regression models (radiation therapy vs. no radiation therapy) will be developed to evaluate the associations with demographic, clinical/pathologic, and treatment-related factors and pembrolizumab treatment.

    2. Impact of radiation therapy on OS [ Time Frame: Up to 4.5 years ]
      OS in each arm will be evaluated by radiation treatment status (radiation vs. no radiation therapy). The analysis will be a planned post-hoc analysis with primary goal of examining whether use of post-operative radiation therapy is associated with OS. Cox multivariate models for OS will be developed to evaluate the impact of radiation therapy while adjusting for pembrolizumab treatment and clinical/ pathological factors. The treatment fields and dose data will also be included in the Cox model as covariates. Secondary analyses for radiation therapy will examine factors associated with use of post-operative RT. Multivariate logistic regression models (radiation therapy vs. no radiation therapy) will be developed to evaluate the associations with demographic, clinical/pathologic, and treatment-related factors and pembrolizumab treatment.

    3. Impact of radiation therapy on distant metastasis free survival (DMFS) [ Time Frame: From randomization to distant metastasis, assessed up to 4.5 years ]
      DMFS will be evaluated by treatment arms. If there is no distant metastasis, cases will be censored at the time of last assessment.

    4. Incidence of adverse events [ Time Frame: Up to 4.5 years ]
      Measured per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Adverse events from each arm will be summarized and compared using the Fisher's exact test.

    TRIAL NUMBER: A031901

    Title: A031901, Duration of Immune Checkpoint Therapy in Locally Advanced or Metastatic Urothelial Carcinoma: A Randomized Phase 3 Non-Inferiority Trial

    Purpose: This phase III trial compares survival in urothelial cancer patients who stop immune checkpoint inhibitor treatment after being treated for about a year to those patients who continue treatment with immune checkpoint inhibitors. Immunotherapy with monoclonal antibodies, such as avelumab, durvalumab, pembrolizumab, atezolizumab, and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stopping immune checkpoint inhibitors early may still make the tumor shrink and patients may have similar survival rates as the patients who continue treatment. Stopping treatment early may also lead to fewer treatment-related side effects, an improvement in mental health, and a lower cost burden to patients.

    TRIAL NUMBER: EA8192

    Title: A Phase II/III trial of MEDI4736 (Durvalumab) and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

    Purpose: This phase III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.

    TRIAL NUMBER: S2011

    Title: Randomized Phase II Trial of Gemcitabine, Avelumab and Carboplatin vs. No Neoadjuvant Therapy Preceding Surgery for Cisplatin-Ineligible Muscle-Invasive Urothelial Carcinoma: SWOG GAP TRIAL

    Purpose: This phase II trial studies the effect of avelumab, gemcitabine and carboplatin before surgery compared with surgery alone in treating patients with muscle invasive bladder or upper urinary tract cancer who are not able to receive cisplatin therapy. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving avelumab together with gemcitabine and carboplatin before surgery may work better in lowering the chance of muscle invasive urinary tract cancer growing or spreading, in patients who cannot receive cisplatin therapy compared to surgery alone.

    TRIAL NUMBER: A091902

    Title: A Multicenter Phase II Trial of Paclitaxel With and Without Nivolumab in Taxane Naive, and Nivolumab and Cabozantinib in Taxane Pretreated Subjects With Angiosarcoma

    Purpose: This phase II trial studies how well paclitaxel with and without nivolumab works in treating patients with soft tissue sarcoma that have not received taxane drugs, and how well nivolumab and cabozantinib work in treating taxane pretreated patients with soft tissue sarcoma. Nivolumab works through the body's immune system to help the immune system act against tumor cells. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial is being done to see if the combination of nivolumab and paclitaxel or cabozantinib can shrink soft tissue sarcoma and possibly prevent it from coming back.

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    TRIAL NUMBER: EA2176

    Title: A Randomized Phase III Study of Immune Checkpoint Inhibition with Chemotherapy in Treatment-Naïve Metastatic Anal Cancer Patients

    Purpose:

    Primary Outcome Measures :
    1. Progression-free survival [ Time Frame: Up to 2 years ]
      Defined as the first of progressive disease or death due to any cause. Analyzed using a stratified two-sided overall 0.05 level log-rank test. Will utilize standard Eastern Cooperative Oncology Group -American College of Radiology Imaging Network interim monitoring for efficacy evaluation.


    Secondary Outcome Measures :
    1. Objective response rate (ORR) [ Time Frame: Up to 2 years ]
      ORR is the ratio of the number of patients with a complete response or partial response, as defined by Response Evaluation Criteria in Solid Tumors version 1.1, to the total number of treated patients.

    2. Overall survival [ Time Frame: Time between treatment randomization and death by any cause, assessed up to 2 years ]
      Evaluated by a stratified log-rank test, and using a two-sided 0.05 level Cochran Mantel-Haenzel.

    3. Incidence of adverse events [ Time Frame: Up to 2 years ]
      Analyses of toxicity will be via frequency tabulations and percentages by worst degree of toxicity and comparisons will be done via chi-square or Fisher's exact tests as appropriate.

    TRIAL NUMBER: A031701

    Title: A031701:A Phase II Study of Dose-Dense Gemcitabine Plus Cisplatin (ddGC) in Patients with Muscle-Invasive Bladder Cancer with Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations

    Purpose: This phase II trial studies how well gemcitabine hydrochloride and cisplatin work in treating participants with invasive bladder urothelial cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

    TRIAL NUMBER: A031803

    Title: PHASE II TRIAL OF INTRAVESICAL GEMCITABINE AND MK-3475 (PEMBROLIZUMAB) IN THE TREATMENT OF PATIENTS WITH BCG- NRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER

    Purpose:

    Primary Outcome Measures :
    1. Complete response rate in the carcinoma in situ (CIS) subpopulation [ Time Frame: At 6 months ]
      A complete response, only for patients with a CIS component, is a cystoscopy without evidence of bladder tumor, negative biopsy (including directed biopsies to any suspicious areas and in addition random bladder biopsies including trigone, left lateral wall, right lateral wall, posterior bladder, dome of bladder, and the prostatic urethra in men) and negative cytology for high grade disease at 6 months (end of cycle 8, week 25).

    2. Event-free survival at 18 months [ Time Frame: From the date of study registration to the first documentation of an event or death whichever comes first, assessed up to 18 months ]
      EFS will be measure from the date of study registration to the first documentation of an event or death whichever comes first. For patients without a documented event and who are still alive, they will be censored at last disease assessment. For patients who start any subsequent ant-cancer therapy without any reported events will be censored at their last disease assessment. will be obtained with a Kaplan-Meier estimator (using the Greenwood formula to estimate the variance) for the entire 155 patient group consisting of patients with CIS, CIS with Ta/T1 or Ta or T1 disease. A 90% confidence interval will be generated for the 18-month EFS estimate.


    Secondary Outcome Measures :
    1. Incidence of adverse events [ Time Frame: Up to 5 years post treatment ]
      Adverse events will be assessed based on the National Cancer Institute (NCI) common toxicity criteria (Common Terminology Criteria for Adverse Events [CTACAE] version [v] 5.0).

    2. Duration of response (DOR) [ Time Frame: From the time a patient had a documented response that had been confirmed (the time would start at the time a response was first noted) until disease-progression, assessed up to 5 years ]
      Analysis will only include those patients with a confirmed response. Patients who are alive and without a documented progression at the time of analysis will be censored at the time of the last disease status evaluation. The Kaplan-Meier product-limit estimator will be used to estimate DOR, medians and 95% confidence intervals (CI).

    3. Progression-free survival (PFS) [ Time Frame: From the date of study registration to the date of progression or death due to any cause, whichever occurs first, assessed up to 5 years ]
      Surviving patients without any documented progressions will be censored at the date of last known contact. Progression will be defined as the development of muscle invasive bladder cancer or metastatic urothelial cancer (nodal and/or distant). The Kaplan-Meier product-limit estimator will be used to estimate PFS, medians and 95% CI.

    4. Overall survival (OS) [ Time Frame: From the date of study registration to date of death due to any cause, assessed up to 5 years ]
      Surviving patients will be censored at the date of last known contact. The Kaplan-Meier product-limit estimator will be used to estimate OS, medians and 95% CI.

    5. Cystectomy-free survival [ Time Frame: From the date of study registration to the date of cystectomy for all patients ]
      The Kaplan-Meier product-limit estimator will be used to estimate cystectomy-free survival, medians and 95% CI.

    6. Recurrence free survival (RFS) [ Time Frame: From the date of study registration to the first documentation of recurrence or death due to any cause, assessed up to 5 years ]
      Surviving patients without any documented recurrence will be censored at the date of last known contact. Recurrence will be defined as the development of high-grade bladder cancer for patients with a CIS component only and those without a CIS component. The Kaplan-Meier product-limit estimator will be used to estimate RFS, medians and 95% CI.

    TRIAL NUMBER: CITN-14

    Title: A Randomized Phase II Study of Atezolizumab (MPDL3280A) Plus Recombinant Human IL7 (CYT107) in Patients with Locally Advanced or Metastatic Urothelial Carcinoma

    Purpose: Primary Outcome Measures : Objective response rate (ORR) [ Time Frame: Up to 2 years ] ORR to be defined by complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1. The Cochran Mantel Haenszel test will be conducted to compare ORR in the experimental arm (atezolizumab + CYT107) to the ORR in the control arm (atezolizumab monotherapy). A one-sided significance level of 0.10 will be considered for the test.

    Secondary Outcome Measures : Clinical benefit rate (CBR) measured by RECIST version (v.) 1.1 and immune-related (ir) RECIST [ Time Frame: Up to 2 years ] CBR is defined as the percentage of patients with advanced or metastatic cancer who have achieved CR, PR, and stable disease (SD) to a therapeutic intervention in clinical trials of anticancer agents. A two-sided test for a difference in proportions will be conducted to compare the CBR in the experimental arm to the CBR in the control arm. A two-sided significance level of 0.05 will be considered for the test. Will also assess CBR in patients stratified by PD-L1 expression levels in the tumor microenvironment, as assayed by Genentech.
    Progression-free survival (PFS) [ Time Frame: Up to 2 years ] PFS to be measured by RECIST v1.1 and irRECIST. PFS will be summarized using Kaplan-Meier estimates. Long-rank tests will be conducted for overall survival (OS) and PFS to compare between the 2 arms. A one-sided significance level of 0.10 will be considered. Will also assess PFS in patients stratified by PD-L1 expression levels in the tumor microenvironment, as assayed by Genentech.
    Duration of response (DOR) [ Time Frame: Up to 2 years ] DOR is measured by RECIST v1.1 and irRECIST. DOR will be summarized using Kaplan-Meier estimates. Long-rank tests will be conducted for OS and PFS to compare between the 2 arms. A one-sided significance level of 0.10 will be considered. Will also assess DOR in patients stratified by PD-L1 expression levels in the tumor microenvironment, as assayed by Genentech.
    Overall survival [ Time Frame: Up to 2 years ] OS will be summarized using Kaplan-Meier estimates. Long-rank tests will be conducted for OS and PFS to compare between the 2 arms. A one-sided significance level of 0.10 will be considered. Will also assess OS in patients stratified by PD-L1 expression levels in the tumor microenvironment, as assayed by Genentech.

    Other Outcome Measures: Assessment of investigation treatment combination on the immune-bias of the tumor microenvironment [ Time Frame: Up to 2 years ] The evaluation of the effect of the investigation treatment combination on the immune-bias of the tumor microenvironment, based upon baseline and post-baseline tumor biopsy comparisons of number, distribution, and phenotype of tumor-infiltrating cells; PD-L1 expression, and expression of Interferon gamma (IFN-gamma) and associated proinflammatory gene expression in the tumor microenvironment.

    TRIAL NUMBER: EA8185

    Title: Phase 2 Study of Bladder-SparIng ChemoradiatioN with MEDI4736 (Durvalumab) in clinical Stage 3, Node PosItive bladdeR cancEr (INSPIRE)

    Purpose:

    Primary Outcome Measures :
    1. Clinical complete response (CR) [ Time Frame: Up to 6 years ]

    Secondary Outcome Measures :
    1. Metastasis-free survival [ Time Frame: From randomization to first evidence of metastatic disease or death from any cause, assessed up to 6 years ]
      Will be estimated by the Kaplan-Meier method.

    2. Bladder-intact event-free survival (BI-EFS) [ Time Frame: From randomization to the first BI-EFS event, assessed up to 6 years ]
      Will be estimated by the Kaplan-Meier method.

    3. Bladder cancer specific survival [ Time Frame: From randomization to death from bladder cancer, assessed up to 6 years ]
      Will be estimated by the Kaplan-Meier method.

    4. Overall survival [ Time Frame: From randomization to death from any cause, assessed up to 6 years ]
      Will be estimated by the Kaplan-Meier method.

    5. Progression-free survival [ Time Frame: From randomization to first of local progression, nodal or distant metastasis, or death from any cause, assessed up to 6 years ]
      Will be estimated by the Kaplan-Meier method.

    6. Complete response duration [ Time Frame: From the date of the biopsy documenting the complete response to the time of muscle invasive recurrence, local progression, evidence of metastatic disease or death due to any cause, assessed up to 6 years ]
      Stratified Cox proportional hazards models will be used to estimate hazard ratios in all eligible patients.

    7. Salvage cystectomy rate [ Time Frame: Up to 6 years ]
      Rate will be reported as a proportion of patients who do not experience clinical benefit after chemoradiotherapy (chemoRT) +/- MEDI4736 (durvalumab) along with a 90% confidence interval. Stratified Cox proportional hazards models will be used to estimate hazard ratios in all eligible patients.

    8. Incidence of adverse events [ Time Frame: Up to 1 year ]
      Assessed using the Common Terminology Criteria for Adverse Events (CTCAE). Toxicity will be evaluated in all treated patients, regardless of eligibility.

    TRIAL NUMBER: S1600

    Title: A Randomized Phase III Double-Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes

    Purpose: This randomized phase III trial studies how well nutrition therapy works in improving immune system in patients with bladder cancer that can be removed by surgery. Improving nutrition before and after surgery may reduce the infections and other problems that sometimes occur after surgery.

    TRIAL NUMBER: S1806

    Title: S1806: Phase III Randomized Trial of Concurrent Chemoradiotherapy with or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer

    Purpose: This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab.

    TRIAL NUMBER: A071701

    Title: Genomically-Guided Treatment Trial in Brain Metastases

    Purpose:

    Primary Outcome Measures :
    1. Objective response rate in the brain [ Time Frame: Up to 5 years ]
      Assessed per Response Assessment in Neuro-Oncology (RANO) criteria for brain metastases. The response rate is defined as the number of patients who have achieved complete response (CR) or partial response (PR) per RANO for brain metastases criteria during treatment with CDK, PI3K, or NTRK/ROS inhibitors divided by total number of evaluable patients. The response rate and associated exact confidence interval will be estimated within each cohort defined by the targeted agent and histology.


    Secondary Outcome Measures :
    1. Systemic response for extracranial disease [ Time Frame: Up to 5 years ]
      Assessed with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Will be estimated using the systemic response rate (SRR) - where SRR is defined as the number of evaluable patients achieving a response (PR or CR per RECIST 1.1) during treatment with study therapy divided by the total number of evaluable patients. Point estimates will be generated for systemic response rates within each cohort with corresponding 95% binomial confidence intervals.

    2. Clinical benefit rate for central nervous system (CNS) [ Time Frame: Up to 5 years ]
      Evaluated by Response Assessment in Neuro-Oncology (RANO) criteria. Will be estimated as the number of evaluable patients achieving stable disease (SD), partial response (PR), or complete response (CR) as their best objective response during treatment with protocol therapy divided by the total number of evaluable patients. Point estimates will be generated for clinical benefit rates within each cohort with corresponding 95% binomial confidence intervals.

    3. Clinical benefit rate for extracranial disease [ Time Frame: Up to 5 years ]
      Assessed by Response Evaluation Criteria in Solid Tumors (RECIST). Will be estimated as the number of evaluable patients achieving stable disease (SD), partial response (PR), or complete response (CR) as their best objective response (per RECIST for extracranial disease) during treatment with protocol therapy divided by the total number of evaluable patients. Point estimates will be generated for clinical benefit rates within each cohort with corresponding 95% binomial confidence intervals.

    4. Duration of response for brain metastases [ Time Frame: From the time measurement criteria are met for CR or PR for brain metastases until the first date that progressive CNS disease or death is documented, assessed up to 5 years ]
      Duration of response for brain metastases is defined for all evaluable patients who have achieved a confirmed response as the time from the date at which the patient's objective status for brain metastases is first noted to be a CR or PR (per Response Assessment in Neuro-Oncology [RANO] for brain metastases) to the date of the earliest progressive CNS disease is documented or death. The median and 95% confidence intervals will be estimated using the Kaplan-Meier estimator. No formal comparison will be made among the cohorts.

    5. Duration of response for extracranial disease [ Time Frame: From the time measurement criteria are met for CR or PR for extracranial disease until the first date that progressive disease for extracranial disease or death is documented, assessed up to 5 years ]
      Duration of response for extracranial disease is defined for all evaluable patients who have achieved a confirmed response as the time from the date at which the patient's objective status for extranial disease is first noted to be a CR or PR (per RECIST1.1) to the date of the earliest progression (PD) for extracranial disease is documented or death. The median and 95% confidence intervals will be estimated using the Kaplan-Meier estimator. No formal comparison will be made among the cohorts.

    6. Progression-free survival (PFS) - intracranial [ Time Frame: From first day of study treatment to the earliest date documentation of intracranial disease progression or death from any cause, assessed up to 5 years ]
      Intracranial PFS is defined as the time from the first day of study treatment to the earliest date of intracranial disease progression (per RANO for brain metastases) or death from any cause, whichever comes first. The median and 95% confidence intervals will be estimated using the Kaplan-Meier estimator. No formal comparison will be made among the cohorts.

    7. Progression-free survival (PFS) - extracranial [ Time Frame: From the first day of study treatment to the earliest date of documentation of extracranial disease progression or death from any cause, assessed up to 5 years ]
      Extracranial PFS is defined as the time from the first day of study treatment to the earliest date of extracranial disease progression (per RECIST1.1) or death from any cause, whichever comes first. The median and 95% confidence intervals will be estimated using the Kaplan-Meier estimator. No formal comparison will be made among the cohorts.

    8. Site of first progression [ Time Frame: Up to 24 months ]
      The site of first progression will be estimated descriptively within each cohort within 12 and 24 months after starting protocol treatment. The first progression is defined as the first documented central nervous system (CNS) progression per Response Assessment in Neuro-Oncology (RANO) or extracranial progression per Response Evaluation Criteria in Solid Tumors (RECIST), whichever occurs first. The percentage of extracranial progression at first progression within 12 and 24 months after starting protocol treatment will be estimated as number of patients who experience the first progression which is extracranial progression divided by number of patients who are still at risk up to 12 and 24 months, respectively.

    9. Overall survival [ Time Frame: From the first day of study treatment to death due to any cause, assessed up to 5 years ]
      Overall survival is defined as the time from the first day of study treatment to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. No formal comparison will be made among the cohorts.

    10. Incidence of adverse events [ Time Frame: Up to 5 years ]
      Assessed per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, toxicity is defined as adverse events that are classified as possibly, probably, or definitely related to study treatment. Toxicities will be evaluated via the ordinal CTCAE standard toxicity grading. Overall toxicity incidence as well as toxicity profiles by patient and treatment cohort will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of the analysis. No formal comparison will be made among the cohorts.

    TRIAL NUMBER: N0577

    Title: N0577 (CODEL): Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

    Purpose: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.

    TRIAL NUMBER: WF-1801

    Title: A Single Arm, Pilot Study of Ramipril for Preventing Radiation-Induced Cognitive Decline in Glioblastoma (GBM) Patients Receiving Brain Radiotherapy

    Purpose: This study is to determine if an oral drug called Ramipril can lower the chance of memory loss in patients with glioblastoma getting chemoradiation. Patients will take Ramipril during chemoradiation and continue until 4 months post-treatment. Memory loss will be assessed using several neurocognitive tests throughout the duration of the study.

    TRIAL NUMBER: A011801

    Title: T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial

    Purpose: This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.

    TRIAL NUMBER: EA1151

    Title: Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer

    Purpose: This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.

    TRIAL NUMBER: EA1181

    Title: CompassHER2-pCR: PREOPERATIVE THP AND POSTOPERATIVE HP IN PATIENTS WHO ACHIEVE A PATHOLOGIC COMPLETE RESPONSE PART 1 COMPONENT OF: THE CompassHER2 TRIALS (COMPREHENSIVE USE OF PATHOLOGIC RESPONSE ASSESSMENT TO OPTIMIZE THERAPY IN HER2-POSITIVE BREAST CANCER)

    Purpose:

    Primary Outcome Measures :
    1. Recurrence-free survival (RFS) [ Time Frame: Up to 3 years after end of treatment ]
      Events include recurrence of ipsilateral invasive breast tumor, recurrence of locoregional invasive breast tumor, and distant recurrence. Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and estrogen receptor (ER) status. Greenwood method will be used to estimate the 95% confidence interval for 3-year rate.


    Secondary Outcome Measures :
    1. Invasive disease-free survival (IDFS) [ Time Frame: Up to 3 years after the end of treatment ]
      Events include recurrence of ipsilateral invasive breast tumor, recurrence of locoregional invasive breast tumor, distant recurrence, contralateral invasive breast cancer, and second primary non-breast invasive cancer (other than squamous or basal cell skin cancer). Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and ER status. The analysis will be descriptive and there will be no statistical test.

    2. Distant disease-free survival (DDFS) [ Time Frame: Up to 3 years after the end of treatment ]
      Events include distant recurrence and second primary non-breast invasive cancer (other than squamous or basal cell skin cancer). Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and ER status. The analysis will be descriptive and there will be no statistical test.

    3. Distant relapse-free survival (DRFS) [ Time Frame: U to 3 years after the end of treatment ]
      Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and ER status. The analysis will be descriptive and there will be no statistical test.

    4. Recurrence-free interval (RFI) [ Time Frame: Up to 3 years after the end of treatment ]
      Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and ER status. The analysis will be descriptive and there will be no statistical test.

    5. Overall survival (OS) [ Time Frame: From date of surgery until the date of death from any cause, assessed up to 3 years after the end of treatment ]
      Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and ER status. The analysis will be descriptive and there will be no statistical test.

    6. Event-free survival (EFS) [ Time Frame: Up to 3 years after the end of treatment ]
      Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and ER status. The analysis will be descriptive and there will be no statistical test.

    7. Incidence of adverse events (AEs) [ Time Frame: Up to 1 week after cycle 4 (all patients) and/or up to cycle 13 post-surgery (Arm A only) (each cycle is 21 days) ]
      Will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. All treatment-emergent and baseline adverse events and hematological/biochemical toxicities based on laboratory measurements, as well as drug related AEs, will be summarized by NCI CTCAE v5.0 worst grade. The incidence of deaths and treatment-emergent serious adverse events (defined as number of patients experiencing the AE divided by all treated patients) will be summarized using binominal proportions and binomial exact 95% confidence intervals. The incidence of adverse events leading to discontinuation of protocol therapy will be summarized and listed as well.

    TRIAL NUMBER: NRG-BR003

    Title: A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel With or Without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

    Purpose: This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.

    TRIAL NUMBER: S1703

    Title: S1703; Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored with Serum Tumor Marker Directed Disease Monitoring (STMDDM) versus Usual Care in Patients with Metastatic Hormone Receptor Positive Breast Cancer

    Purpose: To assess whether patients with HER-2 negative, hormone receptor positive, metastatic breast cancer who are monitored with serum tumor marker directed disease monitoring (STMDDM) have non-inferior overall survival compared to patients monitored with usual care.

    TRIAL NUMBER: S1706

    Title: A PHASE II RANDOMIZED TRIAL OF OLAPARIB (NSC-747856) ADMINISTERED CONCURRENTLY WITH RADIOTHERAPY VERSUS RADIOTHERAPY ALONE FOR INFLAMMATORY BREAST CANCER

    Purpose: Primary Outcome Measures : Invasive Disease-Free Survival (IDFS) [ Time Frame: Up to 8 years ] Time from date of registration to date of first invasive recurrence (local, regional or distant), second invasive primary cancer (breast or not), or death due to any cause. Patients last known to be alive who have not experienced recurrence or second primary cancer are censored at their last contact date. Analysis will be on an intent-to-treat basis and will estimate the survival endpoints using the product-limit method of Kaplan and Meier and will compare the time-to-event distributions using log-rank test statistics. Hazard ratios will be calculated from Cox regression analyses. Effect modification by the stratification variables will be tested as interactions with treatment and separate hazard ratios with 95% confidence intervals by major subgroups will be displayed in a forest plot to examine for consistency of the treatment effect over these subgroups. Secondary Outcome Measures : Locoregional Recurrence-Free Interval (Local Disease-Free Interval (LDFI)) [ Time Frame: Up to 8 years ] Time from date of registration to date of invasive local or regional recurrence. Patients last known to be alive without recurrence are censored at their last contact date. Patients with distant recurrence, second primary cancer or death are censored at the time of that event. A competing risk framework will be conducted separating out the event types of locoregional recurrence from distant recurrence and death. Hazard ratios will be calculated from Cox regression analyses. Effect modification by the stratification variables will be tested as interactions with treatment and separate hazard ratios with 95% confidence intervals by major subgroups will be displayed in a forest plot to examine for consistency of the treatment effect over these subgroups. Distant Relapse-Free Survival (Distant Recurrence-Free Survival) [ Time Frame: Up to 8 years ] Time from date of registration to date of invasive distant disease recurrence, second invasive primary cancer (breast or not) or death due to any cause. Patients last known to be alive who have not experienced disease recurrence, or second primary cancer are censored at their last contact date. Overall Survival [ Time Frame: Up to 8 years ] Time from date of registration to date of death due to any cause. Patients last known to be alive are censored at their last contact date.

    TRIAL NUMBER: URCC-16070

    Title: Netupitant/Palonosetron Hydrochloride and Dexamethasone With or Without Prochlorperazine or Olanzapine in Improving Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer

    Purpose: This randomized phase III trial studies how well netupitant/palonosetron hydrochloride and dexamethasone with prochlorperazine or olanzapine work compared to netupitant/palonosetron hydrochloride and dexamethasone in improving chemotherapy-induced nausea and vomiting in patients with breast cancer. Antiemetic drugs, such as prochlorperazine and olanzapine, may help lessen nausea and vomiting in patients with breast cancer treated with chemotherapy.

    TRIAL NUMBER: WISDOM

    Title: WOMEN INFORMED TO SCREEN DEPENDING ON MEASURES OF RISK

    Purpose:

    Primary Outcome Measures :
    1. Late-stage cancer [ Time Frame: 5 years ]
      Proportion of cancers diagnosed at Stage IIB or higher

    2. Biopsy rate [ Time Frame: 5 years ]
      Rate of biopsies performed


    Secondary Outcome Measures :
    1. Late-stage cancers rate [ Time Frame: 5 years ]
      Rate of Stage IIB or higher cancers

    2. Interval cancers rate [ Time Frame: 5 years ]
      Rate of interval (detected within 12-24 months of a normal screen) cancers

    3. Rate of systemic therapy [ Time Frame: 5 years ]
      Rate of systemic therapy as measure of morbidity

    4. Mammogram recall rate [ Time Frame: 5 years ]
      Mammogram recall rate as measure of morbidity

    5. Breast biopsy rate [ Time Frame: 5 years ]
      Breast biopsy rate as measure of morbidity

    6. DCIS rate [ Time Frame: 5 years ]
      Rate of ductal carcinoma in situ (DCIS) as a measure of morbidity, stratified by biologic type

    7. Chemoprevention uptake rate [ Time Frame: 5 years ]
      Rate of uptake of endocrine prevention interventions

    8. Choice of risk-based versus annual screening in self-assigned cohort [ Time Frame: 5 years ]
      Proportion of participants who choose risk-based versus annual screening in the self-assigned cohort as a measure of acceptability

    9. Adherence to assigned screening schedule [ Time Frame: 5 years ]
      Proportion of participants who adhere to their assigned screening schedules as a measure of acceptability

    10. Breast-cancer anxiety [ Time Frame: 5 years ]
      Breast cancer anxiety (as measured with the PROMIS anxiety scale) as a measure of acceptability

    11. Decisional regret [ Time Frame: 5 years ]
      Decisional regret (as measured with the Decision Regret Scale, a 5-item Likert scale) as a measure of acceptability

    12. Ultra-low risk cancer rate [ Time Frame: 5 years ]
      Rates of ultra-low risk cancer

    TRIAL NUMBER: DCP-001

    Title: DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)

    Purpose: The protocol is not a scientific study; rather, a method to implement the screening tool and allow the collection and analyses of expanded data with informed consent. Investigators also enroll patients into NCI-treatment trials. The tool, based on a screening log successfully used within the NCI Community Cancer Centers Program (NCCCP), has been streamlined and integrated into the sites’ workflow by using OPEN. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. Also missing from the existing data is the context of care, within the communities themselves where most cancer and at risk of cancer patients receive care which is the focus of NCORP. The profile of patients accrued to NCI-sponsored clinical trials lacks both racial/ethnic and socioeconomic diversity. Accrued patients tend to be insured, highly educated and of higher socioeconomic means. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. NCORP's clinical trials portfolio includes cancer control, prevention, screening, symptom science, and cancer care delivery research.

    TRIAL NUMBER: DCP-002

    Title: DCP-002 Early Onset Malignancies Initiative (EOMI): Molecular profiling of Breast, Prostate, Colorectal, Liver, Kidney, and Multiple Myeloma among Racially and Ethnically Diverse Populations

    Purpose: The primary objective of the EOMI (Early Onset Malignancy Initiative) is to acquire tissue and blood, and other biospecimens for research purposes from tests performed for clinical care or for research indications on other research protocols to accelerate our understanding of the molecular basis of early onset cancers occurring in racial and/or ethnic minority populations through the application of genome analysis technologies, including large-scale genome sequencing and clinical data analysis.

    TRIAL NUMBER: S1823

    Title: A PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS miRNA 371 FOR OUTCOME PREDICTION IN PATIENTS WITH NEWLY DIAGNOSED GERM CELL TUMORS

    Purpose:

    Primary Outcome Measures :
    1. Relapse rate of active germ cell malignancy for those undergoing active surveillance of clinical stage I (CSI)/stage IIA germ cell malignancy [ Time Frame: Up to 3 years ]
    2. Positive predictive value [ Time Frame: Up to 3 years ]

    Biospecimen Retention:   Samples With DNA
    Blood

    TRIAL NUMBER: A031702

    Title: Phase II Study of Cabozantinib in Combination with Nivolumab and Ipilimumab in Rare Genitourinary Tumors

    Purpose: Primary Outcome Measures :
    Objective response rate (ORR) [ Time Frame: Up to 5 years ] An objective response is defined as a confirmed complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Will be estimated by the number of confirmed objective responses divided by the total number of evaluable patients. Confidence intervals for the true ORR will be calculated.

    Secondary Outcome Measures :
    Duration of response [ Time Frame: From time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years ] Defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented.
    Progression-free survival (PFS) [ Time Frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years ] The median its 95% confidence interval will be determined and will be summarized using the Kaplan-Meier estimator.
    Overall survival [ Time Frame: Up to 5 years ] The median its 95% confidence interval will be determined and will be summarized using the Kaplan-Meier estimator.
    Clinical benefit rate (CBR) [ Time Frame: Up to 5 years ] A confirmed clinical benefit is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart or a confirmed stable disease at two consecutive tumor assessments at least 3 months apart. The CBR will be estimated by the number of patients with confirmed clinical benefit divided by the total number of evaluable patients. Confidence intervals for the true CBR will be calculated using exact binomial confidence intervals.
    Incidence of adverse events (AE) [ Time Frame: Up to 5 years ] Will be assessed using Common Terminology Criteria for Adverse Events version 5.0. The maximum of a particular AE will be determined for each patient. Tables will summarize the number and relative frequency of patients observing an AE as well as the number and relative frequency of patients experiencing any AE of grade 3 or greater.

    Other Outcome Measures:
    Effects of treatment in patients with bone-only disease [ Time Frame: Up to 5 years ] The bone-only tumor patients will be evaluated in an exploratory fashion (if no RECIST measurements are available). A maximum of 15 patients with bone-only disease will be enrolled and evaluated using PFS for a descriptive analysis of the effect of treatment.

    TRIAL NUMBER: WF-1802

    Title: Influence of Primary Treatment for Prostate Cancer on Work Experience (PCW)

    Purpose: The objective of this study is to examine how adenocarcinoma of the prostate treatment differentially affects African American men's ability to work and to describe and compare changes in work ability (as measured through self-reported global work ability item) reported by African American and white adenocarcinoma of the prostate survivors before treatment and 6 months after treatment completion.

    TRIAL NUMBER: ChemoID

    Title: STANDARD CHEMOTHERAPY VERSUS CANCER STEM CELL ASSAY DIRECTED CHEMOTHERAPY IN RECURRENT PLATINUM RESISTANT OVARIAN CANCER

    Purpose:

    Primary Outcome Measures :
    1. Objective response rate [ Time Frame: 24 months ]
      Objective response rate (ORR) as measured by RECIST version 1.1 criteria in recurrent EOC patients who have had ChemoID-guided treatment versus physician choice control treatment (chemotherapy chosen by the physician from the provided list).


    Secondary Outcome Measures :
    1. Progression Free Survival (PFS) [ Time Frame: 24 months ]
      Progression free survival (PFS) in patients with recurrent epithelial ovarian cancer (EOC) who receive standard of care treatment (chemotherapy chosen by the physician from the provided list) versus ChemoID drug response assay-directed chemotherapy.

    2. Duration of Response [ Time Frame: 24 months ]
      Duration of Response (DOR) in patients with recurrent epithelial ovarian cancer (EOC) who receive standard of care treatment (chemotherapy chosen by the physician from the provided list) versus ChemoID drug response assay-directed chemotherapy.

    3. CA125 levels [ Time Frame: 24 months ]
      Levels of CA125 in patients with recurrent epithelial ovarian cancer (EOC) who receive standard of care treatment (chemotherapy chosen by the physician from the provided list) versus ChemoID drug response assay-directed chemotherapy.

    4. Health-Related Quality of Life (HRQOL) [ Time Frame: 24 months ]
      Health-Related Quality of Life (HRQOL) measured to ChemoID-guided treatment selection vs. standard chemotherapy chosen by the physician using self-reported and validated questionnaires, addressing physical, psychological, emotional, and social issues.

    TRIAL NUMBER: NRG-GY006

    Title: A Randomized Phase II Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer

    Purpose: This randomized phase II trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal cancer.

    TRIAL NUMBER: NRG-GY019

    Title: A RANDOMIZED PHASE III, TWO-ARM TRIAL OF PACLITAXEL/CARBOPLATIN/MAINTENANCE LETROZOLE VERSUS LETROZOLE MONOTHERAPY IN PATIENTS WITH STAGE II-IV, PRIMARY LOW-GRADE SEROUS CARCINOMA OF THE OVARY OR PERITONEUM

    Purpose:

    Primary Outcome Measures :
    1. Progression-free survival (PFS) [ Time Frame: Time from the randomized treatment assignment to documentation of disease progression (Response Evaluation Criteria in Solid Tumors 1.1) or death from any cause, whichever comes first, assessed up to 8 years ]
      The PFS comparison will be assessed at the second interim and final analyses using a logrank test stratified by country and residual disease status. Estimates for the letrozole/letrozole (L/L) vs paclitaxel/carboplatin/letrozole (CT/L) hazard ratio and its confidence interval will be obtained using a stratified Cox proportional hazards model. Potential confounding factors, including the stratification factors, performance status and self-declared racial designation will be considered in a final exploratory model. A forest plot of treatment hazard ratios with confidence intervals within subgroups will also be reported. PFS will be characterized by treatment group with Kaplan-Meier plots and estimates of the median PFS.


    Secondary Outcome Measures :
    1. Incidence of adverse events (AE) [ Time Frame: Up to 8 years ]
      The nature, frequency and degree of toxicity will be tabulated at the System Organ Class and AE Term levels using Common Terminology Criteria for Adverse Events version 5.0. Each patient will be represented according the maximum grade observed for each term, within randomized treatment assignment. Tabulations will show the number and percentage of patients by maximum grade, within their randomized treatment assignment.

    2. Objective response rate (ORR) [ Time Frame: Up to 8 years ]
      Will be estimated as the binomial proportion of patients with best overall response of complete response (CR) or partial response (PR) among patients with measurable disease after cytoreductive surgery. Response rates and their 95% Wilson-Score confidence intervals will be estimated for each treatment arm, using the randomized treatment assignment. The odds-ratio for ORR in the L/L vs CT/L arms will be estimated from the multivariable logistic regression model adjusted for stratification factors.

    3. Duration of response [ Time Frame: Time from documentation of response under documentation of progression or death, which is observed first, assessed up to 8 years ]
      Will be defined among patients with best overall response of CR or PR. Comparison of response duration between the randomized treatment arms will be supported by Kaplan Meier methods, and the corresponding estimates for median duration and its 95% confidence intervals.

    4. Overall survival (OS) [ Time Frame: Time between randomization and death from any cause, assessed up to 8 years ]
      Differences in OS across the randomized treatment groups will be assessed using Kaplan Meier methods, with median time to death estimates and the corresponding 95% confidence intervals. The L/L vs CT/L hazard ratio will be estimated by a proportional hazards model stratified by the randomization stratification factors.

    5. Adherence to letrozole maintenance therapy [ Time Frame: At cycles 1, 6, and 12 ]
      Will be quantified as the mean rate of adherence (MRA), calculated as the proportion of product not returned divided by the number of days since the previous visit at which study products were dispensed. Currently, the letrozole is delivered in a 2.5 mg pill, and the recommended dose is 2.5 mg per day. This outcome will be computed for each treatment cycle (generally 21 days). The mean MRA will be compared between the randomized treatment groups using linear mixed model methods. The model will be specified with a random patient effect, and fixed effects for randomized treatment indicator, time (cycle number) and the interaction, with an adjustment for the protocol stratification factors. Primary interest is in the difference in mean (MRA) at cycles 1, 6 and 12 between the treatment group. The results will be reported as the estimated mean (MRA) and 95% confidence intervals for each treatment/time combination. Treatment differences within stratification factors may also be considered.

    TRIAL NUMBER: EA3132

    Title: EA3132:Phase II Randomized Trial of Radiotherapy with or Without Cisplatin for Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) with TP53 Sequencing

    Purpose: This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known if radiation therapy is more effective with or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.

    TRIAL NUMBER: A031704

    Title: PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab Vs. VEGF TKI Cabozantinib with Nivolumab: A Phase III Trial in Metastatic Untreated REnal Cell CancEr [PDIGREE]

    Purpose: This phase III trial studies how well nivolumab and ipilimumab, followed by nivolumab versus cabozantinib and nivolumab, work in treating patients with renal cell cancer that is untreated and has spread to other parts of the body. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cabozantinib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known how well cabozantinib and nivolumab work in treating patients with untreated renal cell cancer that has spread to other parts of the body.

    TRIAL NUMBER: A081801

    Title: INTEGRATION OF IMMUNOTHERAPY INTO ADJUVANT THERAPY FOR RESECTED NSCLC: ALCHEMIST CHEMO-IO

    Purpose:

    Primary Outcome Measures :
    1. Disease free survival (DFS) [ Time Frame: From randomization to the first of either disease recurrence or death from any cause, assessed up to 5 years after accrual completion ]
      Will be estimated using the Kaplan-Meier method, where the stratified log-rank test will be used to compare the distributions across the treatment arms. DFS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals.

    2. Overall survival (OS) [ Time Frame: From randomization to death from any cause, assessed up to 8 years after accrual completion ]
      Will be estimated using the Kaplan-Meier method, where the stratified log-rank test will be used to compare the distributions across the treatment arms. OS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals.


    Secondary Outcome Measures :
    1. DFS between combination pembrolizumab with standard of care vs. sequential pembrolizumab [ Time Frame: From randomization to the first of either disease recurrence or death from any cause, assessed up to 5 years after accrual completion ]
    2. OS between combination pembrolizumab with standard of care vs. sequential pembrolizumab [ Time Frame: From randomization to death from any cause, assessed up to 8 years after accrual completion ]
    3. Incidence of adverse events [ Time Frame: Up to 10 years ]
      The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5. The frequency and percentage of grade 3+ adverse events will be compared between the 2 experimental treatment arms and the control as well as between the two experimental arms. We will also compare the rate of drug discontinuation due to adverse events between the experimental treatment arms and control, and between the two experimental arms. Comparisons between arms will be made by using the Chi-square test. Analysis of the overall adverse event rates, as well as specific events of interest will involve Chi-square tests or Fisher's exact tests.

    4. DFS between each experimental pembrolizumab plus standard of care arms vs. standard of care by PD-L1 expression status [ Time Frame: From randomization to the first of either disease recurrence or death from any cause, assessed up to 5 years after accrual completion ]
      Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be used as the primary analytical method, where all baseline covariates will be considered in the univariable models and subsequently in the multivariable models based on the criteria for selection for the multivariable models.

    5. OS between each experimental pembrolizumab plus standard of care arms vs. standard of care by PD-L1 expression status [ Time Frame: From randomization to death from any cause, assessed up to 8 years after accrual completion ]
      Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be used as the primary analytical method, where all baseline covariates will be considered in the univariable models and subsequently in the multivariable models based on the criteria for selection for the multivariable models.

    TRIAL NUMBER: A151216

    Title: Genetic Testing For Patients with Resectable or Resected Lung Cancer: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

    Purpose: PRIMARY OBJECTIVES:
    I. To centrally genotype resected lung adenocarcinomas for epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma receptor tyrosine kinase (ALK) rearrangements to facilitate accrual to randomized adjuvant studies.
    II. To obtain clinically annotated tumor tissue and patient-matched non-malignant deoxyribonucleic acid (DNA) from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow clinically annotated advanced genomic analyses in concert with the National Cancer Institute (NCI) Center for Cancer Genomics (CCG).
    SECONDARY OBJECTIVES:
    I. To characterize the natural history of EGFR and ALK wild-type lung cancers to allow subsequent development of targeted therapies against genotype-defined sub-populations in the adjuvant and recurrent settings.
    II. To cross-validate local genotyping assays for EGFR and ALK with a central reference standard.
    TERTIARY OBJECTIVES:
    I. To study the genomic evolution of lung cancers by comparing genomic characteristics at resection and at recurrence.
    OUTLINE:
    Patients undergo collection of blood and tissue samples for EGFR and ALK testing via direct sequencing and fluorescence in situ hybridization (FISH). Patients that have had surgery prior to pre-registration will submit samples from the previous surgery for testing.
    After completion of study, patients that are not enrolled on either A081105 or E4512 are followed up every 6 months for 5 years.

    TRIAL NUMBER: A171901

    Title: Older Non-Small Cell Lung Cancer Patients (>/= 70 Years of Age) Treated With First-Line MK-3475 (Pembrolizumab)+/- Chemotherapy (Oncologist's/Patient's Choice)

    Purpose: This trial studies the side effects of pembrolizumab with or without chemotherapy in treating patients with stage IV non-small cell lung cancer that has come back (recurrent) and has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with or without chemotherapy may shrink the tumor in older patients with non-small cell lung cancer.

    TRIAL NUMBER: EA5163

    Title: EA5163/S1709 INSIGNA : A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-Driven Analysis

    Purpose: Primary Outcome Measures : Overall survival (OS) [ Time Frame: From randomization to death from any cause, assessed up to 5 years post treatment ] OS distributions will be estimated using the Kaplan-Meier method.

    Secondary Outcome Measures : Progression-free survival (PFS) [ Time Frame: From randomization to documented disease progression or death from any cause, assessed up to 5 years post treatment ] PFS distributions will be estimated using the Kaplan-Meier method.
    Best objective response [ Time Frame: Up to 5 years post treatment ] Best objective response will be evaluated via Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
    Incidence of adverse events [ Time Frame: Up to 30 days post treatment ] Toxicities will be reported via the Common Terminology Criteria for Adverse Events (CTCAE) criteria version 5.0. Toxicity rates between arms in the overall population will be compared using Fisher's exact tests with a one-sided type I error rate of 1.25%; multivariable logistic regression modeling will be used to adjust for the effect of any covariates that are associated with these categorical outcomes.
    PD-L1 positivity [ Time Frame: At baseline ] PD-L1 positivity will be defined as >= 1% Tumor Proportion Score (TPS) for the purpose of enrollment onto the trial. Strongly PD-L1 positive is defined as >= 50% TPS; weakly positive is defined as 1% - 49% TPS.

    TRIAL NUMBER: LungMAP

    Title: LungMAP: A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)

    Purpose: 1.1 Primary Objective of the Master Protocol (LungMAP) The primary objective of this screening study is to test patient specimens to determine eligibility for participation in the biomarker-driven and non-matched sub-studies included within the Lung-MAP umbrella protocol. 1.2 Secondary Objectives a. Screening Success Rate Objective To evaluate the screen success rate defined as the percentage of screened patients that register for a therapeutic sub-study. Screen success rates will be evaluated for the total screened population and by the subset of patients screened following progression on previous therapy or pre-screened on current therapy. b. Translational Medicine Objectives 1. To evaluate circulating tumor DNA (ctDNA) and compare to the FMI Foundation tissue molecular profiling results in patients who submit a new biopsy for screening. 2. To establish a tissue/blood repository

    TRIAL NUMBER: RTOG-1308

    Title: RTOG-1308:PHASE III RANDOMIZED TRIAL COMPARING OVERALL SURVIVAL AFTER PHOTON VERSUS PROTON CHEMORADIOTHERAPY FOR INOPERABLE STAGE II-IIIB NSCLC

    Purpose: This randomized phase III trial studies proton chemoradiotherapy to see how well it works compared to photon chemoradiotherapy in treating patients with stage II-III non-small cell lung cancer that cannot be removed by surgery. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor, such as photon or proton beam radiation therapy, may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether proton chemoradiotherapy is more effective than photon chemoradiotherapy in treating non-small cell lung cancer.

    TRIAL NUMBER: S1827

    Title: A RANDOMIZED PHASE III TRIAL OF MRI SURVEILLANCE WITH OR WITHOUT PROPHYLACTIC CRANIAL IRRADIATION (PCI) IN SMALL-CELL LUNG CANCER

    Purpose:

    Primary Outcome Measures :
    1. Overall survival (OS) [ Time Frame: From the date of registration to date of death due to any cause, assessed up to 2 years after randomization ]
      Will evaluate OS with magnetic resonance imaging (MRI) surveillance alone and MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC).


    Secondary Outcome Measures :
    1. Cognitive failure-free survival (CFFS) [ Time Frame: Baseline to first neurocognitive failure CF or death due to any cause, assessed up to 12 months after randomization ]
      The comparison of CFFS up to 12 months between the arms will be done using a 1-sided 5% level log-rank test.

    2. CFFS rate [ Time Frame: Baseline to first neurocognitive failure CF or death due to any cause, assessed at 90, 180, 270, 360, 540, and 720 days after randomization ]
      There will be a comparison of the CFFS rates between the arms at each of the assessment times and the cumulative incidence of cognitive failure, evaluating death as a competing risk. The CFFS rates at the landmark times will be estimated using the method of Kaplan-Meier and the difference in rates will be evaluated using a 90% confidence interval using Greenwood?s formula.

    3. Cumulative incidence of cognitive failure [ Time Frame: Neurocognitive function test will be assessed at 90, 180, 270, 360, 540, and 720 days after randomization ]
      The cumulative incidence of cognitive failure in the presence of the competing risk of death will be estimated used the method of Fine and Gray.

    4. OS in an "as-treated" analysis [ Time Frame: From the date of registration to date of death due to any cause, assessed up to 2 years after randomization. Patients will be seen at day 90, 180, 270, 360, 540, and 720 ]
      The comparison of OS in the ?as-treated? analysis will be done as described for the primary analysis, however patients will be categorized per treatment received (patients who do not accept their randomized assignment will be analyzed per treatment received). The number of patients not accepting the randomized assignment will also be summarized.

    5. Brain metastases-free survival (BMFS) [ Time Frame: Up to 2 years after randomization. Patients will have MRI on day 90, 180, 270, 360, 540, and 720 ]
      This will be estimated using the method of Kaplan-Meier and comparisons will be done using a log-rank test at the 1-sided 0.05 level. Hazard ratios and associated confidence intervals will be estimated using a Cox Proportional hazards model. Confidence intervals for medians will be estimated using the method of Brookmeyer-Crowley.

    6. Incidence of adverse events [ Time Frame: Up to 2 years after randomization. Patients will be assessed for adverse event after PCI (for patients on PCI + MRI arm) and at month 3 (all patients) ]
      Binary proportions and associated confidence intervals will be estimated.

    TRIAL NUMBER: A231601CD

    Title: A231601CD: Improving Surgical Care and Outcomes in Older Cancer Patients Through Implementation of an Efficient Pre-Surgical Toolkit (OPTI-Surg)

    Purpose: This trial studies how well the use of a pre-surgical toolkit (OPTI-Surg) works in improving surgical care and outcomes in older participants with cancer. In many elderly patients, surgery can greatly affect physical condition and the ability to return to pre-surgery levels of physical functioning. Providing pre-surgical recommendations may help improve participants' recovery rate and functioning after surgery.

    TRIAL NUMBER: S1609

    Title: SWOG 1609: DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors Treatment with Ipilimumab and Nivolumab for Rare Cancers

    Purpose: Both Ipilimumab and Nivolumab have already been FDA-approved to treat other cancers. However, Ipilimumab and Nivolumab are investigational and not FDA-approved for use in combination in treating rare cancers or cancers of unknown primary origin.

    TRIAL NUMBER: S1714

    Title: A PROSPECTIVE OBSERVATIONAL COHORT STUDY TO DEVELOP A PREDICTIVE MODEL OF TAXANE-INDUCED PERIPHERAL NEUROPATHY IN CANCER PATIENTS

    Purpose: 1.1 Primary Objective a. To develop and validate a clinical risk prediction model using clinical factors for the development of peripheral neuropathy in patients receiving taxane-based chemotherapy regimens. 1.2 Secondary Objectives a. To examine patient-reported outcomes (PROs) and objective measures of chemotherapy induced peripheral neuropathy (CIPN) to better define the phenotype of peripheral neuropathy in this patient population. b. To assess the incidence of CIPN within one year in this patient population. c. To identify predictors of treatment dose reductions, delays, and discontinuations associated with CIPN symptoms in this patient population. 1.3 Other Objectives a. To collect serum and plasma samples for future testing for biomarker and mechanistic studies of CIPN.

    TRIAL NUMBER: 10323(MOONSHOT)

    Title: Cancer Moonshot Biobank Research Protocol

    Purpose: This trial collects multiple tissue and blood samples, along with medical information, from cancer patients. The "Cancer Moonshot Biobank" is a longitudinal study. This means it collects and stores samples and information over time, throughout the course of a patient's cancer treatment. By looking at samples and information collected from the same people over time, researchers hope to better understand how cancer changes over time and over the course of medical treatments.

    TRIAL NUMBER: A151804

    Title: Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

    Purpose: This trial collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects.

    TRIAL NUMBER: S1803

    Title: S1803; Phase III Study of Daratumumab/rHuPH20 (NSC- 810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)

    Purpose: Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years.

    TRIAL NUMBER: COVID-19 Biospecimen

    Title: COVID-19 Biospecimen Collection

    Purpose:

    TRIAL NUMBER: URCC-21038

    Title: Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated with anti-PD-1/anti-PD-L1 Immunotherapy in a Community Oncology Setting

    Purpose:

    This is a Prospective Observational Cohort Study, designed specifically to investigate racial differences in toxicities and treatment outcomes of cancer patients treated with immune checkpoint inhibitors (ICIs).

    TRIAL NUMBER: EA8171

    Title: EA8171:Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer

    Purpose: This phase II trial studies how well multiparametric magnetic resonance imaging (MRI) works in evaluating cancer stage and helping treatment planning in patients with prostate cancer. Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive disease.

    TRIAL NUMBER: NRG-GU002

    Title: NRG-GU002: PHASE II-III TRIAL OF ADJUVANT RADIOTHERAPY AND ANDROGEN DEPRIVATION FOLLOWING RADICAL PROSTATECTOMY WITH OR WITHOUT ADJUVANT DOCETAXEL

    Purpose: This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.

    TRIAL NUMBER: NRG-GU008

    Title: RANDOMIZED PHASE III TRIAL INCORPORATING ABIRATERONE ACETATE WITH PREDNISONE AND APALUTAMIDE AND ADVANCED IMAGING INTO SALVAGE TREATMENT FOR PATIENTS WITH NODE-POSITIVE PROSTATE CANCER AFTER RADICAL PROSTATECTOMY

    Purpose:

    TRIAL NUMBER: RTOG-3506

    Title: RTOG 3506; A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery (STEEL)

    Purpose: Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive disease features will receive salvage radiation therapy and standard androgen deprivation therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free survival when enhanced ADT is used compared to standard ADT.

    TRIAL NUMBER: S1802

    Title: S1802: Phase III Randomized Trial of Standard Systemic Therapy (SST) versus Standard Systemic Therapy plus Definitive treatment (surgery or radiation) of the primary tumor in Metastatic Prostate Cancer

    Purpose: This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

    TRIAL NUMBER: A031801

    Title: A PHASE II RANDOMIZED TRIAL OF RADIUM-223 DICHLORIDE AND CABOZANTINIB IN PATIENTS WITH ADVANCED RENAL CELL CARCINOMA WITH BONE METASTASIS (RADICAL)

    Purpose:

    Primary Outcome Measures :
    1. Symptomatic skeletal event (SSE)-free survival (FS) [ Time Frame: From the date of randomization to the date of the earliest occurrence of SSE or death from any cause, assessed up to 5 years ]
      SSE-FS distribution will be estimated using the method of Kaplan-Meier by treatment arm. Comparison between the two arms will be performed using a one-sided log-rank test and one-sided p-value less than 0.025 will indicate that the experimental arm is superior to the control arm. SSE-FS will be censored at the date of last SSE assessment for those alive and SSE free. Hazard ratio (experimental over control arm) as well as two-sided 90% confidence interval (CI) for treatment will be estimated using the stratified Cox proportional hazard model with a single treatment covariate.


    Secondary Outcome Measures :
    1. Incidence of adverse events [ Time Frame: Up to 5 years ]
      Will be determined using Common Terminology Criteria for Adverse Events version 5.0. Adverse events will be summarized and compared between arms using chi-square or fisher exact tests as appropriate.

    2. SSE-FS [ Time Frame: From randomization to the date of SSE or death due to any cause, whichever comes first, assessed up to 5 years ]
      Will be estimated with the Kaplan Meier methodology. Comparison between arms or between predefined groups will be conducted using the log-rank test.

    3. Progression-free survival [ Time Frame: From randomization to time of radiographic progression or death due to any cause, whichever occurs first, assessed up to 5 years ]
      Radiographic progression will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Will be estimated with the Kaplan Meier methodology. Comparison between arms or between predefined groups will be conducted using the log-rank test.

    4. Overall survival [ Time Frame: From randomization to the date of death due to any cause, assessed up to 5 years ]
      Will be estimated with the Kaplan Meier methodology. Comparison between arms or between predefined groups will be conducted using the log-rank test. Patients who are alive will be censored at last follow up date.

    5. Time to first SSE [ Time Frame: From randomization to the date of first SSE or death due to any cause, assessed up to 5 years ]
      Will be determined in each treatment. The median estimate to first SSE-FS will be calculated.

    6. Overall response rate (ORR) [ Time Frame: Up to 5 years ]
      Will be defined by RECIST version 1.1. Number and proportion of patients achieving ORR (by RECIST) will be summarized with two-sided 90% CI by treatment arm; comparison between arms will be conducted using chi-square or Fisher's exact test as appropriate.

    TRIAL NUMBER: S1931

    Title: Phase III Trial of Immunotherapy-Based Combination Therapy With or Without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (PROBE Trial)

    Purpose: This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer.

    TRIAL NUMBER: A031901

    Title: A031901, Duration of Immune Checkpoint Therapy in Locally Advanced or Metastatic Urothelial Carcinoma: A Randomized Phase 3 Non-Inferiority Trial

    Purpose: This phase III trial compares survival in urothelial cancer patients who stop immune checkpoint inhibitor treatment after being treated for about a year to those patients who continue treatment with immune checkpoint inhibitors. Immunotherapy with monoclonal antibodies, such as avelumab, durvalumab, pembrolizumab, atezolizumab, and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stopping immune checkpoint inhibitors early may still make the tumor shrink and patients may have similar survival rates as the patients who continue treatment. Stopping treatment early may also lead to fewer treatment-related side effects, an improvement in mental health, and a lower cost burden to patients.

    TRIAL NUMBER: EA8192

    Title: A Phase II/III trial of MEDI4736 (Durvalumab) and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

    Purpose: This phase III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.

    TRIAL NUMBER: S2011

    Title: Randomized Phase II Trial of Gemcitabine, Avelumab and Carboplatin vs. No Neoadjuvant Therapy Preceding Surgery for Cisplatin-Ineligible Muscle-Invasive Urothelial Carcinoma: SWOG GAP TRIAL

    Purpose: This phase II trial studies the effect of avelumab, gemcitabine and carboplatin before surgery compared with surgery alone in treating patients with muscle invasive bladder or upper urinary tract cancer who are not able to receive cisplatin therapy. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving avelumab together with gemcitabine and carboplatin before surgery may work better in lowering the chance of muscle invasive urinary tract cancer growing or spreading, in patients who cannot receive cisplatin therapy compared to surgery alone.

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    TRIAL NUMBER: EA2176

    Title: A Randomized Phase III Study of Immune Checkpoint Inhibition with Chemotherapy in Treatment-Naïve Metastatic Anal Cancer Patients

    Purpose:

    Primary Outcome Measures :
    1. Progression-free survival [ Time Frame: Up to 2 years ]
      Defined as the first of progressive disease or death due to any cause. Analyzed using a stratified two-sided overall 0.05 level log-rank test. Will utilize standard Eastern Cooperative Oncology Group -American College of Radiology Imaging Network interim monitoring for efficacy evaluation.


    Secondary Outcome Measures :
    1. Objective response rate (ORR) [ Time Frame: Up to 2 years ]
      ORR is the ratio of the number of patients with a complete response or partial response, as defined by Response Evaluation Criteria in Solid Tumors version 1.1, to the total number of treated patients.

    2. Overall survival [ Time Frame: Time between treatment randomization and death by any cause, assessed up to 2 years ]
      Evaluated by a stratified log-rank test, and using a two-sided 0.05 level Cochran Mantel-Haenzel.

    3. Incidence of adverse events [ Time Frame: Up to 2 years ]
      Analyses of toxicity will be via frequency tabulations and percentages by worst degree of toxicity and comparisons will be done via chi-square or Fisher's exact tests as appropriate.

    TRIAL NUMBER: A071401

    Title: PHASE II TRIAL OF SMO/AKT/NF2 INHIBITORS IN PROGRESSIVE MENINGIOMAS WITH SMO/AKT/NF2 MUTATIONS

    Purpose: Each arm is a prospective, one-stage phase 2 study evaluating the efficacy of smoothened receptor SMO or FAK inhibitors in patients with SMO-mutated or neurofibromin 2 (NF2)-mutated meningiomas, respectively. There will be a separate phase 2 arm for each of the two tumor mutation groups and each tumor grade cohort. Patients with recurrent or progressive Grade I-III meningiomas will be eligible for this trial. Samples will undergo central pathology review. Patient's tumor samples will be tested for the presence of SMO or NF2 mutations. Patients harboring SMO or NF2 mutations and who meet eligibility criteria will be enrolled. Within each arm, there will be two different patient cohorts based on histology: grade I versus II/III meningiomas.
    The primary and secondary objectives are described below.
    Primary objectives: 1.To determine the activity of a SMO inhibitor in patients with meningiomas harboring SMO mutations as measured by 6-month progression free survival (PFS) and response rate. 2.To determine the activity of a FAK inhibitor in patients with meningiomas harboring NF2 mutations as measured by 6-month PFS and response rate.
    Secondary objectives: 1.To determine overall survival and progression-free survival of SMO and FAK inhibitors in patients with meningioma. 2.To determine adverse event rates of SMO and FAK inhibitors in patients with meningioma.
    NOTE: Afuresertib, the agent identified for patients with AKT1 mutation is not currently available. Testing for the AKT1 mutation will commence once afuresertib becomes available and sites are notified via a protocol amendment. Tumor samples will only be tested for SMO and NF2 mutations until further notice.
    Patients will be followed for 2 years after completion of treatment.

    TRIAL NUMBER: A071701

    Title: Genomically-Guided Treatment Trial in Brain Metastases

    Purpose:

    Primary Outcome Measures :
    1. Objective response rate in the brain [ Time Frame: Up to 5 years ]
      Assessed per Response Assessment in Neuro-Oncology (RANO) criteria for brain metastases. The response rate is defined as the number of patients who have achieved complete response (CR) or partial response (PR) per RANO for brain metastases criteria during treatment with CDK, PI3K, or NTRK/ROS inhibitors divided by total number of evaluable patients. The response rate and associated exact confidence interval will be estimated within each cohort defined by the targeted agent and histology.


    Secondary Outcome Measures :
    1. Systemic response for extracranial disease [ Time Frame: Up to 5 years ]
      Assessed with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Will be estimated using the systemic response rate (SRR) - where SRR is defined as the number of evaluable patients achieving a response (PR or CR per RECIST 1.1) during treatment with study therapy divided by the total number of evaluable patients. Point estimates will be generated for systemic response rates within each cohort with corresponding 95% binomial confidence intervals.

    2. Clinical benefit rate for central nervous system (CNS) [ Time Frame: Up to 5 years ]
      Evaluated by Response Assessment in Neuro-Oncology (RANO) criteria. Will be estimated as the number of evaluable patients achieving stable disease (SD), partial response (PR), or complete response (CR) as their best objective response during treatment with protocol therapy divided by the total number of evaluable patients. Point estimates will be generated for clinical benefit rates within each cohort with corresponding 95% binomial confidence intervals.

    3. Clinical benefit rate for extracranial disease [ Time Frame: Up to 5 years ]
      Assessed by Response Evaluation Criteria in Solid Tumors (RECIST). Will be estimated as the number of evaluable patients achieving stable disease (SD), partial response (PR), or complete response (CR) as their best objective response (per RECIST for extracranial disease) during treatment with protocol therapy divided by the total number of evaluable patients. Point estimates will be generated for clinical benefit rates within each cohort with corresponding 95% binomial confidence intervals.

    4. Duration of response for brain metastases [ Time Frame: From the time measurement criteria are met for CR or PR for brain metastases until the first date that progressive CNS disease or death is documented, assessed up to 5 years ]
      Duration of response for brain metastases is defined for all evaluable patients who have achieved a confirmed response as the time from the date at which the patient's objective status for brain metastases is first noted to be a CR or PR (per Response Assessment in Neuro-Oncology [RANO] for brain metastases) to the date of the earliest progressive CNS disease is documented or death. The median and 95% confidence intervals will be estimated using the Kaplan-Meier estimator. No formal comparison will be made among the cohorts.

    5. Duration of response for extracranial disease [ Time Frame: From the time measurement criteria are met for CR or PR for extracranial disease until the first date that progressive disease for extracranial disease or death is documented, assessed up to 5 years ]
      Duration of response for extracranial disease is defined for all evaluable patients who have achieved a confirmed response as the time from the date at which the patient's objective status for extranial disease is first noted to be a CR or PR (per RECIST1.1) to the date of the earliest progression (PD) for extracranial disease is documented or death. The median and 95% confidence intervals will be estimated using the Kaplan-Meier estimator. No formal comparison will be made among the cohorts.

    6. Progression-free survival (PFS) - intracranial [ Time Frame: From first day of study treatment to the earliest date documentation of intracranial disease progression or death from any cause, assessed up to 5 years ]
      Intracranial PFS is defined as the time from the first day of study treatment to the earliest date of intracranial disease progression (per RANO for brain metastases) or death from any cause, whichever comes first. The median and 95% confidence intervals will be estimated using the Kaplan-Meier estimator. No formal comparison will be made among the cohorts.

    7. Progression-free survival (PFS) - extracranial [ Time Frame: From the first day of study treatment to the earliest date of documentation of extracranial disease progression or death from any cause, assessed up to 5 years ]
      Extracranial PFS is defined as the time from the first day of study treatment to the earliest date of extracranial disease progression (per RECIST1.1) or death from any cause, whichever comes first. The median and 95% confidence intervals will be estimated using the Kaplan-Meier estimator. No formal comparison will be made among the cohorts.

    8. Site of first progression [ Time Frame: Up to 24 months ]
      The site of first progression will be estimated descriptively within each cohort within 12 and 24 months after starting protocol treatment. The first progression is defined as the first documented central nervous system (CNS) progression per Response Assessment in Neuro-Oncology (RANO) or extracranial progression per Response Evaluation Criteria in Solid Tumors (RECIST), whichever occurs first. The percentage of extracranial progression at first progression within 12 and 24 months after starting protocol treatment will be estimated as number of patients who experience the first progression which is extracranial progression divided by number of patients who are still at risk up to 12 and 24 months, respectively.

    9. Overall survival [ Time Frame: From the first day of study treatment to death due to any cause, assessed up to 5 years ]
      Overall survival is defined as the time from the first day of study treatment to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. No formal comparison will be made among the cohorts.

    10. Incidence of adverse events [ Time Frame: Up to 5 years ]
      Assessed per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, toxicity is defined as adverse events that are classified as possibly, probably, or definitely related to study treatment. Toxicities will be evaluated via the ordinal CTCAE standard toxicity grading. Overall toxicity incidence as well as toxicity profiles by patient and treatment cohort will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of the analysis. No formal comparison will be made among the cohorts.

    TRIAL NUMBER: CG01 GBM

    Title: Standard Chemotherapy versus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients with Recurrent Glioblastoma Multiforme (GBM)

    Purpose:

    The purpose of this clinical study is to confirm the utility of chemosensitivity tumor testing on cancer stem cells (ChemoID) as a predictor of clinical response in poor prognosis malignant brain tumors such as recurrent glioblastoma (GBM).

    This study is designed as a parallel group randomized controlled clinical trial to determine if recurrent Glioblastoma (GBM) patients treated with drugs predicted by the ChemoID assay will have better outcomes than patients treated with standard-of-care control therapy chosen by the Physician.

    Upon obtaining informed consent, all eligible participants affected by recurrent GBM will have a tumor biopsy to undergo ChemoID drug response testing with multiple FDA-approved chemotherapeutic agents.

    Eligible participants will be randomized to a standard treatment arm with control treatment (chemotherapy chosen by the Physician from a provided list), or to a study arm of FDA-approved drugs selected by the ChemoID drug response assay.

    TRIAL NUMBER: Southeastern Study of Cancer and the Environment

    Title: Southeastern Study of Cancer and the Environment

    Purpose: STUDY PURPOSE - The purpose of the research is to provide new information on genetic and environmental risk factors for adult-onset glioma and meningioma. Such information is relevant to prevention and treatment. STUDY DESIGN – The study is a multi-institutional, clinic-based case-control study of genetic and environmental risk factors for adult-onset brain tumors (glioma and meningioma). Cases (brain tumor patients) will be identified at leading brain tumor treatment centers and several neurosurgical/neuro-oncology practices in the southeastern US. Community controls will be identified by a survey research firm (SDR Sampling Services - Atlanta, Georgia) with individual matching on age, gender, zipcode and season of enrollment. The second control group, consisting of friends, relatives and other associates of the case, will be matched on age and gender.

    TRIAL NUMBER: WF-1801

    Title: A Single Arm, Pilot Study of Ramipril for Preventing Radiation-Induced Cognitive Decline in Glioblastoma (GBM) Patients Receiving Brain Radiotherapy

    Purpose: This study is to determine if an oral drug called Ramipril can lower the chance of memory loss in patients with glioblastoma getting chemoradiation. Patients will take Ramipril during chemoradiation and continue until 4 months post-treatment. Memory loss will be assessed using several neurocognitive tests throughout the duration of the study.

    TRIAL NUMBER: A011801

    Title: T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial

    Purpose: This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.

    TRIAL NUMBER: DARE

    Title: A RANDOMIZED, PHASE II TRIAL OF CIRCULATING TUMOR DNAGUIDED SECOND LINE ADJUVANT THERAPY FOR HIGH RESIDUAL RISK, STAGE II-III, ESTROGEN RECEPTOR POSITIVE, HER2 NEGATIVE BREAST CANCER (DARE)

    Purpose: To assess if (i) the incidence of ctDNA positivity in stage II/III R+/HER2- breast cancer patients who are receiving standard of care adjuvant endocrine therapy, (ii) and assess if treatment with palbociclib and fulvestrant improves relapse-free survival (RFS) compared to continued standard of care adjuvant endocrine therapy for stage II/III, ER+/HER2- breast cancer in patients with detectable circulating tumor DNA (ctDNA) in their blood without imaging evidence of metastatic disease. 

    TRIAL NUMBER: EA1151

    Title: Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer

    Purpose: This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.

    TRIAL NUMBER: EA1181

    Title: CompassHER2-pCR: PREOPERATIVE THP AND POSTOPERATIVE HP IN PATIENTS WHO ACHIEVE A PATHOLOGIC COMPLETE RESPONSE PART 1 COMPONENT OF: THE CompassHER2 TRIALS (COMPREHENSIVE USE OF PATHOLOGIC RESPONSE ASSESSMENT TO OPTIMIZE THERAPY IN HER2-POSITIVE BREAST CANCER)

    Purpose:

    Primary Outcome Measures :
    1. Recurrence-free survival (RFS) [ Time Frame: Up to 3 years after end of treatment ]
      Events include recurrence of ipsilateral invasive breast tumor, recurrence of locoregional invasive breast tumor, and distant recurrence. Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and estrogen receptor (ER) status. Greenwood method will be used to estimate the 95% confidence interval for 3-year rate.


    Secondary Outcome Measures :
    1. Invasive disease-free survival (IDFS) [ Time Frame: Up to 3 years after the end of treatment ]
      Events include recurrence of ipsilateral invasive breast tumor, recurrence of locoregional invasive breast tumor, distant recurrence, contralateral invasive breast cancer, and second primary non-breast invasive cancer (other than squamous or basal cell skin cancer). Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and ER status. The analysis will be descriptive and there will be no statistical test.

    2. Distant disease-free survival (DDFS) [ Time Frame: Up to 3 years after the end of treatment ]
      Events include distant recurrence and second primary non-breast invasive cancer (other than squamous or basal cell skin cancer). Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and ER status. The analysis will be descriptive and there will be no statistical test.

    3. Distant relapse-free survival (DRFS) [ Time Frame: U to 3 years after the end of treatment ]
      Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and ER status. The analysis will be descriptive and there will be no statistical test.

    4. Recurrence-free interval (RFI) [ Time Frame: Up to 3 years after the end of treatment ]
      Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and ER status. The analysis will be descriptive and there will be no statistical test.

    5. Overall survival (OS) [ Time Frame: From date of surgery until the date of death from any cause, assessed up to 3 years after the end of treatment ]
      Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and ER status. The analysis will be descriptive and there will be no statistical test.

    6. Event-free survival (EFS) [ Time Frame: Up to 3 years after the end of treatment ]
      Survival curve estimated using Kaplan-Meier method in the overall analysis population and by pretreatment clinical stage and ER status. The analysis will be descriptive and there will be no statistical test.

    7. Incidence of adverse events (AEs) [ Time Frame: Up to 1 week after cycle 4 (all patients) and/or up to cycle 13 post-surgery (Arm A only) (each cycle is 21 days) ]
      Will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. All treatment-emergent and baseline adverse events and hematological/biochemical toxicities based on laboratory measurements, as well as drug related AEs, will be summarized by NCI CTCAE v5.0 worst grade. The incidence of deaths and treatment-emergent serious adverse events (defined as number of patients experiencing the AE divided by all treated patients) will be summarized using binominal proportions and binomial exact 95% confidence intervals. The incidence of adverse events leading to discontinuation of protocol therapy will be summarized and listed as well.

    TRIAL NUMBER: S1703

    Title: S1703; Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored with Serum Tumor Marker Directed Disease Monitoring (STMDDM) versus Usual Care in Patients with Metastatic Hormone Receptor Positive Breast Cancer

    Purpose: To assess whether patients with HER-2 negative, hormone receptor positive, metastatic breast cancer who are monitored with serum tumor marker directed disease monitoring (STMDDM) have non-inferior overall survival compared to patients monitored with usual care.

    TRIAL NUMBER: S1706

    Title: A PHASE II RANDOMIZED TRIAL OF OLAPARIB (NSC-747856) ADMINISTERED CONCURRENTLY WITH RADIOTHERAPY VERSUS RADIOTHERAPY ALONE FOR INFLAMMATORY BREAST CANCER

    Purpose: Primary Outcome Measures : Invasive Disease-Free Survival (IDFS) [ Time Frame: Up to 8 years ] Time from date of registration to date of first invasive recurrence (local, regional or distant), second invasive primary cancer (breast or not), or death due to any cause. Patients last known to be alive who have not experienced recurrence or second primary cancer are censored at their last contact date. Analysis will be on an intent-to-treat basis and will estimate the survival endpoints using the product-limit method of Kaplan and Meier and will compare the time-to-event distributions using log-rank test statistics. Hazard ratios will be calculated from Cox regression analyses. Effect modification by the stratification variables will be tested as interactions with treatment and separate hazard ratios with 95% confidence intervals by major subgroups will be displayed in a forest plot to examine for consistency of the treatment effect over these subgroups. Secondary Outcome Measures : Locoregional Recurrence-Free Interval (Local Disease-Free Interval (LDFI)) [ Time Frame: Up to 8 years ] Time from date of registration to date of invasive local or regional recurrence. Patients last known to be alive without recurrence are censored at their last contact date. Patients with distant recurrence, second primary cancer or death are censored at the time of that event. A competing risk framework will be conducted separating out the event types of locoregional recurrence from distant recurrence and death. Hazard ratios will be calculated from Cox regression analyses. Effect modification by the stratification variables will be tested as interactions with treatment and separate hazard ratios with 95% confidence intervals by major subgroups will be displayed in a forest plot to examine for consistency of the treatment effect over these subgroups. Distant Relapse-Free Survival (Distant Recurrence-Free Survival) [ Time Frame: Up to 8 years ] Time from date of registration to date of invasive distant disease recurrence, second invasive primary cancer (breast or not) or death due to any cause. Patients last known to be alive who have not experienced disease recurrence, or second primary cancer are censored at their last contact date. Overall Survival [ Time Frame: Up to 8 years ] Time from date of registration to date of death due to any cause. Patients last known to be alive are censored at their last contact date.

    TRIAL NUMBER: Seattle Genetics SGNLVA-001

    Title: A phase 1, open-label, dose-escalation study to evaluate the safety and tolerability of SGN-LIV1A in patients with LIV-1-positive metastatic breast cancer

    Purpose: This study will examine the safety and tolerability of SGN-LIV1A in patients with metastatic breast cancer. Increasing doses of SGN-LIV1A will be given every 3 weeks alone or in combination with trastuzumab.

    TRIAL NUMBER: URCC-16070

    Title: Netupitant/Palonosetron Hydrochloride and Dexamethasone With or Without Prochlorperazine or Olanzapine in Improving Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer

    Purpose: This randomized phase III trial studies how well netupitant/palonosetron hydrochloride and dexamethasone with prochlorperazine or olanzapine work compared to netupitant/palonosetron hydrochloride and dexamethasone in improving chemotherapy-induced nausea and vomiting in patients with breast cancer. Antiemetic drugs, such as prochlorperazine and olanzapine, may help lessen nausea and vomiting in patients with breast cancer treated with chemotherapy.

    TRIAL NUMBER: DCP-001

    Title: DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)

    Purpose: The protocol is not a scientific study; rather, a method to implement the screening tool and allow the collection and analyses of expanded data with informed consent. Investigators also enroll patients into NCI-treatment trials. The tool, based on a screening log successfully used within the NCI Community Cancer Centers Program (NCCCP), has been streamlined and integrated into the sites’ workflow by using OPEN. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. Also missing from the existing data is the context of care, within the communities themselves where most cancer and at risk of cancer patients receive care which is the focus of NCORP. The profile of patients accrued to NCI-sponsored clinical trials lacks both racial/ethnic and socioeconomic diversity. Accrued patients tend to be insured, highly educated and of higher socioeconomic means. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. NCORP's clinical trials portfolio includes cancer control, prevention, screening, symptom science, and cancer care delivery research.

    TRIAL NUMBER: DCP-002

    Title: DCP-002 Early Onset Malignancies Initiative (EOMI): Molecular profiling of Breast, Prostate, Colorectal, Liver, Kidney, and Multiple Myeloma among Racially and Ethnically Diverse Populations

    Purpose: The primary objective of the EOMI (Early Onset Malignancy Initiative) is to acquire tissue and blood, and other biospecimens for research purposes from tests performed for clinical care or for research indications on other research protocols to accelerate our understanding of the molecular basis of early onset cancers occurring in racial and/or ethnic minority populations through the application of genome analysis technologies, including large-scale genome sequencing and clinical data analysis.

    TRIAL NUMBER: NRG-GI008

    Title: Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease

    Purpose:
    This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

    TRIAL NUMBER: ChemoID

    Title: STANDARD CHEMOTHERAPY VERSUS CANCER STEM CELL ASSAY DIRECTED CHEMOTHERAPY IN RECURRENT PLATINUM RESISTANT OVARIAN CANCER

    Purpose:

    Primary Outcome Measures :
    1. Objective response rate [ Time Frame: 24 months ]
      Objective response rate (ORR) as measured by RECIST version 1.1 criteria in recurrent EOC patients who have had ChemoID-guided treatment versus physician choice control treatment (chemotherapy chosen by the physician from the provided list).


    Secondary Outcome Measures :
    1. Progression Free Survival (PFS) [ Time Frame: 24 months ]
      Progression free survival (PFS) in patients with recurrent epithelial ovarian cancer (EOC) who receive standard of care treatment (chemotherapy chosen by the physician from the provided list) versus ChemoID drug response assay-directed chemotherapy.

    2. Duration of Response [ Time Frame: 24 months ]
      Duration of Response (DOR) in patients with recurrent epithelial ovarian cancer (EOC) who receive standard of care treatment (chemotherapy chosen by the physician from the provided list) versus ChemoID drug response assay-directed chemotherapy.

    3. CA125 levels [ Time Frame: 24 months ]
      Levels of CA125 in patients with recurrent epithelial ovarian cancer (EOC) who receive standard of care treatment (chemotherapy chosen by the physician from the provided list) versus ChemoID drug response assay-directed chemotherapy.

    4. Health-Related Quality of Life (HRQOL) [ Time Frame: 24 months ]
      Health-Related Quality of Life (HRQOL) measured to ChemoID-guided treatment selection vs. standard chemotherapy chosen by the physician using self-reported and validated questionnaires, addressing physical, psychological, emotional, and social issues.

    TRIAL NUMBER: Iovance Biotherapeutics C-145-04

    Title: A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic, or Persistent Cervical Carcinoma

    Purpose: Prospective, multicenter, single-arm, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145) followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma

    TRIAL NUMBER: NRG-GY006

    Title: A Randomized Phase II Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer

    Purpose: This randomized phase II trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal cancer.

    TRIAL NUMBER: NRG-GY018

    Title: A PHASE III RANDOMIZED, PLACEBO-CONTROLLED STUDY OF PEMBROLIZUMAB (MK-3475, NSC #776864) IN ADDITION TO PACLITAXEL AND CARBOPLATIN FOR MEASURABLE STAGE III OR IVA, STAGE IVB OR RECURRENT ENDOMETRIAL CANCER

    Purpose:

    Primary Outcome Measures :
    1. Progression-free survival (PFS) [ Time Frame: Duration of time from study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 5 years ]
      Will be tested with a stratified log-rank statistic.


    Secondary Outcome Measures :
    1. Incidence of adverse events [ Time Frame: 5 years ]
      Assessed by Common Terminology Criteria for Adverse Events (CTCAE). Toxicities will be screened for differences between treatments by using an exact method or a Chi-Square test. For a given adverse event, each patient will be graded according to the worse grade experienced while on therapy (and within 30 days of treatment). These toxicities will then be divided into two or three categories such as mild, moderate, and severe or mild to moderate versus severe. The rates of severe toxicities may be characterized by risk ratios or odds ratios with confidence intervals (unadjusted for multiplicity). The number of toxicities examined is usually fairly large, so these analyses will be considered exploratory and may be inspected in light of other studies.

    2. Objective tumor response [ Time Frame: 5 years ]
      Assessed by Response Evaluation Criteria for Solid Tumors (RECIST) 1.1.

    3. Duration of objective response [ Time Frame: 5 years ]
      The time difference between the dates of first response and first progression; patients who do not progress are considered censored.

    4. Overall survival (OS) [ Time Frame: Time from study entry to time of death or the date of last contact, assessed up to 5 years ]
    5. Quality of life (QoL) and patient-reported outcomes (PROs) [ Time Frame: 5 years ]
      Measured by the Function Assessment of Cancer Therapy (FACT)-Endometrial Trial Outcome Index (En-TOI), the FACT/Gynecologic Oncology Group (GOG)-Neurotoxicity (Ntx) subscale (short), Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue (short form),the PROMIS-physical function (short form) and a single-item measuring bother from side effects of cancer therapy. A linear mixed model for repeated measures will be used to estimate and compare the mean differences between the treatment groups. Model covariates will include the patients' randomly assigned study treatment, age at enrollment onto the study, pre-treatment quality of life/patient reported outcome score, assessment time and treatment-by-time interaction. The stratification factors will be the same factors included in the clinical primary analysis. Hochberg's step-up multiple testing procedure (Hochberg, 1988) will be used to adjust p-values for each assessment time points estimated from the fitted model.

    6. Incidence of pembrolizumab treatment and self-reported neurotoxicity [ Time Frame: 5 years ]
      Assessed with FACT/GOG-Ntx.

    7. Concordance between Institutional Mismatch repair (MMR) immunohistochemistry (IHC) testing and centralized MMR IHC [ Time Frame: 5 years ]
      Concordance between institutional MMR IHC testing and centralized MMR IHC. The patient's MMR status will be assessed for prognostic value by conducting stratified log-rank tests or Cox Proportional Hazards (PH) modeling when assessing the impact on PFS or OS. When assessing the impact on the probability of response, a logistic regression model will be considered and include other pertinent variables that may influence response. A Cox PH model will be used to assess predictive value of MMR status for regimen efficacy through an interaction term. A similar type of analysis may be attempted with response using logistic regression. The concordance of institutional MMR IHC testing and centralized MMR IHC will be characterized by agreement statistics such as kappa statistics (e.g. Cohen's kappa coefficient).

    8. Effect of pembrolizumab on PFS and OS by PD-L1 IHC [ Time Frame: 5 years ]
      Will assess the effect of pembrolizumab on PFS and OS by PD-L1 IHC (combined positive score [CPS]) within proficient MMR (pMMR) and deficient MMR (dMMR) populations. The effectiveness of pembrolizumab will be compared by PD-L1 status (CPS). A formal test will be conducted by examining the interaction term between pembrolizumab treatment (yes or no) with PD-L1 status. The association between PD-L1 CPS status and MMR status will be assessed with odds ratios. A test may be conducted with a Fisher's Exact Test, and confidence intervals will be provided.

    9. Association between Program Death Ligand 1 (PD-L1) IHC and MMR status [ Time Frame: 5 years ]
      Measures of association between PD-L1 IHC (CPS) and MMR status. The concordance of institutional MMR IHC testing and centralized MMR IHC will be characterized by agreement statistics such as kappa statistics (e.g. Cohen's kappa coefficient).

    TRIAL NUMBER: NRG-GY019

    Title: A RANDOMIZED PHASE III, TWO-ARM TRIAL OF PACLITAXEL/CARBOPLATIN/MAINTENANCE LETROZOLE VERSUS LETROZOLE MONOTHERAPY IN PATIENTS WITH STAGE II-IV, PRIMARY LOW-GRADE SEROUS CARCINOMA OF THE OVARY OR PERITONEUM

    Purpose:

    Primary Outcome Measures :
    1. Progression-free survival (PFS) [ Time Frame: Time from the randomized treatment assignment to documentation of disease progression (Response Evaluation Criteria in Solid Tumors 1.1) or death from any cause, whichever comes first, assessed up to 8 years ]
      The PFS comparison will be assessed at the second interim and final analyses using a logrank test stratified by country and residual disease status. Estimates for the letrozole/letrozole (L/L) vs paclitaxel/carboplatin/letrozole (CT/L) hazard ratio and its confidence interval will be obtained using a stratified Cox proportional hazards model. Potential confounding factors, including the stratification factors, performance status and self-declared racial designation will be considered in a final exploratory model. A forest plot of treatment hazard ratios with confidence intervals within subgroups will also be reported. PFS will be characterized by treatment group with Kaplan-Meier plots and estimates of the median PFS.


    Secondary Outcome Measures :
    1. Incidence of adverse events (AE) [ Time Frame: Up to 8 years ]
      The nature, frequency and degree of toxicity will be tabulated at the System Organ Class and AE Term levels using Common Terminology Criteria for Adverse Events version 5.0. Each patient will be represented according the maximum grade observed for each term, within randomized treatment assignment. Tabulations will show the number and percentage of patients by maximum grade, within their randomized treatment assignment.

    2. Objective response rate (ORR) [ Time Frame: Up to 8 years ]
      Will be estimated as the binomial proportion of patients with best overall response of complete response (CR) or partial response (PR) among patients with measurable disease after cytoreductive surgery. Response rates and their 95% Wilson-Score confidence intervals will be estimated for each treatment arm, using the randomized treatment assignment. The odds-ratio for ORR in the L/L vs CT/L arms will be estimated from the multivariable logistic regression model adjusted for stratification factors.

    3. Duration of response [ Time Frame: Time from documentation of response under documentation of progression or death, which is observed first, assessed up to 8 years ]
      Will be defined among patients with best overall response of CR or PR. Comparison of response duration between the randomized treatment arms will be supported by Kaplan Meier methods, and the corresponding estimates for median duration and its 95% confidence intervals.

    4. Overall survival (OS) [ Time Frame: Time between randomization and death from any cause, assessed up to 8 years ]
      Differences in OS across the randomized treatment groups will be assessed using Kaplan Meier methods, with median time to death estimates and the corresponding 95% confidence intervals. The L/L vs CT/L hazard ratio will be estimated by a proportional hazards model stratified by the randomization stratification factors.

    5. Adherence to letrozole maintenance therapy [ Time Frame: At cycles 1, 6, and 12 ]
      Will be quantified as the mean rate of adherence (MRA), calculated as the proportion of product not returned divided by the number of days since the previous visit at which study products were dispensed. Currently, the letrozole is delivered in a 2.5 mg pill, and the recommended dose is 2.5 mg per day. This outcome will be computed for each treatment cycle (generally 21 days). The mean MRA will be compared between the randomized treatment groups using linear mixed model methods. The model will be specified with a random patient effect, and fixed effects for randomized treatment indicator, time (cycle number) and the interaction, with an adjustment for the protocol stratification factors. Primary interest is in the difference in mean (MRA) at cycles 1, 6 and 12 between the treatment group. The results will be reported as the estimated mean (MRA) and 95% confidence intervals for each treatment/time combination. Treatment differences within stratification factors may also be considered.

    TRIAL NUMBER: NRG-GY020

    Title: A Phase III Randomized Trial of Radiation +/- MK-3475 (Pembrolizumab) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer

    Purpose: This phase III trial compares whether the addition of pembrolizumab to radiation therapy is more effective than radiation therapy alone in reducing the risk of cancer coming back (recurrence) in patients with newly diagnosed stage I-II endometrial cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The addition of pembrolizumab to radiation treatment may be more effective than radiation treatment alone in reducing cancer recurrence.

    TRIAL NUMBER: SISTER

    Title: Social Interventions for Support during Treatment for Endometrial Cancer and Recurrence (SISTER): a multi-site randomized controlled trial

    Purpose:

    Aim 1: To determine whether -- and to what extent -- 2 virtual evidenced-based interventions ? (1) facilitated support group and (2) 1:1 peer support compared to receipt of usual care improve recommended treatment completion among Black people with high-risk EC.

    Aim 2: To compare the effectiveness of virtual evidenced-based interventions on level of social isolation during cancer treatment among Black people with high-risk EC.

    TRIAL NUMBER: EA3132

    Title: EA3132:Phase II Randomized Trial of Radiotherapy with or Without Cisplatin for Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) with TP53 Sequencing

    Purpose: This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known if radiation therapy is more effective with or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.

    TRIAL NUMBER: A031704

    Title: PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab Vs. VEGF TKI Cabozantinib with Nivolumab: A Phase III Trial in Metastatic Untreated REnal Cell CancEr [PDIGREE]

    Purpose: This phase III trial studies how well nivolumab and ipilimumab, followed by nivolumab versus cabozantinib and nivolumab, work in treating patients with renal cell cancer that is untreated and has spread to other parts of the body. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cabozantinib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known how well cabozantinib and nivolumab work in treating patients with untreated renal cell cancer that has spread to other parts of the body.

    TRIAL NUMBER: A081801

    Title: INTEGRATION OF IMMUNOTHERAPY INTO ADJUVANT THERAPY FOR RESECTED NSCLC: ALCHEMIST CHEMO-IO

    Purpose:

    Primary Outcome Measures :
    1. Disease free survival (DFS) [ Time Frame: From randomization to the first of either disease recurrence or death from any cause, assessed up to 5 years after accrual completion ]
      Will be estimated using the Kaplan-Meier method, where the stratified log-rank test will be used to compare the distributions across the treatment arms. DFS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals.

    2. Overall survival (OS) [ Time Frame: From randomization to death from any cause, assessed up to 8 years after accrual completion ]
      Will be estimated using the Kaplan-Meier method, where the stratified log-rank test will be used to compare the distributions across the treatment arms. OS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals.


    Secondary Outcome Measures :
    1. DFS between combination pembrolizumab with standard of care vs. sequential pembrolizumab [ Time Frame: From randomization to the first of either disease recurrence or death from any cause, assessed up to 5 years after accrual completion ]
    2. OS between combination pembrolizumab with standard of care vs. sequential pembrolizumab [ Time Frame: From randomization to death from any cause, assessed up to 8 years after accrual completion ]
    3. Incidence of adverse events [ Time Frame: Up to 10 years ]
      The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5. The frequency and percentage of grade 3+ adverse events will be compared between the 2 experimental treatment arms and the control as well as between the two experimental arms. We will also compare the rate of drug discontinuation due to adverse events between the experimental treatment arms and control, and between the two experimental arms. Comparisons between arms will be made by using the Chi-square test. Analysis of the overall adverse event rates, as well as specific events of interest will involve Chi-square tests or Fisher's exact tests.

    4. DFS between each experimental pembrolizumab plus standard of care arms vs. standard of care by PD-L1 expression status [ Time Frame: From randomization to the first of either disease recurrence or death from any cause, assessed up to 5 years after accrual completion ]
      Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be used as the primary analytical method, where all baseline covariates will be considered in the univariable models and subsequently in the multivariable models based on the criteria for selection for the multivariable models.

    5. OS between each experimental pembrolizumab plus standard of care arms vs. standard of care by PD-L1 expression status [ Time Frame: From randomization to death from any cause, assessed up to 8 years after accrual completion ]
      Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be used as the primary analytical method, where all baseline covariates will be considered in the univariable models and subsequently in the multivariable models based on the criteria for selection for the multivariable models.

    TRIAL NUMBER: A151216

    Title: Genetic Testing For Patients with Resectable or Resected Lung Cancer: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

    Purpose: PRIMARY OBJECTIVES:
    I. To centrally genotype resected lung adenocarcinomas for epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma receptor tyrosine kinase (ALK) rearrangements to facilitate accrual to randomized adjuvant studies.
    II. To obtain clinically annotated tumor tissue and patient-matched non-malignant deoxyribonucleic acid (DNA) from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow clinically annotated advanced genomic analyses in concert with the National Cancer Institute (NCI) Center for Cancer Genomics (CCG).
    SECONDARY OBJECTIVES:
    I. To characterize the natural history of EGFR and ALK wild-type lung cancers to allow subsequent development of targeted therapies against genotype-defined sub-populations in the adjuvant and recurrent settings.
    II. To cross-validate local genotyping assays for EGFR and ALK with a central reference standard.
    TERTIARY OBJECTIVES:
    I. To study the genomic evolution of lung cancers by comparing genomic characteristics at resection and at recurrence.
    OUTLINE:
    Patients undergo collection of blood and tissue samples for EGFR and ALK testing via direct sequencing and fluorescence in situ hybridization (FISH). Patients that have had surgery prior to pre-registration will submit samples from the previous surgery for testing.
    After completion of study, patients that are not enrolled on either A081105 or E4512 are followed up every 6 months for 5 years.

    TRIAL NUMBER: A171901

    Title: Older Non-Small Cell Lung Cancer Patients (>/= 70 Years of Age) Treated With First-Line MK-3475 (Pembrolizumab)+/- Chemotherapy (Oncologist's/Patient's Choice)

    Purpose: This trial studies the side effects of pembrolizumab with or without chemotherapy in treating patients with stage IV non-small cell lung cancer that has come back (recurrent) and has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with or without chemotherapy may shrink the tumor in older patients with non-small cell lung cancer.

    TRIAL NUMBER: E4512

    Title: A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

    Purpose: PRIMARY OBJECTIVES:
    I. To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) over placebo for patients with stage IB >= 4 cm, II and IIIA, anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following surgical resection.
    SECONDARY OBJECTIVES:
    I. To evaluate and compare disease-free survival (DFS) associated with crizotinib and placebo.
    II. To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting.
    III. To collect tumor tissue and blood specimens for future research.
    OUTLINE: Patients are randomized to 1 of 2 treatment arms.
    ARM A: Patients receive crizotinib orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    ARM B: Patients receive placebo PO BID on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for 5 years.

    TRIAL NUMBER: EA5163

    Title: EA5163/S1709 INSIGNA : A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-Driven Analysis

    Purpose: Primary Outcome Measures : Overall survival (OS) [ Time Frame: From randomization to death from any cause, assessed up to 5 years post treatment ] OS distributions will be estimated using the Kaplan-Meier method.

    Secondary Outcome Measures : Progression-free survival (PFS) [ Time Frame: From randomization to documented disease progression or death from any cause, assessed up to 5 years post treatment ] PFS distributions will be estimated using the Kaplan-Meier method.
    Best objective response [ Time Frame: Up to 5 years post treatment ] Best objective response will be evaluated via Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
    Incidence of adverse events [ Time Frame: Up to 30 days post treatment ] Toxicities will be reported via the Common Terminology Criteria for Adverse Events (CTCAE) criteria version 5.0. Toxicity rates between arms in the overall population will be compared using Fisher's exact tests with a one-sided type I error rate of 1.25%; multivariable logistic regression modeling will be used to adjust for the effect of any covariates that are associated with these categorical outcomes.
    PD-L1 positivity [ Time Frame: At baseline ] PD-L1 positivity will be defined as >= 1% Tumor Proportion Score (TPS) for the purpose of enrollment onto the trial. Strongly PD-L1 positive is defined as >= 50% TPS; weakly positive is defined as 1% - 49% TPS.

    TRIAL NUMBER: LUNAR

    Title: LUNAR: Pivotal, randomized, open-label study of Tumor Treating Fields (TTFields) concurrent with standard of care therapies for treatment of stage 4 non-small cell lung cancer (NSCLC) following platinum failure

    Purpose: The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of TTFields, using the NovoTTF-100L System, concurrent with standard therapies for stage 4 NSCLC patients, following progression while on or after platinum based treatment. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays. 

    TRIAL NUMBER: LungMAP

    Title: LungMAP: A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)

    Purpose: 1.1 Primary Objective of the Master Protocol (LungMAP) The primary objective of this screening study is to test patient specimens to determine eligibility for participation in the biomarker-driven and non-matched sub-studies included within the Lung-MAP umbrella protocol. 1.2 Secondary Objectives a. Screening Success Rate Objective To evaluate the screen success rate defined as the percentage of screened patients that register for a therapeutic sub-study. Screen success rates will be evaluated for the total screened population and by the subset of patients screened following progression on previous therapy or pre-screened on current therapy. b. Translational Medicine Objectives 1. To evaluate circulating tumor DNA (ctDNA) and compare to the FMI Foundation tissue molecular profiling results in patients who submit a new biopsy for screening. 2. To establish a tissue/blood repository

    TRIAL NUMBER: S1827

    Title: A RANDOMIZED PHASE III TRIAL OF MRI SURVEILLANCE WITH OR WITHOUT PROPHYLACTIC CRANIAL IRRADIATION (PCI) IN SMALL-CELL LUNG CANCER

    Purpose:

    Primary Outcome Measures :
    1. Overall survival (OS) [ Time Frame: From the date of registration to date of death due to any cause, assessed up to 2 years after randomization ]
      Will evaluate OS with magnetic resonance imaging (MRI) surveillance alone and MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC).


    Secondary Outcome Measures :
    1. Cognitive failure-free survival (CFFS) [ Time Frame: Baseline to first neurocognitive failure CF or death due to any cause, assessed up to 12 months after randomization ]
      The comparison of CFFS up to 12 months between the arms will be done using a 1-sided 5% level log-rank test.

    2. CFFS rate [ Time Frame: Baseline to first neurocognitive failure CF or death due to any cause, assessed at 90, 180, 270, 360, 540, and 720 days after randomization ]
      There will be a comparison of the CFFS rates between the arms at each of the assessment times and the cumulative incidence of cognitive failure, evaluating death as a competing risk. The CFFS rates at the landmark times will be estimated using the method of Kaplan-Meier and the difference in rates will be evaluated using a 90% confidence interval using Greenwood?s formula.

    3. Cumulative incidence of cognitive failure [ Time Frame: Neurocognitive function test will be assessed at 90, 180, 270, 360, 540, and 720 days after randomization ]
      The cumulative incidence of cognitive failure in the presence of the competing risk of death will be estimated used the method of Fine and Gray.

    4. OS in an "as-treated" analysis [ Time Frame: From the date of registration to date of death due to any cause, assessed up to 2 years after randomization. Patients will be seen at day 90, 180, 270, 360, 540, and 720 ]
      The comparison of OS in the ?as-treated? analysis will be done as described for the primary analysis, however patients will be categorized per treatment received (patients who do not accept their randomized assignment will be analyzed per treatment received). The number of patients not accepting the randomized assignment will also be summarized.

    5. Brain metastases-free survival (BMFS) [ Time Frame: Up to 2 years after randomization. Patients will have MRI on day 90, 180, 270, 360, 540, and 720 ]
      This will be estimated using the method of Kaplan-Meier and comparisons will be done using a log-rank test at the 1-sided 0.05 level. Hazard ratios and associated confidence intervals will be estimated using a Cox Proportional hazards model. Confidence intervals for medians will be estimated using the method of Brookmeyer-Crowley.

    6. Incidence of adverse events [ Time Frame: Up to 2 years after randomization. Patients will be assessed for adverse event after PCI (for patients on PCI + MRI arm) and at month 3 (all patients) ]
      Binary proportions and associated confidence intervals will be estimated.

    TRIAL NUMBER: MK-2140-003

    Title: A Phase 2/3 Multicenter, Open-label, Randomized, Active-Control Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

    Purpose: The purpose of this Phase 2/3, randomized, multisite, open-label, dose confirmation, and expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in combination with standard of care options for the treatment of rrDLBCL. This study will be divided into 2 parts: Dose Confirmation (Part 1) and Safety Run-in and Efficacy Expansion (Part 2) and will enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx with respect to progression-free survival (PFS) per Lugano response criteria by blinded independent review committee (BICR); and that ZV in combination with bendamustine rituximab (BR) is superior to BR with respect to PFS per Lugano response criteria by BICR.


    TRIAL NUMBER: EAY131

    Title: EAY131: Molecular Analysis for Therapy Choice (NCI-MATCH)

    Purpose: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

    TRIAL NUMBER: S1609

    Title: SWOG 1609: DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors Treatment with Ipilimumab and Nivolumab for Rare Cancers

    Purpose: Both Ipilimumab and Nivolumab have already been FDA-approved to treat other cancers. However, Ipilimumab and Nivolumab are investigational and not FDA-approved for use in combination in treating rare cancers or cancers of unknown primary origin.

    TRIAL NUMBER: S1714

    Title: A PROSPECTIVE OBSERVATIONAL COHORT STUDY TO DEVELOP A PREDICTIVE MODEL OF TAXANE-INDUCED PERIPHERAL NEUROPATHY IN CANCER PATIENTS

    Purpose: 1.1 Primary Objective a. To develop and validate a clinical risk prediction model using clinical factors for the development of peripheral neuropathy in patients receiving taxane-based chemotherapy regimens. 1.2 Secondary Objectives a. To examine patient-reported outcomes (PROs) and objective measures of chemotherapy induced peripheral neuropathy (CIPN) to better define the phenotype of peripheral neuropathy in this patient population. b. To assess the incidence of CIPN within one year in this patient population. c. To identify predictors of treatment dose reductions, delays, and discontinuations associated with CIPN symptoms in this patient population. 1.3 Other Objectives a. To collect serum and plasma samples for future testing for biomarker and mechanistic studies of CIPN.

    TRIAL NUMBER: 10323(MOONSHOT)

    Title: Cancer Moonshot Biobank Research Protocol

    Purpose: This trial collects multiple tissue and blood samples, along with medical information, from cancer patients. The "Cancer Moonshot Biobank" is a longitudinal study. This means it collects and stores samples and information over time, throughout the course of a patient's cancer treatment. By looking at samples and information collected from the same people over time, researchers hope to better understand how cancer changes over time and over the course of medical treatments.

    TRIAL NUMBER: A151804

    Title: Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

    Purpose: This trial collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects.

    TRIAL NUMBER: URCC-21038

    Title: Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated with anti-PD-1/anti-PD-L1 Immunotherapy in a Community Oncology Setting

    Purpose:

    This is a Prospective Observational Cohort Study, designed specifically to investigate racial differences in toxicities and treatment outcomes of cancer patients treated with immune checkpoint inhibitors (ICIs).

    TRIAL NUMBER: Advenchen AL3818-US-002

    Title: A Phase 1/2a Evaluation of the Safety and Efficacy of Adding AL3818, a Dual Receptor Tyrosine Kinase Inhibitor, to Standard Platinum-Based Chemotherapy in Subjects with Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma

    Purpose: This trial is a Phase 1b/2a trial designed to evaluate the safety and efficacy of adding oral AL3818 to standard platinum-based chemotherapy concurrently and continued as a maintenance therapy for up to 12 months.

    TRIAL NUMBER: DF1001-001

    Title: DF1001-001: A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

    Purpose: DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cells activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express human epidermal growth factor receptor 2 (HER2). The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having either selected solid tumors, or solid tumors expressing high levels of HER2. A combination therapy cohort of DF1001 and pembrolizumab will also be opened for enrollment. 

    TRIAL NUMBER: EA6174

    Title: STAMP: Surgically Treated Adjuvant Merkel cell Carcinoma with Pembrolizumab, a Phase III Trial

    Purpose:

    Primary Outcome Measures :
    1. Recurrence free survival (RFS) [ Time Frame: From randomization until disease recurrence or death from any cause; assessed up to 4.5 years ]
      An intention-to-treat (ITT) analysis using the stratified log-rank test will be performed to compare overall survival (OS) and RFS between the two arms.

    2. OS [ Time Frame: From randomization until death, assessed up to 4.5 years ]
      An ITT analysis using the stratified log-rank test will be performed to compare OS and RFS between the two arms.


    Secondary Outcome Measures :
    1. Impact of radiation therapy on RFS [ Time Frame: Up to 4.5 years ]
      RFS in each arm will be evaluated by radiation treatment status (radiation versus [vs.] no radiation therapy). The analysis will be a planned post-hoc analysis with primary goal of examining whether use of post-operative radiation therapy is associated with RFS. Cox multivariate models for RFS will be developed to evaluate the impact of radiation therapy while adjusting for pembrolizumab treatment and clinical/ pathological factors. The treatment fields and dose data will also be included in the Cox model as covariates. Secondary analyses for radiation therapy (RT) will examine factors associated with use of post-operative RT. Multivariate logistic regression models (radiation therapy vs. no radiation therapy) will be developed to evaluate the associations with demographic, clinical/pathologic, and treatment-related factors and pembrolizumab treatment.

    2. Impact of radiation therapy on OS [ Time Frame: Up to 4.5 years ]
      OS in each arm will be evaluated by radiation treatment status (radiation vs. no radiation therapy). The analysis will be a planned post-hoc analysis with primary goal of examining whether use of post-operative radiation therapy is associated with OS. Cox multivariate models for OS will be developed to evaluate the impact of radiation therapy while adjusting for pembrolizumab treatment and clinical/ pathological factors. The treatment fields and dose data will also be included in the Cox model as covariates. Secondary analyses for radiation therapy will examine factors associated with use of post-operative RT. Multivariate logistic regression models (radiation therapy vs. no radiation therapy) will be developed to evaluate the associations with demographic, clinical/pathologic, and treatment-related factors and pembrolizumab treatment.

    3. Impact of radiation therapy on distant metastasis free survival (DMFS) [ Time Frame: From randomization to distant metastasis, assessed up to 4.5 years ]
      DMFS will be evaluated by treatment arms. If there is no distant metastasis, cases will be censored at the time of last assessment.

    4. Incidence of adverse events [ Time Frame: Up to 4.5 years ]
      Measured per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Adverse events from each arm will be summarized and compared using the Fisher's exact test.

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    TRIAL NUMBER: A031701

    Title: A031701:A Phase II Study of Dose-Dense Gemcitabine Plus Cisplatin (ddGC) in Patients with Muscle-Invasive Bladder Cancer with Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations

    Purpose: This phase II trial studies how well gemcitabine hydrochloride and cisplatin work in treating participants with invasive bladder urothelial cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

    TRIAL NUMBER: A031803

    Title: PHASE II TRIAL OF INTRAVESICAL GEMCITABINE AND MK-3475 (PEMBROLIZUMAB) IN THE TREATMENT OF PATIENTS WITH BCG- NRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER

    Purpose:

    Primary Outcome Measures :
    1. Complete response rate in the carcinoma in situ (CIS) subpopulation [ Time Frame: At 6 months ]
      A complete response, only for patients with a CIS component, is a cystoscopy without evidence of bladder tumor, negative biopsy (including directed biopsies to any suspicious areas and in addition random bladder biopsies including trigone, left lateral wall, right lateral wall, posterior bladder, dome of bladder, and the prostatic urethra in men) and negative cytology for high grade disease at 6 months (end of cycle 8, week 25).

    2. Event-free survival at 18 months [ Time Frame: From the date of study registration to the first documentation of an event or death whichever comes first, assessed up to 18 months ]
      EFS will be measure from the date of study registration to the first documentation of an event or death whichever comes first. For patients without a documented event and who are still alive, they will be censored at last disease assessment. For patients who start any subsequent ant-cancer therapy without any reported events will be censored at their last disease assessment. will be obtained with a Kaplan-Meier estimator (using the Greenwood formula to estimate the variance) for the entire 155 patient group consisting of patients with CIS, CIS with Ta/T1 or Ta or T1 disease. A 90% confidence interval will be generated for the 18-month EFS estimate.


    Secondary Outcome Measures :
    1. Incidence of adverse events [ Time Frame: Up to 5 years post treatment ]
      Adverse events will be assessed based on the National Cancer Institute (NCI) common toxicity criteria (Common Terminology Criteria for Adverse Events [CTACAE] version [v] 5.0).

    2. Duration of response (DOR) [ Time Frame: From the time a patient had a documented response that had been confirmed (the time would start at the time a response was first noted) until disease-progression, assessed up to 5 years ]
      Analysis will only include those patients with a confirmed response. Patients who are alive and without a documented progression at the time of analysis will be censored at the time of the last disease status evaluation. The Kaplan-Meier product-limit estimator will be used to estimate DOR, medians and 95% confidence intervals (CI).

    3. Progression-free survival (PFS) [ Time Frame: From the date of study registration to the date of progression or death due to any cause, whichever occurs first, assessed up to 5 years ]
      Surviving patients without any documented progressions will be censored at the date of last known contact. Progression will be defined as the development of muscle invasive bladder cancer or metastatic urothelial cancer (nodal and/or distant). The Kaplan-Meier product-limit estimator will be used to estimate PFS, medians and 95% CI.

    4. Overall survival (OS) [ Time Frame: From the date of study registration to date of death due to any cause, assessed up to 5 years ]
      Surviving patients will be censored at the date of last known contact. The Kaplan-Meier product-limit estimator will be used to estimate OS, medians and 95% CI.

    5. Cystectomy-free survival [ Time Frame: From the date of study registration to the date of cystectomy for all patients ]
      The Kaplan-Meier product-limit estimator will be used to estimate cystectomy-free survival, medians and 95% CI.

    6. Recurrence free survival (RFS) [ Time Frame: From the date of study registration to the first documentation of recurrence or death due to any cause, assessed up to 5 years ]
      Surviving patients without any documented recurrence will be censored at the date of last known contact. Recurrence will be defined as the development of high-grade bladder cancer for patients with a CIS component only and those without a CIS component. The Kaplan-Meier product-limit estimator will be used to estimate RFS, medians and 95% CI.

    TRIAL NUMBER: CITN-14

    Title: A Randomized Phase II Study of Atezolizumab (MPDL3280A) Plus Recombinant Human IL7 (CYT107) in Patients with Locally Advanced or Metastatic Urothelial Carcinoma

    Purpose: Primary Outcome Measures : Objective response rate (ORR) [ Time Frame: Up to 2 years ] ORR to be defined by complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1. The Cochran Mantel Haenszel test will be conducted to compare ORR in the experimental arm (atezolizumab + CYT107) to the ORR in the control arm (atezolizumab monotherapy). A one-sided significance level of 0.10 will be considered for the test.

    Secondary Outcome Measures : Clinical benefit rate (CBR) measured by RECIST version (v.) 1.1 and immune-related (ir) RECIST [ Time Frame: Up to 2 years ] CBR is defined as the percentage of patients with advanced or metastatic cancer who have achieved CR, PR, and stable disease (SD) to a therapeutic intervention in clinical trials of anticancer agents. A two-sided test for a difference in proportions will be conducted to compare the CBR in the experimental arm to the CBR in the control arm. A two-sided significance level of 0.05 will be considered for the test. Will also assess CBR in patients stratified by PD-L1 expression levels in the tumor microenvironment, as assayed by Genentech.
    Progression-free survival (PFS) [ Time Frame: Up to 2 years ] PFS to be measured by RECIST v1.1 and irRECIST. PFS will be summarized using Kaplan-Meier estimates. Long-rank tests will be conducted for overall survival (OS) and PFS to compare between the 2 arms. A one-sided significance level of 0.10 will be considered. Will also assess PFS in patients stratified by PD-L1 expression levels in the tumor microenvironment, as assayed by Genentech.
    Duration of response (DOR) [ Time Frame: Up to 2 years ] DOR is measured by RECIST v1.1 and irRECIST. DOR will be summarized using Kaplan-Meier estimates. Long-rank tests will be conducted for OS and PFS to compare between the 2 arms. A one-sided significance level of 0.10 will be considered. Will also assess DOR in patients stratified by PD-L1 expression levels in the tumor microenvironment, as assayed by Genentech.
    Overall survival [ Time Frame: Up to 2 years ] OS will be summarized using Kaplan-Meier estimates. Long-rank tests will be conducted for OS and PFS to compare between the 2 arms. A one-sided significance level of 0.10 will be considered. Will also assess OS in patients stratified by PD-L1 expression levels in the tumor microenvironment, as assayed by Genentech.

    Other Outcome Measures: Assessment of investigation treatment combination on the immune-bias of the tumor microenvironment [ Time Frame: Up to 2 years ] The evaluation of the effect of the investigation treatment combination on the immune-bias of the tumor microenvironment, based upon baseline and post-baseline tumor biopsy comparisons of number, distribution, and phenotype of tumor-infiltrating cells; PD-L1 expression, and expression of Interferon gamma (IFN-gamma) and associated proinflammatory gene expression in the tumor microenvironment.

    TRIAL NUMBER: EA8185

    Title: Phase 2 Study of Bladder-SparIng ChemoradiatioN with MEDI4736 (Durvalumab) in clinical Stage 3, Node PosItive bladdeR cancEr (INSPIRE)

    Purpose:

    Primary Outcome Measures :
    1. Clinical complete response (CR) [ Time Frame: Up to 6 years ]

    Secondary Outcome Measures :
    1. Metastasis-free survival [ Time Frame: From randomization to first evidence of metastatic disease or death from any cause, assessed up to 6 years ]
      Will be estimated by the Kaplan-Meier method.

    2. Bladder-intact event-free survival (BI-EFS) [ Time Frame: From randomization to the first BI-EFS event, assessed up to 6 years ]
      Will be estimated by the Kaplan-Meier method.

    3. Bladder cancer specific survival [ Time Frame: From randomization to death from bladder cancer, assessed up to 6 years ]
      Will be estimated by the Kaplan-Meier method.

    4. Overall survival [ Time Frame: From randomization to death from any cause, assessed up to 6 years ]
      Will be estimated by the Kaplan-Meier method.

    5. Progression-free survival [ Time Frame: From randomization to first of local progression, nodal or distant metastasis, or death from any cause, assessed up to 6 years ]
      Will be estimated by the Kaplan-Meier method.

    6. Complete response duration [ Time Frame: From the date of the biopsy documenting the complete response to the time of muscle invasive recurrence, local progression, evidence of metastatic disease or death due to any cause, assessed up to 6 years ]
      Stratified Cox proportional hazards models will be used to estimate hazard ratios in all eligible patients.

    7. Salvage cystectomy rate [ Time Frame: Up to 6 years ]
      Rate will be reported as a proportion of patients who do not experience clinical benefit after chemoradiotherapy (chemoRT) +/- MEDI4736 (durvalumab) along with a 90% confidence interval. Stratified Cox proportional hazards models will be used to estimate hazard ratios in all eligible patients.

    8. Incidence of adverse events [ Time Frame: Up to 1 year ]
      Assessed using the Common Terminology Criteria for Adverse Events (CTCAE). Toxicity will be evaluated in all treated patients, regardless of eligibility.

    TRIAL NUMBER: S1806

    Title: S1806: Phase III Randomized Trial of Concurrent Chemoradiotherapy with or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer

    Purpose: This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab.

    TRIAL NUMBER: DCP-001

    Title: DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)

    Purpose: The protocol is not a scientific study; rather, a method to implement the screening tool and allow the collection and analyses of expanded data with informed consent. Investigators also enroll patients into NCI-treatment trials. The tool, based on a screening log successfully used within the NCI Community Cancer Centers Program (NCCCP), has been streamlined and integrated into the sites’ workflow by using OPEN. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. Also missing from the existing data is the context of care, within the communities themselves where most cancer and at risk of cancer patients receive care which is the focus of NCORP. The profile of patients accrued to NCI-sponsored clinical trials lacks both racial/ethnic and socioeconomic diversity. Accrued patients tend to be insured, highly educated and of higher socioeconomic means. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. NCORP's clinical trials portfolio includes cancer control, prevention, screening, symptom science, and cancer care delivery research.

    TRIAL NUMBER: DCP-002

    Title: DCP-002 Early Onset Malignancies Initiative (EOMI): Molecular profiling of Breast, Prostate, Colorectal, Liver, Kidney, and Multiple Myeloma among Racially and Ethnically Diverse Populations

    Purpose: The primary objective of the EOMI (Early Onset Malignancy Initiative) is to acquire tissue and blood, and other biospecimens for research purposes from tests performed for clinical care or for research indications on other research protocols to accelerate our understanding of the molecular basis of early onset cancers occurring in racial and/or ethnic minority populations through the application of genome analysis technologies, including large-scale genome sequencing and clinical data analysis.

    TRIAL NUMBER: A031702

    Title: Phase II Study of Cabozantinib in Combination with Nivolumab and Ipilimumab in Rare Genitourinary Tumors

    Purpose: Primary Outcome Measures :
    Objective response rate (ORR) [ Time Frame: Up to 5 years ] An objective response is defined as a confirmed complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Will be estimated by the number of confirmed objective responses divided by the total number of evaluable patients. Confidence intervals for the true ORR will be calculated.

    Secondary Outcome Measures :
    Duration of response [ Time Frame: From time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years ] Defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented.
    Progression-free survival (PFS) [ Time Frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years ] The median its 95% confidence interval will be determined and will be summarized using the Kaplan-Meier estimator.
    Overall survival [ Time Frame: Up to 5 years ] The median its 95% confidence interval will be determined and will be summarized using the Kaplan-Meier estimator.
    Clinical benefit rate (CBR) [ Time Frame: Up to 5 years ] A confirmed clinical benefit is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart or a confirmed stable disease at two consecutive tumor assessments at least 3 months apart. The CBR will be estimated by the number of patients with confirmed clinical benefit divided by the total number of evaluable patients. Confidence intervals for the true CBR will be calculated using exact binomial confidence intervals.
    Incidence of adverse events (AE) [ Time Frame: Up to 5 years ] Will be assessed using Common Terminology Criteria for Adverse Events version 5.0. The maximum of a particular AE will be determined for each patient. Tables will summarize the number and relative frequency of patients observing an AE as well as the number and relative frequency of patients experiencing any AE of grade 3 or greater.

    Other Outcome Measures:
    Effects of treatment in patients with bone-only disease [ Time Frame: Up to 5 years ] The bone-only tumor patients will be evaluated in an exploratory fashion (if no RECIST measurements are available). A maximum of 15 patients with bone-only disease will be enrolled and evaluated using PFS for a descriptive analysis of the effect of treatment.

    TRIAL NUMBER: NRG-GY006

    Title: A Randomized Phase II Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer

    Purpose: This randomized phase II trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal cancer.

    TRIAL NUMBER: NRG-GY020

    Title: A Phase III Randomized Trial of Radiation +/- MK-3475 (Pembrolizumab) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer

    Purpose: This phase III trial compares whether the addition of pembrolizumab to radiation therapy is more effective than radiation therapy alone in reducing the risk of cancer coming back (recurrence) in patients with newly diagnosed stage I-II endometrial cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The addition of pembrolizumab to radiation treatment may be more effective than radiation treatment alone in reducing cancer recurrence.

    TRIAL NUMBER: A031704

    Title: PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab Vs. VEGF TKI Cabozantinib with Nivolumab: A Phase III Trial in Metastatic Untreated REnal Cell CancEr [PDIGREE]

    Purpose: This phase III trial studies how well nivolumab and ipilimumab, followed by nivolumab versus cabozantinib and nivolumab, work in treating patients with renal cell cancer that is untreated and has spread to other parts of the body. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cabozantinib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known how well cabozantinib and nivolumab work in treating patients with untreated renal cell cancer that has spread to other parts of the body.

    TRIAL NUMBER: A151216

    Title: Genetic Testing For Patients with Resectable or Resected Lung Cancer: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

    Purpose: PRIMARY OBJECTIVES:
    I. To centrally genotype resected lung adenocarcinomas for epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma receptor tyrosine kinase (ALK) rearrangements to facilitate accrual to randomized adjuvant studies.
    II. To obtain clinically annotated tumor tissue and patient-matched non-malignant deoxyribonucleic acid (DNA) from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow clinically annotated advanced genomic analyses in concert with the National Cancer Institute (NCI) Center for Cancer Genomics (CCG).
    SECONDARY OBJECTIVES:
    I. To characterize the natural history of EGFR and ALK wild-type lung cancers to allow subsequent development of targeted therapies against genotype-defined sub-populations in the adjuvant and recurrent settings.
    II. To cross-validate local genotyping assays for EGFR and ALK with a central reference standard.
    TERTIARY OBJECTIVES:
    I. To study the genomic evolution of lung cancers by comparing genomic characteristics at resection and at recurrence.
    OUTLINE:
    Patients undergo collection of blood and tissue samples for EGFR and ALK testing via direct sequencing and fluorescence in situ hybridization (FISH). Patients that have had surgery prior to pre-registration will submit samples from the previous surgery for testing.
    After completion of study, patients that are not enrolled on either A081105 or E4512 are followed up every 6 months for 5 years.

    TRIAL NUMBER: E4512

    Title: A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

    Purpose: PRIMARY OBJECTIVES:
    I. To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) over placebo for patients with stage IB >= 4 cm, II and IIIA, anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following surgical resection.
    SECONDARY OBJECTIVES:
    I. To evaluate and compare disease-free survival (DFS) associated with crizotinib and placebo.
    II. To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting.
    III. To collect tumor tissue and blood specimens for future research.
    OUTLINE: Patients are randomized to 1 of 2 treatment arms.
    ARM A: Patients receive crizotinib orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    ARM B: Patients receive placebo PO BID on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for 5 years.

    TRIAL NUMBER: S1827

    Title: A RANDOMIZED PHASE III TRIAL OF MRI SURVEILLANCE WITH OR WITHOUT PROPHYLACTIC CRANIAL IRRADIATION (PCI) IN SMALL-CELL LUNG CANCER

    Purpose:

    Primary Outcome Measures :
    1. Overall survival (OS) [ Time Frame: From the date of registration to date of death due to any cause, assessed up to 2 years after randomization ]
      Will evaluate OS with magnetic resonance imaging (MRI) surveillance alone and MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC).


    Secondary Outcome Measures :
    1. Cognitive failure-free survival (CFFS) [ Time Frame: Baseline to first neurocognitive failure CF or death due to any cause, assessed up to 12 months after randomization ]
      The comparison of CFFS up to 12 months between the arms will be done using a 1-sided 5% level log-rank test.

    2. CFFS rate [ Time Frame: Baseline to first neurocognitive failure CF or death due to any cause, assessed at 90, 180, 270, 360, 540, and 720 days after randomization ]
      There will be a comparison of the CFFS rates between the arms at each of the assessment times and the cumulative incidence of cognitive failure, evaluating death as a competing risk. The CFFS rates at the landmark times will be estimated using the method of Kaplan-Meier and the difference in rates will be evaluated using a 90% confidence interval using Greenwood?s formula.

    3. Cumulative incidence of cognitive failure [ Time Frame: Neurocognitive function test will be assessed at 90, 180, 270, 360, 540, and 720 days after randomization ]
      The cumulative incidence of cognitive failure in the presence of the competing risk of death will be estimated used the method of Fine and Gray.

    4. OS in an "as-treated" analysis [ Time Frame: From the date of registration to date of death due to any cause, assessed up to 2 years after randomization. Patients will be seen at day 90, 180, 270, 360, 540, and 720 ]
      The comparison of OS in the ?as-treated? analysis will be done as described for the primary analysis, however patients will be categorized per treatment received (patients who do not accept their randomized assignment will be analyzed per treatment received). The number of patients not accepting the randomized assignment will also be summarized.

    5. Brain metastases-free survival (BMFS) [ Time Frame: Up to 2 years after randomization. Patients will have MRI on day 90, 180, 270, 360, 540, and 720 ]
      This will be estimated using the method of Kaplan-Meier and comparisons will be done using a log-rank test at the 1-sided 0.05 level. Hazard ratios and associated confidence intervals will be estimated using a Cox Proportional hazards model. Confidence intervals for medians will be estimated using the method of Brookmeyer-Crowley.

    6. Incidence of adverse events [ Time Frame: Up to 2 years after randomization. Patients will be assessed for adverse event after PCI (for patients on PCI + MRI arm) and at month 3 (all patients) ]
      Binary proportions and associated confidence intervals will be estimated.

    TRIAL NUMBER: EAY131

    Title: EAY131: Molecular Analysis for Therapy Choice (NCI-MATCH)

    Purpose: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

    TRIAL NUMBER: S1609

    Title: SWOG 1609: DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors Treatment with Ipilimumab and Nivolumab for Rare Cancers

    Purpose: Both Ipilimumab and Nivolumab have already been FDA-approved to treat other cancers. However, Ipilimumab and Nivolumab are investigational and not FDA-approved for use in combination in treating rare cancers or cancers of unknown primary origin.

    TRIAL NUMBER: EA8171

    Title: EA8171:Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer

    Purpose: This phase II trial studies how well multiparametric magnetic resonance imaging (MRI) works in evaluating cancer stage and helping treatment planning in patients with prostate cancer. Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive disease.

    TRIAL NUMBER: NRG-GU002

    Title: NRG-GU002: PHASE II-III TRIAL OF ADJUVANT RADIOTHERAPY AND ANDROGEN DEPRIVATION FOLLOWING RADICAL PROSTATECTOMY WITH OR WITHOUT ADJUVANT DOCETAXEL

    Purpose: This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.

    TRIAL NUMBER: NRG-GU009

    Title: PARALLEL PHASE III RANDOMIZED TRIALS FOR HIGH RISK PROSTATE CANCER EVALUATING DE-INTENSIFICATION FOR LOWER GENOMIC RISK AND INTENSIFICATION OF CONCURRENT THERAPY FOR HIGHER GENOMIC RISK WITH RADIATION (PREDICT-RT*)

    Purpose:

    Primary Outcome Measures :
    1. Metastasis-Free Survival (MFS) [ Time Frame: From randomization to the date of detection of distant metastasis on standard imaging or date of death from any cause, assessed up to 13 years ]
      Assessed based on conventional imaging. MFS will be estimated using the Kaplan-Meier method (Kaplan 1958).


    Secondary Outcome Measures :
    1. Overall Survival (OS) [ Time Frame: From the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, assessed up to 13 years ]
      Will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test (Kaplan 1958).

    2. Prostate Specific Antigen (PSA) failure-free survival with non-castrate testosterone and no additional therapies [ Time Frame: From the date of randomization to the date event, or death or censored at the last known follow-up date, assessed up to 13 years ]
      PSA failure-free survival will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test (Kaplan 1958).

    3. Prostate Cancer Specific Mortality (PCSM) [ Time Frame: From the date of randomization to the date of prostate cancer death, assessed up to 13 years ]
    4. Time to testosterone recovery [ Time Frame: Up to 13 years ]
      Defined as testosterone that is non-castrate.

    5. Time to PSA failure or salvage therapy [ Time Frame: Up to 13 years ]
    6. Testosterone levels at the time of PSA failure and metastases [ Time Frame: Up to 13 years ]
    7. Incidence of Adverse Events [ Time Frame: Up to 13 years ]
      Measured by the Common Terminology Criteria for Adverse Events (CTCAE ) version (v) 5.0 and Patient Reported Outcomes (PRO)-CTCAE.

    TRIAL NUMBER: RTOG-3506

    Title: RTOG 3506; A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery (STEEL)

    Purpose: Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive disease features will receive salvage radiation therapy and standard androgen deprivation therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free survival when enhanced ADT is used compared to standard ADT.

    TRIAL NUMBER: S1802

    Title: S1802: Phase III Randomized Trial of Standard Systemic Therapy (SST) versus Standard Systemic Therapy plus Definitive treatment (surgery or radiation) of the primary tumor in Metastatic Prostate Cancer

    Purpose: This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

    TRIAL NUMBER: A031801

    Title: A PHASE II RANDOMIZED TRIAL OF RADIUM-223 DICHLORIDE AND CABOZANTINIB IN PATIENTS WITH ADVANCED RENAL CELL CARCINOMA WITH BONE METASTASIS (RADICAL)

    Purpose:

    Primary Outcome Measures :
    1. Symptomatic skeletal event (SSE)-free survival (FS) [ Time Frame: From the date of randomization to the date of the earliest occurrence of SSE or death from any cause, assessed up to 5 years ]
      SSE-FS distribution will be estimated using the method of Kaplan-Meier by treatment arm. Comparison between the two arms will be performed using a one-sided log-rank test and one-sided p-value less than 0.025 will indicate that the experimental arm is superior to the control arm. SSE-FS will be censored at the date of last SSE assessment for those alive and SSE free. Hazard ratio (experimental over control arm) as well as two-sided 90% confidence interval (CI) for treatment will be estimated using the stratified Cox proportional hazard model with a single treatment covariate.


    Secondary Outcome Measures :
    1. Incidence of adverse events [ Time Frame: Up to 5 years ]
      Will be determined using Common Terminology Criteria for Adverse Events version 5.0. Adverse events will be summarized and compared between arms using chi-square or fisher exact tests as appropriate.

    2. SSE-FS [ Time Frame: From randomization to the date of SSE or death due to any cause, whichever comes first, assessed up to 5 years ]
      Will be estimated with the Kaplan Meier methodology. Comparison between arms or between predefined groups will be conducted using the log-rank test.

    3. Progression-free survival [ Time Frame: From randomization to time of radiographic progression or death due to any cause, whichever occurs first, assessed up to 5 years ]
      Radiographic progression will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Will be estimated with the Kaplan Meier methodology. Comparison between arms or between predefined groups will be conducted using the log-rank test.

    4. Overall survival [ Time Frame: From randomization to the date of death due to any cause, assessed up to 5 years ]
      Will be estimated with the Kaplan Meier methodology. Comparison between arms or between predefined groups will be conducted using the log-rank test. Patients who are alive will be censored at last follow up date.

    5. Time to first SSE [ Time Frame: From randomization to the date of first SSE or death due to any cause, assessed up to 5 years ]
      Will be determined in each treatment. The median estimate to first SSE-FS will be calculated.

    6. Overall response rate (ORR) [ Time Frame: Up to 5 years ]
      Will be defined by RECIST version 1.1. Number and proportion of patients achieving ORR (by RECIST) will be summarized with two-sided 90% CI by treatment arm; comparison between arms will be conducted using chi-square or Fisher's exact test as appropriate.

    TRIAL NUMBER: A031901

    Title: A031901, Duration of Immune Checkpoint Therapy in Locally Advanced or Metastatic Urothelial Carcinoma: A Randomized Phase 3 Non-Inferiority Trial

    Purpose: This phase III trial compares survival in urothelial cancer patients who stop immune checkpoint inhibitor treatment after being treated for about a year to those patients who continue treatment with immune checkpoint inhibitors. Immunotherapy with monoclonal antibodies, such as avelumab, durvalumab, pembrolizumab, atezolizumab, and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stopping immune checkpoint inhibitors early may still make the tumor shrink and patients may have similar survival rates as the patients who continue treatment. Stopping treatment early may also lead to fewer treatment-related side effects, an improvement in mental health, and a lower cost burden to patients.

    TRIAL NUMBER: EA8192

    Title: A Phase II/III trial of MEDI4736 (Durvalumab) and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

    Purpose: This phase III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.

    TRIAL NUMBER: S2011

    Title: Randomized Phase II Trial of Gemcitabine, Avelumab and Carboplatin vs. No Neoadjuvant Therapy Preceding Surgery for Cisplatin-Ineligible Muscle-Invasive Urothelial Carcinoma: SWOG GAP TRIAL

    Purpose: This phase II trial studies the effect of avelumab, gemcitabine and carboplatin before surgery compared with surgery alone in treating patients with muscle invasive bladder or upper urinary tract cancer who are not able to receive cisplatin therapy. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving avelumab together with gemcitabine and carboplatin before surgery may work better in lowering the chance of muscle invasive urinary tract cancer growing or spreading, in patients who cannot receive cisplatin therapy compared to surgery alone.

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    TRIAL NUMBER: A031701

    Title: A031701:A Phase II Study of Dose-Dense Gemcitabine Plus Cisplatin (ddGC) in Patients with Muscle-Invasive Bladder Cancer with Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations

    Purpose: This phase II trial studies how well gemcitabine hydrochloride and cisplatin work in treating participants with invasive bladder urothelial cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

    TRIAL NUMBER: A031803

    Title: PHASE II TRIAL OF INTRAVESICAL GEMCITABINE AND MK-3475 (PEMBROLIZUMAB) IN THE TREATMENT OF PATIENTS WITH BCG- NRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER

    Purpose:

    Primary Outcome Measures :
    1. Complete response rate in the carcinoma in situ (CIS) subpopulation [ Time Frame: At 6 months ]
      A complete response, only for patients with a CIS component, is a cystoscopy without evidence of bladder tumor, negative biopsy (including directed biopsies to any suspicious areas and in addition random bladder biopsies including trigone, left lateral wall, right lateral wall, posterior bladder, dome of bladder, and the prostatic urethra in men) and negative cytology for high grade disease at 6 months (end of cycle 8, week 25).

    2. Event-free survival at 18 months [ Time Frame: From the date of study registration to the first documentation of an event or death whichever comes first, assessed up to 18 months ]
      EFS will be measure from the date of study registration to the first documentation of an event or death whichever comes first. For patients without a documented event and who are still alive, they will be censored at last disease assessment. For patients who start any subsequent ant-cancer therapy without any reported events will be censored at their last disease assessment. will be obtained with a Kaplan-Meier estimator (using the Greenwood formula to estimate the variance) for the entire 155 patient group consisting of patients with CIS, CIS with Ta/T1 or Ta or T1 disease. A 90% confidence interval will be generated for the 18-month EFS estimate.


    Secondary Outcome Measures :
    1. Incidence of adverse events [ Time Frame: Up to 5 years post treatment ]
      Adverse events will be assessed based on the National Cancer Institute (NCI) common toxicity criteria (Common Terminology Criteria for Adverse Events [CTACAE] version [v] 5.0).

    2. Duration of response (DOR) [ Time Frame: From the time a patient had a documented response that had been confirmed (the time would start at the time a response was first noted) until disease-progression, assessed up to 5 years ]
      Analysis will only include those patients with a confirmed response. Patients who are alive and without a documented progression at the time of analysis will be censored at the time of the last disease status evaluation. The Kaplan-Meier product-limit estimator will be used to estimate DOR, medians and 95% confidence intervals (CI).

    3. Progression-free survival (PFS) [ Time Frame: From the date of study registration to the date of progression or death due to any cause, whichever occurs first, assessed up to 5 years ]
      Surviving patients without any documented progressions will be censored at the date of last known contact. Progression will be defined as the development of muscle invasive bladder cancer or metastatic urothelial cancer (nodal and/or distant). The Kaplan-Meier product-limit estimator will be used to estimate PFS, medians and 95% CI.

    4. Overall survival (OS) [ Time Frame: From the date of study registration to date of death due to any cause, assessed up to 5 years ]
      Surviving patients will be censored at the date of last known contact. The Kaplan-Meier product-limit estimator will be used to estimate OS, medians and 95% CI.

    5. Cystectomy-free survival [ Time Frame: From the date of study registration to the date of cystectomy for all patients ]
      The Kaplan-Meier product-limit estimator will be used to estimate cystectomy-free survival, medians and 95% CI.

    6. Recurrence free survival (RFS) [ Time Frame: From the date of study registration to the first documentation of recurrence or death due to any cause, assessed up to 5 years ]
      Surviving patients without any documented recurrence will be censored at the date of last known contact. Recurrence will be defined as the development of high-grade bladder cancer for patients with a CIS component only and those without a CIS component. The Kaplan-Meier product-limit estimator will be used to estimate RFS, medians and 95% CI.

    TRIAL NUMBER: EA8185

    Title: Phase 2 Study of Bladder-SparIng ChemoradiatioN with MEDI4736 (Durvalumab) in clinical Stage 3, Node PosItive bladdeR cancEr (INSPIRE)

    Purpose:

    Primary Outcome Measures :
    1. Clinical complete response (CR) [ Time Frame: Up to 6 years ]

    Secondary Outcome Measures :
    1. Metastasis-free survival [ Time Frame: From randomization to first evidence of metastatic disease or death from any cause, assessed up to 6 years ]
      Will be estimated by the Kaplan-Meier method.

    2. Bladder-intact event-free survival (BI-EFS) [ Time Frame: From randomization to the first BI-EFS event, assessed up to 6 years ]
      Will be estimated by the Kaplan-Meier method.

    3. Bladder cancer specific survival [ Time Frame: From randomization to death from bladder cancer, assessed up to 6 years ]
      Will be estimated by the Kaplan-Meier method.

    4. Overall survival [ Time Frame: From randomization to death from any cause, assessed up to 6 years ]
      Will be estimated by the Kaplan-Meier method.

    5. Progression-free survival [ Time Frame: From randomization to first of local progression, nodal or distant metastasis, or death from any cause, assessed up to 6 years ]
      Will be estimated by the Kaplan-Meier method.

    6. Complete response duration [ Time Frame: From the date of the biopsy documenting the complete response to the time of muscle invasive recurrence, local progression, evidence of metastatic disease or death due to any cause, assessed up to 6 years ]
      Stratified Cox proportional hazards models will be used to estimate hazard ratios in all eligible patients.

    7. Salvage cystectomy rate [ Time Frame: Up to 6 years ]
      Rate will be reported as a proportion of patients who do not experience clinical benefit after chemoradiotherapy (chemoRT) +/- MEDI4736 (durvalumab) along with a 90% confidence interval. Stratified Cox proportional hazards models will be used to estimate hazard ratios in all eligible patients.

    8. Incidence of adverse events [ Time Frame: Up to 1 year ]
      Assessed using the Common Terminology Criteria for Adverse Events (CTCAE). Toxicity will be evaluated in all treated patients, regardless of eligibility.

    TRIAL NUMBER: S1600

    Title: A Randomized Phase III Double-Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes

    Purpose: This randomized phase III trial studies how well nutrition therapy works in improving immune system in patients with bladder cancer that can be removed by surgery. Improving nutrition before and after surgery may reduce the infections and other problems that sometimes occur after surgery.

    TRIAL NUMBER: S1806

    Title: S1806: Phase III Randomized Trial of Concurrent Chemoradiotherapy with or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer

    Purpose: This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab.

    TRIAL NUMBER: DCP-001

    Title: DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)

    Purpose: The protocol is not a scientific study; rather, a method to implement the screening tool and allow the collection and analyses of expanded data with informed consent. Investigators also enroll patients into NCI-treatment trials. The tool, based on a screening log successfully used within the NCI Community Cancer Centers Program (NCCCP), has been streamlined and integrated into the sites’ workflow by using OPEN. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. Also missing from the existing data is the context of care, within the communities themselves where most cancer and at risk of cancer patients receive care which is the focus of NCORP. The profile of patients accrued to NCI-sponsored clinical trials lacks both racial/ethnic and socioeconomic diversity. Accrued patients tend to be insured, highly educated and of higher socioeconomic means. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. NCORP's clinical trials portfolio includes cancer control, prevention, screening, symptom science, and cancer care delivery research.

    TRIAL NUMBER: DCP-002

    Title: DCP-002 Early Onset Malignancies Initiative (EOMI): Molecular profiling of Breast, Prostate, Colorectal, Liver, Kidney, and Multiple Myeloma among Racially and Ethnically Diverse Populations

    Purpose: The primary objective of the EOMI (Early Onset Malignancy Initiative) is to acquire tissue and blood, and other biospecimens for research purposes from tests performed for clinical care or for research indications on other research protocols to accelerate our understanding of the molecular basis of early onset cancers occurring in racial and/or ethnic minority populations through the application of genome analysis technologies, including large-scale genome sequencing and clinical data analysis.

    TRIAL NUMBER: S1823

    Title: A PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS miRNA 371 FOR OUTCOME PREDICTION IN PATIENTS WITH NEWLY DIAGNOSED GERM CELL TUMORS

    Purpose:

    Primary Outcome Measures :
    1. Relapse rate of active germ cell malignancy for those undergoing active surveillance of clinical stage I (CSI)/stage IIA germ cell malignancy [ Time Frame: Up to 3 years ]
    2. Positive predictive value [ Time Frame: Up to 3 years ]

    Biospecimen Retention:   Samples With DNA
    Blood

    TRIAL NUMBER: A031702

    Title: Phase II Study of Cabozantinib in Combination with Nivolumab and Ipilimumab in Rare Genitourinary Tumors

    Purpose: Primary Outcome Measures :
    Objective response rate (ORR) [ Time Frame: Up to 5 years ] An objective response is defined as a confirmed complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Will be estimated by the number of confirmed objective responses divided by the total number of evaluable patients. Confidence intervals for the true ORR will be calculated.

    Secondary Outcome Measures :
    Duration of response [ Time Frame: From time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years ] Defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented.
    Progression-free survival (PFS) [ Time Frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years ] The median its 95% confidence interval will be determined and will be summarized using the Kaplan-Meier estimator.
    Overall survival [ Time Frame: Up to 5 years ] The median its 95% confidence interval will be determined and will be summarized using the Kaplan-Meier estimator.
    Clinical benefit rate (CBR) [ Time Frame: Up to 5 years ] A confirmed clinical benefit is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart or a confirmed stable disease at two consecutive tumor assessments at least 3 months apart. The CBR will be estimated by the number of patients with confirmed clinical benefit divided by the total number of evaluable patients. Confidence intervals for the true CBR will be calculated using exact binomial confidence intervals.
    Incidence of adverse events (AE) [ Time Frame: Up to 5 years ] Will be assessed using Common Terminology Criteria for Adverse Events version 5.0. The maximum of a particular AE will be determined for each patient. Tables will summarize the number and relative frequency of patients observing an AE as well as the number and relative frequency of patients experiencing any AE of grade 3 or greater.

    Other Outcome Measures:
    Effects of treatment in patients with bone-only disease [ Time Frame: Up to 5 years ] The bone-only tumor patients will be evaluated in an exploratory fashion (if no RECIST measurements are available). A maximum of 15 patients with bone-only disease will be enrolled and evaluated using PFS for a descriptive analysis of the effect of treatment.

    TRIAL NUMBER: WF-1802

    Title: Influence of Primary Treatment for Prostate Cancer on Work Experience (PCW)

    Purpose: The objective of this study is to examine how adenocarcinoma of the prostate treatment differentially affects African American men's ability to work and to describe and compare changes in work ability (as measured through self-reported global work ability item) reported by African American and white adenocarcinoma of the prostate survivors before treatment and 6 months after treatment completion.

    TRIAL NUMBER: A031704

    Title: PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab Vs. VEGF TKI Cabozantinib with Nivolumab: A Phase III Trial in Metastatic Untreated REnal Cell CancEr [PDIGREE]

    Purpose: This phase III trial studies how well nivolumab and ipilimumab, followed by nivolumab versus cabozantinib and nivolumab, work in treating patients with renal cell cancer that is untreated and has spread to other parts of the body. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cabozantinib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known how well cabozantinib and nivolumab work in treating patients with untreated renal cell cancer that has spread to other parts of the body.

    TRIAL NUMBER: A231601CD

    Title: A231601CD: Improving Surgical Care and Outcomes in Older Cancer Patients Through Implementation of an Efficient Pre-Surgical Toolkit (OPTI-Surg)

    Purpose: This trial studies how well the use of a pre-surgical toolkit (OPTI-Surg) works in improving surgical care and outcomes in older participants with cancer. In many elderly patients, surgery can greatly affect physical condition and the ability to return to pre-surgery levels of physical functioning. Providing pre-surgical recommendations may help improve participants' recovery rate and functioning after surgery.

    TRIAL NUMBER: S1609

    Title: SWOG 1609: DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors Treatment with Ipilimumab and Nivolumab for Rare Cancers

    Purpose: Both Ipilimumab and Nivolumab have already been FDA-approved to treat other cancers. However, Ipilimumab and Nivolumab are investigational and not FDA-approved for use in combination in treating rare cancers or cancers of unknown primary origin.

    TRIAL NUMBER: EA8171

    Title: EA8171:Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer

    Purpose: This phase II trial studies how well multiparametric magnetic resonance imaging (MRI) works in evaluating cancer stage and helping treatment planning in patients with prostate cancer. Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive disease.

    TRIAL NUMBER: NRG-GU002

    Title: NRG-GU002: PHASE II-III TRIAL OF ADJUVANT RADIOTHERAPY AND ANDROGEN DEPRIVATION FOLLOWING RADICAL PROSTATECTOMY WITH OR WITHOUT ADJUVANT DOCETAXEL

    Purpose: This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.

    TRIAL NUMBER: NRG-GU008

    Title: RANDOMIZED PHASE III TRIAL INCORPORATING ABIRATERONE ACETATE WITH PREDNISONE AND APALUTAMIDE AND ADVANCED IMAGING INTO SALVAGE TREATMENT FOR PATIENTS WITH NODE-POSITIVE PROSTATE CANCER AFTER RADICAL PROSTATECTOMY

    Purpose:

    TRIAL NUMBER: NRG-GU009

    Title: PARALLEL PHASE III RANDOMIZED TRIALS FOR HIGH RISK PROSTATE CANCER EVALUATING DE-INTENSIFICATION FOR LOWER GENOMIC RISK AND INTENSIFICATION OF CONCURRENT THERAPY FOR HIGHER GENOMIC RISK WITH RADIATION (PREDICT-RT*)

    Purpose:

    Primary Outcome Measures :
    1. Metastasis-Free Survival (MFS) [ Time Frame: From randomization to the date of detection of distant metastasis on standard imaging or date of death from any cause, assessed up to 13 years ]
      Assessed based on conventional imaging. MFS will be estimated using the Kaplan-Meier method (Kaplan 1958).


    Secondary Outcome Measures :
    1. Overall Survival (OS) [ Time Frame: From the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, assessed up to 13 years ]
      Will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test (Kaplan 1958).

    2. Prostate Specific Antigen (PSA) failure-free survival with non-castrate testosterone and no additional therapies [ Time Frame: From the date of randomization to the date event, or death or censored at the last known follow-up date, assessed up to 13 years ]
      PSA failure-free survival will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test (Kaplan 1958).

    3. Prostate Cancer Specific Mortality (PCSM) [ Time Frame: From the date of randomization to the date of prostate cancer death, assessed up to 13 years ]
    4. Time to testosterone recovery [ Time Frame: Up to 13 years ]
      Defined as testosterone that is non-castrate.

    5. Time to PSA failure or salvage therapy [ Time Frame: Up to 13 years ]
    6. Testosterone levels at the time of PSA failure and metastases [ Time Frame: Up to 13 years ]
    7. Incidence of Adverse Events [ Time Frame: Up to 13 years ]
      Measured by the Common Terminology Criteria for Adverse Events (CTCAE ) version (v) 5.0 and Patient Reported Outcomes (PRO)-CTCAE.

    TRIAL NUMBER: RTOG-3506

    Title: RTOG 3506; A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery (STEEL)

    Purpose: Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive disease features will receive salvage radiation therapy and standard androgen deprivation therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free survival when enhanced ADT is used compared to standard ADT.

    TRIAL NUMBER: S1802

    Title: S1802: Phase III Randomized Trial of Standard Systemic Therapy (SST) versus Standard Systemic Therapy plus Definitive treatment (surgery or radiation) of the primary tumor in Metastatic Prostate Cancer

    Purpose: This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

    TRIAL NUMBER: A031801

    Title: A PHASE II RANDOMIZED TRIAL OF RADIUM-223 DICHLORIDE AND CABOZANTINIB IN PATIENTS WITH ADVANCED RENAL CELL CARCINOMA WITH BONE METASTASIS (RADICAL)

    Purpose:

    Primary Outcome Measures :
    1. Symptomatic skeletal event (SSE)-free survival (FS) [ Time Frame: From the date of randomization to the date of the earliest occurrence of SSE or death from any cause, assessed up to 5 years ]
      SSE-FS distribution will be estimated using the method of Kaplan-Meier by treatment arm. Comparison between the two arms will be performed using a one-sided log-rank test and one-sided p-value less than 0.025 will indicate that the experimental arm is superior to the control arm. SSE-FS will be censored at the date of last SSE assessment for those alive and SSE free. Hazard ratio (experimental over control arm) as well as two-sided 90% confidence interval (CI) for treatment will be estimated using the stratified Cox proportional hazard model with a single treatment covariate.


    Secondary Outcome Measures :
    1. Incidence of adverse events [ Time Frame: Up to 5 years ]
      Will be determined using Common Terminology Criteria for Adverse Events version 5.0. Adverse events will be summarized and compared between arms using chi-square or fisher exact tests as appropriate.

    2. SSE-FS [ Time Frame: From randomization to the date of SSE or death due to any cause, whichever comes first, assessed up to 5 years ]
      Will be estimated with the Kaplan Meier methodology. Comparison between arms or between predefined groups will be conducted using the log-rank test.

    3. Progression-free survival [ Time Frame: From randomization to time of radiographic progression or death due to any cause, whichever occurs first, assessed up to 5 years ]
      Radiographic progression will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Will be estimated with the Kaplan Meier methodology. Comparison between arms or between predefined groups will be conducted using the log-rank test.

    4. Overall survival [ Time Frame: From randomization to the date of death due to any cause, assessed up to 5 years ]
      Will be estimated with the Kaplan Meier methodology. Comparison between arms or between predefined groups will be conducted using the log-rank test. Patients who are alive will be censored at last follow up date.

    5. Time to first SSE [ Time Frame: From randomization to the date of first SSE or death due to any cause, assessed up to 5 years ]
      Will be determined in each treatment. The median estimate to first SSE-FS will be calculated.

    6. Overall response rate (ORR) [ Time Frame: Up to 5 years ]
      Will be defined by RECIST version 1.1. Number and proportion of patients achieving ORR (by RECIST) will be summarized with two-sided 90% CI by treatment arm; comparison between arms will be conducted using chi-square or Fisher's exact test as appropriate.

    TRIAL NUMBER: S1931

    Title: Phase III Trial of Immunotherapy-Based Combination Therapy With or Without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (PROBE Trial)

    Purpose: This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer.

    TRIAL NUMBER: A031901

    Title: A031901, Duration of Immune Checkpoint Therapy in Locally Advanced or Metastatic Urothelial Carcinoma: A Randomized Phase 3 Non-Inferiority Trial

    Purpose: This phase III trial compares survival in urothelial cancer patients who stop immune checkpoint inhibitor treatment after being treated for about a year to those patients who continue treatment with immune checkpoint inhibitors. Immunotherapy with monoclonal antibodies, such as avelumab, durvalumab, pembrolizumab, atezolizumab, and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stopping immune checkpoint inhibitors early may still make the tumor shrink and patients may have similar survival rates as the patients who continue treatment. Stopping treatment early may also lead to fewer treatment-related side effects, an improvement in mental health, and a lower cost burden to patients.

    TRIAL NUMBER: EA8192

    Title: A Phase II/III trial of MEDI4736 (Durvalumab) and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

    Purpose: This phase III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.

    TRIAL NUMBER: S2011

    Title: Randomized Phase II Trial of Gemcitabine, Avelumab and Carboplatin vs. No Neoadjuvant Therapy Preceding Surgery for Cisplatin-Ineligible Muscle-Invasive Urothelial Carcinoma: SWOG GAP TRIAL

    Purpose: This phase II trial studies the effect of avelumab, gemcitabine and carboplatin before surgery compared with surgery alone in treating patients with muscle invasive bladder or upper urinary tract cancer who are not able to receive cisplatin therapy. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving avelumab together with gemcitabine and carboplatin before surgery may work better in lowering the chance of muscle invasive urinary tract cancer growing or spreading, in patients who cannot receive cisplatin therapy compared to surgery alone.

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    TRIAL NUMBER: AEWS1031

    Title: A PHASE III RANDOMIZED TRIAL OF ADDING VINCRISTINE-TOPOTECAN- CYCLOPHOSPHAMIDE TO STANDARD CHEMOTHERAPY IN INITIAL TREATMENT OF NON-METASTATIC EWING SARCOMA

    Purpose: PRIMARY OBJECTIVES:
    l. To test the effect of the combination of vincristine, cyclophosphamide, and topotecan (VTC) added to the standard 5-drug chemotherapy interval- compressed backbone on event-free survival (EFS) and overall survival of children and young adults with Ewing sarcoma.
    SECONDARY OBJECTIVES:
    I. To evaluate initial volumetric tumor size as a prognostic factor for EFS in patients with localized Ewing tumors.
    II. To evaluate histologic response as a prognostic factor for EFS in patients with localized Ewing tumors.
    III. To continue evaluation of biologic markers both as related to prognosis and as eventual therapeutic targets via encouraging concurrent enrollment on a Ewing sarcoma specimen-collection study.
    IV. To evaluate imaging response by FDG-positron emission tomography (PET) as a prognostic factor for EFS.
    V. To evaluate the effects of the type of local therapy on EFS and overall survival.
    VI. To evaluate the effect of local surgical margins in conjunction with histologic response on EFS in patients with localized Ewing tumors.
    VII. To evaluate the effect of local therapy modality (surgery, radiotherapy, or a combination) as well as the type of surgical reconstruction on musculoskeletal complications.
    OUTLINE: This is a multicenter study. Patients are stratified according to age (= 17 years vs = 18 years) and primary tumor site (pelvic vs non-pelvic vs extra-osseous). Patients are randomized to 1 of 2 treatment arms.
    ARM I:
    INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11.
    CONSOLIDATION THERAPY: Patients receive vincristine sulfate on day 1 in weeks 1, 2, 7, 8, 9,10,13,14, 17,18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19.
    ARM II:
    INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9,10,11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1 and 9, and on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm I; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11.
    CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19.
    Patients with responsive or stable disease undergo may undergo surgery alone in week 13 if lesion can be complete resected with negative margins and with reasonable functional result. Patients with unresectable lesions or inadequate margins after surgery receive radiotherapy during weeks 1-7. Patients with bulky lesions in surgically difficult sites such as the spine, skull, and periacetabular pelvis, patients with a poor response to induction chemotherapy, or those patients in whom surgery would result in unacceptable functional results may undergo radiotherapy alone in weeks 1-7 of consolidation therapy, and surgery should be performed after completion of consolidation chemotherapy. Patients with microscopic residual disease after planned pre-operative radiotherapy receive additional radiotherapy.
    After completion of study therapy, patients are followed up periodically for 10 years.

    TRIAL NUMBER: AEWS1221

    Title: Randomized Phase II Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC #750008, IND #120449) to Multiagent Chemotherapy for Patients with Newly-Diagnosed Metastatic Ewing Sarcoma

    Purpose: PRIMARY OBJECTIVES:
    I. To compare the event-free survival (EFS) in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy with and without the addition of ganitumab (AMG 479).
    SECONDARY OBJECTIVES:
    I. To describe the toxicity of the addition of ganitumab to multimodality therapy for patients with newly diagnosed metastatic Ewing sarcoma.
    TERTIARY OBJECTIVES:
    I. To compare bone marrow response rates and overall survival in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy with and without the addition of ganitumab.
    II. To describe the toxicity of 6 months of ganitumab monotherapy as Maintenance therapy following multimodality therapy in patients with newly diagnosed metastatic Ewing sarcoma.
    III. To describe trough levels of ganitumab in a cohort of patients with Ewing sarcoma < 21 years of age treated with 18 mg/kg.
    IV. To describe the feasibility of and local failure rates following hypofractionated stereotactic body radiotherapy (SBRT) directed at bone metastases in patients with newly diagnosed metastatic Ewing sarcoma.
    V. To determine if EFS, overall survival, bone marrow response rates, and toxicity differ based on serum markers of the insulin-like growth factor 1 (IGF-1) pathway in patients with newly diagnosed metastatic Ewing sarcoma treated with interval compressed chemotherapy with and without the addition of ganitumab.
    VI. To determine if EFS, overall survival, and bone marrow response rates differ based on tumor IGF-1 receptor (IGF-1R), insulin receptor, and epidermal growth factor receptor (EGFR) pathway components in patients with newly diagnosed metastatic Ewing sarcoma treated with interval compressed chemotherapy with and without the addition of ganitumab.
    VII. To evaluate bone marrow micrometastatic disease and tumor cell surface IGF-1R expression at diagnosis and after 3 and 6 cycles of study therapy in patients with newly diagnosed metastatic Ewing sarcoma.
    VIII. To determine if the presence of germline polymorphisms in EGFR correlate with response to multiagent therapy with and without ganitumab.
    IX. To investigate the ability of fludeoxyglucose F 18-positron emission tomography (FDG-PET) to augment conventional response assessment of primary Ewing sarcoma tumors by magnetic resonance imaging (MRI).
    X. To explore FDG-PET response at the primary tumor as a prognostic marker and as a predictive biomarker of clinical activity of IGF-1R inhibition in patients with newly diagnosed metastatic Ewing sarcoma.
    OUTLINE: Patients are randomized to 1 of 2 treatment regimens.
    REGIMEN A (vincristine sulfate, doxorubicin hydrochloride and cyclophosphamide [VDC] and ifosfamide and etoposide [IE]):
    INDUCTION THERAPY: Patients receive vincristine sulfate intravenously (IV) over 1 minute on day 1; doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2; and cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 5, and 9; and ifosfamide IV over 1 hour on days 1 to 5 and etoposide IV over 1-2 hours on days 1 to 5 of weeks 3, 7, and 11.
    LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.
    CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1, 7, 9, and 13; doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2 of weeks 1 and 7; cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 7, 9, and 13; ifosfamide IV over 1 hour on days 1 to 5 of weeks 3, 5, 11, and 15; and etoposide IV over 1-2 hours on days 1 to 5 of weeks 3, 5, 11, and 15.
    METASTATIC SITE IRRADIATION: Patients with lung metastases undergo definitive SBRT or external beam radiation therapy (EBRT) over 5 days.
    REGIMEN B (VDC/IE + ganitumab):
    INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11.
    LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.
    CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15.
    METASTATIC SITE IRRADIATION: Patients with lung metastases undergo definitive SBRT or EBRT over 5 days.
    MAINTENANCE THERAPY: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 in weeks 1, 4, 7, 10, 13, 16, 19, and 22.
    After completion of study treatment, patients are followed up every 3 months for 3 years and every 6 months for 2 years.

    TRIAL NUMBER: ACNS02B3

    Title: A CHILDREN'S ONCOLOGY GROUP PROTOCOL FOR COLLECTING AND BANKING PEDIATRIC BRAIN TUMOR RESEARCH SPECIMENS

    Purpose: OBJECTIVES:
    ?Collect brain tumor tissue and an accompanying blood sample from pediatric patients with brain tumors treated at Children's Oncology Group institutions. ?Provide a repository for long-term storage of specimens from these patients. ?Make these specimens available to qualified researchers to understand the biology of pediatric brain tumors. OUTLINE: This is a multicenter study
    Brain tumor tissue and blood specimens are collected from patients and banked for future study.
    PROJECTED ACCRUAL: An unlimited number of specimens will be collected.

    TRIAL NUMBER: ACNS0831

    Title: PHASE III RANDOMIZED TRIAL OF POST-RADIATION CHEMOTHERAPY IN PATIENTS WITH NEWLY DIAGNOSED EPENDYMOMA AGES 1 TO 21 YEARS

    Purpose: PRIMARY OBJECTIVES:
    I. To determine the event-free survival (EFS) and overall survival (OS) of children with completely resected ependymoma treated with maintenance chemotherapy comprising vincristine sulfate, cisplatin, etoposide, and cyclophosphamide (VCEC) versus observation following post- operative conformal radiotherapy (cRT).
    SECONDARY OBJECTIVES:
    I. To estimate the EFS and OS of children with incompletely resected ependymoma who are unable to achieve a complete response (CR) by post-operative induction chemotherapy or by second surgery who are non-randomly assigned to cRT followed by VCEC.
    II. To further evaluate the EFS and OS of children with supratentorial classic ependymoma who achieve a complete resection at first or second resection or children who achieve a CR to short-course induction chemotherapy following first surgery.
    III. To determine the neurologic, neuropsychological, and endocrine long-term sequelae of surgery, cRT, and VCEC as compared to those patients treated on COG-ACNS0121.
    IV. To determine biologic prognostic factors in childhood ependymoma by utilizing genomic profiles via comparative genomic hybridization and single-nucleotide polymorphism arrays, and microarray gene expression profiling analysis on initial tumor samples and correlating this with clinical outcome.
    V. To evaluate prognostic immune-function gene expression in ependymomas. VI. To build upon the data derived from COG- ACNS0121 to develop genotypically based classification signatures and to correlate these to WHO grade, location, extent of resection, treatment, EFS, and OS.
    VII. To evaluate telomere maintenance as a prognostic marker.
    OUTLINE: This is a multicenter study. Patients are stratified according to extent of resection at initial surgery (total vs near total resection), tumor histology, and tumor location (infratentorial primary tumor vs supratentorial anaplastic tumor). Patients are randomized to 1 of 2 treatment arms. Patients with supratentorial classic tumor are assigned to arm II.
    All patients receive induction chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 15-60 minutes on day 1, and cyclophosphamide IV over 30-60 minutes on days 1-2. Patients also receive etoposide IV over 60-120 minutes on days 1-3 of course 2 only. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, partial response, or locally progressive disease and who are deemed potentially resectable undergo surgery within 15 days after completion of induction chemotherapy.
    ARM I: Patients undergo conformal radiotherapy over 6-7 weeks. Patients then receive vincristine sulfate IV on days 1, 8, and 15 (courses 1-3 only); etoposide IV over 1-2 hours on days 1-3; cisplatin IV over 1-8 hours on day 1; and cyclophosphamide IV over 30-60 minutes on days 1-2. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
    ARM II: Patients undergo conformal radiotherapy over 6-7 weeks. Some patients undergo blood and tissue sample collection before treatment and after surgery for gene expression microarray, genomic hybridization array, and other correlative studies.
    After completion of study therapy, patients are followed up every 4 months for 5 years.

    TRIAL NUMBER: ACNS1022

    Title: A Phase II Randomized Trial of Lenalidomide (NSC #703813, IND #70116) in Pediatric Patients with Recurrent, Refractory or Progressive Juvenile Pilocytic Astrocytomas and Optic Pathway Gliomas

    Purpose: PRIMARY OBJECTIVES:
    I. To determine the objective response rate in children with recurrent, refractory, or progressive juvenile pilocytic astrocytomas and optic pathway gliomas who are treated with Regimen A low-dose (20 mg/m^2/dose) or Regimen B high-dose (115 mg/m^2/dose) lenalidomide.
    SECONDARY OBJECTIVES:
    I. To estimate the event-free survival (EFS) (based on standard two-dimensional tumor measurements, determined by each institution) of children with recurrent, refractory, or progressive juvenile pilocytic astrocytomas and optic pathway gliomas who are treated with lenalidomide.
    II. To compare response categories and EFS across the 3 magnetic resonance (MR) sequences (T2-weighted, fluid attenuated inversion recovery [FLAIR], T1-weighted post-contrast).
    III. To correlate steady-state pharmacokinetics of lenalidomide (1 sample obtained between days 5-21) with objective response and EFS.
    IV. To evaluate toxicities of long-term lenalidomide use.
    OUTLINE: Patients are randomized to 1 of 2 treatment arms.
    ARM I (Regimen A): Patients receive low-dose lenalidomide orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
    ARM II (Regimen B): Patients receive high-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
    After completion of study treatment, patients are followed up annually for approximately 3 years.

    TRIAL NUMBER: ACNS1123

    Title: PHASE 2 TRIAL OF RESPONSE-BASED RADIATION THERAPY FOR PATIENTS WITH LOCALIZED CENTRAL NERVOUS SYSTEM GERM CELL TUMORS (CNS GCT)

    Purpose: PRIMARY OBJECTIVES:
    I. To determine, as measured by the 3-year progression-free survival (PFS) rate and patterns of failure, whether dose and volume of irradiation can be safely reduced to 30.6 Gy whole ventricular-field irradiation (WVI) plus 23.4 Gy primary site boost instead of 36 Gy craniospinal irradiation (CSI) plus primary site boost in the subgroup of children and young adults with localized nongerminomatous germ cell tumor (NGGCT) who have a magnetic resonance imaging (MRI) and tumor marker criteria (CSF and serum) for confirmed complete response (CR) or partial response (PR) to induction chemotherapy and negative serum and cerebrospinal fluid (CSF) tumor markers OR in patients who have less than a PR after induction chemotherapy with negative tumor markers who undergo a second-look surgery and are found to have only mature teratoma, residual scar or fibrosis, and fit the definition of CR/PR after second-look surgery.
    II. To determine, as measured by the 3-year PFS rate and patterns of failure, whether simplified chemotherapy followed by dose-reduced radiation therapy is effective for treating children and young adults with localized primary central nervous system (CNS) germinoma who present with serum and/or CSF human chorionic gonadotropin-beta (hCGß) =< 50 mIU/mL.
    III. To prospectively evaluate and longitudinally model the cognitive, social, and behavioral functioning of children and young adults who are treated with reduced radiation dose and volume of irradiation in Stratum 1 (NGGCT) and with dose-reduced radiation therapy in Stratum 2 (Germinoma) using the ALTE07C1 protocol (This objective will be assessed independently for the two strata).
    SECONDARY OBJECTIVES:
    To estimate the PFS and overall survival (OS) distributions of patients with NGGCT treated with 30.6 Gy WVI and involved-field radiation therapy (IFR) focal boost to 54 Gy. II. To estimate the PFS and OS distributions of localized- germinoma patients who present with serum and/or CSF hCGß = 50 mIU/mL vs serum and/or CSF hCGß > 50 mIU/mL and =< 100 mIU/mL.
    OUTLINE: This is a multicenter study. Patients are stratified according to localized primary disease (nongerminomatous germ cell tumor [NGGCT] vs germinoma).
    Stratum 1 (NGGCT): Patients receive induction therapy comprising carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 1-2 hours on days 1-3 of courses 1, 3, and 5. Patients also receive ifosfamide IV over 1 hour and etoposide over 1-2 hours on days 1-5 of courses 2, 4, and 6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive disease (complete [CR] or partial response [PR]) to induction chemotherapy undergo radiotherapy once daily (QD) 5 days a week for 6 weeks. Patients with PR, stable disease (SD), or progressive disease (PD) and normalization of tumor levels undergo second-look surgery. Patients who achieve CR or PR after second-look surgery undergo radiotherapy.
    Stratum 2 (Germinoma): Patients receive induction therapy comprising carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or continued CR undergo radiotherapy QD 5 days a week for approximately 4 weeks. Patients with PR, SD, or PD with normal tumor markers may undergo second-look surgery. Patients found to have mature teratoma or non-viable tumor during surgery undergo radiotherapy. Patients with PR or SD with residual disease (=< 1.5 cm) and suprasellar (> 0.5 cm) or pineal (> 1 cm) involvement and normal tumor markers undergo radiotherapy after chemotherapy without second-look surgery.
    After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 2 years, and then annually for up to 3 years.

    TRIAL NUMBER: ACNS1422

    Title: A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients

    Purpose: Primary Outcome Measures: PFS [ Time Frame: From the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 10 years ] PFS along with the confidence intervals will be estimated using the Kaplan-Meier method. PFS will also be reported based on central radiology review.

    Secondary Outcome Measures: Change in neurocognitive function (cognitive, social, emotional and behavioral) according to Children Oncology Group Standard Neuropsychological Battery [ Time Frame: Baseline to up to 60 months post-diagnosis ] Neurocognitive function will be measured at 9, 30 and 60 months post diagnosis and will be compared with the neurocognitive outcomes from an age and gender matched ACNS0331 cohort to the WNT patients treated on ACNS1422. Data for all assessments will be available as standardized t-scores. The change over time for each component of the neuropsychological testing will be estimated using the Generalized Estimating Equation (GEE) approach, with the standardized t-scores as the dependent variable and the assessment times as a covariate. Within the ACNS1422 cohort GEE models will also be used to exp
    DNA methylation profiling as real-time classification of WNT-driven medulloblastoma [ Time Frame: Within 32 days of definitive surgery ] Results will be compared to the results of the molecular screening tests. The sensitivity and specificity comparison between DNA methylation arrays and the standard methods (molecular screening tests for WNT using IHC and CTNNB1 sequencing) will be performed using McNemar's test.

    Other Outcome Measures: DNA methylation profiling of medulloblastoma real-time" predictive classification scheme for the SHH, group 3 and group 4 medulloblastoma subgroups according to the Heidelberg classifier [ Time Frame: Within 32 days of definitive surgery ] The proportion of patients classified into each medulloblastoma subgroup in "real time" will be reported.

    Estimated Enrollment: 45 Study Start Date: October 2016 Estimated Primary Completion Date: May 2025 (Final data collection date for primary outcome measure)

    TRIAL NUMBER: ANBL00B1

    Title: NEUROBLASTOMA BIOLOGY STUDIES

    Purpose:

    TRIAL NUMBER: ANBL1232

    Title: Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma; A Groupwide Historically-Controlled Phase III Study

    Purpose: PRIMARY OBJECTIVES:
    I. To eliminate therapy as the initial approach for infants < 12 months of age with small International Neuroblastoma Risk Group (INRG) stage L1 neuroblastoma while maintaining an overall survival (OS) of 99%.
    II. To eliminate therapy as the initial approach for non-high-risk patients < 18 months of age with localized neuroblastoma and favorable biology (histologic and genomic features) while maintaining an OS of 99%.
    III. To achieve a 3-year OS of > 81% for infants < 18 months of age with INRG stage Ms neuroblastoma using objective criteria for early initiation of a response-based treatment algorithm.
    IV. To achieve a 3-year event free survival (EFS) of > 70% for non-high-risk infants < 12 months of age with INRG stage M neuroblastoma and unfavorable biology (histologic and/or genomic features) through the addition of isotretinoin therapy.
    SECONDARY OBJECTIVES:
    I. To describe the time to intervention or tumor progression, type of intervention and site of progression for patients with localized neuroblastoma who experience progression after an initial period of observation.
    II. To characterize the pharmacokinetic profile of the chemotherapeutic agents carboplatin and etoposide in patients with stage Ms disease.
    III. To define the genomic profile of tumors from patients with non-high-risk neuroblastoma both at initial biopsy and at the time of subsequent biopsy or surgical resection.
    IV. To describe the histology of tumor specimens obtained at the time of subsequent biopsy or surgical resection.
    V. To determine the salvage rate (OS) of patients with tumor relapse or disease progression.
    VI. To determine the procedural complication rate (initial biopsy, resection [intraoperative and postoperative], subsequent biopsy) and correlate with the degree of surgical resection.
    VII. To determine the rate of reduction in image defined risk factors (IDRF) in L2 tumors following observation or chemotherapy.
    VIII. To describe bone abnormalities on bilateral tibial radiographs obtained before and after isotretinoin therapy.
    IX. To determine the variability of isotretinoin pharmacokinetics and relationship to pharmacogenomic parameters and determine if these levels and/or genetic variations correlate with EFS or systemic toxicity.
    OUTLINE: Patients are assigned to 1 of 4 treatment groups.
    GROUP A: Patients undergo clinical observation for 96 weeks.
    GROUP B: Patients undergo clinical observation for 3 years in the absence of disease progression. Upon disease progression, patients undergo surgery or receive first-line chemotherapy comprising carboplatin intravenously (IV) over 1 hour on day 1 (courses 1, 2, 4, 6, and 7), etoposide IV over 1 hour on days 1-3 (courses 1, 3, 4, 5, and 7), cyclophosphamide IV over 1 hour on day 1 (courses 2, 3, 5, 6, and 8), and doxorubicin hydrochloride IV over 15 minutes on day 1 (courses 2, 4, 6 and 8). Treatment with chemotherapy repeats every 21 days for 2-8 courses in the absence of disease progression or unacceptable toxicity. Once a partial response (PR) or better is achieved, patients undergo clinical observation for 3 years.
    GROUP C: Patients at high risk for deterioration and a poor outcome immediately receive first-line chemotherapy as in Group B. All other patients undergo clinical observation for 3 years in the absence of disease progression. Upon disease progression, patients receive first-line chemotherapy as in Group B. Once a PR or better is achieved, patients undergo clinical observation for 3 years.
    GROUP D: Patients receive first-line chemotherapy as in Group B. Patients who achieve a complete response (CR) or very good partial response (VGPR) following first-line chemotherapy receive isotretinoin orally (PO) twice daily (BID) on days 1-14. Treatment with isotretinoin repeats every 28 days for 6 courses. Patients then undergo clinical observation for 3 years. Patients who achieve a PR or stable disease (SD) following first-line chemotherapy receive salvage chemotherapy comprising cyclophosphamide IV over 30 minutes and topotecan hydrochloride IV over 30 minutes on days 1-5. Treatment with salvage chemotherapy repeats every 21 days for 2-6 courses. Patients then receive isotretinoin PO BID on days 1-14. Treatment with isotretinoin repeats every 28 days for 6 courses. Patients then undergo clinical observation for 3 years.
    After completion of study treatment, patients are followed up annually for 5 years.

    TRIAL NUMBER: AAML08B1

    Title: BIOLOGY STUDY OF TRANSIENT MYELOPROLIFERATIVE DISORDER (TMD) IN CHILDREN WITH DOWN SYNDROME (DS)

    Purpose: OBJECTIVES:
    •To further our biological understanding of the natural history of transient myeloproliferative disorder (TMD) and its relationship to subsequent leukemia by facilitating the development of a TMD cell and protein bank, and repository of DNA/RNA from megakaryoblasts for future biological studies. •To investigate the biology of TMD molecular changes associated with resolution of TMD or its conversion to acute myeloid leukemia within each mortality-risk group by conducting GATA1 mutational analyses, hematopoiesis clonality studies, assessment of RAS mutations, and genomic instability studies using glycophorin A assays. •To determine if high-resolution microarray genomic analysis of TMD blasts (using Affymetrix SNP Genechip technology to assess gene expression, copy number variation, and loss of heterozygosity) can predict the development of subsequent leukemia. •To determine the relationship of minimal residual disease (monitored by peripheral blood flow cytometry and GATA1 mutational studies) to clinical remission status and development of subsequent leukemia within each mortality-risk group of TMD patients. •To evaluate the relationship between karyotype (including FISH analysis) and subsequent leukemia in TMD patients. •To examine pharmacogenetics and in vitro drug sensitivity to cytarabine (MTT assay) in blasts from TMD patients. •To examine the relationship of functional polymorphisms in Phase I and Phase II drug detoxification genes, DNA repair, and DNA synthesis pathways that may modify susceptibility to leukemia and outcome in TMD patients. •To determine the relationship between fibrosis-associated serum factors (e.g., platelet-derived growth factor, transforming growth factor beta, N-terminal peptide of III procollagen, type IV collagen, and hyaluronic acid) and event-free survival. OUTLINE: This is a multicenter study.
    Patients undergo peripheral blood collection periodically for biomarker analysis. Samples are analyzed for GATA1 mutations by real-time PCR, polymorphisms, cytogenetics, - and K-RAS mutations, gene expression, drug sensitivity patterns, and minimal residual disease by flow cytometry.
    Patients are followed up periodically for 5 years.

    TRIAL NUMBER: ALTE03N1

    Title: KEY ADVERSE EVENTS AFTER CHILDHOOD CANCER

    Purpose: PRIMARY OBJECTIVES:
    I. To identify key adverse events developing in patients (cases) with a primary cancer diagnosed at age 21 or younger.
    II. To characterize the key adverse events with respect to the nature of the primary malignancy (pathology, stage) and coded details of the therapeutic protocol.
    III. To identify treatment-related and demographic risk factors through a direct comparison of the case-group and controls identified from the remaining patients with the same primary diagnosis.
    IV. To compare the frequency of mutations or polymorphisms in specific candidate genes in cases and controls, using constitutional DNA and RNA from the cases and controls.
    V. To explore the role and nature of gene-environment interaction in the development of key adverse events.
    OUTLINE: This is a multicenter study.
    DNA from peripheral blood or buccal sample of patients is analyzed for the presence of polymorphisms in candidate genes associated with an increased risk of late-occurring complications, such as cardiac dysfunction (closed to accrual as of 4/17/09), myocardial infarction (closed to accrual as of 6/5/06), ischemic stroke, avascular necrosis (closed to accrual as of 11/26/08), and subsequent malignant neoplasms.
    Patients also complete a questionnaire detailing family history and health history.

    TRIAL NUMBER: CHDCP-001

    Title: DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)

    Purpose:

    TRIAL NUMBER: DCP-001

    Title: DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)

    Purpose: The protocol is not a scientific study; rather, a method to implement the screening tool and allow the collection and analyses of expanded data with informed consent. Investigators also enroll patients into NCI-treatment trials. The tool, based on a screening log successfully used within the NCI Community Cancer Centers Program (NCCCP), has been streamlined and integrated into the sites’ workflow by using OPEN. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. Also missing from the existing data is the context of care, within the communities themselves where most cancer and at risk of cancer patients receive care which is the focus of NCORP. The profile of patients accrued to NCI-sponsored clinical trials lacks both racial/ethnic and socioeconomic diversity. Accrued patients tend to be insured, highly educated and of higher socioeconomic means. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. NCORP's clinical trials portfolio includes cancer control, prevention, screening, symptom science, and cancer care delivery research.

    TRIAL NUMBER: ANBL1531

    Title: ANBL1531, A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)

    Purpose: ANBL1531 is a COG group-wide Phase III study for patients between 1-30 years of age with neuroblastoma or ganglioneuroblastoma (nodular). In this study, researchers want to find out if we can improve the treatment for subjects with high-risk NBL by adding the experimental drug 131I-MIBG or the experimental drug crizotinib to COG recommended therapy. (Subjects are people who agree to take part in this study). 131I-MIBG is an experimental anticancer drug that has not been approved by the Food and Drug Administration (FDA) for use in treating high-risk NBL. 131I-MIBG has been used to treat NBL that did not respond to standard therapy or that has come back. 131I-MIBG has been shown to be well tolerated in children with cancer. Crizotinib is an experimental anticancer drug that has not been approved by the FDA for use in treating high-risk NBL. Crizotinib has been approved by the FDA for use in treating adults with certain types of lung cancer that has spread. Crizotinib has been welltolerated in children and adults with cancer. Crizotinib will only be used in subjects whose tumor shows changes (mutations or increased number of copies) in a gene called ALK. Changes in the ALK gene are only found in 10-15% of children with high-risk NBL. The overall goals of this study are to: • Compare the effects, good and/or bad, of the experimental drug 131I-MIBG added to current COG recommended therapy to the effects of current COG recommended therapy without the experimental drug 131I-MIBG. • Compare the effects, good and/or bad, of the experimental drug crizotinib added to current COG recommended therapy to the effects of current COG recommended therapy without the experimental drug crizotinib. Another goal of this study is to: • Evaluate the effects, good and/or bad, of using the experimental drug 131I-MIBG and reducing the number of stem cell transplants from 2 to 1 by giving the drugs BuMel during Consolidation therapy. The goal for subjects in Arm D of this study is: • To see if subjects with a tumor that is 123I-MIBG non-avid and does not have changes in the ALK gene have better outcomes than those with 123I-MIBG avid NBL when treated with COG recommended therapy for high-risk neuroblastoma. An 123I-MIBG avid tumor means that the tumor took up 123I-MIBG during a scan. An 123IMIBG non-avid tumor means that the tumor did not take up 123I-MIBG during a scan. The goal for subjects in Arm E of this study is: • To see if subjects with a tumor that shows changes in the ALK gene will have improved outcomes when the experimental drug crizotinib is added to COG recommended therapy for high-risk neuroblastoma. Each subject on the ANBL1531 study will have genetic tests done on his/her tumor tissue. The tumor tissue will be tested for changes to a gene called ALK. The experimental drug crizotinib may be effective against tumors with ALK gene changes.

    TRIAL NUMBER: APEC14B1

    Title: Project: Every Child for Younger Patients With Cancer

    Purpose: This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

    TRIAL NUMBER: ARST1431

    Title: COG ARST1431, A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating with Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864, IND# 122782) in Patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS)

    Purpose: ARST1431, states that Unfortunately about 25% of patients with intermediate-risk (IR) embryonal rhabdomyosarcoma (ERMS) and 50% of those with IR alveolar rhabdomyosarcoma (ARMS) will experience disease recurrence with a resulting long-term event-free survival (EFS) of 65%. The mTOR pathway is important in RMS biology, and temsirolimus (TORI), an mTOR inhibitor, has demonstrated clinical activity in patients with relapsed RMS. In an attempt to improve long-term survival for patients with IR RMS, ARST1431 will compare the EFS of patients with newly diagnosed IR RMS randomly assigned to standard vincristine, dactinomycin, and cyclophosphamide (VAC) alternating with vincristine and irinotecan (VI) versus VAC/VI plus TORI. Radiotherapy will start at Week 13 of therapy for all patients. Correlative biology studies will be performed including a determination of the FOXO1 gene fusion status in the tumor and impact on patient outcome. Children’s Hospital/LSUHSC-NO sees several diagnosed patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS), We estimate seeing up to 5-10 patients per year.

    TRIAL NUMBER: ACCL1033

    Title: A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL

    Purpose: PRIMARY OBJECTIVES:
    I. Determine the impact of interventions proposed in intervention program (IP) vs. education alone (EDU) on adherence to oral 6MP (mercaptopurine) in children with acute lymphoblastic leukemia (ALL). Adherence will be measured by: i) Medication Event Monitoring Systems (MEMS) (primary measure of adherence to oral 6MP, providing real-time data; ii) red cell thioguanine nucleotide (TGN) levels (providing data on chronic, systemic 6MP exposure).
    SECONDARY OBJECTIVES:
    I. Examine the modifying effect of sociodemographic and psychosocial variables, and the mediating effect of health beliefs/ knowledge on change in adherence with intervention.
    II. Determine impact of IP vs. EDU on risk of relapse of ALL.
    OUTLINE: Patients are randomized to 1 of 2 intervention arms.
    ARM I: Patients receive the Patients Supply Kit containing an electronic pill monitoring system, a MEMS® medication bottle with TrackCap? with standard resistant cap, and written instructions for the patient and pharmacist. Parents and/or caregivers are also trained to supervise patients' intake of the medication. Beginning on day 1, patients start using the MEMS® medication bottle with TrackCap?. Clinical research assistants contact patients and parents by telephone the next day to confirm that TrackCap? is being used, to identify any obstacles, and to determine solutions. Beginning on day 29, patients and caregivers view an interactive multimedia educational program on-line or via DVD. Patients also receive a customized electronic mercaptopurine schedule and automated customized text message reminders delivered via cellular phone or web-based interface. Patients and caregivers are instructed to return the MEMS® medication bottle with TrackCap? to the clinic by day 141.
    ARM II: Patients receive the usual standard of care and the mercaptopurine from the MEMS® medication bottle with TrackCap? as patients in arm I.
    After completion of study treatment, patients are followed up every 6 months for 5 years and then annually until 10 years from diagnosis.

    TRIAL NUMBER: AHOD1331

    Title: A Randomized Phase III Study of Brentuximab Vedotin (Bv, IND #117117) for Newly-Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Adolescents

    Purpose: PRIMARY OBJECTIVES:
    I. To assess the event free survival (EFS) of a novel regimen incorporating brentuximab vedotin (Bv; Adcetris) in the chemotherapy backbone of doxorubicin (Adriamycin) (doxorubicin hydrochloride), vincristine (vincristine sulfate), etoposide, prednisone and cyclophosphamide (Bv-AVEPC) in newly diagnosed high-risk classical Hodgkin lymphoma (cHL) compared to those treated with Adriamycin, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide (ABVE-PC).
    SECONDARY OBJECTIVES:
    I. To determine whether children/adolescents with high-risk cHL treated with Bv-AVEPC have a higher rate of early response (determined by fludeoxyglucose F 18 [FDG]-positron emission tomography [PET]) and a reduction in protocol directed radiation therapy (RT) compared to those treated with ABVE-PC.
    II. To compare the rate of neuropathy (>= grade 3) among patients treated on the Bv-AVEPC (experimental arm) to patients treated on the ABVE-PC (standard arm).
    TERTIARY OBJECTIVES:
    I. To validate and compare the Childhood Hodgkin International Prognostic Score (CHIPS) to conventional Ann Arbor Stage (Stages II B with bulk, III B, IV A or B) in predicting outcome in high-risk childhood cHL.
    II. To determine the incidence of preferentially expressed antigen in melanoma (PRAME) and testis-specific antigens in Epstein-Barr virus (EBV)- cHL tumors and the incidence of EBV antigens (Epstein-Barr nuclear antigen 1 [EBNA1], Epstein-Barr virus latent membrane protein 1 [LMP1], large multifunctional peptidase 2 [LMP2]) in EBV+ cHL tumors, with the goal of developing strategies to integrate cellular therapy into treatment for newly diagnosed high-risk cHL. (Biology) III. To incorporate qualitative visual FDG-PET into response-directed treatment algorithms and explore quantitative FDG-PET and computed tomography (CT) definitions of tumor burden and response for incorporation into next generation pediatric cHL risk-stratification schemes. (Imaging) IV. To evaluate the reduction in normal tissue irradiation associated with the current treatment approach compared to the volume of historic involved field radiation therapy (IFRT) fields. (Radiation Therapy) V. To evaluate EFS and patterns of relapse following protocol-specified RT utilization and treatment volumes. (Radiation Therapy) VI. To characterize the extent of chemotherapy induced peripheral neuropathy (CIPN), as reported by patients and parent proxies, through serial administration of the Functional Assessment of Cancer Therapy-Gynecologic Oncology Group-Neurotoxicity (FACT-GOG-NTX). (Patient Reported Outcomes [PRO] of Peripheral Neuropathy and Health-Related Quality of Life) VII. To describe the Health-Related Quality of Life (HRQL) consequences of peripheral neuropathy over time by correlating total neuropathy scale scores with the individual items with the Child Health Ratings Inventories (CHRIs)-Global scale (e.g., physical health, pain, emotional functioning). (PRO of Peripheral Neuropathy and Health-Related Quality of Life) VIII. To perform a cross validation of the FACT-GOG-NTX with the Total Neuropathy Score-Pediatric Vincristine (TNS-PV) to determine the performance of both measures with the use of brentuximab vedotin in a limited institutional approach in children and adolescents with cHL. (PRO of Peripheral Neuropathy and Health-Related Quality of Life) IX. To assess the resource use and cost implications of Bv in combination with chemotherapy and radiotherapy for newly diagnosed high-risk cHL in children and adolescents. (Economic)
    OUTLINE: Patients are randomized to 1 of 2 treatment arms.
    ARM I (ABVE-PC): Patients receive doxorubicin hydrochloride intravenously (IV) over 1-15 minutes on days 1-2, bleomycin sulfate IV over 10 minutes or subcutaneously (SC) on days 1 and 8, vincristine sulfate IV over 1 minute on days 1 and 8, etoposide IV over 60-120 minutes on days 1-3, prednisone orally (PO) twice daily (BID) on days 1-7, and cyclophosphamide IV over 30-60 minutes on days 1 and 2.
    ARM II (Bv-AVEPC): Patients receive brentuximab vedotin IV over 30 minutes on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone, and cyclophosphamide as in Arm I and vincristine sulfate IV over 1 minute on day 8.
    In both arms, treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity.
    After completion of study treatment, patients are followed up at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.

    TRIAL NUMBER: 9442/4941L

    Title: NATIONAL WILMS TUMOR LATE EFFECTS STUDY

    Purpose:

    TRIAL NUMBER: AREN03B2

    Title: RENAL TUMORS CLASSIFICATION, BIOLOGY, AND BANKING STUDY

    Purpose: PRIMARY OBJECTIVES:
    I. Classify patients with renal tumors by histological categorization, surgico- pathological stage, presence of metastases, age at diagnosis, tumor weight, and loss of heterozygosity for chromosomes 1p and 16q, to define eligibility for a series of therapeutic studies.
    II. Maintain a biological samples bank to make specimens available to scientists to evaluate additional potential biological prognostic variables and for the conduct of other research by scientists.
    SECONDARY OBJECTIVES:
    I. Monitor outcome for those patients who are not eligible for a subsequent therapeutic study.
    II. Describe whether the pulmonary tumor burden correlates with outcome in patients with stage IV disease.
    III. Describe the sensitivity and specificity of abdominal computed tomography (CT) scan by comparing it with surgical and pathologic findings for identification of local tumor spread beyond the renal capsule to adjacent muscle and organs, lymph node involvement at the renal hilum and in the retroperitoneum, preoperative tumor rupture, and metastases to the liver.
    IV. Compare the sensitivity and specificity of pre-operative abdominal CT scan and MRI for the identification and differentiation of nephrogenic rests and Wilms' tumor in children with multiple renal lesions.
    V. Correlate the method of conception (natural vs assisted reproductive technology) with the development of Wilms' tumor.
    OUTLINE: This is a multicenter study.
    Tumor tissue, blood, and urine samples are collected for research studies, including immunohistochemistry. CT scans and magnetic resonance imaging (MRIs) are also performed. Loss of heterozygosity analyses (chromosome 1p and 16q) are performed by extraction of DNA. DNA polymorphisms are assayed by polymerase chain reaction using standard methodology. Leftover specimens are archived for future studies.
    Patients are followed periodically for 5 years.

    TRIAL NUMBER: ACCL0933

    Title: A RANDOMIZED OPEN-LABEL TRIAL OF CASPOFUNGIN VERSUS FLUCONAZOLE TO PREVENT INVASIVE FUNGAL INFECTIONS IN CHILDREN UNDERGOING CHEMOTHERAPY FOR ACUTE MYELOID LEUKEMIA (AML)

    Purpose: OBJECTIVES:
    Primary
    ?To determine if prophylaxis with caspofungin administered during periods of neutropenia following chemotherapy for acute myeloid leukemia (AML) is associated with a lower incidence of proven or probable invasive fungal infections (IFI) compared with fluconazole. Secondary
    ?To determine if prophylaxis with caspofungin will result in a lower incidence of proven or probable cases of invasive aspergillosis (IA) compared with fluconazole. ?To determine if prophylaxis with caspofungin will result in improved survival compared to fluconazole. ?To determine if prophylaxis with caspofungin will result in less empiric antifungal therapy compared to fluconazole. ?To determine the sensitivity, specificity, and positive and negative predictive value of biweekly galactomannan (GM) and beta-D glucan testing in diagnosing IFI. ?To test the association between single nucleotide polymorphisms (SNPs) in genes involved in innate immunity and proven or probable IFI. ?To develop predictive models of IFI using SNP in genes involved in immunity and clinical covariates. OUTLINE: This is a multicenter study. Patients are stratified according to disease (de novo acute myeloid leukemia vs all other patients). Patients are randomized to 1 of 2 treatment arms.
    ?Arm I: Patients receive caspofungin acetate IV over 1 hour once daily (QD) beginning within 24 hours following completion of each course of chemotherapy and continuing until ANC > 100/?L (recommended > 200/?L for 2 consecutive days) or the next chemotherapy course begins. ?Arm II: Patients receive fluconazole IV over 2 hours or orally (PO) QD beginning within 24 hours following completion of each course of chemotherapy and continuing until ANC > 100/?L (recommended > 200/?L for 2 consecutive days) or the next chemotherapy course begins. In both arms, treatment continues in the absence of invasive fungal infections or disease progression.
    Blood samples may be collected twice weekly for antifungal antigen assays and at the end of course 1 for single nucleotide polymorphism analysis.
    After completion of study treatment, patients are followed up periodically for 2 years.

    TRIAL NUMBER: ACCL1333

    Title: A Phase III Randomized, Open Label, Multi-center Study of the Safety and Efficacy of Apixaban for Thromboembolism Prevention versus No Systemic Anticoagulant Prophylaxis during Induction Chemotherapy in Children with Newly-Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoma (T or B cell) Treated with Pegylated Asparaginase; Protocol CV185155

    Purpose: Study Objectives: Primary Objectives: ? To compare the effect of prophylactic oral or enteric apixaban versus no administration of systemic prophylactic anticoagulant during induction chemotherapy, on the composite endpoint of adjudicated non-fatal deep vein thrombosis (DVT, including symptomatic and asymptomatic), pulmonary embolism (PE), and cerebral venous sinus thrombosis (CVST); and venous thromboembolism (VTE)-related-death during 25-28 days of open-label treatment in pediatric subjects (1 to < 18 years) with newly diagnosed ALL or lymphoma (T or B cell), a functioning central venous access device (CVAD) and receiving PEG L-asparaginase during chemotherapy induction. ? To assess the effect of prophylactic oral or enteric apixaban versus no administration of systemic prophylactic anticoagulant during induction chemotherapy, on adjudicated major bleeding events during 25 - 28 days of open-label treatment in pediatric subjects (1 to < 18 years) with newly diagnosed ALL or lymphoma (T or B cell), a functioning CVAD and receiving PEG L-asparaginase during chemotherapy induction. Secondary Objectives: ? To assess the effect of prophylactic oral or enteric apixaban versus no administration of systemic prophylactic anticoagulant during induction chemotherapy, on single adjudicated endpoints of non-fatal DVT (including symptomatic and asymptomatic), PE, and CVST; and VTE-related-death during 25 - 28 days of open-label treatment in pediatric subjects (1 to < 18 years) with newly diagnosed ALL or lymphoma (T or B cell), a functioning CVAD and receiving PEG L-asparaginase during chemotherapy induction. ? To assess the effect of prophylactic oral or enteric apixaban versus no administration of systemic prophylactic anticoagulant during induction chemotherapy, on the composite endpoint of adjudicated major and clinically relevant non-major bleeding (CRNMB) events during 25 - 28 days of open-label treatment in pediatric subjects (1 to < 18 years) with newly diagnosed acute ALL or lymphoma (T or B cell), a functioning CVAD and receiving PEG L-asparaginase during chemotherapy induction. Other Objectives: ? To assess the effect of prophylactic oral or enteric apixaban versus no administration of systemic prophylactic anticoagulant during induction chemotherapy, on single adjudicated endpoints of all cause death; arterial thromboembolic events including paradoxical embolism and stroke and CVAD-related infection events during 25 - 28 days of open-label treatment in pediatric subjects (1 to < 18 years) with newly diagnosed ALL or lymphoma (T or B cell), a functioning CVAD and receiving PEG L-asparaginase during chemotherapy induction. ? To assess the effect of prophylactic oral or enteric apixaban versus no administration of systemic prophylactic anticoagulant during induction chemotherapy, on single adjudicated endpoints of CRNMB and minor bleeding events during 25 - 28 days of open-label treatment in pediatric subjects (1 to < 18 years) with newly diagnosed ALL or lymphoma (T or B cell), a functioning CVAD and receiving PEG L-asparaginase during chemotherapy induction. ? To assess the effect of prophylactic oral or enteric apixaban versus no administration of systemic prophylactic anticoagulant during induction chemotherapy, on single endpoints of number of catheter replacements needed during the study; events of CVAD dysfunction with improvement after thrombolytic therapy; and number of platelet transfusions during 25 - 28 days of open-label treatment in pediatric subjects (1 to < 18 years) with newly diagnosed ALL or lymphoma (T or B cell), a functioning CVAD and receiving PEG L-asparaginase during chemotherapy induction. ? To assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy for ALL or lymphoma (T or B cell), using a population pharmacokinetic (PPK) approach. ? To characterize the relationship between apixaban plasma concentration and anti-FXa activity in pediatric subjects receiving induction chemotherapy for ALL or lymphoma (T or B cell). ? To explore the exposure-response relationship between apixaban exposure and safety and efficacy endpoints in pediatric subjects with newly diagnosed ALL or lymphoma (T or B cell).

    TRIAL NUMBER: COG-AAML1031

    Title: A PHASE III RANDOMIZED TRIAL FOR PATIENTS WITH DE NOVO AML USING BORTEZOMIB (IND# 58443, NSC# 681239) AND SORAFENIB (BAY 43-9006, IND#69896, NSC# 724772) FOR PATIENTS WITH HIGH ALLELIC RATIO FLT3/ITD

    Purpose: PRIMARY OBJECTIVES:
    I. To compare event-free survival (EFS) and overall survival (OS) of patients with de novo acute myeloid leukemia (AML) with or without high allelic ratio FLT3/ITD+ mutations who are randomized to standard therapy versus bortezomib/standard combination therapy.
    II. To determine the feasibility of combining bortezomib with standard chemotherapy in patients with de novo AML.
    III. To compare the OS and EFS of high-risk patients treated with intensive Induction II with historical controls from COG-AAML03P1 and COG- AAML0531.
    IV. To determine the feasibility of combining sorafenib with standard chemotherapy in patients with de novo high allelic ratio FLT3/ITD+ AML.
    SECONDRY OBJECTIVES:
    I. To assess the anti-leukemic activity of sorafenib in patients with de novo high allelic ratio FLT3/ITD+ AML.
    II. To compare the percentage of patients converting from positive MRD to negative MRD after Intensive Induction II with historical controls from COG- AAML03P1 and COG-AAML0531.
    III. To compare OS, disease-free survival (DFS), cumulative incidence of relapse, and treatment-related mortality from end of Intensification I between patients allocated to best allogenic donor stem cell transplant (SCT) and comparable patients on COG-AAML0531 who did not receive allogenic donor SCT.
    IV. To compare OS, DFS, cumulative incidence of relapse, treatment-related mortality, and severe toxicity between patients allocated to matched family donor SCT on COG-AAML103P1 and COG-AAML0531.
    V. To assess the health-related quality of life (HRQOL) of patients treated with chemotherapy and SCT for AML.
    VI. To compare the changes in shortening fraction/ejection fraction over time between patients treated with and without dexrazoxane.
    VII. To refine the use of minimal-residual disease (MRD) detection with 4- color flow cytometry.
    VIII. To evaluate the prognostic significance of molecular MRD and its contribution to risk identification with multidimensional flow cytometry (MDF)-based MRD in patients with translocations amenable to quantitative RT-PCR (e.g., t(8;21), inv(16), t(9;11), WT1 expression).
    IX. To determine the leukemic involvement of the hematopoietic early progenitor cell and its role in defining response to therapy.
    X. To define the leukemic stem cell population in patients with AML. XI. To determine the prevalence and prognostic significance of molecular abnormalities of WT1, RUNX1, MLL-PTD, TET2, c-CBL, KIT, and other novel AML-associated genes in pediatric AML.
    XII. To correlate the expression of CD74 antigen as well as PSMB5 gene expression and mutation with response to bortezomib.
    XIII. To evaluate the changes in protein expression and unfolded protein response (UPR) in patients with AML. XIV. To determine the expression level of wild-type FLT3, and correlate with outcome and in vitro sensitivity to FLT3 inhibition.
    XV. To obtain sorafenib and metabolite steady state pharmacokinetics and pharmacokinetic- pharmacodynamic data in subjects with FLT3/ITD receiving sorafenib.
    XVI. To collect biology specimens at diagnosis, treatment time points, and relapse for future biology studies.
    OUTLINE: This is a multicenter, dose-escalation study of sorafenib tosylate and an open-label randomized study. Patients are stratified according to disease risk (low vs high). Patients are randomized to 1 of 2 treatment arms or offered treatment on a third arm.
    INDUCTION I:
    ARM A: Patients receive cytarabine intrathecally (IT) on day 1 and ADE chemotherapy comprising cytarabine IV over 15-30 minutes on days 1-10; daunorubicin IV over 1-15 minutes on days 1, 3, and 5; and etoposide IV over 1-2 hours on days 1-5.
    ARM B: Patients receive cytarabine IT and ADE chemotherapy as in Induction I, Arm A. Patients also receive bortezomib IV on days 1, 4, and 8.
    ARM C (high-risk [HR] FLT3/ITD+ disease): Patients receive cytarabine IT and ADE chemotherapy as in Induction I, Arm A and sorafenib tosylate orally (PO) on days 11-28.
    INDUCTION II: Patients without HR FLT3/ITD+ disease begin Induction II administration on day 29.
    ARM A (low-risk [LR] patients): Patients receive cytarabine IT and ADE chemotherapy as in Induction I Arm A.
    ARM A (HR patients): Patients receive cytarabine IT on day 1 and MA chemotherapy comprising high-dose cytarabine IV over 1-3 hours on days 1- 4, and mitoxantrone IV over 15-30 minutes on days 3-6.
    ARM B (LR patients): Patients receive cytarabine IT, ADE chemotherapy, and bortezomib as in Induction I Arm B.
    ARM B (HR patients): Patients receive cytarabine IT and MA chemotherapy as in Induction II, Arm A (HR patients) and bortezomib IV on days 1, 4, and 8.
    ARM C (patients with HR FLT3/ITD+ disease, cohorts 1 and 2): Patients receive cytarabine IT on day 1, cytarabine IV over 15-30 minutes on days 1-8, daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and etoposide IV over 1-2 hours on days 1-5, and sorafenib tosylate PO on days 1-28.
    Patients who achieve complete remission (CR) proceed to Intensification I (beginning on day 29). Patients with refractory disease are off protocol therapy.
    INTENSIFICATION I:
    ARM A: Patients receive cytarabine IT on day 1 and AE chemotherapy comprising high-dose cytarabine IV over 1-3 hours, and etoposide IV over 1- 2 hours on days 1-5.
    ARM B: Patients receive cytarabine IT and AE chemotherapy in Intensification II, Arm A, and bortezomib IV on days 1, 4, and 8.
    ARM C (cohorts 1 and 2): Patients receive cytarabine IT and AE chemotherapy in Intensification II, Arm A, and sorafenib tosylate PO on daily on days 1-28.
    Patients who achieve CR proceed to Intensification II or stem cell transplantation (SCT) beginning on day 29. Patients with refractory disease are off protocol therapy.
    INTENSIFICATION II:
    ARM A (LR): Patients receive cytarabine IT on day 1 and MA chemotherapy as in Induction II, Arm A (HR patients).
    ARM B (LR): Patients receive cytarabine IT on day 1, MA chemotherapy as in Induction II, Arm A (HR patients), and bortezomib IV on days 1, 4, and 8.
    ARMS A AND B (HR and no donor for SCT): Patients receive high-dose cytarabine IV over 3 hours on days 1, 2, 8, and 9 and asparaginase intramuscularly (IM) on days 2 and 9.
    ARM C (HR cohorts 1 and 2): Patients receive cytarabine IT on day 1, MA chemotherapy as in Induction II, Arm A (HR patients), and sorafenib tosylate PO on days 1-28.
    STEM CELL TRANPLANTATION (SCT) (HR patients with matched family [MFD] or unrelated donor):
    CONDITIONING REGIMEN: Patients receive fludarabine IV over 30 minutes once daily on days -5 to -2 and busulfan IV over 2 hours 4 times daily on days -5 to -2.
    TRANSPLANTATION: Patients undergo allogeneic SCT within 36 to 48 hours after the last dose of busulfan.
    GRAFT-VS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO beginning on day -2 and continuing until day 98 (matched sibling donor) or day 180 (with taper) (other related/unrelated donors or cord blood) and methotrexate IV on days 1, 3, and 6 (matched sibling/cord blood donors) or days 1, 3, 6, and 11 (other related/unrelated donors). Patients with unrelated donors also receive antithymocyte globulin IV over 6-8 hours on days -3 to -1.
    Blood, bone marrow, and tissue samples are collected at baseline and periodically during study for mutation and translocation analysis, cytogenetic/FISH analysis, gene and protein expression, and other studies. Some patients (aged 2 to 18 years) and/or parents may complete questionnaires about health-related quality of life (Pediatric Quality of Life (PedsQL) 4.0 Generic Core Scale, the PedsQL 3.0 Acute Cancer Module, and the PedsQL Multidimensional Fatigue Scale) and parental stress (Pediatric Inventory for Parents (PIP) scale) at baseline and periodically during the study and follow-up.
    After completion of study therapy, patients are followed up monthly for 6 months, every 2 months for 6 months, every 3 months for 1 year, every 6 months for 1 year, and then yearly for up to 8 years.

    TRIAL NUMBER: AHEP0731

    Title: TREATMENT OF CHILDREN WITH ALL STAGES OF HEPATOBLASTOMA

    Purpose: PRIMARY OBJECTIVES:
    I. To estimate the event-free survival (EFS) in pediatric patients with stage I (non-PFH, non-SCU) and stage II (non- SCU) hepatoblastoma treated with surgical resection followed by 2 courses of cisplatin, fluorouracil, and vincristine (C5V).
    II. To determine the feasibility and toxicity of adding doxorubicin hydrochloride to the chemotherapy regimen of C5V for pediatric patients with intermediate-risk hepatoblastoma.
    III. To estimate the response rate to vincristine and irinotecan hydrochloride in previously untreated pediatric patients with high-risk, metastatic hepatoblastoma.
    IV. To determine whether timely (between diagnosis and end of second course of chemotherapy) consultation with a treatment center with surgical expertise in major pediatric liver resection and transplant can be achieved in 70% of patients with potentially unresectable hepatoblastoma.
    V. To foster the collection of tumor tissue and biologic samples to facilitate translational research and to provide data that may aid in risk-adapted approaches for subsequent clinical trials.
    SECONDARY OBJECTIVES:
    I. To estimate the EFS of patients with stage I PFH treated with surgery alone. II. To determine whether liver transplantation (OLT) can be accomplished after successful referral and completion of 4 courses of initial chemotherapy.
    III. To estimate the 2-year EFS for patients once identified as candidates for possible OLT, the 2-year EFS for patients referred to a transplant center that are resected without OLT, and the 2-year EFS for patients referred to a transplant center who receive OLT.
    IV. To register pediatric patients with hepatoblastoma who receive OLT with PLUTO (Pediatric Liver Unresectable Tumor Observatory), an international cooperative registry for pediatric patients transplanted for liver tumors.
    V. To determine if PRETEXT grouping can predict tumor resectability. VI. To monitor the concordance between institutional assessment of PRETEXT grouping and PRETEXT grouping as performed by expert panel review.
    VII. To estimate the proportion of stage IV patients who have surgical resection of metastatic pulmonary lesions.
    VIII. To determine the proportion and estimate the EFS of patients with potentially poor prognostic factors including AFP < 100 ng/mL at diagnosis, microscopic positive surgical margins, surgical complications, multifocal tumors, microscopic vascular invasion, macrotrabecular histologic subtype, and SCU histologic subtype.
    OUTLINE: This is a multicenter study. Patients are stratified according to risk (very low vs low vs intermediate vs high). Patients are assigned to 1 of 4 treatment groups according to risk group.
    VERY LOW-RISK GROUP: Patients undergo surgery and receive no further treatment.
    LOW-RISK GROUP: (regimen T) Patients undergo surgery and then receive adjuvant cisplatin IV over 6 hours on day 1, fluorouracil IV on day 2, and vincristine sulfate IV on days 2, 9, and 16. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
    INTERMEDIATE-RISK GROUP: (regimen F) Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV on day 2, vincristine sulfate IV on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD.
    HIGH-RISK GROUP: (regimen W) Patients receive up front VI chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1- 5. Treatment with VI repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 1 courses of VI in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection or liver transplantation after course 4 of C5VD followed by 2 courses of adjuvant C5VD.
    After completion of study therapy, patients who receive chemotherapy are followed up periodically for at least 4 years.

    TRIAL NUMBER: AHEP1531

    Title: Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

    Purpose: Primary Outcome Measures : Event-free survival (EFS) [ Time Frame: From date of randomization until progression of existing disease or occurrence of disease at new sites, death from any cause prior to disease progression, or diagnosis of a second malignant neoplasm, assessed up to 5 years ] Descriptive analysis for each non-randomized and randomized question (by treatment arm and overall) will include: the number (and proportion) of each failure event and in total, survival curves will be estimated by the method of Kaplan-Meier, EFS estimates at 3 and 5 years with 95% confidence intervals (CI), median EFS with CI will be reported if appropriate. A Cox proportional hazards model with EFS as an outcome measure and treatment and stratification factors as covariates will be constructed. This model will be used in the context of a Bayesian analysis and a log Hazard Ratio (HR) will be derived. Bayesian Normal-Normal conjugate analysis of the data will be used to compare treatments. The analysis will use non-informative prior to represent no information about prior beliefs regarding relative treatment difference.
    Response in hepatocellular carcinoma (HCC), defined as complete (CR) or partial (PR) response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria [ Time Frame: Up to 5 years ] The main analysis will be based on a log-binomial model for a Bernoulli response variable. This model will be used in the context of a Bayesian analysis. A non-informative null centered proper prior distributions for the parameters will be used. Response rate (RR) and 95% credible interval (CrI) will be presented. Posterior probabilities for the pre-specified values of interest will be provided. Additionally, the posterior probabilities of RR being larger than 0.7, 0.8, 0.9, 1, 1.1, 1.2 and 1.3 will be also provided.

    Secondary Outcome Measures : Failure free survival [ Time Frame: From date of randomization until the date of first documented progression, date of death from any cause, diagnosis of a second malignant neoplasm or failure to go to resection, whichever came first, assessed up to 5 years ] Descriptive analysis for each non-randomized and randomized question (by treatment arm and overall) will include: the number (and proportion) of each failure event and in total, survival curves will be estimated by the method of Kaplan-Meier. Bayesian Normal-Normal conjugate analysis of the data will be used to compare treatments. The analysis will use non-informative prior to represent no information about prior beliefs regarding relative treatment difference.
    Overall survival [ Time Frame: From date of randomization (or registration for non-randomized patients) until the date of death from any cause, assessed up to 5 years ] Incidence of adverse events [ Time Frame: Up to 5 years ] Will be categorized and graded using Common Terminology Criteria for Adverse Events (CTCAE).
    Chemotherapy-related cardiac, nephro- and oto-toxicity [ Time Frame: Up to 5 years ] Will be recorded in relation to each cycle of treatment and will be categorized and graded using Common Terminology Criteria for Adverse Events.
    Hearing loss measured according to the SIOP Boston Scale for oto-toxicity [ Time Frame: Up to 5 years ] Descriptive analysis for each non-randomized and randomized question (by treatment arm and overall) will include: the number (and proportion) of patients at each the SIOP Boston Scale for oto-toxicity category (i.e. grade 0 to grade 4) and the number (and proportion) of patients who are not assessable for this outcome, (i.e. because of early stopping of treatment, additional treatments to protocol treatment, progression prior to the response assessment or death). The number (and proportion) of patients experiencing any grade hearing loss. Grades 1 to grade 4 will be combined in this analysis. The above will be presented for each assessment time point (EOT and at least 1 year and 2 years of follow up).
    Best response defined as compete response (CR) or partial response (PR) based on radiological response (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) and AFP decline [ Time Frame: Up to 5 years ] Descriptive analysis for each non-randomized and randomized question (by treatment arm and overall) will include: best response will be calculated by taking best RECIST category (i.e. CR, PR, stable disease [SD], progressive disease [PD]) for each patient. CR and PR patients will then be grouped into responders. The number (and proportion) of patients at each best response RECIST category (i.e. CR, PR, SD, PD) and the number (and proportion) of patients who are not assessable for response, e.g. because of early stopping of treatment, progression prior to the response assessment or death. The number (and proportion) of responders (CR and PR) and non-responders.
    Surgical resectability defined as complete resection, partial resection or transplant following randomization (or enrollment for non-randomized patients) [ Time Frame: Up to 5 years ] Descriptive analysis for each non-randomized and randomized question (by treatment arm and overall) will include: The number (and proportion) of patients undergoing complete resection, partial resection or transplant. Time to complete resection, partial resection or transplant following randomization (or enrollment for non-randomized patients) will be analyzed using the Kaplan-Meier method.
    Adherence to surgical guidelines defined as the local clinician?s surgical decision to resect or not compared to the current SIOPEL surgical guidelines [ Time Frame: Up to 5 years ] Descriptive analysis for each non-randomized and randomized question (by treatment arm and overall) will include: The number (and proportion) of patients at each combination of SIOPEL surgical guideline (to resect or not) and local clinician?s surgical decision. The degree of agreement will be measured by Cohen?s kappa with CI.

    TRIAL NUMBER: COG-AALL1731

    Title: A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy)

    Purpose:

    Primary Outcome Measures :
    1. Post-Consolidation disease free survival (DFS) with addition of 2 cycle of blinatumomab in patients with standard risk (SR) B-lymphoblastic leukemia (B-ALL) and higher risk features, and patients with standard risk average (SR-Avg) B-ALL [ Time Frame: 5 years ]
      Efficacy design and standard survival analysis methods used to detect improvement in post-Consolidation DFS due to the addition of 2 cycles of blinatumomab to standard therapy in patients with SR B-ALL and higher risk features, and patients with SR-Avg B-ALL who are negative for minimal residual disease (MRD) by flow cytometry but have detectable or indeterminate MRD as measured by high-throughput sequencing (HTS) at end of induction (EOI), and patients with double trisomy of chromosomes 4 and 10 (DT) with MRD (flow) 0.01% - <0.1%.

    2. DFS in boys in the SR-favorable subset of SR B-ALL [ Time Frame: 5 years ]
      Time from end of consolidation to first event (relapse, second malignant neoplasm, remission, death) or censored at date of last contact for those who are disease-free.


    Secondary Outcome Measures :
    1. DFS for patients with SR-Avg B-ALL who are negative for MRD measured by flow cytometry and HTS at EOI when treated with standard chemotherapy with a treatment duration of 2 years from the start of interim maintenance (IM)1, regardless of sex [ Time Frame: 5 years ]
      Time from end of consolidation to first event (relapse, second malignant neoplasm, remission, death) or censored at date of last contact for those who are disease-free.

    2. DFS for patients with standard-risk favorable (SR-Fav) B-ALL [ Time Frame: 5 years ]
      Time from end of consolidation to first event (relapse, second malignant neoplasm, remission, death) or censored at date of last contact for those who are disease-free.

    3. Treatment-related mortality in Down syndrome high risk (DS-high) patients after replacement of intensive elements of standard chemotherapy (omission of anthracyclines in induction, omission of the second month of DI) with 3 cycles of blinatumomab [ Time Frame: 5 years ]
    4. DFS of DS-High B-ALL patients when intensive elements of chemotherapy are replaced with 3 cycles of blinatumomab [ Time Frame: 5 years ]
      Time from end of consolidation to first event (relapse, second malignant neoplasm, remission, death) or censored at date of last contact for those who are disease-free.

    5. DFS of patients with localized B-lymphoblastic lymphoma receiving standard risk acute lymphoblastic leukemia therapy [ Time Frame: 5 years ]
      Time from end of consolidation to first event (relapse, second malignant neoplasm, remission, death) or censored at date of last contact for those who are disease-free.

    6. Neurocognitive functioning [ Time Frame: Baseline to 2 years after IM1 ]
      Compare the change in neurocognitive functioning, as measured by the CogState Cognitive Composite, from baseline to end-of-therapy among patients with ALL ages 4-< 10 years at the time of diagnosis between children from poor families (defined as presence of household material hardship (HMH), including either food, housing or energy insecurity) and non-poor families (absence of HMH).

    7. Caregiver burden and patient/proxy-reported symptoms among those enrolled in HMH [ Time Frame: Baseline to 2 years after IM1 ]
      Compare the demands and work limitations on caregivers of children with ALL receiving chemotherapy versus chemotherapy with the addition of blinatumomab and to compare the change in the demands and work limitations over time, measured by the Care of My Child with Cancer questionnaire and the Caregiver Work Limitations questionnaire during post-Induction therapy. Patient/proxy reported symptoms measured by Memorial Symptom Assessment Scale.


    Other Outcome Measures:
    1. Adaptive and innate immune functions and host genetic factors associated with severe infectious complications in children with DS B-ALL [ Time Frame: 5 years ]
      FlowSom high resolution clustering approach to identify cellular subsets and/or activation states (endophenotypes) that distinguish cases from controls. Conduct a genome-wide assessment using a case-control approach comparing those who develop grade 4-5 microbiologically documented infections (cases) compared to those who do not (controls).

    2. Neurocognitive, functional, and quality of life outcomes in patients with DS and ALL [ Time Frame: 5 years ]
      Measured by caregiver (parent/legal guardian) questionnaires.

    3. Prevalence of minimal marrow disease (MMD) in B-LLy [ Time Frame: 5 years ]
      Correlate MMD at diagnosis with outcome in patients with B-LLy.

    TRIAL NUMBER: S1826

    Title: A PHASE III, RANDOMIZED STUDY OF NIVOLUMAB (OPDIVO) PLUS AVD OR BRENTUXIMAB VEDOTIN (ADCETRIS) PLUS AVD IN PATIENTS (AGE >/= 12 YEARS) WITH NEWLY DIAGNOSED ADVANCED STAGE CLASSICAL HODGKIN LYMPHOMA

    Purpose:

    Primary Outcome Measures :
    1. Progression free survival (PFS) [ Time Frame: From date of registration to date of first observation of progressive disease according to the 2014 Lugano classification, or death due to any cause, assessed at 2 years ]
      Will test the null hypothesis (HR=1) for PFS using stratified log-rank test with a one-sided alpha of 0.021. The analysis will be based on modified intent-to-treat and will include all eligible patients as randomized regardless of treatment received. The one-sided alpha of .021 will control of the overall type-one error of the study (including the 2 interim superiority analyses) to be less than .025.


    Secondary Outcome Measures :
    1. Overall survival [ Time Frame: 2 years ]
    2. Event-free survival (EFS) [ Time Frame: From date of registration to date of first occurrence of EFS event, assessed at 2 years ]
      Will be estimated using Kaplan-Meier method and compared between treatment arms using cox regression model.

    3. Metabolic complete response rate [ Time Frame: Up to 10 years ]
      Defined using 2014 Lugano classification.

    4. Incidence of adverse events [ Time Frame: Up to 10 years ]
      Toxicity will be evaluated using Common Terminology Criteria of Adverse Events (CTCAE) version 5 items. Treatment-related toxicities between arms will be compared using Fisher's exact test stratified by age groups. Targeted patient-reported toxicities also will be collected at each time point using the Patient Reported Outcome (PRO)-CTCAE for patients 18 years and older and from youth 12-17 years, using the Pediatric (Ped) PRO-CTCAE

    TRIAL NUMBER: ABTR01B1

    Title: A CHILDREN'S ONCOLOGY GROUP PROTOCOL FOR COLLECTING AND BANKING PEDIATRIC RESEARCH SPECIMENS

    Purpose:

    TRIAL NUMBER: ACCL0934

    Title: A RANDOMIZED TRIAL OF LEVOFLOXACIN TO PREVENT BACTEREMIA IN CHILDREN BEING TREATED FOR ACUTE LEUKEMIA (AL) OR UNDERGOING HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT)

    Purpose: OBJECTIVES:
    Primary
    ?To determine whether levofloxacin given prophylactically during periods of neutropenia to patients being treated with chemotherapy for acute leukemia (AL) or undergoing hematopoietic stem cell transplantation (HSCT) will decrease the incidence of bacteremia. Secondary
    ?To determine the effect of prophylactic levofloxacin on resistance patterns of bacterial isolates from all sterile site cultures, and the evolution of antimicrobial resistance from peri-rectal swab isolates of Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Streptococcus mitis. ?To determine the effect of levofloxacin prophylaxis on total number of days of antibiotic administration (prophylactic, empiric, and treatment) in children undergoing therapy for AL or HSCT. ?To determine whether levofloxacin prophylaxis reduces the incidence of fever with neutropenia, severe infection, and death from bacterial infection. ?To assess the safety of levofloxacin prophylaxis, with specific attention to musculoskeletal disorders including tendinopathy and tendon rupture. ?To assess the impact of prophylactic levofloxacin on the incidence of Clostridium difficile-associated diarrhea (CDAD), and the incidence of microbiologically documented invasive fungal infections (IFI). OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (de novo acute myeloid leukemia [AML] vs secondary AML vs relapsed AML vs relapsed acute lymphoblastic leukemia [ALL]), and therapy (undergoing autologous HSCT vs undergoing allogeneic HSCT). Patients are randomized to 1 of 2 treatment groups.
    ?Arm I: Patients receive levofloxacin orally (PO) or IV over 60-90 minutes once or twice daily beginning on day 1 during 2 consecutive courses of chemotherapy or beginning on day -2 during hematopoietic stem cell transplantation (HSCT) and continuing until blood counts recover. ?Arm II: Patients receive established standard of care and receive chemotherapy or HSCT as patients in arm 1. Musculoskeletal assessment is conducted at baseline and at 2 and 12 months.
    Patients may undergo perirectal or stool swab collection for ancillary studies.
    After completion of study therapy, patients are followed up for 1 year.

    TRIAL NUMBER: ACCL1034

    Title: Impact of Cleansing with Chlorhexidine Gluconate (CHG) on Reducing Central Line Associated Bloodstream Infection (CLABSI) and Acquisition of Multi-drug Resistant Organisms (MDRO) in Children with Cancer or Those Receiving Allogeneic Hematopoietic Cell Transplantation (HCT): A Limited Phase III Study

    Purpose: PRIMARY OBJECTIVES:
    I. To determine whether chlorhexidine gluconate (CHG) cleansing decreases central line associated bloodstream infection (CLABSI) in children with cancer or those receiving an allogeneic hematopoietic cell transplantation (HCT).
    SECONDARY OBJECTIVES:
    I. To determine whether CHG cleansing decreases acquisition of multi-drug resistant organisms (MDRO: vancomycin resistant enterococci [VRE], methicillin resistant Staphylococcus aureus [MRSA], etc.) in children with cancer or those receiving allogeneic HCT.
    II. To determine whether CHG cleansing in children with cancer or those receiving allogeneic HCT is associated with cutaneous bacterial isolates with reduced susceptibility to CHG.
    III. To determine whether CHG cleansing decreases positive blood cultures in children with cancer or those receiving allogeneic HCT.
    OUTLINE: Patients are randomized to 1 of 2 arms.
    ARM I: Patients receive CHG cleansing with topical skin wipes once daily (QD) for 90 days.
    ARM II: Patients receive control cleansing with topical skin wipes QD for 90 days.

    TRIAL NUMBER: ACCL1131

    Title: A Phase III Open-Label Trial of Caspofungin vs. Azole Prophylaxis for Patients at High-Risk for Invasive Fungal Infections (IFI) Following Allogeneic Hematopoietic Cell Transplantation (HCT)

    Purpose: PRIMARY OBJECTIVES:
    I. To determine if caspofungin (caspofungin acetate) is associated with a lower incidence of proven/probable invasive fungal infections (IFI) during the first 42 days following allogeneic hematopoietic cell transplantation (HCT) at high-risk for IFI compared with azole (fluconazole or voriconazole) prophylaxis.
    SECONDARY OBJECTIVES:
    I. To determine if caspofungin is associated with a lower incidence of proven/probable IFI during the first 100 days following high-risk allogeneic HCT compared with azole (fluconazole or voriconazole) prophylaxis. (Exploratory) II. To determine if caspofungin is associated with a lower incidence of proven/probable IFI during the first 42 and 100 days following high-risk allogeneic HCT compared with fluconazole prophylaxis. (Exploratory) III. To determine if caspofungin is associated with a lower incidence of proven/probable IFI during the first 42 and 100 days following high-risk allogeneic HCT compared with voriconazole prophylaxis. (Exploratory) IV. To determine if caspofungin is associated with a superior fungal-free survival (FFS) (time to death or proven/probable IFI) at 42 and 100 days following high-risk allogeneic HCT compared with azole prophylaxis. (Exploratory) V. To describe the effect that caspofungin and azoles have on the incidence and severity of acute graft-versus-host disease (GVHD). (Exploratory) VI. To create a deoxyribonucleic acid (DNA) specimen bank in anticipation of the development of biology correlative studies exploring the relationship between IFI and single nucleotide polymorphisms (SNPs) of genes involved in immunity. (Exploratory)
    OUTLINE: Patients are randomized to 1 of 2 treatment arms.
    ARM I: Patients receive caspofungin acetate intravenously (IV) over 1 hour once daily (QD) beginning within 24 hours of allogeneic hematopoietic stem cell transplantation (HSCT) (day -1 or 0) and continuing until day 42 in the absence of invasive fungal infections or disease progression.
    ARM II: Patients receive fluconazole IV over 1-2 hours QD or orally (PO) QD; or voriconazole IV over 1-2 hours QD or PO twice daily (BID) beginning within 24 hours of allogeneic HSCT (day -1 or 0) and continuing until day 42 in the absence of invasive fungal infections or disease progression.
    After completion of study treatment, patients are followed up until day 100.

    TRIAL NUMBER: ACCL1633

    Title: COG ACCL1633, The Effectiveness of Lactobacillus plantarum in Preventing Acute Graft-versus-Host Disease (GvHD) in Children undergoing Alternative Hematopoietic Progenitor Cell Transplantation (HCT)

    Purpose: Graft vs Host Disease affect up to 45% of pediatric patients that receive allogeneic hematopietic cel transplantation. There is a need for better prevention and therapy for aGVHD, has cause 20% of deaths. This study is to determine the efficacy of orally-administered LBP in preventing GI aGVHD, hoping it will decrease the severity.

    TRIAL NUMBER: ACCRN07

    Title: PROTOCOL FOR THE ENROLLMENT ON THE OFFICIAL COG REGISTRY, THE CHILDHOOD CANCER RESEARCH NETWORK (CCRN)

    Purpose: Institutional membership in the Children's Oncology Group (COG) requires registration of all pediatric cancer patients seen at their site. This registration process includes all patients. It has previously been shown that the two major pediatric cooperative groups (CCG and POG), which currently comprise COG, identify approximately 90% of children diagnosed with cancer under the age of 15 years in the U.S (1) The cooperative group resource provides the basis to build a childhood cancer network to facilitate research. In order to maximize the resource that a network would provide, it is necessary to have identifying information on a large proportion of the cases included within the network. Moreover, the resource would be further enhanced if informed consent from parents/patients was obtained to allow future contact regarding possible participation in non-therapeutic and prevention research. This protocol is designed to facilitate the systematic entry of pediatric and adolescent patients diagnosed with cancer into a Childhood Cancer Research Network (CCRN). There are two levels of entry in the CCRN: 1) Entry in the CCRN with consent but without permission for future contact. The data collected for these registry entries will include Protected Health Information (PHI) and will therefore be uniquely identifying (see Section 5.0 for specific data to be collected). 2) Entry in the CCRN with consent including permission for future contact. The data collected for these registry entries will include PHI and will therefore be uniquely identifying (see Section 5.0 for specific data to be collected). Additionally, patient and parent contact information will be collected to facilitate future contact.

    TRIAL NUMBER: ALTE05N1

    Title: Umbrella Long-Term Follow-Up Protocol

    Purpose: OBJECTIVES:
    ?To develop a mechanism for tracking and retaining patients enrolled on COG protocols. ?To maintain regular, lifetime contact with patients in order to obtain current identification and contact information, and self/parent-reported health status. ?To locate patients who are lost-to-follow-up for COG (or Legacy Group) protocols targeted for follow-up by the Long-Term Follow-Up Center (LTFC). ?To provide current patient contact information and self/parent-reported health status updates to the COG Statistics and Data Center (SDC) and to each patient's COG institution. ?To facilitate collection of protocol-specific outcome data through collaboration with the COG Late Effects Committee, the SDC, and the member institutions. ?To collect cumulative therapeutic exposure data (via therapeutic summaries completed online by treating institutions) on patients completing active therapy. OUTLINE: This is an umbrella protocol for all long-term follow-up at COG institutions. Approximately 6 months after completion of therapy patients receive a mailed packet introducing the Long-Term Follow-Up Center (LTFC) and containing information related to their individualized, protocol-specific follow-up guidelines. Patients are asked to complete a patient response form, verify information provided in packet, update contact information, and complete a Health Status Update Form. The Health Status Update Form is a brief document including questions about current health status, disease status, and cancer therapy received since the last mailing. Patients receive protocol-specific automatic reminders, and may respond by use of postage prepaid envelopes, email, or 24-hour toll-free telephone.

    TRIAL NUMBER: ALTE07C1

    Title: NEUROPSYCHOLOGICAL, SOCIAL, EMOTIONAL, AND BEHAVIORAL OUTCOMES IN CHILDREN WITH CANCER

    Purpose: OBJECTIVES:
    I. To utilize a standardized battery of age-appropriate neuropsychological and behavioral tests in conjunction with Children's Oncology Group (COG) Phase III clinical trials to evaluate cognitive, social, emotional, and behavioral functioning over time.
    II. To institute procedures to ensure a consistent, streamlined, and efficient administration of the neuropsychological/behavioral tests in a cooperative group setting in order to maximize compliance with a standardized assessment battery conducted at 3 standardized timepoints.
    OUTLINE:
    Parent and child participants complete the COG Standard Neuropsychological and Behavioral Battery testing at 9, 30, and 60 months post-diagnosis in a 1-hour session conducted by a neuropsychologist or psychologist. The Battery consists of tests of intelligence, processing speed/attention, memory, language preference, general developmental progress, attention and behavior/social/emotional function, executive function, adoptive function, and quality of life. Additionally, parents complete a parent-report questionnaire to gather information about patient's function in terms of attention, memory, executive abilities, and behavioral, social, and emotional adaption.

    TRIAL NUMBER: APEC1621A

    Title: Pediatric MATCH: Trk Inhibitor LOXO-101 in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions

    Purpose: This phase II trial studies Trk inhibitor LOXO-101 in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that have spread to other places in the body and have come back or do not respond to treatment. Trk inhibitor LOXO-101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth

    TRIAL NUMBER: APEC1621B

    Title: Pediatric MATCH: Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations

    Purpose: This phase II trial studies how well erdafitinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have spread to other places in the body and have come back or do not respond to treatment with FGFR mutations. Erdafitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621C

    Title: Pediatric MATCH: Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations

    Purpose: This phase II trial studies how well tazemetostat works in treating patients with solid tumors, non-hodgkin lymphoma, or histiocytic disorders that have spread to other places in the body and have come back or do not respond to treatment and have EZH2, SMARCB1, or SMARCA4 gene mutations. Tazemetostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621D

    Title: Pediatric MATCH: PI3K/mTOR Inhibitor LY3023414 in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations

    Purpose: This phase II trial studies how well PI3K/mTOR inhibitor LY3023414 works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with TSC or PI3K/MTOR mutations that have spread to other places in the body and have come back or do not respond to treatment. PI3K/mTOR inhibitor LY3023414 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621E

    Title: Pediatric MATCH: Selumetinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating MAPK Pathway Mutations

    Purpose: This phase II trial studies how well selumetinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with MAPK pathway activation mutations that have spread to other places in the body and have come back or do not respond to treatment. Selumetinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621F

    Title: Pediatric MATCH: Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations

    Purpose: This phase II trial studies how well ensartinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that have come back or do not respond to treatment and have spread to other places in the body. Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621G

    Title: Pediatric MATCH: Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations

    Purpose: This phase II trial studies how well vemurafenib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with BRAF V600 mutations that have spread to other places in the body and have come back or do not respond to treatment. Vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621H

    Title: Pediatric MATCH: Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes

    Purpose: This phase II trial studies how well olaparib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with defects in deoxyribonucleic acid (DNA) damage repair genes that have spread to other places in the body and have come back or do not respond to treatment. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621SC

    Title: Pediatric MATCH: Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders

    Purpose: This screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.

    TRIAL NUMBER: ARST1321

    Title: Pazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC #737754, IND #118613)

    Purpose: PRIMARY OBJECTIVES:
    I. To identify the dose of pazopanib (pazopanib hydrochloride) that is feasible when given in combination with radiation or chemoradiation in pediatric and adult patients newly diagnosed with unresected intermediate- and high-risk non-rhabdomyosarcoma soft tissue sarcomas (NRSTS).
    II. To compare the rates of near complete pathologic response (> 90% necrosis) with the addition of pazopanib to preoperative chemoradiation versus preoperative chemoradiation alone for potentially resectable > 5 cm, grade 3 intermediate to high risk chemotherapy-sensitive NRSTS in the phase II portion of the study for this cohort.
    III. To compare the rates of near complete pathologic response (> 90% necrosis) with the addition of pazopanib to preoperative radiotherapy versus preoperative radiotherapy alone for potentially resectable intermediate to high risk adult and pediatric NRSTS in the phase II portion of the study for this cohort (using a phase II decision rule to go onto the Phase III portion of the study).
    IV. To compare the rates of event-free survival (EFS) with the addition of pazopanib to preoperative radiotherapy versus preoperative radiotherapy alone for localized intermediate to high risk adult and pediatric NRSTS in the phase III portion of the study for this cohort if the phase II decision rule is passed.
    SECONDARY OBJECTIVES:
    I. To estimate the rates of local failure, regional failure, distant metastasis free survival, disease-free survival, and overall survival with the addition of pazopanib to preoperative chemoradiation or preoperative radiation in intermediate to high risk adult and pediatric NRSTS.
    II. To compare the pattern of recurrence (local, regional and distant) between preoperative chemoradiation or radiation with the addition of pazopanib for adult and pediatric NRSTS.
    III. To define the toxicities of ifosfamide and doxorubicin (doxorubicin hydrochloride) chemotherapy and radiation when used in combination with pazopanib in intermediate to high risk adult and pediatric NRSTS.
    IV. To define the toxicities of preoperative radiotherapy when used in combination with pazopanib in intermediate to high risk adult and pediatric NRSTS.
    TERTIARY OBJECTIVES:
    I. To gain insight into the disease biology of childhood and adult NRSTS through analysis of actionable mutations and whole genome sequencing.
    II. To determine if microvessel density and circulating tumor deoxyribonucleic acid (DNA) predict response to pazopanib and outcome.
    III. To determine the effect of pazopanib on doxorubicin exposure in children and adults with NRSTS.
    IV. To evaluate change in fludeoxyglucose F 18 (FDG) positron emission tomography (PET) maximum standard uptake value (SUVmax) from baseline to week 10 or 13 in patients with unresected tumors and to correlate this change with pathologic response and EFS.
    V. To compare the rate of response by standard imaging and pathologic assessment to determine which correlates better with local tumor control, distant tumor control, EFS, and overall survival.
    OUTLINE: This is a dose-escalation study of pazopanib hydrochloride.
    CHEMOTHERAPY COHORT: Patients eligible for chemotherapy cohort are randomized to 1 of 2 treatment regimens.
    REGIMEN A:
    INDUCTION PHASE: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on weeks 1-12, ifosfamide intravenously (IV) over 2-4 hours on days 1-3 on weeks 1, 4, 7, 10, and doxorubicin hydrochloride IV over 1-15 minutes on days 1-2 on weeks 1 and 4. Patients undergo radiation therapy on weeks 4-10.
    SURGERY: Patients undergo surgery on week 13.
    CONTINUATION PHASE: Patients receive pazopanib hydrochloride PO QD on weeks 16-25, ifosfamide IV over 2-4 hours on days 1-3 on weeks 16 and 19, and doxorubicin hydrochloride IV over 1-15 minutes on days 1-2 on weeks 16, 19, and 22. Patients undergo radiation therapy on weeks 16-25 for a total of 45 Gy.
    REGIMEN B:
    INDUCTION PHASE: Patients receive ifosfamide IV over 2-4 hours on days 1-3 on weeks 1, 4, 7, 10 and doxorubicin hydrochloride IV over 1-15 minutes on days 1-2 on weeks 1 and 4. Patients undergo radiation therapy on weeks 4-10.
    SURGERY: Patients undergo surgery on week 13.
    CONTINUATION PHASE: Patients receive ifosfamide IV over 2-4 hours on days 1-3 on weeks 16 and 19 and doxorubicin hydrochloride IV over 1-15 minutes on days 1-2 on weeks 16, 19, and 22. Patients undergo radiation therapy on weeks 16-25 for a total of 45 Gy.
    NON-CHEMOTHERAPY COHORT: Patients eligible for non-chemotherapy cohort are randomized to 1 of 2 treatment regimens.
    REGIMEN C:
    INDUCTION PHASE: Patients receive pazopanib hydrochloride PO QD on weeks 1-9. Patients undergo radiation therapy on weeks 1-7.
    SURGERY: Patients undergo surgery on week 10.
    CONTINUATION PHASE: Patients receive pazopanib hydrochloride PO QD on weeks 13-25. Patients undergo radiation therapy on weeks 13-16 for a total of 50 Gy.
    REGIMEN D:
    INDUCTION PHASE: Patients undergo radiation therapy on weeks 1-7.
    SURGERY: Patients undergo surgery on week 10.
    CONTINUATION PHASE: Patients undergo radiation therapy on weeks 13-16 for a total of 50 Gy.
    After completion of study treatment, patients are followed up at 6, 12, 18, 24, 30, 36, 48, and 60 months.

    TRIAL NUMBER: ARST1921

    Title: A Safety, Pharmacokinetic and Efficacy Study of a ?-Secretase Inhibitor, Nirogacestat (PF-03084014; IND# 146375), in Children and Adolescents with Progressive, Surgically Unresectable Desmoid Tumors

    Purpose:

    Primary Outcome Measures :
    1. Progression-free survival (PFS) [ Time Frame: From initiation of treatment to occurrence of disease progression or death from any cause, assessed up to 2 years ]
      Will be estimated using the Kaplan-Meier method with the 95% confidence interval estimated by the Peto-Peto method.

    2. Incidence of adverse events [ Time Frame: Up to 2 years ]
      Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0. All grade 3 or above toxicities deemed related to study drug will be summarized. All grade 1 and 2 toxicities observed in > 5% of participants and deemed related to study drug will be reported.

    3. Pharmacokinetic (PK) parameter: systemic exposure [ Time Frame: Up to Cycle 3 (each cycle lasts 28 days) ]
      PK parameters of nirogacestat will be defined to quantify systemic exposure, drug clearance, terminal half-life and other pharmacokinetic characteristics. These PK parameters will be summarized with descriptive statistics, including means, medians, ranges, and standard deviations.

    4. Pharmacokinetic (PK) parameter: drug clearance [ Time Frame: Up to Cycle 3 (each cycle lasts 28 days) ]
      PK parameters of nirogacestat will be defined to quantify systemic exposure, drug clearance, terminal half-life and other pharmacokinetic characteristics. These PK parameters will be summarized with descriptive statistics, including means, medians, ranges, and standard deviations.

    5. Pharmacokinetic (PK) parameter: half-life [ Time Frame: Up to Cycle 3 (each cycle lasts 28 days) ]
      PK parameters of nirogacestat will be defined to quantify systemic exposure, drug clearance, terminal half-life and other pharmacokinetic characteristics. These PK parameters will be summarized with descriptive statistics, including means, medians, ranges, and standard deviations.


    Secondary Outcome Measures :
    1. Objective response rate [ Time Frame: Up to 24 months ]
      Defined by the rate of a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.


    Other Outcome Measures:
    1. CTNNB1 and APC gene mutations and genomic signatures [ Time Frame: Up to 2 years ]
      The chi-square test will be used to assess the correlation of CTNNB1 and APC gene mutations and genomic signatures with tumor response, and the long-rank test will be used to assess the correlation of CTNNB1 and APC gene mutations and genomic signatures with PFS.

    2. Changes in the levels of each of the lymphocyte subsets and immunoglobulins [ Time Frame: Up to 2 years ]
      Lymphocyte subsets include CD3 (total T cells), CD3+CD4+ (T helper cells), CD3+CD8+ (T cytotoxic cells), CD4:CD8 ratio, CD3+HLA-DR+ (activated T cells) percentages and absolute counts. The chi-square test will be used to assess the correlation of the levels of lymphocyte and immunoglobulin with tumor response, and the Cox regression will be used to assess the correlation of the levels of lymphocyte and immunoglobulin with PFS.

    3. Response assessments by the RECIST criteria [ Time Frame: Up to cycle 24 ]
    4. Response assessment by the World Health Organization (WHO) criteria [ Time Frame: Up to cycle 24 ]
    5. Patient reported outcomes (PROs) [ Time Frame: Up to 2 years ]
      The chi-square test will be used to assess the correlation of PROs summary scores with tumor response, and the Cox regression will be used to assess the correlation of PROs summary scores with PFS. Correlation between PRO summary scores using Patient Reported Outcomes Measurement Information System (PROMIS) and GOunder/DTRF DEsmoid Symptom/Impact Scale (GODDESS) will be assessed by performing inferences on the Pearson correlation coefficients.

    TRIAL NUMBER: D9902

    Title: A COG SOFT TISSUE SARCOMA DIAGNOSIS, BIOLOGY AND BANKING PROTOCOL

    Purpose:

    TRIAL NUMBER: ACNS0821

    Title: Temozolomide with Irinotecan versus Temozolomide, Irinotecan plus Bevacizumab for Recurrent/Refractory Medulloblastoma/CNS PNET of Childhood, A COG Randomized Phase II Screening Trial

    Purpose: PRIMARY OBJECTIVES:
    l. To compare the overall survival (OS) of subjects receiving the combination of temozolomide and irinotecan with that of subjects receiving temozolomide, irinotecan (irinotecan hydrochloride), and bevacizumab for recurrent medulloblastoma (MB)/primitive neuroectodermal tumor (PNET) of childhood.
    SECONDARY OBJECTIVES:
    I. To assess the response rate for each treatment arm amongst patients who are enrolled with measurable disease.
    II. To determine event-free survival (EFS) for each patient compared across regimens.
    OUTLINE: Patients are randomized to 1 of 2 treatment arms.
    ARM I: Patients receive temozolomide orally (PO) and irinotecan hydrochloride IV over 90 minutes on days 1-5.
    ARM II: Patients receive temozolomide PO and irinotecan hydrochloride IV as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15.
    In both arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
    After completion of study treatment, patients are followed up for 5 years.

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    TRIAL NUMBER: ACNS1422

    Title: A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients

    Purpose: Primary Outcome Measures: PFS [ Time Frame: From the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 10 years ] PFS along with the confidence intervals will be estimated using the Kaplan-Meier method. PFS will also be reported based on central radiology review.

    Secondary Outcome Measures: Change in neurocognitive function (cognitive, social, emotional and behavioral) according to Children Oncology Group Standard Neuropsychological Battery [ Time Frame: Baseline to up to 60 months post-diagnosis ] Neurocognitive function will be measured at 9, 30 and 60 months post diagnosis and will be compared with the neurocognitive outcomes from an age and gender matched ACNS0331 cohort to the WNT patients treated on ACNS1422. Data for all assessments will be available as standardized t-scores. The change over time for each component of the neuropsychological testing will be estimated using the Generalized Estimating Equation (GEE) approach, with the standardized t-scores as the dependent variable and the assessment times as a covariate. Within the ACNS1422 cohort GEE models will also be used to exp
    DNA methylation profiling as real-time classification of WNT-driven medulloblastoma [ Time Frame: Within 32 days of definitive surgery ] Results will be compared to the results of the molecular screening tests. The sensitivity and specificity comparison between DNA methylation arrays and the standard methods (molecular screening tests for WNT using IHC and CTNNB1 sequencing) will be performed using McNemar's test.

    Other Outcome Measures: DNA methylation profiling of medulloblastoma real-time" predictive classification scheme for the SHH, group 3 and group 4 medulloblastoma subgroups according to the Heidelberg classifier [ Time Frame: Within 32 days of definitive surgery ] The proportion of patients classified into each medulloblastoma subgroup in "real time" will be reported.

    Estimated Enrollment: 45 Study Start Date: October 2016 Estimated Primary Completion Date: May 2025 (Final data collection date for primary outcome measure)

    TRIAL NUMBER: ANBL00B1

    Title: NEUROBLASTOMA BIOLOGY STUDIES

    Purpose:

    TRIAL NUMBER: ANBL1232

    Title: Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma; A Groupwide Historically-Controlled Phase III Study

    Purpose: PRIMARY OBJECTIVES:
    I. To eliminate therapy as the initial approach for infants < 12 months of age with small International Neuroblastoma Risk Group (INRG) stage L1 neuroblastoma while maintaining an overall survival (OS) of 99%.
    II. To eliminate therapy as the initial approach for non-high-risk patients < 18 months of age with localized neuroblastoma and favorable biology (histologic and genomic features) while maintaining an OS of 99%.
    III. To achieve a 3-year OS of > 81% for infants < 18 months of age with INRG stage Ms neuroblastoma using objective criteria for early initiation of a response-based treatment algorithm.
    IV. To achieve a 3-year event free survival (EFS) of > 70% for non-high-risk infants < 12 months of age with INRG stage M neuroblastoma and unfavorable biology (histologic and/or genomic features) through the addition of isotretinoin therapy.
    SECONDARY OBJECTIVES:
    I. To describe the time to intervention or tumor progression, type of intervention and site of progression for patients with localized neuroblastoma who experience progression after an initial period of observation.
    II. To characterize the pharmacokinetic profile of the chemotherapeutic agents carboplatin and etoposide in patients with stage Ms disease.
    III. To define the genomic profile of tumors from patients with non-high-risk neuroblastoma both at initial biopsy and at the time of subsequent biopsy or surgical resection.
    IV. To describe the histology of tumor specimens obtained at the time of subsequent biopsy or surgical resection.
    V. To determine the salvage rate (OS) of patients with tumor relapse or disease progression.
    VI. To determine the procedural complication rate (initial biopsy, resection [intraoperative and postoperative], subsequent biopsy) and correlate with the degree of surgical resection.
    VII. To determine the rate of reduction in image defined risk factors (IDRF) in L2 tumors following observation or chemotherapy.
    VIII. To describe bone abnormalities on bilateral tibial radiographs obtained before and after isotretinoin therapy.
    IX. To determine the variability of isotretinoin pharmacokinetics and relationship to pharmacogenomic parameters and determine if these levels and/or genetic variations correlate with EFS or systemic toxicity.
    OUTLINE: Patients are assigned to 1 of 4 treatment groups.
    GROUP A: Patients undergo clinical observation for 96 weeks.
    GROUP B: Patients undergo clinical observation for 3 years in the absence of disease progression. Upon disease progression, patients undergo surgery or receive first-line chemotherapy comprising carboplatin intravenously (IV) over 1 hour on day 1 (courses 1, 2, 4, 6, and 7), etoposide IV over 1 hour on days 1-3 (courses 1, 3, 4, 5, and 7), cyclophosphamide IV over 1 hour on day 1 (courses 2, 3, 5, 6, and 8), and doxorubicin hydrochloride IV over 15 minutes on day 1 (courses 2, 4, 6 and 8). Treatment with chemotherapy repeats every 21 days for 2-8 courses in the absence of disease progression or unacceptable toxicity. Once a partial response (PR) or better is achieved, patients undergo clinical observation for 3 years.
    GROUP C: Patients at high risk for deterioration and a poor outcome immediately receive first-line chemotherapy as in Group B. All other patients undergo clinical observation for 3 years in the absence of disease progression. Upon disease progression, patients receive first-line chemotherapy as in Group B. Once a PR or better is achieved, patients undergo clinical observation for 3 years.
    GROUP D: Patients receive first-line chemotherapy as in Group B. Patients who achieve a complete response (CR) or very good partial response (VGPR) following first-line chemotherapy receive isotretinoin orally (PO) twice daily (BID) on days 1-14. Treatment with isotretinoin repeats every 28 days for 6 courses. Patients then undergo clinical observation for 3 years. Patients who achieve a PR or stable disease (SD) following first-line chemotherapy receive salvage chemotherapy comprising cyclophosphamide IV over 30 minutes and topotecan hydrochloride IV over 30 minutes on days 1-5. Treatment with salvage chemotherapy repeats every 21 days for 2-6 courses. Patients then receive isotretinoin PO BID on days 1-14. Treatment with isotretinoin repeats every 28 days for 6 courses. Patients then undergo clinical observation for 3 years.
    After completion of study treatment, patients are followed up annually for 5 years.

    TRIAL NUMBER: A011202

    Title: A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (CT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy

    Purpose: Study Outline: All patients will undergo surgery to identify sentinel lymph node(s). If a lymph node (sentinel or non-sentinel) is determined to be positive on intra-operative pathology the patient will be registered/randomized intra-operatively. Patients who do not have a sentinel lymph node identified will not be registered/randomized to the study. Patients whose sentinel lymph node status is cannot be/is not determined intra- operatively, and have not undergone ALND, but had at least one lymph node (sentinel or non-sentinel) found to be positive on final pathology review will be registered/randomized post-operatively. Patients whose sentinel lymph node status is found to be negative intra-operatively and have not undergone ALND, but had at least one lymph node (sentinel or non-sentinel) found to be positive on final pathology review will be registered/randomized post-operatively. ALND is not to be performed prior to registration/randomization. Patients who are determined to have negative lymph nodes on final pathology will not be registered/randomized, but can be offered participation in another cooperative group trial. The primary and secondary objectives of the study are described below. Please see the "Arms" section for a detailed description of the treatment regimens. Primary Objective: To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive SLN(s) after completion of neoadjuvant chemotherapy Secondary Objectives: To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of the incidence of invasive loco-regional recurrences in patients with a positive SLN(s) after completion of neoadjuvant chemotherapy To obtain an estimate of the distribution of residual disease burden scores for each treatment arm To estimate the distribution of overall survival for each treatment arm Patients may receive adjuvant and ancillary therapy as appropriate per the protocol. Adjuvant Therapy: Adjuvant endocrine therapy: Patients with hormone receptor (ER and/or PR) positive disease should receive a minimum of 5 years of standard endocrine therapy (experimental agents/regimens are not permitted). Endocrine therapy should begin following completion of neoadjuvant chemotherapy and surgery, either before, during or after radiation therapy at the discretion of the oncologist. Selection of the agents is at the treating physician's discretion. Patients with HER 2 positive disease should complete a total of one year of trastuzumab therapy (over the neoadjuvant and adjuvant period). Chemotherapy, biologic therapy or vaccine therapy in the adjuvant setting is not allowed. Patients who wish to receive any of these therapies after surgery must go off study at the time of their initiation. Ancillary Therapy: Patients should receive full supportive care, including transfusions of blood and blood products, erythropoetin (unless otherwise specified in the protocol), antibiotics, antiemetics, etc. when appropriate. Patients are followed up for 5 years after completion of radiation therapy.

    TRIAL NUMBER: A221505

    Title: PHASE III RANDOMIZED TRIAL OF HYPOFRACTIONATED POST MASTECTOMY RADIATION WITH BREAST RECONSTRUCTION

    Purpose: 2.1 Primary Objective To evaluate whether the reconstruction complication rate at 24 months post radiation is non-inferior with hypofractionation. Complications will include those listed in Section 10.1. 2.2 Secondary Objectives 2.2.1 To evaluate the incidence of acute and late radiation complications based on CTCAE 4.0 toxicity. 2.2.2 To evaluate the local and local regional recurrence rate. 2.2.3 To compare reconstruction complication rates based on reconstruction method (autologous +/- implant vs implant only) and timing of reconstruction received (immediate vs. intent for delayed).

    TRIAL NUMBER: EA1131

    Title: A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Observation in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy

    Purpose: The purpose of this study is to compare the IDFS in TNBC patients with residual basal-like disease after neoadjuvant chemotherapy who are randomized to post-preoperative platinum based chemotherapy with those who are randomized to observation. At present, upon completion of neoadjuvant therapy, the standard of care for patients with TNBC (who have no clinical evidence of metastatic disease after surgical excision of the cancer regardless of burden of residual disease) is observation, since there is no additional therapies available with proven impact. This study could provide a possible alternative treatment, which makes it appropriate for the population.

    TRIAL NUMBER: NSABP B-51

    Title: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

    Purpose: This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer

    TRIAL NUMBER: S1501

    Title: PROSPECTIVE EVALUATION OF CARVEDILOL IN PREVENTION OF CARDIAC TOXICITY IN PATIENTS WITH METASTATIC HER-2+ BREAST CANCER, PHASE III

    Purpose: Primary Objective To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy. Secondary Objectives a. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of predefined subsequent cardiac events in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy. b. To evaluate if prophylactic carvedilol compared with no intervention results in a longer time to first interruption of trastuzumab?based HER-2 targeted therapy due to either cardiac dysfunction or events. c. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction OR events in this population. d. To establish and prospectively collect a predefined panel of baseline core cardiovascular measures and develop a predictive model of cardiac dysfunction (see Section 11.2). e. To evaluate the rate of cardiac dysfunction in an observational arm consisting of individuals otherwise eligible for the study except for use of beta blockers, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitors for other medical reasons.

    TRIAL NUMBER: WF-97116

    Title: Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil - WF 97116

    Purpose: This study is to compare the safety and effects of donepezil (Aricept) or if it decreases memory loss after receiving chemotherapy for breast cancer.

    TRIAL NUMBER: ALTE11C2

    Title: HEALTH EFFECTS AFTER ANTHRACYCLINE AND RADIATION THERAPY (HEART): DEXRAZOXANE AND PREVENTION OF ANTHRACYCLINE-RELATED CARDIOMYOPATHY

    Purpose: Given the critical role anthracyclines have in many effective cancer treatments and the risk for subsequent cardiotoxicity associated with this class of agents, development of an effective cardioprotective strategy is of great importance. Although adult studies have shown that dexrazoxane (DRZ) is effective in minimizing cardiomyopathy/heart failure (CHF) after anthracycline therapy, short and long-term data in children are much more limited. Furthermore, concerns regarding DRZ's interaction with cancer therapies and possible association with an increased risk of second cancers have limited its use among children despite possible protection against premature CHF. To address these gaps in knowledge, using a cross-sectional study design, we propose to ascertain echocardiographic and serum biomarkers of cardiac injury in a cohort of long-term pediatric T-cell leukemia and Hodgkin lymphoma survivors enrolled on 3 front-line Children's Oncology Group (COG) clinical trials (POG 9404, 9425, 9426) between 1996-2001 that featured upfront DRZ randomization and a range of anthracycline exposures commonly used in contemporary therapy (100-360 mg/m2 doxorubicin). Our primary aim will be to determine whether patients randomized to the experimental DRZ arms have decreased markers of myocardial injury compared with patients treated without DRZ. Specifically, this will include a one-time measurement of an echocardiographic index of pathologic left ventricular (LV) remodeling (wall thickness-dimension ratio), complemented by serum biomarkers and a physical examination for signs and symptoms of CHF. We will also evaluate whether DRZ's cardioprotective effect is modified by anthracycline dose, chest radiation, and selected demographic factors (age at cancer diagnosis, current age, sex). In secondary analysis, we will also update the overall- and event-free survival rates between patients on the DRZ and non-DRZ arms. Finally, we will determine whether projected quality-adjusted life years differed by randomization status, accounting for premature cardiac disease, primary disease relapse, and second cancers.

    TRIAL NUMBER: WF-10217

    Title: Work Ability in Young Adult Survivors (WAYS)

    Purpose: Brief Summary: To document levels of labor force participation, occupation, educational attainment, and financial toxicity following cancer treatment in YA cancer survivors aged 25-34 years.
    Detailed Description: This observational, cross-sectional study will recruit 200 YA survivors through the Wake Forest National Cancer Institute Community Oncology Research Program (NCORP) Research Base (WF NCORP RB). Data will be collected using a web-based interface and will capture physical, psychosocial and cognitive late effects; work ability; work-related outcomes, including labor force participation, occupation, work place characteristics, and educational attainment; survivor characteristics; and cancer diagnosis/treatment information (from clinical records). We will evaluate the relationships among these measures using the theoretical framework to guide statistical analysis.

    TRIAL NUMBER: A021502

    Title: Randomized Trial of Standard Chemotherapy Alone or Combined With Atezolizumab as Adjuvant Therapy for Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair

    Purpose: This randomized phase III trial studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy with atezolizumab may work better than combination chemotherapy alone in treating patients with colon cancer.

    TRIAL NUMBER: EA2174

    Title: A PHASE II/III STUDY OF PERI-OPERATIVE NIVOLUMAB AND IPILIMUMAB IN PATIENTS WITH LOCOREGIONAL ESOPHAGEAL AND GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA

    Purpose: Primary Outcome Measures : Pathologic complete response (Step I) [ Time Frame: Up to 5 weeks ] The study with compare the pathologic complete response of Arm A and Arm B using a one-sided 0.10 level chi-squared test for proportions.
    Disease-free survival (DFS) (Step 2) [ Time Frame: From the adjuvant treatment randomization assessed for up to 7 years ] DFS measured from the adjuvant treatment randomization will be the endpoint of the adjuvant portion of the study and to achieve the desired power it is expected that patients will be followed for an additional year post completion of accrual to the adjuvant portion. The DFS comparison will be between patients randomized to Arm C (nivolumab) versus Arm D (nivolumab plus ipilimumab) using a one-sided 0.10 level stratified log rank test.

    Secondary Outcome Measures : Incidence of adverse events [ Time Frame: Up to 7 years ] Graded according to Common Terminology Criteria for Adverse Events version 5.0. Toxicity will be evaluated among all treated patients regardless of eligibility and interim analyses of toxicity are performed twice yearly. The study will have sufficient precision to provide 95% confidence intervals on toxicity
    Overall survival [ Time Frame: From the time of first randomization up to 7 years ] Analyses will be descriptive in nature and will not follow any formal interim monitoring.
    DFS [ Time Frame: From the time of first randomization up to 7 years ] The DFS comparison will be between patients randomized to Arm C (nivolumab) versus Arm D (nivolumab plus ipilimumab) using a one-sided 0.10 level stratified log rank test.

    Other Outcome Measures: Percent change in mean volumetric apparent diffusion coefficient (ADC) [ Time Frame: Baseline to mid-treatment ] The study will assess the area under the receiver operating characteristic curve of the changes of apparent diffusion coefficient (ADC) value.

    TRIAL NUMBER: S1815

    Title: A PHASE III RANDOMIZED TRIAL OF GEMCITABINE, CISPLATIN, AND NAB-PACLITAXEL VERSUS GEMCITABINE AND CISPLATIN IN NEWLY DIAGNOSED, ADVANCED BILIARY TRACT CANCERS

    Purpose: Primary Outcome Measures : Overall survival (OS) [ Time Frame: Up to 3 years ] OS will be determined using the log-rank test with stratification by disease site (gallbladder adenocarcinoma versus [vs.] intrahepatic cholangiocarcinoma vs. extrahepatic cholangiocarcinoma), disease stage (locally advanced vs. metastatic), and Zubrod performance status (0 vs. 1). Distributions of overall survival by treatment arm will be estimated using the method of Kaplan-Meier.

    Secondary Outcome Measures : Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: Up to 3 years ] Rates of serious toxicities will be compared between arms.
    Progression-free survival (PFS) [ Time Frame: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years ] Distributions of PFS will be described using cumulative incidence estimates with differences in these estimates between treatment arms assessed by a stratified Cox regression model.
    Overall response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria [ Time Frame: Up to 3 years ] ORR is defined as confirmed and unconfirmed; complete response + partial response + stable disease. The chi-square test will be used to compare ORR, disease control rate (DCR), and rates of toxicity events across arms. ORR will be assessed in the subset of patients with measurable disease.
    Disease control rate as measured by RECIST 1.1 criteria [ Time Frame: Up to 3 years ] The chi-square test will be used to compare ORR, DCR, and rates of toxicity events across arms. Disease control includes confirmed and unconfirmed complete response, confirmed and unconfirmed partial response, and stable disease. In patients with non-measurable disease, disease control will be defined as those who are alive without disease progression.
    Changes in carbohydrate antigen 19-9 (CA 19-9) levels [ Time Frame: Baseline up to course 3 ] Correlations between changes in CA19-9 levels from baseline to post-treatment and ORR will be estimated via logistic regression models, both within each treatment arm and in the overall cohort. Analyses will explore the prognostic and predictive values of CA19-9 for disease response.

    TRIAL NUMBER: EA2142

    Title: Randomized Phase II Study of Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced G3 Non-small Cell Gastroenteropancreatic Neuroendocrine Carcinomas

    Purpose: This randomized phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, capecitabine, cisplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Certain types of neuroendocrine carcinomas may respond better to treatments other than the current standard treatment of cisplatin and etoposide. It is not yet known whether temozolomide and capecitabine may work better than cisplatin and etoposide in treating patients with this type of neuroendocrine carcinoma, called non-small cell neuroendocrine carcinoma.

    TRIAL NUMBER: ARST1431

    Title: COG ARST1431, A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating with Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864, IND# 122782) in Patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS)

    Purpose: ARST1431, states that Unfortunately about 25% of patients with intermediate-risk (IR) embryonal rhabdomyosarcoma (ERMS) and 50% of those with IR alveolar rhabdomyosarcoma (ARMS) will experience disease recurrence with a resulting long-term event-free survival (EFS) of 65%. The mTOR pathway is important in RMS biology, and temsirolimus (TORI), an mTOR inhibitor, has demonstrated clinical activity in patients with relapsed RMS. In an attempt to improve long-term survival for patients with IR RMS, ARST1431 will compare the EFS of patients with newly diagnosed IR RMS randomly assigned to standard vincristine, dactinomycin, and cyclophosphamide (VAC) alternating with vincristine and irinotecan (VI) versus VAC/VI plus TORI. Radiotherapy will start at Week 13 of therapy for all patients. Correlative biology studies will be performed including a determination of the FOXO1 gene fusion status in the tumor and impact on patient outcome. Children’s Hospital/LSUHSC-NO sees several diagnosed patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS), We estimate seeing up to 5-10 patients per year.

    TRIAL NUMBER: COG-AALL1331

    Title: Risk-Stratified Randomized Phase III Testing of Blinatumomab (IND #117467, NSC #765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL): A Groupwide Phase III Study

    Purpose: PRIMARY OBJECTIVES:
    I. To compare disease free survival (DFS) of high-risk (HR) and intermediate-risk (IR) relapse B-cell acute lymphoblastic leukemia (B-ALL) patients who are randomized following induction block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR randomization).
    II. To compare the DFS of low risk (LR) relapse B-ALL patients who are randomized following block 2 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR randomization).
    SECONDARY OBJECTIVES:
    I. To compare overall survival (OS) of HR and IR relapse B-ALL patients who are randomized following induction block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR randomization).
    II. To compare OS of LR relapse B-ALL patients who are randomized following block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR randomization).
    TERTIARY OBJECTIVES:
    I. To compare the rates of minimal residual disease (MRD) >= 0.01% at the end of block 2 and block 3 for HR and IR relapse B-ALL patients in HR/IR randomization.
    II. To estimate, for treatment failure (TF) patients not previously receiving blinatumomab, the hematologic complete remission rate (CR), rate of MRD < 0.01%, and proportion able to proceed to hematopoietic stem cell transplant (HSCT) in CR after treatment with blinatumomab.
    III. To assess the feasibility and safety of rapid taper of immune suppression for the subset of HSCT patients with MRD >= 0.01% pre- and/or post-HSCT with no acute graft versus host disease (aGVHD).
    OUTLINE:
    All patients receive Block 1 over 4 weeks.
    BLOCK 1: Patients receive dexamethasone orally (PO) twice daily (BID) or intravenously (IV) on days 1-5 and 15-19; vincristine sulfate IV over 1 minute on days 1, 8, 15, and 22; pegaspargase IV over 1-2 hours on days 3 and 17; and mitoxantrone hydrochloride IV over 15-30 minutes on days 1-2. Patients with central nervous system (CNS) 1 or CNS2 also receive methotrexate intrathecally (IT) on days 1 and 8. Patients with CNS3 or isolated CNS relapse also receive methotrexate IT, hydrocortisone IT, and cytarabine IT on days 1, 8, 15, and 22. High risk and intermediate risk patients are then assigned to randomization R1. Low risk patients are assigned to randomization R2.
    RANDOMIZATION R1 (HR and IR patients): Patients are randomized to 1 of 2 treatment arms.
    ARM A: Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, and then undergo allogeneic HSCT.
    ARM B: Patients receive Blinatumomab Block 1 over 5 weeks, Blinatumomab Block 2 over 5 weeks, and then undergo allogeneic HSCT.
    RANDOMIZATION R2 (LR patients): Patients are then randomized to 1 of 2 treatment arms.
    ARM C: Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, Continuation 1 over 8 weeks, Continuation 2 over 8 weeks, and then Maintenance.
    ARM D: Patients receive Block 2 over 4 weeks, Blinatumomab Block 2 over 5 weeks, Continuation 1 over 8 weeks, Blinatumomab Block 3 over 5 weeks, Continuation 2 over 8 weeks, Blinatumomab Block 3 over 5 weeks, and then Maintenance.
    BLOCK 2: Patients receive dexamethasone PO BID or IV on days 1-5; vincristine sulfate IV over 1 minute on day 1; methotrexate IV over 36 hours on day 8; leucovorin calcium IV or PO on days 9-10; pegaspargase IV over 1-2 hours on day 9; cyclophosphamide IV over 15-30 minutes on days 15-19; and etoposide IV over 1-2 hours on days 15-19. Patients with CNS1 or CNS2 also receive methotrexate IT on day 8. Patients with CNS3 also receive methotrexate IT, hydrocortisone IT, and cytarabine IT on days 8 and 22.
    BLOCK 3: Patients receive dexamethasone PO BID or IV on days 1-5; vincristine sulfate IV over 1 minute on day 1; cytarabine IV over 3 hours every 12 hours on days 1, 2, 8, and 9; asparaginase intramuscularly (IM) on days 2, 4, 9, 11, and 23; methotrexate IT on day 1 and IV over 36 hours on day 22; leucovorin calcium PO or IV on days 23-24. Patients with CNS1 or CNS2 also receive methotrexate IT on day 22. Patients with CNS3 also receive methotrexate IT, hydrocortisone IT, and cytarabine IT on days 1 and 22.
    BLINATUMOMAB BLOCK 1: Patients blinatumomab IV continuously on days 1-28 and dexamethasone PO or IV on day 1. Patients with CNS1 or CNS2 also receive methotrexate IT on days 15 and 29. Patients with CNS3 also receive methotrexate IT, hydrocortisone IT, and cytarabine IT on days 15 and 29.
    BLINATUMOMAB BLOCK 2: Patients blinatumomab IV continuously on days 1-28 and dexamethasone PO or IV on day 1. Patients with CNS1 or CNS2 also receive methotrexate IT on days 8 and 29. Patients with CNS3 also receive methotrexate IT, hydrocortisone IT, and cytarabine IT on days 8 and 29.
    BLINATUMOMAB BLOCK 3: Patients blinatumomab IV continuously on days 1-28 and dexamethasone PO or IV on day 1.
    CONTINUATION 1 & 2: Patients receive dexamethasone PO BID or IV on days 1-5; vincristine sulfate IV over 1 minute on day 1; mercaptopurine tablet PO on days 1-42; methotrexate PO on days 8, 15, 29, and 36; leucovorin calcium PO or IV on days 23-24; cyclophosphamide IV over 15-30 minutes on days 42 and 49; etoposide IV over 1-2 hours on days 42 and 49; thioguanine PO once daily on days 42-48; and cytarabine IV or subcutaneously (SC) on days 43-46 and 50-53. Patients with CNS1 or CNS2 also receive methotrexate IT on days 1 and 43. Patients with CNS3 also receive methotrexate IT, hydrocortisone IT, and cytarabine IT on days 1 and 43; methotrexate PO every 6 hours on day 22; and methotrexate IV over 36 hours on day 22.
    MAINTENANCE: Patients receive dexamethasone PO BID or IV on days 1-5, 29-33, and 57-61; vincristine sulfate IV over 1 minute on days 1, 29, and 57; mercaptopurine tablet PO on days 1-84; and methotrexate PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Patients with CNS1 or CNS2 also receive methotrexate IT on day 1. Patients with CNS3 also receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 1. Courses repeat every 12 weeks for up to 2 years since the beginning of treatment in the absence of disease progression or unacceptable toxicity.
    After completion of study treatment, patients are followed up annually for 10 years.

    TRIAL NUMBER: A031704

    Title: PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab Vs. VEGF TKI Cabozantinib with Nivolumab: A Phase III Trial in Metastatic Untreated REnal Cell CancEr [PDIGREE]

    Purpose: This phase III trial studies how well nivolumab and ipilimumab, followed by nivolumab versus cabozantinib and nivolumab, work in treating patients with renal cell cancer that is untreated and has spread to other parts of the body. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cabozantinib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known how well cabozantinib and nivolumab work in treating patients with untreated renal cell cancer that has spread to other parts of the body.

    TRIAL NUMBER: AREN03B2

    Title: RENAL TUMORS CLASSIFICATION, BIOLOGY, AND BANKING STUDY

    Purpose: PRIMARY OBJECTIVES:
    I. Classify patients with renal tumors by histological categorization, surgico- pathological stage, presence of metastases, age at diagnosis, tumor weight, and loss of heterozygosity for chromosomes 1p and 16q, to define eligibility for a series of therapeutic studies.
    II. Maintain a biological samples bank to make specimens available to scientists to evaluate additional potential biological prognostic variables and for the conduct of other research by scientists.
    SECONDARY OBJECTIVES:
    I. Monitor outcome for those patients who are not eligible for a subsequent therapeutic study.
    II. Describe whether the pulmonary tumor burden correlates with outcome in patients with stage IV disease.
    III. Describe the sensitivity and specificity of abdominal computed tomography (CT) scan by comparing it with surgical and pathologic findings for identification of local tumor spread beyond the renal capsule to adjacent muscle and organs, lymph node involvement at the renal hilum and in the retroperitoneum, preoperative tumor rupture, and metastases to the liver.
    IV. Compare the sensitivity and specificity of pre-operative abdominal CT scan and MRI for the identification and differentiation of nephrogenic rests and Wilms' tumor in children with multiple renal lesions.
    V. Correlate the method of conception (natural vs assisted reproductive technology) with the development of Wilms' tumor.
    OUTLINE: This is a multicenter study.
    Tumor tissue, blood, and urine samples are collected for research studies, including immunohistochemistry. CT scans and magnetic resonance imaging (MRIs) are also performed. Loss of heterozygosity analyses (chromosome 1p and 16q) are performed by extraction of DNA. DNA polymorphisms are assayed by polymerase chain reaction using standard methodology. Leftover specimens are archived for future studies.
    Patients are followed periodically for 5 years.

    TRIAL NUMBER: A041501

    Title: A PHASE III TRIAL TO EVALUATE THE EFFICACY OF THE ADDITION OF INOTUZUMAB OZOGAMICIN (A CONJUGATED ANTI-CD22 MONOCLONAL ANTIBODY) TO FRONTLINE THERAPY IN YOUNG ADULTS (AGES 18-39 YEARS) WITH NEWLY DIAGNOSED PRECURSOR B-CELL ALL

    Purpose: Primary Outcome Measures : EFS [ Time Frame: Time from induction response to the time of progressive-disease, secondary malignancy, or death, assessed up to 3 years ] Will be compared using log-rank tests. EFS curves will be constructed using the Kaplan-Meier product limit method, and additional analyses will be done using the Cox proportional hazards model. The corresponding hazard ratio, 2- and 3-year EFS estimates will be assessed, and EFS medians along with their 95% confidence intervals for the two treatment arms.

    Secondary Outcome Measures : DFS [ Time Frame: Time from achievement of CR to the time of relapse and/or death, assessed up to 10 years ] OS [ Time Frame: Time from randomization to the time of death due to any cause, assessed up to 10 years ] Will be evaluated using Kaplan-Meier as well as Cox regression models.
    Proportion of patients who achieve CR or any response to induction therapy [ Time Frame: Up to 10 years ] Will be summarized as the proportion of patients who achieve any type of response to induction therapy divided by the number of all evaluable patients registered to this trial and who received at least one dose of induction therapy. Corresponding 95% binomial confidence intervals will also be calculated.
    Overall induction response rates [ Time Frame: Up to 10 years ] Will be summarized as the proportion of patients who achieve any type of response to induction therapy divided by the number of all evaluable patients registered to this trial and who received at least one dose of induction therapy. Corresponding 95% binomial confidence intervals will also be calculated.
    Incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 10 years ] The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, all adverse event data that is graded as 3, 4, or 5 will be reviewed and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The incidence of severe (grade 3+) adverse events or toxicities will be described for each treatment arm, but will also be compared between the arms. Fisher's exact tests will be used to quantitatively compare the incidence of severe as well as specific toxicities of interest between the treatment arms and we will graphically assess differences in maximum grades observed for toxicities between the arms. Tolerability of the treatment arms will be assessed through assessing the number of patients who required dose modifications and/or dose delays.
    Proportion of patients who go off treatment due to adverse reactions [ Time Frame: Up to 10 years ] Will be assessed within each of the treatment arms and differences explores in these measures between the arms.
    Proportion of patients who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial [ Time Frame: Up to 10 years ] Will be assessed within each of the treatment arms and differences explores in these measures between the arms.

    TRIAL NUMBER: ACCL16N1CD

    Title: Documentation and Delivery of Guideline-Consistent Treatment in Adolescent and Young Adult (AYA) Acute Lymphoblastic Leukemia (ALL)

    Purpose: This research trial studies cancer care delivery in adolescent and young adult patients with acute lymphoblastic leukemia. Surveying institutions, evaluating delivery of care at the patient level and seeking input from healthcare providers may help doctors increase rates of adherence to National Comprehensive Cancer Network (NCCN) treatment guidelines. It may also improve care for adolescent and young adult patients with acute lymphoblastic leukemia.
    PRIMARY OBJECTIVES:
    I. To evaluate the proportion of adolescent and young adult (AYA) acute lymphoblastic leukemia (ALL) patients with a documented treatment plan consistent with NCCN guidelines for AYAs with ALL.
    II. To evaluate the proportion of AYA ALL patients whose delivered treatment during induction and post-induction therapy (PIT) is consistent with NCCN guidelines for AYAs with ALL.
    III. To determine the impact of treating physician specialty and facility type on likelihood of AYA ALL patients having a documented treatment plan concordant with NCCN guidelines when stratified by age group (15-17year[y], 18-21y, and 22-39y).
    IV. To determine the impact of treating physician specialty and facility type on the likelihood of AYA ALL patients receiving induction and post-induction therapy (PIT) concordant with NCCN guidelines when stratified by age group (15-17y, 18-21y, and 22-39y).
    V. To identify for AYAs with ALL, targetable structure- and process-level barriers and facilitators which will increase the proportion of patients having a documented treatment plan and receiving treatment according to NCCN guidelines.
    SECONDARY OBJECTIVES:
    I. To explore potential correlations with clinical and social demographic variables to the presence of a documented treatment plan and delivered treatment consistent with NCCN guidelines in AYAs with ALL.
    OUTLINE:
    CHART REVIEW: Patient medical record data is abstracted and treatment plans are reviewed for consistency to NCCN guidelines. For each patient, induction and post-induction care is recorded as either concordant with NCCN guidelines or non-concordant with NCCN guidelines.
    SITE QUESTIONNAIRE: Participating sites complete a questionnaire which is designed to capture facility-oriented data.
    FOCUS GROUPS: Healthcare providers participate in focus groups over 1-2 hours to discuss facilitators and barriers to AYA ALL guideline concordance. Participants provide responses via electronic handheld technology in order to maintain anonymity followed by discussion of the ideas for clarification.

    TRIAL NUMBER: ALTE1631

    Title: A RANDOMIZED WEB-BASED PHYSICAL ACTIVITY INTERVENTION AMONG CHILDREN AND ADOLESCENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA

    Purpose:

    Primary Outcome Measures :
    1. Physiologic cost index (PCI) [ Time Frame: Up to 24 weeks (end of intervention) ]
      Differences in PCI will be compared between groups at the end of the intervention. Intent to treat analysis of variance (either transforming the data or employing a non-parametric equivalent if the data are not normally distributed) controlling for the stratification factors (sex, age, and treatment related risk group) will be used for comparison. General linear mixed models will be utilized to evaluate the effects of group assignment on changes in PCI over time to account for repeated measures on individual children, and for potential random effects such as original treating institution.


    Secondary Outcome Measures :
    1. Change in markers of cardiometabolic health [ Time Frame: Baseline up to 48 weeks post intervention ]
      Markers of Cardiometabolic health include blood pressure, body mass index, waist to height ration, fasting insulin, glucose, and lipid levels. Differences in these markers between randomized groups and the effects of group assignment on changes over time will be evaluated.

    2. Change in inflammation [ Time Frame: Baseline up to 48 weeks post intervention ]
      Markers of an Inflammatory state include High sensitivity C-reactive protein, interleukin-6, and tumor necrosis factor alpha. Differences in these markers between groups and the effects of group assignment on changes over time will be evaluated.

    3. Change in quality of life assessed using Pediatric Quality of Life (PedsQL) 4.0 Generic Core Scale [ Time Frame: Baseline up to 48 weeks post intervention ]
      The 23-item PedsQL Generic Core Scales were designed to measure the core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning. Scores range from 0-100, higher is better.. There are four scales (Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning).. Emotional, Social and School Functioning can be combined to create a psychosocial summary (summed and divided by total number of items). Differences between groups and the effects of group assignment on changes over time will be evaluated.

    4. Change in fatigue assessed using Pediatric Quality of Life Multidimensional Fatigue Scale [ Time Frame: Baseline up to 48 weeks post intervention ]
      The PedsQL Multidimensional Fatigue Scale was designed as a generic symptom-specific instrument to measure fatigue in patients with acute and chronic health conditions as well as healthy school and community populations. It has three dimensions, general fatigue, sleep/rest fatigue and cognitive fatigue. Scores range from 0-100 and items are summed and divided by the total to get the mean. Differences between groups and the effects of group assignment on changes over time will be evaluated.

    5. Change in school attendance assessed using parent report [ Time Frame: Baseline up to 48 weeks post intervention ]
      Differences between groups and the effects of group assignment on changes over time will be evaluated.

    6. Markers of cardiometabolic health [ Time Frame: Up to 48 weeks post intervention ]
      Markers of cardiometabolic health include blood pressure, body mass index, waist to height ration, fasting insulin, glucose, and lipid levels. It will be determined if the effect of an interactive web-based physical activity intervention on markers of cardiometabolic health is mediated by changes in fitness among children and adolescents following treatment for acute lymphoblastic leukemia. A causal inference approach will evaluate whether group assignment results in an improved outcome in the presence of a lower PCI. This requires decomposing the averaged total effect into indirect and direct effects of group assignment of on the cardiometabolic outcomes. A principal stratification method will be used that classifies participants into strata based on their performance on the PCI (mediator variable) for each group of the randomized intervention. Mediation analyses would then be based on intent-to-treat effects of group assignment on cardiometabolic health outcome within each strata.

    TRIAL NUMBER: COG-AALL15P1

    Title: A GROUPWIDE PILOT STUDY TO TEST THE TOLERABILITY AND BIOLOGIC ACTIVITY OF THE ADDITION OF AZACITIDINE TO CHEMOTHERAPY IN INFANTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) AND KMT2A (MLL) GENE REARRANGEMENT

    Purpose: Primary Outcome Measures: Incidence of adverse events of azacitidine and combination chemotherapy, graded according to Common Terminology Criteria for Adverse Events 4.0 [ Time Frame: From the first course of azacitidine administration up to fourth course of azacitidine administration ]
    Secondary Outcome Measures: Biologic activity, defined as global DNA methylation change in PBMCs [ Time Frame: Prior to first course of azacitidine up to day 5 of second course of azacitidine ] Will calculate the mean long interspersed nucleotide element-1 (LINE-1) methylation for all patients before and after azacitidine and perform paired t-test analysis to determine if there is significant demethylation in the study population for the tested dose level.

    Other Outcome Measures: EFS [ Time Frame: From time of enrollment up to 5 years ] Descriptive analysis will be conducted to correlate MRD with the EFS for the KMT2A-R patients. PD data for asparaginase activity following pegaspargase administration in infants will be collected and correlated with EFS for the KMT2A-R patients. Standard errors and confidence intervals for EFS will be calculated using Peto's method.
    Expansion of infant T lymphocytes by stimulation with artificial antigen presenting cells [ Time Frame: Up to the end of consolidation therapy, assessed up to 5 years ] Minimal residual disease [ Time Frame: Up to 5 years ] Descriptive analysis will be conducted to correlate MRD with the EFS for the KMT2A-R patients.
    PD data for asparaginase activity following pegaspargase administration [ Time Frame: From 7 days following pegaspargase administration during induction therapy up to 7 days following pegaspargase administration during delayed intensification part 2 ] Will be collected and correlated with EFS for the KMT2A-R patients
    PK parameters of azacitidine [ Time Frame: Pre-dose on days 3 and 4, at 5 and 30 minutes, and 1, 4, and 6 hours post-dose of azacitidine block I ]

    TRIAL NUMBER: COG-AAML1531

    Title: RISK-STRATIFIED THERAPY FOR ACUTE MYELOID LEUKEMIA IN DOWN SYNDROME

    Purpose: PRIMARY OBJECTIVES:
    I. To determine the 2-year event-free-survival (EFS) for children with standard risk Down syndrome (DS) acute myeloid leukemia (AML) (minimal residual disease [MRD]-negative after one cycle of induction therapy) after elimination of high dose (HD) Ara-C (cytarabine) from the treatment regimen.
    II. To determine the 2-year EFS for children with high risk DS AML (MRD-positive after one cycle of induction therapy) after intensification of treatment equivalent to that used for high risk AML in children without DS.
    EXPLORATORY OBJECTIVES:
    I. To determine the extent to which elimination of HD Ara-C from the treatment of standard risk DS AML decreases adverse events and resource utilization.
    II. To determine if elimination of HD Ara-C from treatment of standard risk DS AML results in a significant decrease in the number of days per patient spent on protocol therapy compared to predecessor study AAML0431.
    III. To determine if elimination of HD Ara-C from treatment of standard risk DS AML results in a significant decrease in the average number of days of hospitalization per patient compared to predecessor studies AAML0431 and A2971.
    IV. To determine if elimination of HD Ara-C from treatment of standard risk DS AML results in a significant decrease in the number (per patient) and rate (per duration of treatment) of sterile site infections compared to the predecessor study AAML0431.
    V. To determine if elimination of HD Ara-C from treatment of standard risk DS AML results in a significant decrease of resource utilization by AML treatment compared to the predecessor study AAML0431.
    VI. To compare the feasibility and analytical characteristics of flow cytometry, polymerase chain reaction (PCR) and targeted error-corrected sequencing of GATA binding protein 1 (globin transcription factor 1) (GATA1) mutations as methods to detect MRD in DS AML.
    VII. To establish a DS AML cell bank of viably frozen bone marrow samples collected at the end of induction and corresponding non-tumor deoxyribonucleic acid (DNA) samples collected at end of Induction 1.
    OUTLINE:
    INDUCTION I: Patients receive cytarabine intrathecally (IT) on day 1 and intravenously (IV) continuously over 96 hours, daunorubicin hydrochloride IV over 1-15 minutes, and thioguanine orally (PO) twice daily (BID) on days 1-4. Induction I continues for a minimum of 28 days.
    Patients are assigned to 1 of 2 treatment arms based on their MRD status after completion of Induction I.
    ARM A (STANDARD RISK):
    INDUCTION II: Patients receive cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV over 1-15 minutes, and thioguanine PO BID on days 1-4. Induction II continues for a minimum of 28 days.
    INDUCTION III: Patients receive cytarabine, daunorubicin hydrochloride, and thioguanine as in Induction II. Induction III continues for a minimum of 28 days.
    INTENSIFICATION I: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 60-120 minutes on days 1-3. Intensification I continues for a minimum of 28 days.
    INTENSIFICATION II: Patients receive cytarabine and etoposide as in Intensification I. Intensification II continues for a minimum of 28 days.
    ARM B (HIGH RISK):
    INDUCTION II: Patients receive high dose cytarabine IV over 1-3 hours BID on days 1-4 and mitoxantrone hydrochloride IV over 15-30 minutes on days 3-6. Induction II continues for a minimum of 28 days.
    INTENSIFICATION I: Patients receive high dose cytarabine IV over 1-3 hours BID and etoposide IV over 60-120 minutes on days 1-5. Intensification I continues for a minimum of 28 days.
    INTENSIFICATION II: Patients receive high dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9. Patients also receive asparaginase or asparaginase Erwinia chrysanthemi (E. carotovora) intramuscularly (IM) or IV over 30 minutes on days 2 and 9. Intensification II continues for a minimum of 28 days.
    After completion of study treatment, patients are followed up at 1 month, monthly for 12 months, every 3 months for 12 months, every 6 months for 3 years, annually for 5 years, and then at relapse.

    TRIAL NUMBER: E1910

    Title: A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults

    Purpose: This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as blinatumomab, may block cancer growth in different ways by targeting certain cells. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.

    TRIAL NUMBER: EA9161

    Title: A RANDOMIZED PHASE III STUDY OF THE ADDITION OF VENETOCLAX TO IBRUTINIB AND OBINUTUZUMAB VERSUS IBRUTINIB AND OBINUTUZUMAB IN UNTREATED YOUNGER PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)

    Purpose: Primary Outcome Measures : Progression-free survival [ Time Frame: Time from randomization to progression or death without documented progression, assessed up to 10 years ] The analysis will be performed using the repeated confidence intervals methodology. At each interim or final analysis, two-sided repeated confidence interval will be constructed using the partial likelihood estimate from stratified Cox proportional hazards model and the critical value based on the Lan-DeMets error-spending function that corresponds to the truncated O'brien-Fleming boundaries.

    Secondary Outcome Measures : Overall survival [ Time Frame: Time from randomization to death due to any cause, assessed up to 10 years ] A hierarchical testing strategy will be used. The analysis will be performed using the repeated confidence intervals methodology. At each interim or final analysis, two-sided repeated confidence interval will be constructed using the partial likelihood estimate from stratified Cox proportional hazards model and the critical value based on the Lan-DeMets error-spending function that corresponds to the truncated O'brien-Fleming boundaries.
    Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events version 5.0 [ Time Frame: Up to 10 years ]
    Other Outcome Measures: Quality of life (QOL) assessed using Functional Assessment of Cancer Therapy-General (FACT-G) and the leukemia sub-scale [ Time Frame: Baseline up to 10 years ] Linear mixed effects models will be used to perform repeated measures regression analysis. Will compare treatment toxicity-related QOL between the two arms. The entire FACT-Leukemia instrument (FACT-G and the leukemia subscale) at baseline will be analyzed using descriptive statistics to assess the impact of chronic lymphocytic leukemia on QOL independent of treatment.
    FACT-Leu Trial Outcome Index (TOI) score over time [ Time Frame: Baseline up to 10 years ] Will use linear mixed effects models will be used to perform repeated measures regression analysis to examine the treatment effect and time effect on FACT-Leu TOI score.
    Adherence defined as patients taking 80% or more of their prescribed doses [ Time Frame: Baseline up to 10 years ] The ASK-12 Survey will be used to measure the likelihood that a patient will take prescribed medications for patients on both arms at baseline and on day 1 +/- 4 days of the following cycles 3, 7, 15, at the time of response evaluation (end of cycle 19), every 6 months for 2 years post response evaluation, at 48 months after randomization, and at time of disease progression. Descriptive statistics will be used to summarize trend in adherence to prescription.

    TRIAL NUMBER: AHEP1531

    Title: Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

    Purpose: Primary Outcome Measures : Event-free survival (EFS) [ Time Frame: From date of randomization until progression of existing disease or occurrence of disease at new sites, death from any cause prior to disease progression, or diagnosis of a second malignant neoplasm, assessed up to 5 years ] Descriptive analysis for each non-randomized and randomized question (by treatment arm and overall) will include: the number (and proportion) of each failure event and in total, survival curves will be estimated by the method of Kaplan-Meier, EFS estimates at 3 and 5 years with 95% confidence intervals (CI), median EFS with CI will be reported if appropriate. A Cox proportional hazards model with EFS as an outcome measure and treatment and stratification factors as covariates will be constructed. This model will be used in the context of a Bayesian analysis and a log Hazard Ratio (HR) will be derived. Bayesian Normal-Normal conjugate analysis of the data will be used to compare treatments. The analysis will use non-informative prior to represent no information about prior beliefs regarding relative treatment difference.
    Response in hepatocellular carcinoma (HCC), defined as complete (CR) or partial (PR) response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria [ Time Frame: Up to 5 years ] The main analysis will be based on a log-binomial model for a Bernoulli response variable. This model will be used in the context of a Bayesian analysis. A non-informative null centered proper prior distributions for the parameters will be used. Response rate (RR) and 95% credible interval (CrI) will be presented. Posterior probabilities for the pre-specified values of interest will be provided. Additionally, the posterior probabilities of RR being larger than 0.7, 0.8, 0.9, 1, 1.1, 1.2 and 1.3 will be also provided.

    Secondary Outcome Measures : Failure free survival [ Time Frame: From date of randomization until the date of first documented progression, date of death from any cause, diagnosis of a second malignant neoplasm or failure to go to resection, whichever came first, assessed up to 5 years ] Descriptive analysis for each non-randomized and randomized question (by treatment arm and overall) will include: the number (and proportion) of each failure event and in total, survival curves will be estimated by the method of Kaplan-Meier. Bayesian Normal-Normal conjugate analysis of the data will be used to compare treatments. The analysis will use non-informative prior to represent no information about prior beliefs regarding relative treatment difference.
    Overall survival [ Time Frame: From date of randomization (or registration for non-randomized patients) until the date of death from any cause, assessed up to 5 years ] Incidence of adverse events [ Time Frame: Up to 5 years ] Will be categorized and graded using Common Terminology Criteria for Adverse Events (CTCAE).
    Chemotherapy-related cardiac, nephro- and oto-toxicity [ Time Frame: Up to 5 years ] Will be recorded in relation to each cycle of treatment and will be categorized and graded using Common Terminology Criteria for Adverse Events.
    Hearing loss measured according to the SIOP Boston Scale for oto-toxicity [ Time Frame: Up to 5 years ] Descriptive analysis for each non-randomized and randomized question (by treatment arm and overall) will include: the number (and proportion) of patients at each the SIOP Boston Scale for oto-toxicity category (i.e. grade 0 to grade 4) and the number (and proportion) of patients who are not assessable for this outcome, (i.e. because of early stopping of treatment, additional treatments to protocol treatment, progression prior to the response assessment or death). The number (and proportion) of patients experiencing any grade hearing loss. Grades 1 to grade 4 will be combined in this analysis. The above will be presented for each assessment time point (EOT and at least 1 year and 2 years of follow up).
    Best response defined as compete response (CR) or partial response (PR) based on radiological response (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) and AFP decline [ Time Frame: Up to 5 years ] Descriptive analysis for each non-randomized and randomized question (by treatment arm and overall) will include: best response will be calculated by taking best RECIST category (i.e. CR, PR, stable disease [SD], progressive disease [PD]) for each patient. CR and PR patients will then be grouped into responders. The number (and proportion) of patients at each best response RECIST category (i.e. CR, PR, SD, PD) and the number (and proportion) of patients who are not assessable for response, e.g. because of early stopping of treatment, progression prior to the response assessment or death. The number (and proportion) of responders (CR and PR) and non-responders.
    Surgical resectability defined as complete resection, partial resection or transplant following randomization (or enrollment for non-randomized patients) [ Time Frame: Up to 5 years ] Descriptive analysis for each non-randomized and randomized question (by treatment arm and overall) will include: The number (and proportion) of patients undergoing complete resection, partial resection or transplant. Time to complete resection, partial resection or transplant following randomization (or enrollment for non-randomized patients) will be analyzed using the Kaplan-Meier method.
    Adherence to surgical guidelines defined as the local clinician?s surgical decision to resect or not compared to the current SIOPEL surgical guidelines [ Time Frame: Up to 5 years ] Descriptive analysis for each non-randomized and randomized question (by treatment arm and overall) will include: The number (and proportion) of patients at each combination of SIOPEL surgical guideline (to resect or not) and local clinician?s surgical decision. The degree of agreement will be measured by Cohen?s kappa with CI.

    TRIAL NUMBER: R1112

    Title: RANDOMIZED PHASE III STUDY OF SORAFENIB VERSUS STEREOTACTIC BODY RADIATION THERAPY FOLLOWED BY SORAFENIB IN HEPATOCELLULAR CARCINOMA

    Purpose: PRIMARY OBJECTIVES:
    I. To determine if stereotactic body radiation therapy (SBRT) improves overall survival in hepatocellular carcinoma (HCC) patients treated with sorafenib (sorafenib tosylate).
    SECONDARY OBJECTIVES:
    I. To determine the difference in time to progression (TTP) and progression- free survival (PFS) in HCC patients treated with sorafenib compared to SBRT followed by sorafenib.
    II. To measure differences in toxicity in HCC patients treated with sorafenib versus SBRT followed by sorafenib.
    III. To measure vascular thrombosis response post sorafenib versus SBRT followed by sorafenib.
    IV. To measure differences in health related quality of life (QOL) and quality- adjusted survival in HCC patients treated with sorafenib compared to SBRT followed by sorafenib.
    V. Collection of biospecimens for future correlative studies to investigate differences in potential biomarkers in patients treated with sorafenib versus SBRT followed by sorafenib.
    OUTLINE: Patients are randomized to 1 of 2 treatment arms.
    ARM 1: Patients receive sorafenib tosylate orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
    ARM 2: Patients undergo SBRT every 24-72 hours for a total of 5 fractions over 5 to 15 days. Within 1-5 days post-SBRT, patients receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
    Patients are followed weekly during SBRT, monthly during sorafenib tosylate and on the following schedule as a whole from study entry: every 3 months for 3 years, then every 6 months for 2 years and then annually.

    TRIAL NUMBER: E4512

    Title: A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

    Purpose: PRIMARY OBJECTIVES:
    I. To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) over placebo for patients with stage IB >= 4 cm, II and IIIA, anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following surgical resection.
    SECONDARY OBJECTIVES:
    I. To evaluate and compare disease-free survival (DFS) associated with crizotinib and placebo.
    II. To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting.
    III. To collect tumor tissue and blood specimens for future research.
    OUTLINE: Patients are randomized to 1 of 2 treatment arms.
    ARM A: Patients receive crizotinib orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    ARM B: Patients receive placebo PO BID on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for 5 years.

    TRIAL NUMBER: EA5163

    Title: EA5163/S1709 INSIGNA : A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-Driven Analysis

    Purpose: Primary Outcome Measures : Overall survival (OS) [ Time Frame: From randomization to death from any cause, assessed up to 5 years post treatment ] OS distributions will be estimated using the Kaplan-Meier method.

    Secondary Outcome Measures : Progression-free survival (PFS) [ Time Frame: From randomization to documented disease progression or death from any cause, assessed up to 5 years post treatment ] PFS distributions will be estimated using the Kaplan-Meier method.
    Best objective response [ Time Frame: Up to 5 years post treatment ] Best objective response will be evaluated via Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
    Incidence of adverse events [ Time Frame: Up to 30 days post treatment ] Toxicities will be reported via the Common Terminology Criteria for Adverse Events (CTCAE) criteria version 5.0. Toxicity rates between arms in the overall population will be compared using Fisher's exact tests with a one-sided type I error rate of 1.25%; multivariable logistic regression modeling will be used to adjust for the effect of any covariates that are associated with these categorical outcomes.
    PD-L1 positivity [ Time Frame: At baseline ] PD-L1 positivity will be defined as >= 1% Tumor Proportion Score (TPS) for the purpose of enrollment onto the trial. Strongly PD-L1 positive is defined as >= 50% TPS; weakly positive is defined as 1% - 49% TPS.

    TRIAL NUMBER: LungMAP

    Title: LungMAP: A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)

    Purpose: 1.1 Primary Objective of the Master Protocol (LungMAP) The primary objective of this screening study is to test patient specimens to determine eligibility for participation in the biomarker-driven and non-matched sub-studies included within the Lung-MAP umbrella protocol. 1.2 Secondary Objectives a. Screening Success Rate Objective To evaluate the screen success rate defined as the percentage of screened patients that register for a therapeutic sub-study. Screen success rates will be evaluated for the total screened population and by the subset of patients screened following progression on previous therapy or pre-screened on current therapy. b. Translational Medicine Objectives 1. To evaluate circulating tumor DNA (ctDNA) and compare to the FMI Foundation tissue molecular profiling results in patients who submit a new biopsy for screening. 2. To establish a tissue/blood repository

    TRIAL NUMBER: S1800A

    Title: Ramucirumab and Pembrolizumab Versus Standard of Care in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Non-Match Treatment Trial)

    Purpose: This phase II Lung-MAP non-Match treatment trial studies how well ramucirumab and pembrolizumab work versus standard of care in treating patients with non-small cell lung cancer that is stage IV or has come back. Immunotherapy with monoclonal antibodies, such as ramucirumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in standard of care chemotherapy for non-small cell lung cancer, such as docetaxel, gemcitabine hydrochloride, and pemetrexed, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ramucirumab and pembrolizumab together may work better in treating patients with non-small lung cancer compared to standard of care.

    TRIAL NUMBER: COG-AALL1731

    Title: A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy)

    Purpose:

    Primary Outcome Measures :
    1. Post-Consolidation disease free survival (DFS) with addition of 2 cycle of blinatumomab in patients with standard risk (SR) B-lymphoblastic leukemia (B-ALL) and higher risk features, and patients with standard risk average (SR-Avg) B-ALL [ Time Frame: 5 years ]
      Efficacy design and standard survival analysis methods used to detect improvement in post-Consolidation DFS due to the addition of 2 cycles of blinatumomab to standard therapy in patients with SR B-ALL and higher risk features, and patients with SR-Avg B-ALL who are negative for minimal residual disease (MRD) by flow cytometry but have detectable or indeterminate MRD as measured by high-throughput sequencing (HTS) at end of induction (EOI), and patients with double trisomy of chromosomes 4 and 10 (DT) with MRD (flow) 0.01% - <0.1%.

    2. DFS in boys in the SR-favorable subset of SR B-ALL [ Time Frame: 5 years ]
      Time from end of consolidation to first event (relapse, second malignant neoplasm, remission, death) or censored at date of last contact for those who are disease-free.


    Secondary Outcome Measures :
    1. DFS for patients with SR-Avg B-ALL who are negative for MRD measured by flow cytometry and HTS at EOI when treated with standard chemotherapy with a treatment duration of 2 years from the start of interim maintenance (IM)1, regardless of sex [ Time Frame: 5 years ]
      Time from end of consolidation to first event (relapse, second malignant neoplasm, remission, death) or censored at date of last contact for those who are disease-free.

    2. DFS for patients with standard-risk favorable (SR-Fav) B-ALL [ Time Frame: 5 years ]
      Time from end of consolidation to first event (relapse, second malignant neoplasm, remission, death) or censored at date of last contact for those who are disease-free.

    3. Treatment-related mortality in Down syndrome high risk (DS-high) patients after replacement of intensive elements of standard chemotherapy (omission of anthracyclines in induction, omission of the second month of DI) with 3 cycles of blinatumomab [ Time Frame: 5 years ]
    4. DFS of DS-High B-ALL patients when intensive elements of chemotherapy are replaced with 3 cycles of blinatumomab [ Time Frame: 5 years ]
      Time from end of consolidation to first event (relapse, second malignant neoplasm, remission, death) or censored at date of last contact for those who are disease-free.

    5. DFS of patients with localized B-lymphoblastic lymphoma receiving standard risk acute lymphoblastic leukemia therapy [ Time Frame: 5 years ]
      Time from end of consolidation to first event (relapse, second malignant neoplasm, remission, death) or censored at date of last contact for those who are disease-free.

    6. Neurocognitive functioning [ Time Frame: Baseline to 2 years after IM1 ]
      Compare the change in neurocognitive functioning, as measured by the CogState Cognitive Composite, from baseline to end-of-therapy among patients with ALL ages 4-< 10 years at the time of diagnosis between children from poor families (defined as presence of household material hardship (HMH), including either food, housing or energy insecurity) and non-poor families (absence of HMH).

    7. Caregiver burden and patient/proxy-reported symptoms among those enrolled in HMH [ Time Frame: Baseline to 2 years after IM1 ]
      Compare the demands and work limitations on caregivers of children with ALL receiving chemotherapy versus chemotherapy with the addition of blinatumomab and to compare the change in the demands and work limitations over time, measured by the Care of My Child with Cancer questionnaire and the Caregiver Work Limitations questionnaire during post-Induction therapy. Patient/proxy reported symptoms measured by Memorial Symptom Assessment Scale.


    Other Outcome Measures:
    1. Adaptive and innate immune functions and host genetic factors associated with severe infectious complications in children with DS B-ALL [ Time Frame: 5 years ]
      FlowSom high resolution clustering approach to identify cellular subsets and/or activation states (endophenotypes) that distinguish cases from controls. Conduct a genome-wide assessment using a case-control approach comparing those who develop grade 4-5 microbiologically documented infections (cases) compared to those who do not (controls).

    2. Neurocognitive, functional, and quality of life outcomes in patients with DS and ALL [ Time Frame: 5 years ]
      Measured by caregiver (parent/legal guardian) questionnaires.

    3. Prevalence of minimal marrow disease (MMD) in B-LLy [ Time Frame: 5 years ]
      Correlate MMD at diagnosis with outcome in patients with B-LLy.

    TRIAL NUMBER: S1608

    Title: RANDOMIZED PHASE II TRIAL IN EARLY RELAPSING OR REFRACTORY FOLLICULAR LYMPHOMA

    Purpose: Primary Outcome Measures: Complete response (CR) [ Time Frame: Up to 6 courses ] Will be assessed.

    Secondary Outcome Measures: Duration of response (complete response, partial response) [ Time Frame: Up to 5 years ] Will be calculated using the method of Kaplan-Meier.
    Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 5 years ] Toxicity rates can be estimated to within at least ± 15% with 95% confidence.
    M7-LIPI model validation [ Time Frame: Up to 5 years ] The Cox proportional hazards model will be used to assess the association of the m7-FLIPI with to PFS.
    Non-invasive genotyping and circulating tumor deoxyribonucleic acid (DNA) assessment [ Time Frame: Up to 5 years ] Sensitivity, specificity, positive predictive value, negative predictive value, and kappa coefficient will be used to evaluate the concordance. Will evaluate the association of detection of active lymphoma by positron emission tomography-computed tomography and the detection of circulating tumor DNA in plasma at baseline, after 6 and 12 cycles, and at 30 months after initiation of study therapy. Chi-square test will be used to evaluate the association and odds ratio will be calculated.
    Overall survival [ Time Frame: Up to 5 years ] Will be calculated using the method of Kaplan-Meier. 95% confidence for the survival estimates will be constructed using the method of Brookmeyer-Crowley. With 45 eligible patients in each arm, overall survival (OS) at a particular time point, and the 30-month sustained response rate can be estimated to within at least ± 15% with 95% confidence
    Progression-free survival [ Time Frame: From date of registration to date of first observation of progressive disease, or death due to any cause, assessed up to 5 years ] Will be calculated using the method of Kaplan-Meier. 95% confidence for the survival estimates will be constructed using the method of Brookmeyer-Crowley. With 45 eligible patients in each arm, progression free survival (PFS) at a particular time point, and the 30-month sustained response rate can be estimated to within at least ± 15% with 95% confidence

    Estimated Enrollment: 150 Actual Study Start Date: August 10, 2017 Estimated Study Completion Date: December 31, 2022 Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

    TRIAL NUMBER: EA6134

    Title: A Randomized Phase III Trial of Dabrafenib + Trametinib Followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab Followed by Dabrafenib + Trametinib at Progression in Patients With Advanced BRAFV600 Mutant Melanoma

    Purpose: This randomized phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III-IV melanoma that contains a mutation known as v-raf murine sarcoma viral oncogene homolog B V600 (BRAFV600) and cannot be removed by surgery. Ipilimumab and nivolumab may block tumor growth by targeting certain cells. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.

    TRIAL NUMBER: S1801

    Title: A PHASE II RANDOMIZED STUDY OF ADJUVANT VERSUS NEOADJUVANT MK-3475 (PEMBROLIZUMAB) FOR CLINICALLY DETECTABLE STAGE III-IV HIGH RISK MELANOMA

    Purpose: Primary Outcome Measures : Event-free survival (EFS) in patients with high-risk resectable melanoma randomized to neoadjuvant pembrolizumab with patients randomized to adjuvant pembrolizumab [ Time Frame: Date of randomization to date of first progression or death assessed up to 10 years ] We will use exponential-mixture cure models to describe EFS patterns in the arms.

    Secondary Outcome Measures : Overall survival (OS) [ Time Frame: Up to 10 years ] Will be estimated using the Kaplan-Meier method and compared between arms using log-rank tests and Cox regression models.
    Disease control [ Time Frame: At 24 weeks ] Will be estimated using the Kaplan-Meier method and compared between arms using log-rank tests and Cox regression models.
    Local/regional control in the surgical site(s) [ Time Frame: Up to 10 years ] Will be estimated using the Kaplan-Meier method and compared between arms using log-rank tests and Cox regression models.
    Total number of pembrolizumab doses [ Time Frame: Up to 10 years ] Will use Fisher's exact test to compare the number of pembrolizumab doses received by patients on each treatment arm.
    Pathologic response rate [ Time Frame: Up to 10 years ] Will be tabulated for the neoadjuvant arm and exact 95% confidence intervals will be constructed.
    Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 response rate [ Time Frame: Up to 10 years ] Will be tabulated for the neoadjuvant arm and exact 95% confidence intervals will be constructed.
    Immune-related (i)RECIST response rate [ Time Frame: Up to 10 years ] Will be tabulated for the neoadjuvant arm and exact 95% confidence intervals will be constructed.

    TRIAL NUMBER: A031102

    Title: A RANDOMIZED PHASE III TRIAL COMPARING CONVENTIONAL-DOSE CHEMOTHERAPY USING PACLITAXEL, IFOSFAMIDE, AND CISPLATIN (TIP) WITH HIGH-DOSE CHEMOTHERAPY USING MOBILIZING PACLITAXEL PLUS IFOSFAMIDE FOLLOWED BY HIGH-DOSE CARBOPLATIN AND ETOPOSIDE (TI-CE) AS FIRST SALVAGE TREATMENT IN RELAPSED OR REFRACTORY GERM CELL TUMORS

    Purpose: The study is an international collaboration with European sites. Collaborators on the study include the National Cancer Institute, the European Organization for Research and Treatment of Cancer and the Movember Foundation. Randomization will be stratified by region (North America and Europe) and by modified IPFSG (International Prognostic Factor Study Group) risk classification (low, intermediate and high). The primary and secondary objectives are described below.
    Primary Objective:
    1. To compare the overall survival in patients treated with conventional-dose chemotherapy using the TIP regimen with high-dose chemotherapy (HDCT) plus autologous stem cell transplant (ASCT) using the TI-CE regimen as initial salvage treatment of patients with relapsed or refractory germ cell tumors (GCT)
    Secondary Objectives: 1.To compare the progression-free survival (PFS) of patients treated with initial salvage HDCT with TI-CE versus initial salvage CDCT with TIP 2.To compare the favorable response rate (FRR) of patients treated with initial salvage HDCT with TI-CE versus initial salvage CDCT with TIP 3.To compare the toxicity, including treatment-related mortality, associated with high-dose chemotherapy and ASCT using TI-CE compared with conventional-dose chemotherapy using TIP as initial salvage treatment for patients with relapsed or refractory GCT 4.To prospectively evaluate the IPFSG scoring system as a predictor of outcome to initial salvage therapy in patients with relapsed or refractory GCT. In this trial, randomization will be stratified by a modification of their IPFSG category and we will prospectively evaluate whether or not actual outcomes vary by risk group in the appropriate manner (low risk patients have higher OS than high-risk group). 5.To evaluate the association between tumor marker decline rates of Alpha-Fetoprotein (AFP) and Human Chorionic Gonadotropin (HCG) with OS and PFS.
    Treatment is to continue until disease progression, unacceptable toxicity or completion of all protocol treatment.

    TRIAL NUMBER: ABTR04B1

    Title: ESTABLISHING CONTINUOUS CELL LINES AND XENOGRAFTS FROM PEDIATRIC CANCERS FOR BIOLOGICAL AND PRE-CLINICAL THERAPEUTIC STUDIES

    Purpose: OBJECTIVES: ?Establish and bank cell lines and/or xenografts from pediatric patients with cancer. ?Establish continuous cell lines, under carefully controlled conditions, from pediatric patients with cancer. ?Establish transplantable xenografts in immunocompromised mice from tumor cells that are difficult to establish as continuous cell lines in vitro. ?Create a bank of cell lines and generate sufficient vials of cryopreserved cells for distribution to investigators with approved COG biology protocols. ?Characterize cell lines from childhood cancers with respect to DNA short tandem repeat molecular profile as a "fingerprint" of original cell line identity. ?Characterize cell lines for the ability for sustained growth in tissue culture and/or as mouse xenografts. ?Characterize cell lines for mycoplasma contamination. ?Characterize cell lines for expression of molecular makers that confirm the tumor-type of the cell line and the immortal nature of the cells (telomerase) and the expression of molecular markers that may correlate with drug resistance.
    OUTLINE: This is a multicenter study. Specimens are stratified according to disease (acute lymphoblastic leukemia vs acute myeloid leukemia vs lymphoma vs osteogenic sarcoma vs Ewing family of tumors vs rhabdomyosarcoma vs primitive neuroectodermal tumor vs glioma vs astrocytoma vs rhabdoid tumors vs hepatoblastoma vs retinoblastoma vs Wilms tumor vs germ cell tumors vs other diagnoses).
    Leftover tissue from diagnostic procedures and/or surgery is cryopreserved and banked. Blood and/or bone marrow are also collected and banked.
    Cell lines are established and characterized via reverse-transcriptase polymerase chain reaction and/or flow cytometry for biomarkers and by DNA fingerprinting.
    Markers to be identified may include the following: ?Neuroblastoma: tyrosine hydroxylase, protein gene product (PGP) 9.5, GD2, HLA class I, and HSAN 1.2 antigens ?Ewing family of tumors: EWS-FLI1, EWS-ERG, and PGP 9.5 ?Retinoblastoma: interphotoreceptor retinoid-binding protein ?Acute lymphoblastic leukemia: immunophenotype ?Alveolar rhabdomyosarcoma: PAX3-FKHR, PAX7-FKHR, and MyoD1 ?All cell types: telomerase expression including hTR and hTERT Mutations of TP53 gene are detected by flow cytometry and/or immunocytochemistry.
    No results of these tests are provided to the patient, the patient's physician, or the patient's medical records.
    PROJECTED ACCRUAL: A total of 500 specimens per stratum will be accrued for this study.

    TRIAL NUMBER: AGCT1532

    Title: Phase 3 Accelerated BEP Trial: A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours

    Purpose: The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumours.
    Bleomycin, Etoposide, Cisplatin (BEP) administered 3-weekly x 4 remains standard 1st line chemotherapy for intermediate- and poor-risk metastatic germ cell tumours (GCTs). Cure rates are over 90% for good-risk disease, 85% with intermediate-risk, and about 70% for poor-risk disease. Previous strategies to improve first-line chemotherapy have failed to improve cure rates and were more toxic than BEP. New strategies are needed for patients with intermediate and poor-risk disease. BEP is accelerated by cycling Cisplatin and etoposide 2-weekly instead of 3-weekly. The Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) is conducting a trial comparing accelerated BEP with standard BEP. The aim of this study is to determine if accelerated BEP is superior to standard BEP as first-line chemotherapy for intermediate and poor risk metastatic GCTs.

    TRIAL NUMBER: ALTE05N1

    Title: Umbrella Long-Term Follow-Up Protocol

    Purpose: OBJECTIVES:
    ?To develop a mechanism for tracking and retaining patients enrolled on COG protocols. ?To maintain regular, lifetime contact with patients in order to obtain current identification and contact information, and self/parent-reported health status. ?To locate patients who are lost-to-follow-up for COG (or Legacy Group) protocols targeted for follow-up by the Long-Term Follow-Up Center (LTFC). ?To provide current patient contact information and self/parent-reported health status updates to the COG Statistics and Data Center (SDC) and to each patient's COG institution. ?To facilitate collection of protocol-specific outcome data through collaboration with the COG Late Effects Committee, the SDC, and the member institutions. ?To collect cumulative therapeutic exposure data (via therapeutic summaries completed online by treating institutions) on patients completing active therapy. OUTLINE: This is an umbrella protocol for all long-term follow-up at COG institutions. Approximately 6 months after completion of therapy patients receive a mailed packet introducing the Long-Term Follow-Up Center (LTFC) and containing information related to their individualized, protocol-specific follow-up guidelines. Patients are asked to complete a patient response form, verify information provided in packet, update contact information, and complete a Health Status Update Form. The Health Status Update Form is a brief document including questions about current health status, disease status, and cancer therapy received since the last mailing. Patients receive protocol-specific automatic reminders, and may respond by use of postage prepaid envelopes, email, or 24-hour toll-free telephone.

    TRIAL NUMBER: APEC1621A

    Title: Pediatric MATCH: Trk Inhibitor LOXO-101 in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions

    Purpose: This phase II trial studies Trk inhibitor LOXO-101 in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that have spread to other places in the body and have come back or do not respond to treatment. Trk inhibitor LOXO-101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth

    TRIAL NUMBER: APEC1621B

    Title: Pediatric MATCH: Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations

    Purpose: This phase II trial studies how well erdafitinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have spread to other places in the body and have come back or do not respond to treatment with FGFR mutations. Erdafitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621C

    Title: Pediatric MATCH: Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations

    Purpose: This phase II trial studies how well tazemetostat works in treating patients with solid tumors, non-hodgkin lymphoma, or histiocytic disorders that have spread to other places in the body and have come back or do not respond to treatment and have EZH2, SMARCB1, or SMARCA4 gene mutations. Tazemetostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621D

    Title: Pediatric MATCH: PI3K/mTOR Inhibitor LY3023414 in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations

    Purpose: This phase II trial studies how well PI3K/mTOR inhibitor LY3023414 works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with TSC or PI3K/MTOR mutations that have spread to other places in the body and have come back or do not respond to treatment. PI3K/mTOR inhibitor LY3023414 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621E

    Title: Pediatric MATCH: Selumetinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating MAPK Pathway Mutations

    Purpose: This phase II trial studies how well selumetinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with MAPK pathway activation mutations that have spread to other places in the body and have come back or do not respond to treatment. Selumetinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621F

    Title: Pediatric MATCH: Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations

    Purpose: This phase II trial studies how well ensartinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that have come back or do not respond to treatment and have spread to other places in the body. Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621G

    Title: Pediatric MATCH: Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations

    Purpose: This phase II trial studies how well vemurafenib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with BRAF V600 mutations that have spread to other places in the body and have come back or do not respond to treatment. Vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621H

    Title: Pediatric MATCH: Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes

    Purpose: This phase II trial studies how well olaparib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with defects in deoxyribonucleic acid (DNA) damage repair genes that have spread to other places in the body and have come back or do not respond to treatment. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621SC

    Title: Pediatric MATCH: Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders

    Purpose: This screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.

    TRIAL NUMBER: EAY131

    Title: EAY131: Molecular Analysis for Therapy Choice (NCI-MATCH)

    Purpose: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

    TRIAL NUMBER: S1609

    Title: SWOG 1609: DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors Treatment with Ipilimumab and Nivolumab for Rare Cancers

    Purpose: Both Ipilimumab and Nivolumab have already been FDA-approved to treat other cancers. However, Ipilimumab and Nivolumab are investigational and not FDA-approved for use in combination in treating rare cancers or cancers of unknown primary origin.

    TRIAL NUMBER: EAA173

    Title: DARATUMUMAB TO ENHANCE THERAPEUTIC EFFECTIVENESS OF REVLIMID IN SMOLDERING MYELOMA (DETER-SMM)

    Purpose: Primary Outcome Measures :
    Overall survival (OS) [ Time Frame: From randomization to death due to any cause, or censored at date last known alive, assessed up to 15 years ] Will be estimated using the Kaplan-Meier (KM) method and compared using a stratified log-rank test. Stratified cox proportional hazards regression will produce a treatment hazard ratio estimate.
    Functional Assessment of Cancer Therapy-General (FACT-G) score [ Time Frame: Baseline to 24 cycles of treatment (each cycle is 28 days) ] A general effect size measure of half standard deviation will be used to establish the minimally important difference. Descriptive statistics (mean, standard deviation [SD], median, range) will be used to evaluate the distribution of levels and changes for the set of health-related quality of life (QOL) evaluations. Levels and changes will also be assessed graphically. Changes from baseline will be analyzed using linear mixed models based on restricted maximum likelihood estimation with covariance matrix maximizing Akaike information criteria. Models with treatment, assessment time, and treatment by assessment time interaction with and without other predictors will be fit. If there is substantial missingness, will analyze the data according to the methods described in Schluchter and Schluchter, Greene and Beck.

    Secondary Outcome Measures :
    Progression-free survival (PFS) [ Time Frame: From randomization until disease progression or death due to any cause, or censored at date of last disease evaluation, assessed up to 15 years ] Will be estimated using the KM method and compared using a stratified log-rank test. Stratified cox proportional hazards regression will produce a treatment hazard ratio estimate.
    Best response on treatment based on International Myeloma Working Group (IMWG) criteria [ Time Frame: At 12 and 24 months ] Response will be tabulated by category. Response rates of very good partial response (VGPR) or better and partial response (PR) or better will be compared using the Fisher's exact test. Ineligible patients are excluded from the analysis and unevaluable patients are counted in the denominator.
    Incidence of adverse events by worst grade and type for treated patients determined using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: Up to 28 days post-treatment ] Will monitor the toxicities experienced by all treated patients. Will compare rates of worst grade 3 or higher non-hematologic treatment-related events using the Fisher's exact test.
    Incidence of grade 3 or higher infusion-related reactions over course 1 determined based on CTCAE [ Time Frame: During cycle 1 of treatment (each cycle is 28 days) ] Will monitor the toxicities experienced by all treated patients. Will compare rates of worst grade 3 or higher non-hematologic treatment-related events using the Fisher's exact test.
    Stem cell (SC) mobilization failure [ Time Frame: After 4 to 6 cycles of treatment (each cycle is 28 days) ] Defined as not collecting a minimum of 5x10^6 CD34 cells per kilogram weight. SC mobilization and type of growth factor support will be summarized overall and by treatment arm with descriptive statistics.
    Early SC mobilization feasibility [ Time Frame: Up to 6 cycles of treatment (each cycle is 28 days) ] Defined as the proportion of patients less than 65 years of age treated for 6 courses who opt for SC mobilization. SC mobilization and type of growth factor support will be summarized overall and by treatment arm with descriptive statistics.
    Type of growth factor support [ Time Frame: During 4 to 6 cycles of treatment (each cycle is 28 days) ] SC mobilization and type of growth factor support will be summarized overall and by treatment arm with descriptive statistics.
    Change in FACT-G score [ Time Frame: From treatment end to 6 months post-treatment ] A general effect size measure of half standard deviation will be used to establish the minimally important difference. Descriptive statistics (mean, SD, median, range) will be used to evaluate the distribution of levels and changes for the set of health-related QOL evaluations. Levels and changes will also be assessed graphically. Changes from baseline will be analyzed using linear mixed models based on restricted maximum likelihood estimation with covariance matrix maximizing Akaike information criteria. Models with treatment, assessment time, and treatment by assessment time interaction with and without other predictors will be fit. If there is substantial missingness, will analyze the data according to the methods described in Schluchter and Schluchter, Greene and Beck.
    Levels of FACT-G score at each assessment time point [ Time Frame: From baseline, at 3, f7, 13, 19 cycles of treatment, and early discontinuation of treatment, assessed up to 24 cycles of treatment (each cycle is 28 days) ] A general effect size measure of half standard deviation will be used to establish the minimally important difference. Descriptive statistics (mean, SD, median, range) will be used to evaluate the distribution of levels and changes for the set of health-related QOL evaluations. Levels and changes will also be assessed graphically. Changes from baseline will be analyzed using linear mixed models based on restricted maximum likelihood estimation with covariance matrix maximizing Akaike information criteria. Models with treatment, assessment time, and treatment by assessment time interaction with and without other predictors will be fit. If there is substantial missingness, will analyze the data according to the methods described in Schluchter and Schluchter, Greene and Beck.
    Time to worsening of FACT-G [ Time Frame: From baseline until a decrease of 9 points, or censored at date of last assessment, assessed up to 6 months post-treatment ] Will be analyzed with Kaplan-Meier methods and Cox regression with the related treatment arm as the only factor. Correlation between time to worsening of symptoms with PFS and OS will be assessed with Kendall's Tau adjusted for censored observations.

    Other Outcome Measures:
    Cumulative dose calculated as the sum of all doses taken across all cycles [ Time Frame: Up to 24 months ] Cumulative dose will be calculated overall and by cycle. Data will be summarized by treatment arm with descriptive statistics and graphically over time. Patients will be classified into dichotomous groups based on a 75% relative dose intensity cutoff (< 75% versus [vs] >= 75% represents poor vs good treatment adherence). The proportion of patients with poor lenalidomide treatment adherence will be compared between arms using the Fisher's exact test. In addition, multi-variable logistic regression analysis will be conducted to identify the baseline factors associated with calculated good treatment adherence.
    Dose intensity calculated as cumulative dose received divided by treatment duration [ Time Frame: Up to 24 months ] Dose intensity will be calculated overall and by cycle. Data will be summarized by treatment arm with descriptive statistics and graphically over time. Patients will be classified into dichotomous groups based on a 75% relative dose intensity cutoff (< 75% vs >= 75% represents poor vs good treatment adherence). The proportion of patients with poor lenalidomide treatment adherence will be compared between arms using the Fisher's exact test. In addition, multi-variable logistic regression analysis will be conducted to identify the baseline factors associated with calculated good treatment adherence.
    Relative dose intensity calculated as the dose intensity divided by planned dose intensity [ Time Frame: Up to 24 months ] Dose intensity will be calculated overall and by cycle. Data will be summarized by treatment arm with descriptive statistics and graphically over time. Patients will be classified into dichotomous groups based on a 75% relative dose intensity cutoff (< 75% vs >= 75% represents poor vs good treatment adherence). The proportion of patients with poor lenalidomide treatment adherence will be compared between arms using the Fisher's exact test. In addition, multi-variable logistic regression analysis will be conducted to identify the baseline factors associated with calculated good treatment adherence.
    Duration of treatment [ Time Frame: From randomization to date off treatment, or censored at the date of last treatment, assessed up to 24 months ] Treatment duration in each arm will be estimated using Kaplan-Meier methods and compared between arms with the log-rank test.
    Time to progression [ Time Frame: From randomization to progression, or censored at date of last disease evaluation, assessed up to 15 years ] Will be estimated using the Kaplan-Meier method.
    Presence, frequency, interference, amount and/or severity of select patient reported outcomes (PRO)-CTCAEs [ Time Frame: Assessed at each treatment cycle, from cycle 1 of treatment to end of treatment, up to 24 cycles of treatment (each cycle is 28 days) ] Descriptive statistics (mean, standard deviation, median, range) will be used to summarize selected PRO-CTCAEs tabulated at each cycle overall and by arm. Will map PRO-CTCAEs with provider reported adverse events (AEs) and evaluate differences in incidence and worst severity. Items correspond to 5 attributes measured [frequency (F), severity (S), interference (I), presence/absence (P) and amount (A)] based on multiple choice questions. Response for each attribute except P which is binary is on a 5-point Likert scale with 5 indicating 'almost constantly' frequency, 'very severe' severity, 'very much' amount or 'very much' interference. An overall PRO-CTCAE score will be calculated at each time point.
    Overall PRO-CTCAE score [ Time Frame: Up to 15 years ] Defined as the sum of item scores on all symptomatic adverse events (AEs). Descriptive statistics will be used to summarize selected PRO-CTCAEs tabulated at each cycle overall and by arm. Will map PRO-CTCAEs with provider reported AEs and evaluate differences in incidence and worst severity. An overall PRO-CTCAE score will be calculated at each time point.
    Adherence Starts with Knowledge (ASK)-12 scores [ Time Frame: At 7, 13, and 19 cycles of treatment (each cycle is 28 days) ] Descriptive statistics will be used to summarize ASK-12 scores tabulated at cycles 7, 13 and 19 overall and by arm. Differences between arms will be evaluated based a t-test (or Wilcoxon rank sum test). Patients will also be classified into high versus low likelihood of medication adherence groups according to tertile distributions (lowest tertile vs second and top). Association between likelihood of medication adherence and calculated treatment adherence dichotomous groups will be evaluated in patients with both ASK-12 and treatment data at cycles 7, 13 and 19 post randomization. In addition, multivariable logistic regression analysis will be conducted to identify the baseline factors associated with low likelihood of medication adherence.
    PRO compliance rate [ Time Frame: Up to 15 years ] Defined as the proportion of patients who submit the given PRO instrument among those eligible at each time point which excludes those missing by design (due to death or disease progression, early treatment discontinuation).
    PRO completion rate [ Time Frame: Up to 15 years ] Defined as the proportion of patients who complete given PRO instrument based on the instrument's scoring system among those eligible at each time point.

    TRIAL NUMBER: ANBL1821

    Title: A PHASE 2 RANDOMIZED STUDY OF IRINOTECAN/TEMOZOLOMIDE/DINUTUXIMAB WITH OR WITHOUT EFLORNITHINE (DFMO) (IND#141913) IN CHILDREN WITH RELAPSED, REFRACTORY OR PROGRESSIVE NEUROBLASTOMA

    Purpose:

    Primary Outcome Measures :
    1. Response rate [ Time Frame: Up to the first 6 cycles of treatment ]
      Responders are defined as patients who achieve a >= minor response (MR) per the International Neuroblastoma Response Criteria (INRC) as their best overall response by the end of 6 cycles. The response rate to treatment will be calculated among all eligible patients, including placement of a 95% confidence interval on the response rate.


    Secondary Outcome Measures :
    1. Progression-free survival (PFS) [ Time Frame: Up to 5 years ]
      Kaplan-Meier method will be used to estimate progression-free survival (PFS). PFS time will be calculated from the time of randomization to the occurrence of relapse, progressive disease, or death. Patients without a PFS event will be censored at the time of last follow-up.

    2. Overall survival (OS) [ Time Frame: Up to 5 years ]
      Kaplan-Meier method will be used to estimate overall survival (OS). OS time will be calculated from the time of randomization to the occurrence of death. Patients still alive will be censored at the time of last follow-up.

    3. Incidence of adverse events >= Grade 3 (Regimen B) [ Time Frame: Up to 5 years ]
      The percentage of patients on Regimen B with at least one Grade 3 or higher toxicity will be calculated, assessed with Common Terminology Criteria for Adverse Events version 5.0.


    Other Outcome Measures:
    1. Immune and cytokine profiles [ Time Frame: Up to 6 cycles ]
      Will be assessed by exploring the relationship between response (responder versus [vs.] non-responder) after 6 cycles on Regimen B with serum cytokine levels (IL1, IL6, tumor necrosis factor [TNF]-alpha, IFN-gamma, etc.), tumor resident immune cells (natural killer [NK] cells, tumor-associated macrophages [TAMS], tumor infiltrating lymphocyte [TILS]), and critical immune cell suppressing proteins (B7H3, PDL-1) using Fisher's exact test for categorical and Wilcoxon rank-sum test for continuous factors.

    2. GD2 levels in tumor cells from bone marrow samples [ Time Frame: Up to 5 years ]
      Will be correlated with response (responder vs. non-responder) after 6 cycles using Fisher?s exact test for categorical and the Wilcoxon rank-sum test for continuous factors.

    3. Patient reported pain and opiate usage [ Time Frame: Up to 5 years ]
      The occurrence of pain on each regimen as reported by patient report and opiate use will be descriptively summarized. Descriptive and summary statistics will be used to describe the scores from the Faces Pain Scale-Revised during the dinutuximab infusion and on day 1 with irinotecan and temozolomide alone for each arm separately. Confidence intervals will be constructed for the mean and frequency estimates. The day 1 patient reported outcome data are expected to be similar between the 2 regimens, while differences during or after completion of treatment may be observed.

    TRIAL NUMBER: A191402CD

    Title: Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer

    Purpose: This randomized phase III trial studies how well decision aids work in improving knowledge in patients with newly diagnosed prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.

    TRIAL NUMBER: AREN1721

    Title: A RANDOMIZED PHASE 2 TRIAL OF AXITINIB/NIVOLUMAB COMBINATION THERAPY VS. SINGLE AGENT AXITINIB OR NIVOLUMAB FOR THE TREATMENT OF TFE/TRANSLOCATION RENAL CELL CARCINOMA (tRCC) ACROSS ALL AGE GROUPS

    Purpose:

    Primary Outcome Measures :
    1. Progression free survival [ Time Frame: From initiation of treatment assessed up to 4 years ]

    Other Outcome Measures:
    1. Translocation morphology renal cell carcinoma clinical behavior [ Time Frame: Up to 4 years ]
      Will list and summarize the frequency of site(s) of disease at presentation (including extent of lymph node involvement), site(s) of relapse, surgical practices on protocol therapy, and radiotherapy practices on protocol therapy.

    2. Type of antitumor immune response and stability of T cell activation [ Time Frame: Baseline up to 4 years ]
      Will summarize the levels of analytes and tumor expression before and after treatment and evaluate the changes due to treatment after logarithmic transformation using the paired t-test. Analytes include myeloid derived stem cells: CD45, CD11b, CD33, CD14, CD15, HLA-DR, viability, stain 1; regulatory T cells: viability, CD45, CE4, CD3, CD24, FoxP3; CD8 T cells (CD45, CD8, CD3); CD8 phenotype and activation and exhaustion (CD69, CD38, PD1, CD244, TIM3). Tumor expression of PDL-1, PD1, CD3, CD4 and CD8 will be assessed using TFE renal cell carcinoma samples from the study and scored for intensity (0 - 3).

    TRIAL NUMBER: S1400F

    Title: A PHASE II STUDY OF MEDI4736 (DURVALUMAB) PLUS TREMELIMUMAB AS THERAPY FOR PATIENTS WITH PREVIOUSLY TREATED ANTI-PD-1/PD-L1 RESISTANT STAGE IV SQUAMOUS CELL LUNG CANCER (LUNG-MAP NON-MATCH SUB-STUDY)

    Purpose: Primary Outcome Measures: Investigator-assessed progression-free survival as defined by Response Evaluation Criteria in Solid Tumors 1.1 (Design #1, Phase II) [ Time Frame: From date of sub-study registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 18 months since completion of accrual ] A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to investigator-assessed progression-free survival, comparing the two treatment arms.
    Investigator-assessed progression-free survival in patients with advanced stage refractory squamous cell carcinoma of the lung randomized to receive investigational therapy vs standard therapy (Design #2,Phase III,Option for Biomarker-driven sub-studies) [ Time Frame: Up to 3 years ] Estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median investigator-assessed progression-free survival. A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to progression free survival comparing the two treatment arms at the levels specified.
    Less than 33% improvement in median investigator-assessed progression-free survival as defined as Response Evaluation Criteria in Solid Tumors 1.1 (Design #1, Phase III) [ Time Frame: From date of sub-study registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 18 months since completion of accrual ] A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to investigator-assessed progression-free survival, comparing the two treatment arms. A Cox PH model will be used to estimate the hazard ratios and associated confidence intervals.
    Objective response rate (confirmed and unconfirmed, complete and partial) (Design #2, Phase II, Option for Biomarker-driven Sub-studies) [ Time Frame: Up to 3 years ] The investigational therapy arm will be judged to have provided sufficient evidence to proceed to the Phase III component if the objective response rate is at least 25%. Response rates and associated confidence intervals will be calculated.
    Objective response rate (confirmed and unconfirmed, complete and partial) in patients treated with investigational non-match therapy with advanced stage refractory squamous cell carcinoma of the lung (Design #2, Option for Non-Match Sub-Studies) [ Time Frame: Up to 3 years ] Response rates and associated confidence intervals will be calculated.
    Overall survival (Design #1, Phase III) [ Time Frame: From date of sub-study registration (or date of screening registration if patient never enrolls in a sub-study) to date of death due to any cause, assessed up to 3 years ] A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to overall survival, comparing the two treatment arms. A Cox PH model will be used to estimate the hazard ratios and associated confidence intervals.
    Overall survival in patients with advanced stage refractory squamous cell carcinoma of the lung randomized to receive investigational therapy versus standard therapy (Design #2, Phase III, Option for Biomarker-driven Sub-studies) [ Time Frame: Up to 3 years ] The Brookmeyer-Crowley method will be used to calculate confidence intervals for median overall survival. A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to overall survival comparing the two treatment arms at the levels specified.

    Secondary Outcome Measures: Duration of response among patients who achieve a complete response or partial response by Response Evaluation Criteria in Solid Tumors 1.1 (Design #2, Phase II, Option for Biomarker-driven Sub-studies and Design #2, Option for Non-Match Sub-studies) [ Time Frame: Up to 3 years ] Estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median duration of response.
    Frequency and severity of toxicities associated with investigational therapy versus standard therapy (Design #2, Phase III, Option for Biomarker-driven Sub-studies) [ Time Frame: Up to 3 years ] Analysis of toxicities will be performed using a chi-square or Fisher?s exact test, as appropriate.
    Investigator-assessed progression-free survival, censoring patients with symptomatic deterioration at the time of symptomatic deterioration (Design #1, Phase III) [ Time Frame: From date of sub-study registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 3 years ] Descriptive data will be presented.
    Overall survival with investigational therapy (Design #2, Phase II, Option for Biomarker-driven Sub-studies and Design #2, Option for Non-Match Sub-studies) [ Time Frame: Up to 3 years ] A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to overall survival comparing the two treatment arms at the levels specified. A Cox PH model will be used to estimate the hazard ratios and associated confidence intervals.
    Progression free survival with investigational therapy (Design #2, Phase II, Option for Biomarker-driven Sub-studies and Design #2, Option for Non-Match Sub-studies) [ Time Frame: Up to 3 years ] A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to progression free survival comparing the two treatment arms at the levels specified. A Cox PH model will be used to estimate the hazard ratios and associated confidence intervals.
    Response rate (confirmed and unconfirmed) in patients with measurable disease as defined by Response Evaluation Criteria in Solid Tumors 1.1 (Design #1, Phase II and III) [ Time Frame: Up to 3 years ] Analysis will be performed using a chi squared or Fisher?s exact test, as appropriate. Response proportions will be compared using a 1-sided Fisher?s exact test at the 0.001 level.
    Response rates (confirmed and unconfirmed, complete and partial) among patients randomized to receive investigational therapy versus standard therapy (Design #2, Phase III, Option for Biomarker-driven Sub-studies) [ Time Frame: Up to 3 years ] Analysis of response rates will be performed using a chi-square or Fisher?s exact test, as appropriate.
    Severity of toxicities associated with investigational therapy versus standard therapy (Design #2, Phase II, Option for Biomarker-driven Sub-studies and Design #2, Option for Non-Match Sub-studies) [ Time Frame: Up to 3 years ] Analysis of toxicities will be performed using a chi-square or Fisher?s exact test, as appropriate.
    Toxicity frequencies, monitored using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Design #1, Phase II and III) [ Time Frame: Up to 3 years ] Analysis will be performed using a chi squared or Fisher?s exact test, as appropriate.

    Other Outcome Measures: Screen success rate, monitored by the percentage of screened patients that register to a therapeutic sub-study [ Time Frame: Up to 3 years ] Descriptive data will be presented.
    Treatment arm randomization acceptance rate, monitored by the percentage of patients that receive at least one dose of the treatment they are randomized to (Design #1) [ Time Frame: Up to 3 years ] Descriptive data will be presented.

    Estimated Enrollment: 10000 Actual Study Start Date: June 16, 2014 Estimated Study Completion Date: April 1, 2022 Estimated Primary Completion Date: April 1, 2022 (Final data collection date for primary outcome measure)

    TRIAL NUMBER: APEC1621 (Master)

    Title: NCI-COG PEDIATRIC MATCH (MOLECULAR ANALYSIS FOR THERAPY CHOICE) MASTER VERSION CONTROL PROTOCOL

    Purpose:

    TRIAL NUMBER: APEC1621J

    Title: NCI-COG PEDIATRIC MATCH (MOLECULAR ANALYSIS FOR THERAPY CHOICE)- PHASE 2 SUBPROTOCOL OF BVD-523FB (ULIXERTINIB) IN PATIENTS WITH TUMORS HARBORING ACTIVATING MAPK PATHWAY MUTATIONS

    Purpose: Primary Outcome Measures : Objective response rate (ORR = complete response [CR] + partial response [PR]) in pediatric patients treated with BVD-523FB (ulixertinib) [ Time Frame: Up to 2 years ] Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method

    Secondary Outcome Measures : Progression free survival (PFS) in pediatric patients treated with ulixertinib [ Time Frame: From initiation of treatment to disease progression, disease recurrence, or death from any cause assessed up to 2 years ] PFS along with the confidence intervals will be estimated using the Kaplan-Meier method.
    Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events version 5.0 [ Time Frame: Up to 2 years ] Toxicity tables will be constructed to summarize the observed incidence by type of toxicity and grade. A patient will be counted only once for a given toxicity for the worst grade of that toxicity reported for that patient. Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen.
    Preliminary estimates of the pharmacokinetics of ulixertinib in children and adolescents with relapsed or refractory cancer [ Time Frame: Pre-dose and 1, 2, 4, and 6-8 hours after dose on course 1, day 1; and pre-dose on course 1, day 2, and course 1, day 15 ] Will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).

    Other Outcome Measures: Other biomarkers as predictors of response to ulixertinib and whether tumors that harbor different mutations or fusions will demonstrate differential response to treatment [ Time Frame: Up to 2 years ] Will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.
    Profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA) [ Time Frame: Up to 2 years ] Will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.

    TRIAL NUMBER: A091605

    Title: A RANDOMIZED PHASE II STUDY OF ANTI-PD1 ANTIBODY [MK-3475 (PEMBROLIZUMAB)] ALONE VERSUS ANTI-PD1 ANTIBODY PLUS STEREOTACTIC BODY RADIATION THERAPY IN ADVANCED MERKEL CELL CARCINOMA

    Purpose: This randomized phase II trial studies how well pembrolizumab with or without stereotactic body radiation therapy works in treating patients with merkel cell cancer that has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving pembrolizumab with stereotactic body radiation therapy may work better in treating patients with merkel cell cancer.

    • Ochsner Medical Center Jefferson
    • Orleans Parish
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    TRIAL NUMBER: ACNS1422

    Title: A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients

    Purpose: Primary Outcome Measures: PFS [ Time Frame: From the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 10 years ] PFS along with the confidence intervals will be estimated using the Kaplan-Meier method. PFS will also be reported based on central radiology review.

    Secondary Outcome Measures: Change in neurocognitive function (cognitive, social, emotional and behavioral) according to Children Oncology Group Standard Neuropsychological Battery [ Time Frame: Baseline to up to 60 months post-diagnosis ] Neurocognitive function will be measured at 9, 30 and 60 months post diagnosis and will be compared with the neurocognitive outcomes from an age and gender matched ACNS0331 cohort to the WNT patients treated on ACNS1422. Data for all assessments will be available as standardized t-scores. The change over time for each component of the neuropsychological testing will be estimated using the Generalized Estimating Equation (GEE) approach, with the standardized t-scores as the dependent variable and the assessment times as a covariate. Within the ACNS1422 cohort GEE models will also be used to exp
    DNA methylation profiling as real-time classification of WNT-driven medulloblastoma [ Time Frame: Within 32 days of definitive surgery ] Results will be compared to the results of the molecular screening tests. The sensitivity and specificity comparison between DNA methylation arrays and the standard methods (molecular screening tests for WNT using IHC and CTNNB1 sequencing) will be performed using McNemar's test.

    Other Outcome Measures: DNA methylation profiling of medulloblastoma real-time" predictive classification scheme for the SHH, group 3 and group 4 medulloblastoma subgroups according to the Heidelberg classifier [ Time Frame: Within 32 days of definitive surgery ] The proportion of patients classified into each medulloblastoma subgroup in "real time" will be reported.

    Estimated Enrollment: 45 Study Start Date: October 2016 Estimated Primary Completion Date: May 2025 (Final data collection date for primary outcome measure)

    TRIAL NUMBER: ANBL00B1

    Title: NEUROBLASTOMA BIOLOGY STUDIES

    Purpose:

    TRIAL NUMBER: ANBL1232

    Title: Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma; A Groupwide Historically-Controlled Phase III Study

    Purpose: PRIMARY OBJECTIVES:
    I. To eliminate therapy as the initial approach for infants < 12 months of age with small International Neuroblastoma Risk Group (INRG) stage L1 neuroblastoma while maintaining an overall survival (OS) of 99%.
    II. To eliminate therapy as the initial approach for non-high-risk patients < 18 months of age with localized neuroblastoma and favorable biology (histologic and genomic features) while maintaining an OS of 99%.
    III. To achieve a 3-year OS of > 81% for infants < 18 months of age with INRG stage Ms neuroblastoma using objective criteria for early initiation of a response-based treatment algorithm.
    IV. To achieve a 3-year event free survival (EFS) of > 70% for non-high-risk infants < 12 months of age with INRG stage M neuroblastoma and unfavorable biology (histologic and/or genomic features) through the addition of isotretinoin therapy.
    SECONDARY OBJECTIVES:
    I. To describe the time to intervention or tumor progression, type of intervention and site of progression for patients with localized neuroblastoma who experience progression after an initial period of observation.
    II. To characterize the pharmacokinetic profile of the chemotherapeutic agents carboplatin and etoposide in patients with stage Ms disease.
    III. To define the genomic profile of tumors from patients with non-high-risk neuroblastoma both at initial biopsy and at the time of subsequent biopsy or surgical resection.
    IV. To describe the histology of tumor specimens obtained at the time of subsequent biopsy or surgical resection.
    V. To determine the salvage rate (OS) of patients with tumor relapse or disease progression.
    VI. To determine the procedural complication rate (initial biopsy, resection [intraoperative and postoperative], subsequent biopsy) and correlate with the degree of surgical resection.
    VII. To determine the rate of reduction in image defined risk factors (IDRF) in L2 tumors following observation or chemotherapy.
    VIII. To describe bone abnormalities on bilateral tibial radiographs obtained before and after isotretinoin therapy.
    IX. To determine the variability of isotretinoin pharmacokinetics and relationship to pharmacogenomic parameters and determine if these levels and/or genetic variations correlate with EFS or systemic toxicity.
    OUTLINE: Patients are assigned to 1 of 4 treatment groups.
    GROUP A: Patients undergo clinical observation for 96 weeks.
    GROUP B: Patients undergo clinical observation for 3 years in the absence of disease progression. Upon disease progression, patients undergo surgery or receive first-line chemotherapy comprising carboplatin intravenously (IV) over 1 hour on day 1 (courses 1, 2, 4, 6, and 7), etoposide IV over 1 hour on days 1-3 (courses 1, 3, 4, 5, and 7), cyclophosphamide IV over 1 hour on day 1 (courses 2, 3, 5, 6, and 8), and doxorubicin hydrochloride IV over 15 minutes on day 1 (courses 2, 4, 6 and 8). Treatment with chemotherapy repeats every 21 days for 2-8 courses in the absence of disease progression or unacceptable toxicity. Once a partial response (PR) or better is achieved, patients undergo clinical observation for 3 years.
    GROUP C: Patients at high risk for deterioration and a poor outcome immediately receive first-line chemotherapy as in Group B. All other patients undergo clinical observation for 3 years in the absence of disease progression. Upon disease progression, patients receive first-line chemotherapy as in Group B. Once a PR or better is achieved, patients undergo clinical observation for 3 years.
    GROUP D: Patients receive first-line chemotherapy as in Group B. Patients who achieve a complete response (CR) or very good partial response (VGPR) following first-line chemotherapy receive isotretinoin orally (PO) twice daily (BID) on days 1-14. Treatment with isotretinoin repeats every 28 days for 6 courses. Patients then undergo clinical observation for 3 years. Patients who achieve a PR or stable disease (SD) following first-line chemotherapy receive salvage chemotherapy comprising cyclophosphamide IV over 30 minutes and topotecan hydrochloride IV over 30 minutes on days 1-5. Treatment with salvage chemotherapy repeats every 21 days for 2-6 courses. Patients then receive isotretinoin PO BID on days 1-14. Treatment with isotretinoin repeats every 28 days for 6 courses. Patients then undergo clinical observation for 3 years.
    After completion of study treatment, patients are followed up annually for 5 years.

    TRIAL NUMBER: A011202

    Title: A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (CT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy

    Purpose: Study Outline: All patients will undergo surgery to identify sentinel lymph node(s). If a lymph node (sentinel or non-sentinel) is determined to be positive on intra-operative pathology the patient will be registered/randomized intra-operatively. Patients who do not have a sentinel lymph node identified will not be registered/randomized to the study. Patients whose sentinel lymph node status is cannot be/is not determined intra- operatively, and have not undergone ALND, but had at least one lymph node (sentinel or non-sentinel) found to be positive on final pathology review will be registered/randomized post-operatively. Patients whose sentinel lymph node status is found to be negative intra-operatively and have not undergone ALND, but had at least one lymph node (sentinel or non-sentinel) found to be positive on final pathology review will be registered/randomized post-operatively. ALND is not to be performed prior to registration/randomization. Patients who are determined to have negative lymph nodes on final pathology will not be registered/randomized, but can be offered participation in another cooperative group trial. The primary and secondary objectives of the study are described below. Please see the "Arms" section for a detailed description of the treatment regimens. Primary Objective: To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive SLN(s) after completion of neoadjuvant chemotherapy Secondary Objectives: To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of the incidence of invasive loco-regional recurrences in patients with a positive SLN(s) after completion of neoadjuvant chemotherapy To obtain an estimate of the distribution of residual disease burden scores for each treatment arm To estimate the distribution of overall survival for each treatment arm Patients may receive adjuvant and ancillary therapy as appropriate per the protocol. Adjuvant Therapy: Adjuvant endocrine therapy: Patients with hormone receptor (ER and/or PR) positive disease should receive a minimum of 5 years of standard endocrine therapy (experimental agents/regimens are not permitted). Endocrine therapy should begin following completion of neoadjuvant chemotherapy and surgery, either before, during or after radiation therapy at the discretion of the oncologist. Selection of the agents is at the treating physician's discretion. Patients with HER 2 positive disease should complete a total of one year of trastuzumab therapy (over the neoadjuvant and adjuvant period). Chemotherapy, biologic therapy or vaccine therapy in the adjuvant setting is not allowed. Patients who wish to receive any of these therapies after surgery must go off study at the time of their initiation. Ancillary Therapy: Patients should receive full supportive care, including transfusions of blood and blood products, erythropoetin (unless otherwise specified in the protocol), antibiotics, antiemetics, etc. when appropriate. Patients are followed up for 5 years after completion of radiation therapy.

    TRIAL NUMBER: A221505

    Title: PHASE III RANDOMIZED TRIAL OF HYPOFRACTIONATED POST MASTECTOMY RADIATION WITH BREAST RECONSTRUCTION

    Purpose: 2.1 Primary Objective To evaluate whether the reconstruction complication rate at 24 months post radiation is non-inferior with hypofractionation. Complications will include those listed in Section 10.1. 2.2 Secondary Objectives 2.2.1 To evaluate the incidence of acute and late radiation complications based on CTCAE 4.0 toxicity. 2.2.2 To evaluate the local and local regional recurrence rate. 2.2.3 To compare reconstruction complication rates based on reconstruction method (autologous +/- implant vs implant only) and timing of reconstruction received (immediate vs. intent for delayed).

    TRIAL NUMBER: EA1131

    Title: A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Observation in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy

    Purpose: The purpose of this study is to compare the IDFS in TNBC patients with residual basal-like disease after neoadjuvant chemotherapy who are randomized to post-preoperative platinum based chemotherapy with those who are randomized to observation. At present, upon completion of neoadjuvant therapy, the standard of care for patients with TNBC (who have no clinical evidence of metastatic disease after surgical excision of the cancer regardless of burden of residual disease) is observation, since there is no additional therapies available with proven impact. This study could provide a possible alternative treatment, which makes it appropriate for the population.

    TRIAL NUMBER: NRG-BR003

    Title: A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel With or Without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

    Purpose: This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.

    TRIAL NUMBER: NSABP B-51

    Title: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

    Purpose: This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer

    TRIAL NUMBER: S1418

    Title: A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer With ? 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy

    Purpose: This randomized phase III trial studies how well pembrolizumab works in treating triple-negative breast cancer. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

    TRIAL NUMBER: S1501

    Title: PROSPECTIVE EVALUATION OF CARVEDILOL IN PREVENTION OF CARDIAC TOXICITY IN PATIENTS WITH METASTATIC HER-2+ BREAST CANCER, PHASE III

    Purpose: Primary Objective To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy. Secondary Objectives a. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of predefined subsequent cardiac events in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy. b. To evaluate if prophylactic carvedilol compared with no intervention results in a longer time to first interruption of trastuzumab?based HER-2 targeted therapy due to either cardiac dysfunction or events. c. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction OR events in this population. d. To establish and prospectively collect a predefined panel of baseline core cardiovascular measures and develop a predictive model of cardiac dysfunction (see Section 11.2). e. To evaluate the rate of cardiac dysfunction in an observational arm consisting of individuals otherwise eligible for the study except for use of beta blockers, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitors for other medical reasons.

    TRIAL NUMBER: ALTE11C2

    Title: HEALTH EFFECTS AFTER ANTHRACYCLINE AND RADIATION THERAPY (HEART): DEXRAZOXANE AND PREVENTION OF ANTHRACYCLINE-RELATED CARDIOMYOPATHY

    Purpose: Given the critical role anthracyclines have in many effective cancer treatments and the risk for subsequent cardiotoxicity associated with this class of agents, development of an effective cardioprotective strategy is of great importance. Although adult studies have shown that dexrazoxane (DRZ) is effective in minimizing cardiomyopathy/heart failure (CHF) after anthracycline therapy, short and long-term data in children are much more limited. Furthermore, concerns regarding DRZ's interaction with cancer therapies and possible association with an increased risk of second cancers have limited its use among children despite possible protection against premature CHF. To address these gaps in knowledge, using a cross-sectional study design, we propose to ascertain echocardiographic and serum biomarkers of cardiac injury in a cohort of long-term pediatric T-cell leukemia and Hodgkin lymphoma survivors enrolled on 3 front-line Children's Oncology Group (COG) clinical trials (POG 9404, 9425, 9426) between 1996-2001 that featured upfront DRZ randomization and a range of anthracycline exposures commonly used in contemporary therapy (100-360 mg/m2 doxorubicin). Our primary aim will be to determine whether patients randomized to the experimental DRZ arms have decreased markers of myocardial injury compared with patients treated without DRZ. Specifically, this will include a one-time measurement of an echocardiographic index of pathologic left ventricular (LV) remodeling (wall thickness-dimension ratio), complemented by serum biomarkers and a physical examination for signs and symptoms of CHF. We will also evaluate whether DRZ's cardioprotective effect is modified by anthracycline dose, chest radiation, and selected demographic factors (age at cancer diagnosis, current age, sex). In secondary analysis, we will also update the overall- and event-free survival rates between patients on the DRZ and non-DRZ arms. Finally, we will determine whether projected quality-adjusted life years differed by randomization status, accounting for premature cardiac disease, primary disease relapse, and second cancers.

    TRIAL NUMBER: DCP-001

    Title: DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)

    Purpose: The protocol is not a scientific study; rather, a method to implement the screening tool and allow the collection and analyses of expanded data with informed consent. Investigators also enroll patients into NCI-treatment trials. The tool, based on a screening log successfully used within the NCI Community Cancer Centers Program (NCCCP), has been streamlined and integrated into the sites’ workflow by using OPEN. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. Also missing from the existing data is the context of care, within the communities themselves where most cancer and at risk of cancer patients receive care which is the focus of NCORP. The profile of patients accrued to NCI-sponsored clinical trials lacks both racial/ethnic and socioeconomic diversity. Accrued patients tend to be insured, highly educated and of higher socioeconomic means. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. NCORP's clinical trials portfolio includes cancer control, prevention, screening, symptom science, and cancer care delivery research.

    TRIAL NUMBER: WF-10217

    Title: Work Ability in Young Adult Survivors (WAYS)

    Purpose: Brief Summary: To document levels of labor force participation, occupation, educational attainment, and financial toxicity following cancer treatment in YA cancer survivors aged 25-34 years.
    Detailed Description: This observational, cross-sectional study will recruit 200 YA survivors through the Wake Forest National Cancer Institute Community Oncology Research Program (NCORP) Research Base (WF NCORP RB). Data will be collected using a web-based interface and will capture physical, psychosocial and cognitive late effects; work ability; work-related outcomes, including labor force participation, occupation, work place characteristics, and educational attainment; survivor characteristics; and cancer diagnosis/treatment information (from clinical records). We will evaluate the relationships among these measures using the theoretical framework to guide statistical analysis.

    TRIAL NUMBER: A021502

    Title: Randomized Trial of Standard Chemotherapy Alone or Combined With Atezolizumab as Adjuvant Therapy for Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair

    Purpose: This randomized phase III trial studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy with atezolizumab may work better than combination chemotherapy alone in treating patients with colon cancer.

    TRIAL NUMBER: EA2174

    Title: A PHASE II/III STUDY OF PERI-OPERATIVE NIVOLUMAB AND IPILIMUMAB IN PATIENTS WITH LOCOREGIONAL ESOPHAGEAL AND GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA

    Purpose: Primary Outcome Measures : Pathologic complete response (Step I) [ Time Frame: Up to 5 weeks ] The study with compare the pathologic complete response of Arm A and Arm B using a one-sided 0.10 level chi-squared test for proportions.
    Disease-free survival (DFS) (Step 2) [ Time Frame: From the adjuvant treatment randomization assessed for up to 7 years ] DFS measured from the adjuvant treatment randomization will be the endpoint of the adjuvant portion of the study and to achieve the desired power it is expected that patients will be followed for an additional year post completion of accrual to the adjuvant portion. The DFS comparison will be between patients randomized to Arm C (nivolumab) versus Arm D (nivolumab plus ipilimumab) using a one-sided 0.10 level stratified log rank test.

    Secondary Outcome Measures : Incidence of adverse events [ Time Frame: Up to 7 years ] Graded according to Common Terminology Criteria for Adverse Events version 5.0. Toxicity will be evaluated among all treated patients regardless of eligibility and interim analyses of toxicity are performed twice yearly. The study will have sufficient precision to provide 95% confidence intervals on toxicity
    Overall survival [ Time Frame: From the time of first randomization up to 7 years ] Analyses will be descriptive in nature and will not follow any formal interim monitoring.
    DFS [ Time Frame: From the time of first randomization up to 7 years ] The DFS comparison will be between patients randomized to Arm C (nivolumab) versus Arm D (nivolumab plus ipilimumab) using a one-sided 0.10 level stratified log rank test.

    Other Outcome Measures: Percent change in mean volumetric apparent diffusion coefficient (ADC) [ Time Frame: Baseline to mid-treatment ] The study will assess the area under the receiver operating characteristic curve of the changes of apparent diffusion coefficient (ADC) value.

    TRIAL NUMBER: S0820

    Title: A DOUBLE BLIND PLACEBO-CONTROLLED TRIAL OF EFLORNITHINE AND SULINDAC TO PREVENT RECURRENCE OF HIGH RISK ADENOMAS AND SECOND PRIMARY COLORECTAL CANCERS IN PATIENTS WITH STAGE 0-III COLON CANCER, PHASE III

    Purpose: The purpose of this study is to assess whether eflornithine 500 mg or sulindac 150 mg are effective in reducing the 3-year event rate of high risk adenoma or second primary colorectal cancer in Stage 0, I II and III colon cancer patients. The primary hypothesis will test the main effect of each agent, as well as the comparison of placebo alone to the combination of sulindac and eflornithine.

    TRIAL NUMBER: NRG-GY006

    Title: A Randomized Phase II Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer

    Purpose: This randomized phase II trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal cancer.

    TRIAL NUMBER: A041701

    Title: A Randomized Phase II/III Study of Conventional Chemotherapy +/- Uproleselan (GMI-1271) in Older Adults With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy

    Purpose: This phase II/III trial studies how well daunorubicin and cytarabine with or without uproleselan works in treating older adult patients with acute myeloid leukemia receiving intensive induction chemotherapy. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Uproleselan may prevent cancer from returning or getting worse. Giving daunorubicin and cytarabine with uproleselan may work better in treating patients with acute myeloid leukemia compared to daunorubicin and cytarabine alone.

    TRIAL NUMBER: R1008

    Title: A RANDOMIZED PHASE II STUDY OF ADJUVANT CONCURRENT RADIATION AND CHEMOTHERAPY VERSUS RADIATION ALONE IN RESECTED HIGH-RISK MALIGNANT SALIVARY GLAND TUMORS

    Purpose: OBJECTIVES:
    Primary ?Determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors. ?Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin.
    Secondary ?Compare the acute toxicities of these 2 adjuvant treatments. ?Compare long-term efficacy results at 5 years and late treatment-related adverse events in patients receiving postoperative radiation to those receiving concurrent chemoradiation. ?Investigate quality of life and patient-reported outcomes in patients enrolled in the study. ?Identify the histopathology and tumor marker expression from patients enrolled on this trial and assemble a tissue bank for future correlative studies. ?Establish a Radiation Therapy Oncology Group (RTOG) baseline database for salivary gland malignancies to serve as a resource for future exploration of innovative and/or targeted approaches for this disease.
    OUTLINE: This is a multicenter study. Patients are stratified according to histology (high-grade mucoepidermoid carcinoma vs salivary duct carcinoma vs high-grade adenocarcinoma) and nodal status (N0 vs N1-3). Patients are randomized to 1 of 2 treatment arms. ?Arm I: Patients undergo 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) 5 days a week for 6-6.5 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiotherapy. ?Arm II: Patients undergo 3D-CRT or IMRT as in arm I. Tissue and blood samples may be collected for translational research studies. Patients may complete quality-of-life assessments periodically.
    After completion of study treatment, patients are followed up at 3, 6, 9, 12, and 24 months, every 6 months for 2 years, and then annually thereafter.

    TRIAL NUMBER: RTOG-1008

    Title: A RANDOMIZED PHASE II/PHASE III STUDY OF ADJUVANT CONCURRENT RADIATION AND CHEMOTHERAPY VERSUS RADIATION ALONE IN RESECTED HIGH-RISK MALIGNANT SALIVARY GLAND TUMORS

    Purpose:

    Primary Outcome Measures :
    1. Progression-free survival (PFS), defined by the events of local-regional progression or recurrence, distant metastasis, or death from any cause, primarily at 2 years [ Time Frame: From randomization to 2 years. ]

    Secondary Outcome Measures :
    1. Overall survival (OS) rate at 2 years [ Time Frame: From randomization to 2 years. ]
    2. PFS rate at 5 years [ Time Frame: From randomization to 5 years. ]
    3. OS rate at 5 years [ Time Frame: From randomization to 5 years. ]
    4. Treatment-related toxicity, defined as any grade 3-4 adverse events (CTCAE v. 4) deemed to be definitely, probably, or possibly related to protocol treatment [ Time Frame: From start of treatment to last follow-up. ]
    5. Treatment-related mortality, defined as any death during or within 30 days of discontinuation of protocol treatment [ Time Frame: From start of treatment to 30 days after the end of treatment. ]
    6. Chemotherapy delivery as measured by percentage of protocol prescription given [ Time Frame: From start of treatment to end of treatment. ]
    7. Radiation delivery as measured by elapsed treatment days [ Time Frame: From start of treatment to end of treatment. ]
    8. Determine whether quality of life, fatigue and xerostomia differ as a function of treatment assignment at 3, 12, and 24 months after completing radiotherapy. [ Time Frame: From randomization to 2 years. ]

    TRIAL NUMBER: APEC14B1

    Title: Project: Every Child for Younger Patients With Cancer

    Purpose: This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

    TRIAL NUMBER: ARST1431

    Title: COG ARST1431, A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating with Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864, IND# 122782) in Patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS)

    Purpose: ARST1431, states that Unfortunately about 25% of patients with intermediate-risk (IR) embryonal rhabdomyosarcoma (ERMS) and 50% of those with IR alveolar rhabdomyosarcoma (ARMS) will experience disease recurrence with a resulting long-term event-free survival (EFS) of 65%. The mTOR pathway is important in RMS biology, and temsirolimus (TORI), an mTOR inhibitor, has demonstrated clinical activity in patients with relapsed RMS. In an attempt to improve long-term survival for patients with IR RMS, ARST1431 will compare the EFS of patients with newly diagnosed IR RMS randomly assigned to standard vincristine, dactinomycin, and cyclophosphamide (VAC) alternating with vincristine and irinotecan (VI) versus VAC/VI plus TORI. Radiotherapy will start at Week 13 of therapy for all patients. Correlative biology studies will be performed including a determination of the FOXO1 gene fusion status in the tumor and impact on patient outcome. Children’s Hospital/LSUHSC-NO sees several diagnosed patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS), We estimate seeing up to 5-10 patients per year.

    TRIAL NUMBER: COG-AALL1331

    Title: Risk-Stratified Randomized Phase III Testing of Blinatumomab (IND #117467, NSC #765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL): A Groupwide Phase III Study

    Purpose: PRIMARY OBJECTIVES:
    I. To compare disease free survival (DFS) of high-risk (HR) and intermediate-risk (IR) relapse B-cell acute lymphoblastic leukemia (B-ALL) patients who are randomized following induction block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR randomization).
    II. To compare the DFS of low risk (LR) relapse B-ALL patients who are randomized following block 2 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR randomization).
    SECONDARY OBJECTIVES:
    I. To compare overall survival (OS) of HR and IR relapse B-ALL patients who are randomized following induction block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR randomization).
    II. To compare OS of LR relapse B-ALL patients who are randomized following block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR randomization).
    TERTIARY OBJECTIVES:
    I. To compare the rates of minimal residual disease (MRD) >= 0.01% at the end of block 2 and block 3 for HR and IR relapse B-ALL patients in HR/IR randomization.
    II. To estimate, for treatment failure (TF) patients not previously receiving blinatumomab, the hematologic complete remission rate (CR), rate of MRD < 0.01%, and proportion able to proceed to hematopoietic stem cell transplant (HSCT) in CR after treatment with blinatumomab.
    III. To assess the feasibility and safety of rapid taper of immune suppression for the subset of HSCT patients with MRD >= 0.01% pre- and/or post-HSCT with no acute graft versus host disease (aGVHD).
    OUTLINE:
    All patients receive Block 1 over 4 weeks.
    BLOCK 1: Patients receive dexamethasone orally (PO) twice daily (BID) or intravenously (IV) on days 1-5 and 15-19; vincristine sulfate IV over 1 minute on days 1, 8, 15, and 22; pegaspargase IV over 1-2 hours on days 3 and 17; and mitoxantrone hydrochloride IV over 15-30 minutes on days 1-2. Patients with central nervous system (CNS) 1 or CNS2 also receive methotrexate intrathecally (IT) on days 1 and 8. Patients with CNS3 or isolated CNS relapse also receive methotrexate IT, hydrocortisone IT, and cytarabine IT on days 1, 8, 15, and 22. High risk and intermediate risk patients are then assigned to randomization R1. Low risk patients are assigned to randomization R2.
    RANDOMIZATION R1 (HR and IR patients): Patients are randomized to 1 of 2 treatment arms.
    ARM A: Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, and then undergo allogeneic HSCT.
    ARM B: Patients receive Blinatumomab Block 1 over 5 weeks, Blinatumomab Block 2 over 5 weeks, and then undergo allogeneic HSCT.
    RANDOMIZATION R2 (LR patients): Patients are then randomized to 1 of 2 treatment arms.
    ARM C: Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, Continuation 1 over 8 weeks, Continuation 2 over 8 weeks, and then Maintenance.
    ARM D: Patients receive Block 2 over 4 weeks, Blinatumomab Block 2 over 5 weeks, Continuation 1 over 8 weeks, Blinatumomab Block 3 over 5 weeks, Continuation 2 over 8 weeks, Blinatumomab Block 3 over 5 weeks, and then Maintenance.
    BLOCK 2: Patients receive dexamethasone PO BID or IV on days 1-5; vincristine sulfate IV over 1 minute on day 1; methotrexate IV over 36 hours on day 8; leucovorin calcium IV or PO on days 9-10; pegaspargase IV over 1-2 hours on day 9; cyclophosphamide IV over 15-30 minutes on days 15-19; and etoposide IV over 1-2 hours on days 15-19. Patients with CNS1 or CNS2 also receive methotrexate IT on day 8. Patients with CNS3 also receive methotrexate IT, hydrocortisone IT, and cytarabine IT on days 8 and 22.
    BLOCK 3: Patients receive dexamethasone PO BID or IV on days 1-5; vincristine sulfate IV over 1 minute on day 1; cytarabine IV over 3 hours every 12 hours on days 1, 2, 8, and 9; asparaginase intramuscularly (IM) on days 2, 4, 9, 11, and 23; methotrexate IT on day 1 and IV over 36 hours on day 22; leucovorin calcium PO or IV on days 23-24. Patients with CNS1 or CNS2 also receive methotrexate IT on day 22. Patients with CNS3 also receive methotrexate IT, hydrocortisone IT, and cytarabine IT on days 1 and 22.
    BLINATUMOMAB BLOCK 1: Patients blinatumomab IV continuously on days 1-28 and dexamethasone PO or IV on day 1. Patients with CNS1 or CNS2 also receive methotrexate IT on days 15 and 29. Patients with CNS3 also receive methotrexate IT, hydrocortisone IT, and cytarabine IT on days 15 and 29.
    BLINATUMOMAB BLOCK 2: Patients blinatumomab IV continuously on days 1-28 and dexamethasone PO or IV on day 1. Patients with CNS1 or CNS2 also receive methotrexate IT on days 8 and 29. Patients with CNS3 also receive methotrexate IT, hydrocortisone IT, and cytarabine IT on days 8 and 29.
    BLINATUMOMAB BLOCK 3: Patients blinatumomab IV continuously on days 1-28 and dexamethasone PO or IV on day 1.
    CONTINUATION 1 & 2: Patients receive dexamethasone PO BID or IV on days 1-5; vincristine sulfate IV over 1 minute on day 1; mercaptopurine tablet PO on days 1-42; methotrexate PO on days 8, 15, 29, and 36; leucovorin calcium PO or IV on days 23-24; cyclophosphamide IV over 15-30 minutes on days 42 and 49; etoposide IV over 1-2 hours on days 42 and 49; thioguanine PO once daily on days 42-48; and cytarabine IV or subcutaneously (SC) on days 43-46 and 50-53. Patients with CNS1 or CNS2 also receive methotrexate IT on days 1 and 43. Patients with CNS3 also receive methotrexate IT, hydrocortisone IT, and cytarabine IT on days 1 and 43; methotrexate PO every 6 hours on day 22; and methotrexate IV over 36 hours on day 22.
    MAINTENANCE: Patients receive dexamethasone PO BID or IV on days 1-5, 29-33, and 57-61; vincristine sulfate IV over 1 minute on days 1, 29, and 57; mercaptopurine tablet PO on days 1-84; and methotrexate PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Patients with CNS1 or CNS2 also receive methotrexate IT on day 1. Patients with CNS3 also receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 1. Courses repeat every 12 weeks for up to 2 years since the beginning of treatment in the absence of disease progression or unacceptable toxicity.
    After completion of study treatment, patients are followed up annually for 10 years.

    TRIAL NUMBER: A031704

    Title: PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab Vs. VEGF TKI Cabozantinib with Nivolumab: A Phase III Trial in Metastatic Untreated REnal Cell CancEr [PDIGREE]

    Purpose: This phase III trial studies how well nivolumab and ipilimumab, followed by nivolumab versus cabozantinib and nivolumab, work in treating patients with renal cell cancer that is untreated and has spread to other parts of the body. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cabozantinib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known how well cabozantinib and nivolumab work in treating patients with untreated renal cell cancer that has spread to other parts of the body.

    TRIAL NUMBER: AREN03B2

    Title: RENAL TUMORS CLASSIFICATION, BIOLOGY, AND BANKING STUDY

    Purpose: PRIMARY OBJECTIVES:
    I. Classify patients with renal tumors by histological categorization, surgico- pathological stage, presence of metastases, age at diagnosis, tumor weight, and loss of heterozygosity for chromosomes 1p and 16q, to define eligibility for a series of therapeutic studies.
    II. Maintain a biological samples bank to make specimens available to scientists to evaluate additional potential biological prognostic variables and for the conduct of other research by scientists.
    SECONDARY OBJECTIVES:
    I. Monitor outcome for those patients who are not eligible for a subsequent therapeutic study.
    II. Describe whether the pulmonary tumor burden correlates with outcome in patients with stage IV disease.
    III. Describe the sensitivity and specificity of abdominal computed tomography (CT) scan by comparing it with surgical and pathologic findings for identification of local tumor spread beyond the renal capsule to adjacent muscle and organs, lymph node involvement at the renal hilum and in the retroperitoneum, preoperative tumor rupture, and metastases to the liver.
    IV. Compare the sensitivity and specificity of pre-operative abdominal CT scan and MRI for the identification and differentiation of nephrogenic rests and Wilms' tumor in children with multiple renal lesions.
    V. Correlate the method of conception (natural vs assisted reproductive technology) with the development of Wilms' tumor.
    OUTLINE: This is a multicenter study.
    Tumor tissue, blood, and urine samples are collected for research studies, including immunohistochemistry. CT scans and magnetic resonance imaging (MRIs) are also performed. Loss of heterozygosity analyses (chromosome 1p and 16q) are performed by extraction of DNA. DNA polymorphisms are assayed by polymerase chain reaction using standard methodology. Leftover specimens are archived for future studies.
    Patients are followed periodically for 5 years.

    TRIAL NUMBER: A041501

    Title: A PHASE III TRIAL TO EVALUATE THE EFFICACY OF THE ADDITION OF INOTUZUMAB OZOGAMICIN (A CONJUGATED ANTI-CD22 MONOCLONAL ANTIBODY) TO FRONTLINE THERAPY IN YOUNG ADULTS (AGES 18-39 YEARS) WITH NEWLY DIAGNOSED PRECURSOR B-CELL ALL

    Purpose: Primary Outcome Measures : EFS [ Time Frame: Time from induction response to the time of progressive-disease, secondary malignancy, or death, assessed up to 3 years ] Will be compared using log-rank tests. EFS curves will be constructed using the Kaplan-Meier product limit method, and additional analyses will be done using the Cox proportional hazards model. The corresponding hazard ratio, 2- and 3-year EFS estimates will be assessed, and EFS medians along with their 95% confidence intervals for the two treatment arms.

    Secondary Outcome Measures : DFS [ Time Frame: Time from achievement of CR to the time of relapse and/or death, assessed up to 10 years ] OS [ Time Frame: Time from randomization to the time of death due to any cause, assessed up to 10 years ] Will be evaluated using Kaplan-Meier as well as Cox regression models.
    Proportion of patients who achieve CR or any response to induction therapy [ Time Frame: Up to 10 years ] Will be summarized as the proportion of patients who achieve any type of response to induction therapy divided by the number of all evaluable patients registered to this trial and who received at least one dose of induction therapy. Corresponding 95% binomial confidence intervals will also be calculated.
    Overall induction response rates [ Time Frame: Up to 10 years ] Will be summarized as the proportion of patients who achieve any type of response to induction therapy divided by the number of all evaluable patients registered to this trial and who received at least one dose of induction therapy. Corresponding 95% binomial confidence intervals will also be calculated.
    Incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 10 years ] The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, all adverse event data that is graded as 3, 4, or 5 will be reviewed and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The incidence of severe (grade 3+) adverse events or toxicities will be described for each treatment arm, but will also be compared between the arms. Fisher's exact tests will be used to quantitatively compare the incidence of severe as well as specific toxicities of interest between the treatment arms and we will graphically assess differences in maximum grades observed for toxicities between the arms. Tolerability of the treatment arms will be assessed through assessing the number of patients who required dose modifications and/or dose delays.
    Proportion of patients who go off treatment due to adverse reactions [ Time Frame: Up to 10 years ] Will be assessed within each of the treatment arms and differences explores in these measures between the arms.
    Proportion of patients who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial [ Time Frame: Up to 10 years ] Will be assessed within each of the treatment arms and differences explores in these measures between the arms.

    TRIAL NUMBER: A041702

    Title: A RANDOMIZED PHASE III STUDY OF IBRUTINIB PLUS OBINUTUZUMAB VERSUS IBRUTINIB PLUS VENETOCLAX AND OBINUTUZUMAB IN UNTREATED OLDER PATIENTS (? 70 YEARS OF AGE) WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)

    Purpose: Primary Outcome Measures : Progression-free survival (PFS) [ Time Frame: From randomization date until the earlier of disease progression or death from any cause, assessed up to 10 years ] PFS will be compared between the experimental and control treatment strategy groups using a stratified log-rank test (stratified on Rai stage, intermediate versus [vs.] high, and del(17p13.1) by fluorescence in situ hybridization [FISH], present vs. absent). The Kaplan-Meier method will be used to estimate PFS distributions. Five-year PFS estimates, medians, and corresponding hazard ratios will be provided with 95% confidence intervals for each treatment strategy.

    Secondary Outcome Measures : Bone marrow (BM) minimal residual disease (MRD)- complete response (CR) rate [ Time Frame: Up to 10 years ] BM MRD- CR rate will be calculated and will be estimated using the number of patients meeting the BM MRD- CR criteria divided by the total number of patients randomized to each of the treatment arms. The stratified Cochran-Mantel-Haenszel test will be used to compare the BM MRD- CR rates between treatment arms (stratified on Rai stage, intermediate vs. high, and del(17p13.1) by FISH, present vs. absent).
    Overall survival (OS) [ Time Frame: From randomization date until death from any cause, assessed up to 10 years ] The Kaplan-Meier method will be used to estimate the OS distribution for each treatment strategy. Estimates at 5 years will be calculated with corresponding 95% confidence intervals, and differences in these estimates between the treatment strategies will be tested using a stratified chi-square test based on the complementary log-log transformation of the Kaplan-Meier estimates. Comparisons in OS curves between experimental and control treatment strategies will use a stratified log-rank test (stratified on Rai stage, intermediate vs. high, and del(17p13.1) by FISH, present vs. absent). Hazard ratios with 95% confidence intervals will be estimated from the corresponding, stratified proportional hazard model.
    Incidence of adverse events (AEs) defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment, graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 [ Time Frame: Up to 10 years ] Frequency and severity of adverse events and tolerability for each treatment strategy group will be summarized using descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. The incidence of severe (grade 3+) adverse events or toxicities will be described.

    TRIAL NUMBER: ACCL16N1CD

    Title: Documentation and Delivery of Guideline-Consistent Treatment in Adolescent and Young Adult (AYA) Acute Lymphoblastic Leukemia (ALL)

    Purpose: This research trial studies cancer care delivery in adolescent and young adult patients with acute lymphoblastic leukemia. Surveying institutions, evaluating delivery of care at the patient level and seeking input from healthcare providers may help doctors increase rates of adherence to National Comprehensive Cancer Network (NCCN) treatment guidelines. It may also improve care for adolescent and young adult patients with acute lymphoblastic leukemia.
    PRIMARY OBJECTIVES:
    I. To evaluate the proportion of adolescent and young adult (AYA) acute lymphoblastic leukemia (ALL) patients with a documented treatment plan consistent with NCCN guidelines for AYAs with ALL.
    II. To evaluate the proportion of AYA ALL patients whose delivered treatment during induction and post-induction therapy (PIT) is consistent with NCCN guidelines for AYAs with ALL.
    III. To determine the impact of treating physician specialty and facility type on likelihood of AYA ALL patients having a documented treatment plan concordant with NCCN guidelines when stratified by age group (15-17year[y], 18-21y, and 22-39y).
    IV. To determine the impact of treating physician specialty and facility type on the likelihood of AYA ALL patients receiving induction and post-induction therapy (PIT) concordant with NCCN guidelines when stratified by age group (15-17y, 18-21y, and 22-39y).
    V. To identify for AYAs with ALL, targetable structure- and process-level barriers and facilitators which will increase the proportion of patients having a documented treatment plan and receiving treatment according to NCCN guidelines.
    SECONDARY OBJECTIVES:
    I. To explore potential correlations with clinical and social demographic variables to the presence of a documented treatment plan and delivered treatment consistent with NCCN guidelines in AYAs with ALL.
    OUTLINE:
    CHART REVIEW: Patient medical record data is abstracted and treatment plans are reviewed for consistency to NCCN guidelines. For each patient, induction and post-induction care is recorded as either concordant with NCCN guidelines or non-concordant with NCCN guidelines.
    SITE QUESTIONNAIRE: Participating sites complete a questionnaire which is designed to capture facility-oriented data.
    FOCUS GROUPS: Healthcare providers participate in focus groups over 1-2 hours to discuss facilitators and barriers to AYA ALL guideline concordance. Participants provide responses via electronic handheld technology in order to maintain anonymity followed by discussion of the ideas for clarification.

    TRIAL NUMBER: COG-AALL15P1

    Title: A GROUPWIDE PILOT STUDY TO TEST THE TOLERABILITY AND BIOLOGIC ACTIVITY OF THE ADDITION OF AZACITIDINE TO CHEMOTHERAPY IN INFANTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) AND KMT2A (MLL) GENE REARRANGEMENT

    Purpose: Primary Outcome Measures: Incidence of adverse events of azacitidine and combination chemotherapy, graded according to Common Terminology Criteria for Adverse Events 4.0 [ Time Frame: From the first course of azacitidine administration up to fourth course of azacitidine administration ]
    Secondary Outcome Measures: Biologic activity, defined as global DNA methylation change in PBMCs [ Time Frame: Prior to first course of azacitidine up to day 5 of second course of azacitidine ] Will calculate the mean long interspersed nucleotide element-1 (LINE-1) methylation for all patients before and after azacitidine and perform paired t-test analysis to determine if there is significant demethylation in the study population for the tested dose level.

    Other Outcome Measures: EFS [ Time Frame: From time of enrollment up to 5 years ] Descriptive analysis will be conducted to correlate MRD with the EFS for the KMT2A-R patients. PD data for asparaginase activity following pegaspargase administration in infants will be collected and correlated with EFS for the KMT2A-R patients. Standard errors and confidence intervals for EFS will be calculated using Peto's method.
    Expansion of infant T lymphocytes by stimulation with artificial antigen presenting cells [ Time Frame: Up to the end of consolidation therapy, assessed up to 5 years ] Minimal residual disease [ Time Frame: Up to 5 years ] Descriptive analysis will be conducted to correlate MRD with the EFS for the KMT2A-R patients.
    PD data for asparaginase activity following pegaspargase administration [ Time Frame: From 7 days following pegaspargase administration during induction therapy up to 7 days following pegaspargase administration during delayed intensification part 2 ] Will be collected and correlated with EFS for the KMT2A-R patients
    PK parameters of azacitidine [ Time Frame: Pre-dose on days 3 and 4, at 5 and 30 minutes, and 1, 4, and 6 hours post-dose of azacitidine block I ]

    TRIAL NUMBER: COG-AALL1631

    Title: INTERNATIONAL PHASE 3 TRIAL IN PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (Ph+ ALL) TESTING IMATINIB IN COMBINATION WITH TWO DIFFERENT CYTOTOXIC CHEMOTHERAPY BACKBONES

    Purpose: Primary Outcome Measures : DFS [ Time Frame: Up to 3 years ] Will compare the DFS of standard risk Ph+ ALL patients treated continuous imatinib mesylate with high risk COG/BFM ALL chemotherapy backbone or more intensive EsPhALL chemotherapy backbone.

    Secondary Outcome Measures : DFS of high risk pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission, and post-HSCT imatinib mesylate [ Time Frame: Up to 3 years ] The 3-year DFS for these patients will be estimated with a maximum standard error of 0.053.
    Imatinib mesylate administration after allogeneic HSCT in high risk Ph+ ALL patients [ Time Frame: Up to 2 years ] Feasibility of post-HSCT imatinib mesylate is determined based on the proportion of patients who receive at least 75% of intended doses.
    Incidence of grade 3 or higher infections in standard risk Ph+ ALL patients in the two randomized arms evaluated according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 3 years ] The rate of infections during the post IB/pre-maintenance phases of treatment will be compared accounting for follow-up time.

    Other Outcome Measures: Adherence to imatinib mesylate after allogeneic HSCT in high risk Ph+ ALL patients [ Time Frame: Up to 12 months post-HSCT ] Longitudinal binomial regression will be conducted using generalized estimating equation methods by modeling monthly adherence rate as an unstructured mean model using five indicator variables of time for the study months. Time in months will also be treated as a continuous variable to explore temporal trends in adherence rate. Compound symmetry will be assumed as the working correlation matrix over time. Covariates that will be considered for adjustment include those hypothesized to be predictors of adherence, annual household income, parental education, time since start of maintenance, risk
    Adherence to oral chemotherapeutic agents in standard risk Ph+ ALL patients [ Time Frame: Up to day 168 of maintenance phase ] Adherence to imatinib mesylate, 6-mercaptopurine, and methotrexate will be evaluated in COG-enrolled participants using an electronic monitoring device. Adherence rate will be computed for each month of adherence monitoring. Longitudinal binomial regression will be conducted using generalized estimating equation methods by modeling monthly adherence rate as an unstructured mean model using five indicator variables of time for the study months. Time in months will also be treated as a continuous variable to explore temporal trends in adherence rate. Compound symmetry will be assumed as the work
    Frequency of p210 BCR-ABL1 fusion variants [ Time Frame: Up to 2 years ] For both SR and HR risk groups, frequencies and prognostic significance (OS, DFS) will be explored for p210 BCR-ABL1 fusion variants in pediatric Ph+ ALL.
    IKZF1 gene aberrations and deletions [ Time Frame: Up to 2 years ] For both SR and HR risk groups, frequencies and prognostic significance (OS, DFS) will be explored for IKZF1 gene aberrations and deletions.
    Incidence of long-term toxicities in patients treated with chemotherapy plus imatinib mesylate (no transplant) in both arms evaluated according to NCI CTCAE version 4.0 [ Time Frame: Up to 3 years ] Frequencies of long-term toxicities will be described and differences between randomized arms will be explored. Specific long-term toxicities to be explored include cardiac (echocardiographic abnormalities, including decreased left ventricular (LV) function and decreased LV wall thickness), growth (linear height, bone age), and second malignant neoplasm.
    Incidence of toxicities associated with post-HSCT administration of imatinib mesylate evaluated according to NCI CTCAE version 4.0 [ Time Frame: Up to 1 year post-HSCT ] Frequencies of target toxicities in HR patients after the initiation of post-HSCT imatinib mesylate will be described. For the HR patients, the specific targeted toxicities will include grade 4 neutropenia, grade 4 thrombocytopenia, grade 3 or higher bilirubin, grade 4 or higher transaminitis, and grade 3 or higher infection.
    MRD assessments made by IGH-TCR PCR assay and NGS assay [ Time Frame: Up to 2 years ] Concordance of MRD assessments made by IGH-TCR PCR assay and NGS assay will be described and evaluated. Scatter plots and diagrams will be used to examine agreements and patterns of agreement or any differences found. Concordance will be explored both for the overall cohort, as well as by risk group. The increased sensitivity of the NGS will be closely examined to find cases where the MRD levels are detectable by NGS but undetectable by PCR, as well as cases in which one test yields results and the other does not (test failure). Prognostic relationships on outcomes for these subjects will be i
    MRD in HR patients measured by IGH-TCR PCR and NGS assay [ Time Frame: Up to 12 months post-HSCT ] The outcome of HR patients will be described, including proportion of patients who achieve MRD-negativity just prior to HSCT, and at regular intervals post-HSCT. Associations between these findings and long-term outcomes (e.g., OS, DFS) will be explored.
    MRD in SR patients measured by IGH-TCR PCR and NGS assay [ Time Frame: Up to 2 years ] The proportion of patients with detectable MRD will be described, and association between MRD levels at later time points and long-term outcomes (e.g., DFS and OS) will be explored. The proportion of SR patients in each of the randomized arms at each of the time points who are not MRD-negative (i.e., MRD non-detectable), or who revert to MRD-positive (i.e., MRD value >= 5 x 10^-4) after previously attaining MRD-negative status will also be explored. Odds ratio estimates comparing the rates of not being MRD-negative at start of delayed intensification phase or MRD-positive at any subsequent mon
    MRD measured by IGH-TCR PCR and NGS assay [ Time Frame: At the end of induction IA ] For both SR and HR risk groups, frequencies and prognostic significance (overall survival [OS], DFS) will be explored for MRD negativity (< 5 x 10^-4) at end of Induction IA.

    TRIAL NUMBER: COG-AAML1531

    Title: RISK-STRATIFIED THERAPY FOR ACUTE MYELOID LEUKEMIA IN DOWN SYNDROME

    Purpose: PRIMARY OBJECTIVES:
    I. To determine the 2-year event-free-survival (EFS) for children with standard risk Down syndrome (DS) acute myeloid leukemia (AML) (minimal residual disease [MRD]-negative after one cycle of induction therapy) after elimination of high dose (HD) Ara-C (cytarabine) from the treatment regimen.
    II. To determine the 2-year EFS for children with high risk DS AML (MRD-positive after one cycle of induction therapy) after intensification of treatment equivalent to that used for high risk AML in children without DS.
    EXPLORATORY OBJECTIVES:
    I. To determine the extent to which elimination of HD Ara-C from the treatment of standard risk DS AML decreases adverse events and resource utilization.
    II. To determine if elimination of HD Ara-C from treatment of standard risk DS AML results in a significant decrease in the number of days per patient spent on protocol therapy compared to predecessor study AAML0431.
    III. To determine if elimination of HD Ara-C from treatment of standard risk DS AML results in a significant decrease in the average number of days of hospitalization per patient compared to predecessor studies AAML0431 and A2971.
    IV. To determine if elimination of HD Ara-C from treatment of standard risk DS AML results in a significant decrease in the number (per patient) and rate (per duration of treatment) of sterile site infections compared to the predecessor study AAML0431.
    V. To determine if elimination of HD Ara-C from treatment of standard risk DS AML results in a significant decrease of resource utilization by AML treatment compared to the predecessor study AAML0431.
    VI. To compare the feasibility and analytical characteristics of flow cytometry, polymerase chain reaction (PCR) and targeted error-corrected sequencing of GATA binding protein 1 (globin transcription factor 1) (GATA1) mutations as methods to detect MRD in DS AML.
    VII. To establish a DS AML cell bank of viably frozen bone marrow samples collected at the end of induction and corresponding non-tumor deoxyribonucleic acid (DNA) samples collected at end of Induction 1.
    OUTLINE:
    INDUCTION I: Patients receive cytarabine intrathecally (IT) on day 1 and intravenously (IV) continuously over 96 hours, daunorubicin hydrochloride IV over 1-15 minutes, and thioguanine orally (PO) twice daily (BID) on days 1-4. Induction I continues for a minimum of 28 days.
    Patients are assigned to 1 of 2 treatment arms based on their MRD status after completion of Induction I.
    ARM A (STANDARD RISK):
    INDUCTION II: Patients receive cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV over 1-15 minutes, and thioguanine PO BID on days 1-4. Induction II continues for a minimum of 28 days.
    INDUCTION III: Patients receive cytarabine, daunorubicin hydrochloride, and thioguanine as in Induction II. Induction III continues for a minimum of 28 days.
    INTENSIFICATION I: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 60-120 minutes on days 1-3. Intensification I continues for a minimum of 28 days.
    INTENSIFICATION II: Patients receive cytarabine and etoposide as in Intensification I. Intensification II continues for a minimum of 28 days.
    ARM B (HIGH RISK):
    INDUCTION II: Patients receive high dose cytarabine IV over 1-3 hours BID on days 1-4 and mitoxantrone hydrochloride IV over 15-30 minutes on days 3-6. Induction II continues for a minimum of 28 days.
    INTENSIFICATION I: Patients receive high dose cytarabine IV over 1-3 hours BID and etoposide IV over 60-120 minutes on days 1-5. Intensification I continues for a minimum of 28 days.
    INTENSIFICATION II: Patients receive high dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9. Patients also receive asparaginase or asparaginase Erwinia chrysanthemi (E. carotovora) intramuscularly (IM) or IV over 30 minutes on days 2 and 9. Intensification II continues for a minimum of 28 days.
    After completion of study treatment, patients are followed up at 1 month, monthly for 12 months, every 3 months for 12 months, every 6 months for 3 years, annually for 5 years, and then at relapse.

    TRIAL NUMBER: E1910

    Title: A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults

    Purpose: This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as blinatumomab, may block cancer growth in different ways by targeting certain cells. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.

    TRIAL NUMBER: EA9161

    Title: A RANDOMIZED PHASE III STUDY OF THE ADDITION OF VENETOCLAX TO IBRUTINIB AND OBINUTUZUMAB VERSUS IBRUTINIB AND OBINUTUZUMAB IN UNTREATED YOUNGER PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)

    Purpose: Primary Outcome Measures : Progression-free survival [ Time Frame: Time from randomization to progression or death without documented progression, assessed up to 10 years ] The analysis will be performed using the repeated confidence intervals methodology. At each interim or final analysis, two-sided repeated confidence interval will be constructed using the partial likelihood estimate from stratified Cox proportional hazards model and the critical value based on the Lan-DeMets error-spending function that corresponds to the truncated O'brien-Fleming boundaries.

    Secondary Outcome Measures : Overall survival [ Time Frame: Time from randomization to death due to any cause, assessed up to 10 years ] A hierarchical testing strategy will be used. The analysis will be performed using the repeated confidence intervals methodology. At each interim or final analysis, two-sided repeated confidence interval will be constructed using the partial likelihood estimate from stratified Cox proportional hazards model and the critical value based on the Lan-DeMets error-spending function that corresponds to the truncated O'brien-Fleming boundaries.
    Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events version 5.0 [ Time Frame: Up to 10 years ]
    Other Outcome Measures: Quality of life (QOL) assessed using Functional Assessment of Cancer Therapy-General (FACT-G) and the leukemia sub-scale [ Time Frame: Baseline up to 10 years ] Linear mixed effects models will be used to perform repeated measures regression analysis. Will compare treatment toxicity-related QOL between the two arms. The entire FACT-Leukemia instrument (FACT-G and the leukemia subscale) at baseline will be analyzed using descriptive statistics to assess the impact of chronic lymphocytic leukemia on QOL independent of treatment.
    FACT-Leu Trial Outcome Index (TOI) score over time [ Time Frame: Baseline up to 10 years ] Will use linear mixed effects models will be used to perform repeated measures regression analysis to examine the treatment effect and time effect on FACT-Leu TOI score.
    Adherence defined as patients taking 80% or more of their prescribed doses [ Time Frame: Baseline up to 10 years ] The ASK-12 Survey will be used to measure the likelihood that a patient will take prescribed medications for patients on both arms at baseline and on day 1 +/- 4 days of the following cycles 3, 7, 15, at the time of response evaluation (end of cycle 19), every 6 months for 2 years post response evaluation, at 48 months after randomization, and at time of disease progression. Descriptive statistics will be used to summarize trend in adherence to prescription.

    TRIAL NUMBER: AHEP1531

    Title: Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

    Purpose: Primary Outcome Measures : Event-free survival (EFS) [ Time Frame: From date of randomization until progression of existing disease or occurrence of disease at new sites, death from any cause prior to disease progression, or diagnosis of a second malignant neoplasm, assessed up to 5 years ] Descriptive analysis for each non-randomized and randomized question (by treatment arm and overall) will include: the number (and proportion) of each failure event and in total, survival curves will be estimated by the method of Kaplan-Meier, EFS estimates at 3 and 5 years with 95% confidence intervals (CI), median EFS with CI will be reported if appropriate. A Cox proportional hazards model with EFS as an outcome measure and treatment and stratification factors as covariates will be constructed. This model will be used in the context of a Bayesian analysis and a log Hazard Ratio (HR) will be derived. Bayesian Normal-Normal conjugate analysis of the data will be used to compare treatments. The analysis will use non-informative prior to represent no information about prior beliefs regarding relative treatment difference.
    Response in hepatocellular carcinoma (HCC), defined as complete (CR) or partial (PR) response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria [ Time Frame: Up to 5 years ] The main analysis will be based on a log-binomial model for a Bernoulli response variable. This model will be used in the context of a Bayesian analysis. A non-informative null centered proper prior distributions for the parameters will be used. Response rate (RR) and 95% credible interval (CrI) will be presented. Posterior probabilities for the pre-specified values of interest will be provided. Additionally, the posterior probabilities of RR being larger than 0.7, 0.8, 0.9, 1, 1.1, 1.2 and 1.3 will be also provided.

    Secondary Outcome Measures : Failure free survival [ Time Frame: From date of randomization until the date of first documented progression, date of death from any cause, diagnosis of a second malignant neoplasm or failure to go to resection, whichever came first, assessed up to 5 years ] Descriptive analysis for each non-randomized and randomized question (by treatment arm and overall) will include: the number (and proportion) of each failure event and in total, survival curves will be estimated by the method of Kaplan-Meier. Bayesian Normal-Normal conjugate analysis of the data will be used to compare treatments. The analysis will use non-informative prior to represent no information about prior beliefs regarding relative treatment difference.
    Overall survival [ Time Frame: From date of randomization (or registration for non-randomized patients) until the date of death from any cause, assessed up to 5 years ] Incidence of adverse events [ Time Frame: Up to 5 years ] Will be categorized and graded using Common Terminology Criteria for Adverse Events (CTCAE).
    Chemotherapy-related cardiac, nephro- and oto-toxicity [ Time Frame: Up to 5 years ] Will be recorded in relation to each cycle of treatment and will be categorized and graded using Common Terminology Criteria for Adverse Events.
    Hearing loss measured according to the SIOP Boston Scale for oto-toxicity [ Time Frame: Up to 5 years ] Descriptive analysis for each non-randomized and randomized question (by treatment arm and overall) will include: the number (and proportion) of patients at each the SIOP Boston Scale for oto-toxicity category (i.e. grade 0 to grade 4) and the number (and proportion) of patients who are not assessable for this outcome, (i.e. because of early stopping of treatment, additional treatments to protocol treatment, progression prior to the response assessment or death). The number (and proportion) of patients experiencing any grade hearing loss. Grades 1 to grade 4 will be combined in this analysis. The above will be presented for each assessment time point (EOT and at least 1 year and 2 years of follow up).
    Best response defined as compete response (CR) or partial response (PR) based on radiological response (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) and AFP decline [ Time Frame: Up to 5 years ] Descriptive analysis for each non-randomized and randomized question (by treatment arm and overall) will include: best response will be calculated by taking best RECIST category (i.e. CR, PR, stable disease [SD], progressive disease [PD]) for each patient. CR and PR patients will then be grouped into responders. The number (and proportion) of patients at each best response RECIST category (i.e. CR, PR, SD, PD) and the number (and proportion) of patients who are not assessable for response, e.g. because of early stopping of treatment, progression prior to the response assessment or death. The number (and proportion) of responders (CR and PR) and non-responders.
    Surgical resectability defined as complete resection, partial resection or transplant following randomization (or enrollment for non-randomized patients) [ Time Frame: Up to 5 years ] Descriptive analysis for each non-randomized and randomized question (by treatment arm and overall) will include: The number (and proportion) of patients undergoing complete resection, partial resection or transplant. Time to complete resection, partial resection or transplant following randomization (or enrollment for non-randomized patients) will be analyzed using the Kaplan-Meier method.
    Adherence to surgical guidelines defined as the local clinician?s surgical decision to resect or not compared to the current SIOPEL surgical guidelines [ Time Frame: Up to 5 years ] Descriptive analysis for each non-randomized and randomized question (by treatment arm and overall) will include: The number (and proportion) of patients at each combination of SIOPEL surgical guideline (to resect or not) and local clinician?s surgical decision. The degree of agreement will be measured by Cohen?s kappa with CI.

    TRIAL NUMBER: R1112

    Title: RANDOMIZED PHASE III STUDY OF SORAFENIB VERSUS STEREOTACTIC BODY RADIATION THERAPY FOLLOWED BY SORAFENIB IN HEPATOCELLULAR CARCINOMA

    Purpose: PRIMARY OBJECTIVES:
    I. To determine if stereotactic body radiation therapy (SBRT) improves overall survival in hepatocellular carcinoma (HCC) patients treated with sorafenib (sorafenib tosylate).
    SECONDARY OBJECTIVES:
    I. To determine the difference in time to progression (TTP) and progression- free survival (PFS) in HCC patients treated with sorafenib compared to SBRT followed by sorafenib.
    II. To measure differences in toxicity in HCC patients treated with sorafenib versus SBRT followed by sorafenib.
    III. To measure vascular thrombosis response post sorafenib versus SBRT followed by sorafenib.
    IV. To measure differences in health related quality of life (QOL) and quality- adjusted survival in HCC patients treated with sorafenib compared to SBRT followed by sorafenib.
    V. Collection of biospecimens for future correlative studies to investigate differences in potential biomarkers in patients treated with sorafenib versus SBRT followed by sorafenib.
    OUTLINE: Patients are randomized to 1 of 2 treatment arms.
    ARM 1: Patients receive sorafenib tosylate orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
    ARM 2: Patients undergo SBRT every 24-72 hours for a total of 5 fractions over 5 to 15 days. Within 1-5 days post-SBRT, patients receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
    Patients are followed weekly during SBRT, monthly during sorafenib tosylate and on the following schedule as a whole from study entry: every 3 months for 3 years, then every 6 months for 2 years and then annually.

    TRIAL NUMBER: A151216

    Title: Genetic Testing For Patients with Resectable or Resected Lung Cancer: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

    Purpose: PRIMARY OBJECTIVES:
    I. To centrally genotype resected lung adenocarcinomas for epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma receptor tyrosine kinase (ALK) rearrangements to facilitate accrual to randomized adjuvant studies.
    II. To obtain clinically annotated tumor tissue and patient-matched non-malignant deoxyribonucleic acid (DNA) from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow clinically annotated advanced genomic analyses in concert with the National Cancer Institute (NCI) Center for Cancer Genomics (CCG).
    SECONDARY OBJECTIVES:
    I. To characterize the natural history of EGFR and ALK wild-type lung cancers to allow subsequent development of targeted therapies against genotype-defined sub-populations in the adjuvant and recurrent settings.
    II. To cross-validate local genotyping assays for EGFR and ALK with a central reference standard.
    TERTIARY OBJECTIVES:
    I. To study the genomic evolution of lung cancers by comparing genomic characteristics at resection and at recurrence.
    OUTLINE:
    Patients undergo collection of blood and tissue samples for EGFR and ALK testing via direct sequencing and fluorescence in situ hybridization (FISH). Patients that have had surgery prior to pre-registration will submit samples from the previous surgery for testing.
    After completion of study, patients that are not enrolled on either A081105 or E4512 are followed up every 6 months for 5 years.

    TRIAL NUMBER: E4512

    Title: A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

    Purpose: PRIMARY OBJECTIVES:
    I. To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) over placebo for patients with stage IB >= 4 cm, II and IIIA, anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following surgical resection.
    SECONDARY OBJECTIVES:
    I. To evaluate and compare disease-free survival (DFS) associated with crizotinib and placebo.
    II. To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting.
    III. To collect tumor tissue and blood specimens for future research.
    OUTLINE: Patients are randomized to 1 of 2 treatment arms.
    ARM A: Patients receive crizotinib orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    ARM B: Patients receive placebo PO BID on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for 5 years.

    TRIAL NUMBER: LungMAP

    Title: LungMAP: A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)

    Purpose: 1.1 Primary Objective of the Master Protocol (LungMAP) The primary objective of this screening study is to test patient specimens to determine eligibility for participation in the biomarker-driven and non-matched sub-studies included within the Lung-MAP umbrella protocol. 1.2 Secondary Objectives a. Screening Success Rate Objective To evaluate the screen success rate defined as the percentage of screened patients that register for a therapeutic sub-study. Screen success rates will be evaluated for the total screened population and by the subset of patients screened following progression on previous therapy or pre-screened on current therapy. b. Translational Medicine Objectives 1. To evaluate circulating tumor DNA (ctDNA) and compare to the FMI Foundation tissue molecular profiling results in patients who submit a new biopsy for screening. 2. To establish a tissue/blood repository

    TRIAL NUMBER: S1800A

    Title: Ramucirumab and Pembrolizumab Versus Standard of Care in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Non-Match Treatment Trial)

    Purpose: This phase II Lung-MAP non-Match treatment trial studies how well ramucirumab and pembrolizumab work versus standard of care in treating patients with non-small cell lung cancer that is stage IV or has come back. Immunotherapy with monoclonal antibodies, such as ramucirumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in standard of care chemotherapy for non-small cell lung cancer, such as docetaxel, gemcitabine hydrochloride, and pemetrexed, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ramucirumab and pembrolizumab together may work better in treating patients with non-small lung cancer compared to standard of care.

    TRIAL NUMBER: EA4181

    Title: A RANDOMIZED 3-ARM PHASE II STUDY COMPARING 1.) BENDAMUSTINE, RITUXIMAB AND HIGH DOSE CYTARABINE (BR/CR) 2.) BENDAMUSTINE, RITUXIMABM HIGH DOSE CYTARABINE AND ACALABRUTINIB (BR/CR-A), AND 3.) BENDUMUSTINEM RITUXIMAB AND ACALABRUTINIB (BR0A) IN PATIENT

    Purpose:

    Primary Outcome Measures :
    1. Composite of positron emission tomography (PET)/computed tomography (CT) complete response (CR) and peripheral blood (PB) minimal residual disease (MRD) negative rate [ Time Frame: Up to 8 weeks post treatment ]
      MRD status is defined as positive, negative, or indeterminate as measured from PB specimens following completion of treatment. Measures of frequencies and proportion, and location and dispersion will be used to describe categorical, and continuous variables respectively; 90% confidence intervals around these estimates will be computed. Kaplan-Meier method will be used to describe time-to-event endpoints and log-rank test to assess difference in time-to-event endpoints by levels of a categorical predictor. Cox proportional hazards (PH) regression model would be used to model the impact of baseline and other relevant variables on time-to-event endpoints.


    Secondary Outcome Measures :
    1. Progression-free survival (PFS) [ Time Frame: From randomization to earliest of disease progression or death, assessed at 36 months ]
    2. Incidence of adverse events [ Time Frame: Up to 10 years post randomization ]
      Assessed by Common Terminology Criteria for Adverse Events (CTCAE). The cumulative dose of high dose cytarabine and proportion of patients that discontinued treatment due to toxicity will be assessed.

    3. Objective response rate (ORR) [ Time Frame: Up to 10 years post randomization ]
      ORR is defined as the proportion of patients achieving a best response to treatment of complete response (CR) or partial response (PR). ORR and PET/CT CR will be estimated in each treatment arm in the efficacy population, as well as among all treated patients, regardless of informative tissue status.

    4. Overall survival (OS) [ Time Frame: From randomization to death, assessed at 36 months ]
      Patients that are alive will be censored at the time of last follow-up. OS will be described using the Kaplan-Meier method and log-rank test will be used to compare survival by treatment arm.

    5. Mobilization failure rate [ Time Frame: Up to 10 years post randomization ]
      Defined as a yield < 2 x10^6 CD34+ stem cells/kg with a maximum of 4 course of apheresis will be summarized as a categorical variable, and compared, between treatment arms using Z- test.


    Other Outcome Measures:
    1. PET/CT negative rate between the three arms [ Time Frame: Up to 10 years post randomization ]
    2. PET quantitative assessment (qPET) [ Time Frame: At end of treatment (within 6 months after the "8 weeks post treatment" timeframe) ]
      Will evaluate the association between baseline qPET and MRD status.

    3. Change of qPET parameters [ Time Frame: Baseline to end of treatment (within 6 months after the "8 weeks post treatment" timeframe) ]
      Will evaluate the association between the change of qPET parameters and MRD and compare this association across all 3 arms.

    4. Incremental prognostic value of baseline qPET to standard risk markers (Mantle Cell Lymphoma International Prognostic Index [MIPI]) [ Time Frame: At end of treatment (within 6 months after the "8 weeks post treatment" timeframe) ]
      Will assess the incremental prognostic value of baseline to standard risk markers (MIPI) in predicting MRD status.

    5. Interim PET status [ Time Frame: At end of treatment (within 6 months after the "8 weeks post treatment" timeframe) ]
      Interim PET status both qualitatively (Deauville) and quantitatively will be correlated with MRD status. Will fit a logistic regression model to evaluate this aim with binary MRD status at end of treatment (EOT) as the response variable and interim PET status as the predictor.

    6. Incremental prognostic value of interim qPET to standard risk markers (MIPI) [ Time Frame: At end of treatment (within 6 months after the "8 weeks post treatment" timeframe) ]
      Will assess the incremental prognostic value of interim qPET to standard risk markers (MIPI) in predicting MRD status.

    7. Incremental prognostic value of interim qPET to Ki67 [ Time Frame: At end of treatment (within 6 months after the "8 weeks post treatment" timeframe) ]
      Will assess the incremental prognostic value of interim qPET to Ki67 in predicting MRD status.

    8. Incremental prognostic value of baseline qPET to Ki67 [ Time Frame: At end of treatment (within 6 months after the "8 weeks post treatment" timeframe) ]
      Will assess the incremental prognostic value of baseline qPET to Ki67 in predicting MRD status.

    TRIAL NUMBER: S1608

    Title: RANDOMIZED PHASE II TRIAL IN EARLY RELAPSING OR REFRACTORY FOLLICULAR LYMPHOMA

    Purpose: Primary Outcome Measures: Complete response (CR) [ Time Frame: Up to 6 courses ] Will be assessed.

    Secondary Outcome Measures: Duration of response (complete response, partial response) [ Time Frame: Up to 5 years ] Will be calculated using the method of Kaplan-Meier.
    Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 5 years ] Toxicity rates can be estimated to within at least ± 15% with 95% confidence.
    M7-LIPI model validation [ Time Frame: Up to 5 years ] The Cox proportional hazards model will be used to assess the association of the m7-FLIPI with to PFS.
    Non-invasive genotyping and circulating tumor deoxyribonucleic acid (DNA) assessment [ Time Frame: Up to 5 years ] Sensitivity, specificity, positive predictive value, negative predictive value, and kappa coefficient will be used to evaluate the concordance. Will evaluate the association of detection of active lymphoma by positron emission tomography-computed tomography and the detection of circulating tumor DNA in plasma at baseline, after 6 and 12 cycles, and at 30 months after initiation of study therapy. Chi-square test will be used to evaluate the association and odds ratio will be calculated.
    Overall survival [ Time Frame: Up to 5 years ] Will be calculated using the method of Kaplan-Meier. 95% confidence for the survival estimates will be constructed using the method of Brookmeyer-Crowley. With 45 eligible patients in each arm, overall survival (OS) at a particular time point, and the 30-month sustained response rate can be estimated to within at least ± 15% with 95% confidence
    Progression-free survival [ Time Frame: From date of registration to date of first observation of progressive disease, or death due to any cause, assessed up to 5 years ] Will be calculated using the method of Kaplan-Meier. 95% confidence for the survival estimates will be constructed using the method of Brookmeyer-Crowley. With 45 eligible patients in each arm, progression free survival (PFS) at a particular time point, and the 30-month sustained response rate can be estimated to within at least ± 15% with 95% confidence

    Estimated Enrollment: 150 Actual Study Start Date: August 10, 2017 Estimated Study Completion Date: December 31, 2022 Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

    TRIAL NUMBER: EA6134

    Title: A Randomized Phase III Trial of Dabrafenib + Trametinib Followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab Followed by Dabrafenib + Trametinib at Progression in Patients With Advanced BRAFV600 Mutant Melanoma

    Purpose: This randomized phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III-IV melanoma that contains a mutation known as v-raf murine sarcoma viral oncogene homolog B V600 (BRAFV600) and cannot be removed by surgery. Ipilimumab and nivolumab may block tumor growth by targeting certain cells. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.

    TRIAL NUMBER: A031102

    Title: A RANDOMIZED PHASE III TRIAL COMPARING CONVENTIONAL-DOSE CHEMOTHERAPY USING PACLITAXEL, IFOSFAMIDE, AND CISPLATIN (TIP) WITH HIGH-DOSE CHEMOTHERAPY USING MOBILIZING PACLITAXEL PLUS IFOSFAMIDE FOLLOWED BY HIGH-DOSE CARBOPLATIN AND ETOPOSIDE (TI-CE) AS FIRST SALVAGE TREATMENT IN RELAPSED OR REFRACTORY GERM CELL TUMORS

    Purpose: The study is an international collaboration with European sites. Collaborators on the study include the National Cancer Institute, the European Organization for Research and Treatment of Cancer and the Movember Foundation. Randomization will be stratified by region (North America and Europe) and by modified IPFSG (International Prognostic Factor Study Group) risk classification (low, intermediate and high). The primary and secondary objectives are described below.
    Primary Objective:
    1. To compare the overall survival in patients treated with conventional-dose chemotherapy using the TIP regimen with high-dose chemotherapy (HDCT) plus autologous stem cell transplant (ASCT) using the TI-CE regimen as initial salvage treatment of patients with relapsed or refractory germ cell tumors (GCT)
    Secondary Objectives: 1.To compare the progression-free survival (PFS) of patients treated with initial salvage HDCT with TI-CE versus initial salvage CDCT with TIP 2.To compare the favorable response rate (FRR) of patients treated with initial salvage HDCT with TI-CE versus initial salvage CDCT with TIP 3.To compare the toxicity, including treatment-related mortality, associated with high-dose chemotherapy and ASCT using TI-CE compared with conventional-dose chemotherapy using TIP as initial salvage treatment for patients with relapsed or refractory GCT 4.To prospectively evaluate the IPFSG scoring system as a predictor of outcome to initial salvage therapy in patients with relapsed or refractory GCT. In this trial, randomization will be stratified by a modification of their IPFSG category and we will prospectively evaluate whether or not actual outcomes vary by risk group in the appropriate manner (low risk patients have higher OS than high-risk group). 5.To evaluate the association between tumor marker decline rates of Alpha-Fetoprotein (AFP) and Human Chorionic Gonadotropin (HCG) with OS and PFS.
    Treatment is to continue until disease progression, unacceptable toxicity or completion of all protocol treatment.

    TRIAL NUMBER: ABTR04B1

    Title: ESTABLISHING CONTINUOUS CELL LINES AND XENOGRAFTS FROM PEDIATRIC CANCERS FOR BIOLOGICAL AND PRE-CLINICAL THERAPEUTIC STUDIES

    Purpose: OBJECTIVES: ?Establish and bank cell lines and/or xenografts from pediatric patients with cancer. ?Establish continuous cell lines, under carefully controlled conditions, from pediatric patients with cancer. ?Establish transplantable xenografts in immunocompromised mice from tumor cells that are difficult to establish as continuous cell lines in vitro. ?Create a bank of cell lines and generate sufficient vials of cryopreserved cells for distribution to investigators with approved COG biology protocols. ?Characterize cell lines from childhood cancers with respect to DNA short tandem repeat molecular profile as a "fingerprint" of original cell line identity. ?Characterize cell lines for the ability for sustained growth in tissue culture and/or as mouse xenografts. ?Characterize cell lines for mycoplasma contamination. ?Characterize cell lines for expression of molecular makers that confirm the tumor-type of the cell line and the immortal nature of the cells (telomerase) and the expression of molecular markers that may correlate with drug resistance.
    OUTLINE: This is a multicenter study. Specimens are stratified according to disease (acute lymphoblastic leukemia vs acute myeloid leukemia vs lymphoma vs osteogenic sarcoma vs Ewing family of tumors vs rhabdomyosarcoma vs primitive neuroectodermal tumor vs glioma vs astrocytoma vs rhabdoid tumors vs hepatoblastoma vs retinoblastoma vs Wilms tumor vs germ cell tumors vs other diagnoses).
    Leftover tissue from diagnostic procedures and/or surgery is cryopreserved and banked. Blood and/or bone marrow are also collected and banked.
    Cell lines are established and characterized via reverse-transcriptase polymerase chain reaction and/or flow cytometry for biomarkers and by DNA fingerprinting.
    Markers to be identified may include the following: ?Neuroblastoma: tyrosine hydroxylase, protein gene product (PGP) 9.5, GD2, HLA class I, and HSAN 1.2 antigens ?Ewing family of tumors: EWS-FLI1, EWS-ERG, and PGP 9.5 ?Retinoblastoma: interphotoreceptor retinoid-binding protein ?Acute lymphoblastic leukemia: immunophenotype ?Alveolar rhabdomyosarcoma: PAX3-FKHR, PAX7-FKHR, and MyoD1 ?All cell types: telomerase expression including hTR and hTERT Mutations of TP53 gene are detected by flow cytometry and/or immunocytochemistry.
    No results of these tests are provided to the patient, the patient's physician, or the patient's medical records.
    PROJECTED ACCRUAL: A total of 500 specimens per stratum will be accrued for this study.

    TRIAL NUMBER: AGCT1531

    Title: A PHASE 3 STUDY OF ACTIVE SURVEILLANCE FOR LOW RISK AND A RANDOMIZED TRIAL OF CARBOPLATIN VS. CISPLATIN FOR STANDARD RISK PEDIATRIC AND ADULT PATIENTS WITH GERM CELL TUMORS

    Purpose: Primary Outcome Measures:
    EFS [ Time Frame: The time from study entry to the date of death, date of disease progression or recurrence, date of second malignant neoplasm or date of last contact and ascertained as alive, whichever comes first, assessed up to 5 years ] Overall survival (OS) [ Time Frame: The time from randomization to date of date of death or date of last follow-up and ascertained as alive, assessed up to 8 years ] A 1-sided lower 85% confidence limit for the 2-year survival will be constructed, and if this confidence limit is greater than 0.95, it will be concluded that the strategy provides sufficient OS.

    Secondary Outcome Measures:
    Content validity and understandability of AYA-Hearing Screen assessed by questionnaire [ Time Frame: Baseline ] Incidence of ototoxicity [ Time Frame: 4 weeks after the last dose of platin therapy ] Will compare the proportion of patients who demonstrate hearing loss according to the International Society of Pediatric Oncology criteria.
    Novel genetic variants associated with an increased risk of platinum-associated ototoxicity as determined by standard audiology [ Time Frame: Up to 10 years ] For each candidate gene, will perform an exact two-sided test for the equality of binomial proportions for the event - patient has the candidate gene. The two groups compared will be defined by the presence of SHL. Will use the Bonferroni correction to control experiment-wise error and designate the result as significant if the observed p-value is less than or equal to 0.0025.
    Utility of the 4-miRNA panel as markers diagnostic of MGCTs [ Time Frame: Up to 10 years ] Will use categorical data methods and estimate the probability of demonstrating an elevated miRNA value as the proportion of patients who have the particular miRNA elevated.
    Utility of the 4-miRNA panel as markers diagnostic of MGCTs [ Time Frame: Up to 10 years ] Will compare the diagnostic sensitivity of serum markers, particularly elevated alpha-fetoprotein, to that of elevated microRNA for each of the microRNAs, as well as the characteristic any microRNA elevated. Will perform McNemar's test. The result for each serum evaluation (elevated or not elevated) for each sample on which both serum marker and microRNA evaluation are obtained will be cross tabulated and the p-value associated with McNemar's test calculated. A p-value of 0.05 or less will be considered evidence of differential sensitivity.

    Other Outcome Measures:
    Activation of protein signaling pathway [ Time Frame: Up to 10 years ] Will assess the relationship between pathway activation, including EGFR, MAP Kinase and P3K and risk for disease progression. Tumor materials will be evaluated for the activation of specific pathways, including the three mentioned above. The effect of pathway activation, coded as yes vs. no, on the cause-specific hazard of EFS component disease progression will be estimated by relative risk regression considering other EFS events as censoring events. Will use the Benjamini and Hochberg procedure to control the false discovery rate.
    Binomial data [ Time Frame: Up to 10 years ] Will use repeated measures binomial data as the initial approach to investigating this exploratory aim. Each biomarker will be examined individually. The predictor variables will be the measured value of particular novel biomarker and randomized treatment regimen. The response variable will be the occurrence of grade 3 or higher nephrotoxicity during the next treatment cycle. Will use logistic regression with a shared random frailty for outcomes for the same individual, when the subject's biomarkers are evaluated more than once during protocol therapy and the particular toxicity type is revers
    Incidence of kidney dysfunction [ Time Frame: 12-16 weeks after the last dose of platin therapy ] Two patient characteristics will be used to measure kidney dysfunction: (1) the presence of Grade 1 or greater elevation of serum creatinine; and a second measure that is more sensitive for damage to the renal endothelium (2) albuminuria.
    Incidence of self-reported peripheral neuropathy assessed by the 11-item Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale [ Time Frame: Up to 12 months ] Will compare the characteristics obtained at the start of chemotherapy of patients from the relevant groups who contribute to the patient reported outcome analyses with those who do not to investigate whether the measured group may not be representative of the study population. Will also conduct other sensitivity analysis as appropriate to assess the effects of missing data on the analysis for this aim.
    Incidence of self-reported peripheral neuropathy assessed by the 11-item Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale [ Time Frame: Up to 12 months ] Will compare self-reported peripheral neuropathy and other patient-reported outcomes between children, adolescents and young adults with standard risk germ cell tumors treated with carboplatin-based chemotherapy as compared to cisplatin based chemotherapy.
    Prognostic effects of the marker defined by microRNA signature present or high values of alpha-fetoprotein or beta-HCG [ Time Frame: Up to 10 years ] Will be assessed using a proportional approach. EFS from time of enrollment will be used for markers that are obtained at enrollment. EFS post complete evaluation of marker decline will be used for markers where the characteristic is the change in a putative marker.
    Prognostic significance of the 4-miRNA panel [ Time Frame: Up to 10 years ] Will be assessed using time-dependent covariate analysis.

    TRIAL NUMBER: AGCT1532

    Title: Phase 3 Accelerated BEP Trial: A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours

    Purpose: The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumours.
    Bleomycin, Etoposide, Cisplatin (BEP) administered 3-weekly x 4 remains standard 1st line chemotherapy for intermediate- and poor-risk metastatic germ cell tumours (GCTs). Cure rates are over 90% for good-risk disease, 85% with intermediate-risk, and about 70% for poor-risk disease. Previous strategies to improve first-line chemotherapy have failed to improve cure rates and were more toxic than BEP. New strategies are needed for patients with intermediate and poor-risk disease. BEP is accelerated by cycling Cisplatin and etoposide 2-weekly instead of 3-weekly. The Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) is conducting a trial comparing accelerated BEP with standard BEP. The aim of this study is to determine if accelerated BEP is superior to standard BEP as first-line chemotherapy for intermediate and poor risk metastatic GCTs.

    TRIAL NUMBER: ALTE05N1

    Title: Umbrella Long-Term Follow-Up Protocol

    Purpose: OBJECTIVES:
    ?To develop a mechanism for tracking and retaining patients enrolled on COG protocols. ?To maintain regular, lifetime contact with patients in order to obtain current identification and contact information, and self/parent-reported health status. ?To locate patients who are lost-to-follow-up for COG (or Legacy Group) protocols targeted for follow-up by the Long-Term Follow-Up Center (LTFC). ?To provide current patient contact information and self/parent-reported health status updates to the COG Statistics and Data Center (SDC) and to each patient's COG institution. ?To facilitate collection of protocol-specific outcome data through collaboration with the COG Late Effects Committee, the SDC, and the member institutions. ?To collect cumulative therapeutic exposure data (via therapeutic summaries completed online by treating institutions) on patients completing active therapy. OUTLINE: This is an umbrella protocol for all long-term follow-up at COG institutions. Approximately 6 months after completion of therapy patients receive a mailed packet introducing the Long-Term Follow-Up Center (LTFC) and containing information related to their individualized, protocol-specific follow-up guidelines. Patients are asked to complete a patient response form, verify information provided in packet, update contact information, and complete a Health Status Update Form. The Health Status Update Form is a brief document including questions about current health status, disease status, and cancer therapy received since the last mailing. Patients receive protocol-specific automatic reminders, and may respond by use of postage prepaid envelopes, email, or 24-hour toll-free telephone.

    TRIAL NUMBER: APEC1621A

    Title: Pediatric MATCH: Trk Inhibitor LOXO-101 in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions

    Purpose: This phase II trial studies Trk inhibitor LOXO-101 in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that have spread to other places in the body and have come back or do not respond to treatment. Trk inhibitor LOXO-101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth

    TRIAL NUMBER: APEC1621B

    Title: Pediatric MATCH: Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations

    Purpose: This phase II trial studies how well erdafitinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have spread to other places in the body and have come back or do not respond to treatment with FGFR mutations. Erdafitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621C

    Title: Pediatric MATCH: Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations

    Purpose: This phase II trial studies how well tazemetostat works in treating patients with solid tumors, non-hodgkin lymphoma, or histiocytic disorders that have spread to other places in the body and have come back or do not respond to treatment and have EZH2, SMARCB1, or SMARCA4 gene mutations. Tazemetostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621D

    Title: Pediatric MATCH: PI3K/mTOR Inhibitor LY3023414 in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations

    Purpose: This phase II trial studies how well PI3K/mTOR inhibitor LY3023414 works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with TSC or PI3K/MTOR mutations that have spread to other places in the body and have come back or do not respond to treatment. PI3K/mTOR inhibitor LY3023414 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621E

    Title: Pediatric MATCH: Selumetinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating MAPK Pathway Mutations

    Purpose: This phase II trial studies how well selumetinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with MAPK pathway activation mutations that have spread to other places in the body and have come back or do not respond to treatment. Selumetinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621F

    Title: Pediatric MATCH: Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations

    Purpose: This phase II trial studies how well ensartinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that have come back or do not respond to treatment and have spread to other places in the body. Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621G

    Title: Pediatric MATCH: Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations

    Purpose: This phase II trial studies how well vemurafenib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with BRAF V600 mutations that have spread to other places in the body and have come back or do not respond to treatment. Vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621H

    Title: Pediatric MATCH: Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes

    Purpose: This phase II trial studies how well olaparib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with defects in deoxyribonucleic acid (DNA) damage repair genes that have spread to other places in the body and have come back or do not respond to treatment. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621SC

    Title: Pediatric MATCH: Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders

    Purpose: This screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.

    TRIAL NUMBER: EAY131

    Title: EAY131: Molecular Analysis for Therapy Choice (NCI-MATCH)

    Purpose: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

    TRIAL NUMBER: S1609

    Title: SWOG 1609: DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors Treatment with Ipilimumab and Nivolumab for Rare Cancers

    Purpose: Both Ipilimumab and Nivolumab have already been FDA-approved to treat other cancers. However, Ipilimumab and Nivolumab are investigational and not FDA-approved for use in combination in treating rare cancers or cancers of unknown primary origin.

    TRIAL NUMBER: EAA173

    Title: DARATUMUMAB TO ENHANCE THERAPEUTIC EFFECTIVENESS OF REVLIMID IN SMOLDERING MYELOMA (DETER-SMM)

    Purpose: Primary Outcome Measures :
    Overall survival (OS) [ Time Frame: From randomization to death due to any cause, or censored at date last known alive, assessed up to 15 years ] Will be estimated using the Kaplan-Meier (KM) method and compared using a stratified log-rank test. Stratified cox proportional hazards regression will produce a treatment hazard ratio estimate.
    Functional Assessment of Cancer Therapy-General (FACT-G) score [ Time Frame: Baseline to 24 cycles of treatment (each cycle is 28 days) ] A general effect size measure of half standard deviation will be used to establish the minimally important difference. Descriptive statistics (mean, standard deviation [SD], median, range) will be used to evaluate the distribution of levels and changes for the set of health-related quality of life (QOL) evaluations. Levels and changes will also be assessed graphically. Changes from baseline will be analyzed using linear mixed models based on restricted maximum likelihood estimation with covariance matrix maximizing Akaike information criteria. Models with treatment, assessment time, and treatment by assessment time interaction with and without other predictors will be fit. If there is substantial missingness, will analyze the data according to the methods described in Schluchter and Schluchter, Greene and Beck.

    Secondary Outcome Measures :
    Progression-free survival (PFS) [ Time Frame: From randomization until disease progression or death due to any cause, or censored at date of last disease evaluation, assessed up to 15 years ] Will be estimated using the KM method and compared using a stratified log-rank test. Stratified cox proportional hazards regression will produce a treatment hazard ratio estimate.
    Best response on treatment based on International Myeloma Working Group (IMWG) criteria [ Time Frame: At 12 and 24 months ] Response will be tabulated by category. Response rates of very good partial response (VGPR) or better and partial response (PR) or better will be compared using the Fisher's exact test. Ineligible patients are excluded from the analysis and unevaluable patients are counted in the denominator.
    Incidence of adverse events by worst grade and type for treated patients determined using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: Up to 28 days post-treatment ] Will monitor the toxicities experienced by all treated patients. Will compare rates of worst grade 3 or higher non-hematologic treatment-related events using the Fisher's exact test.
    Incidence of grade 3 or higher infusion-related reactions over course 1 determined based on CTCAE [ Time Frame: During cycle 1 of treatment (each cycle is 28 days) ] Will monitor the toxicities experienced by all treated patients. Will compare rates of worst grade 3 or higher non-hematologic treatment-related events using the Fisher's exact test.
    Stem cell (SC) mobilization failure [ Time Frame: After 4 to 6 cycles of treatment (each cycle is 28 days) ] Defined as not collecting a minimum of 5x10^6 CD34 cells per kilogram weight. SC mobilization and type of growth factor support will be summarized overall and by treatment arm with descriptive statistics.
    Early SC mobilization feasibility [ Time Frame: Up to 6 cycles of treatment (each cycle is 28 days) ] Defined as the proportion of patients less than 65 years of age treated for 6 courses who opt for SC mobilization. SC mobilization and type of growth factor support will be summarized overall and by treatment arm with descriptive statistics.
    Type of growth factor support [ Time Frame: During 4 to 6 cycles of treatment (each cycle is 28 days) ] SC mobilization and type of growth factor support will be summarized overall and by treatment arm with descriptive statistics.
    Change in FACT-G score [ Time Frame: From treatment end to 6 months post-treatment ] A general effect size measure of half standard deviation will be used to establish the minimally important difference. Descriptive statistics (mean, SD, median, range) will be used to evaluate the distribution of levels and changes for the set of health-related QOL evaluations. Levels and changes will also be assessed graphically. Changes from baseline will be analyzed using linear mixed models based on restricted maximum likelihood estimation with covariance matrix maximizing Akaike information criteria. Models with treatment, assessment time, and treatment by assessment time interaction with and without other predictors will be fit. If there is substantial missingness, will analyze the data according to the methods described in Schluchter and Schluchter, Greene and Beck.
    Levels of FACT-G score at each assessment time point [ Time Frame: From baseline, at 3, f7, 13, 19 cycles of treatment, and early discontinuation of treatment, assessed up to 24 cycles of treatment (each cycle is 28 days) ] A general effect size measure of half standard deviation will be used to establish the minimally important difference. Descriptive statistics (mean, SD, median, range) will be used to evaluate the distribution of levels and changes for the set of health-related QOL evaluations. Levels and changes will also be assessed graphically. Changes from baseline will be analyzed using linear mixed models based on restricted maximum likelihood estimation with covariance matrix maximizing Akaike information criteria. Models with treatment, assessment time, and treatment by assessment time interaction with and without other predictors will be fit. If there is substantial missingness, will analyze the data according to the methods described in Schluchter and Schluchter, Greene and Beck.
    Time to worsening of FACT-G [ Time Frame: From baseline until a decrease of 9 points, or censored at date of last assessment, assessed up to 6 months post-treatment ] Will be analyzed with Kaplan-Meier methods and Cox regression with the related treatment arm as the only factor. Correlation between time to worsening of symptoms with PFS and OS will be assessed with Kendall's Tau adjusted for censored observations.

    Other Outcome Measures:
    Cumulative dose calculated as the sum of all doses taken across all cycles [ Time Frame: Up to 24 months ] Cumulative dose will be calculated overall and by cycle. Data will be summarized by treatment arm with descriptive statistics and graphically over time. Patients will be classified into dichotomous groups based on a 75% relative dose intensity cutoff (< 75% versus [vs] >= 75% represents poor vs good treatment adherence). The proportion of patients with poor lenalidomide treatment adherence will be compared between arms using the Fisher's exact test. In addition, multi-variable logistic regression analysis will be conducted to identify the baseline factors associated with calculated good treatment adherence.
    Dose intensity calculated as cumulative dose received divided by treatment duration [ Time Frame: Up to 24 months ] Dose intensity will be calculated overall and by cycle. Data will be summarized by treatment arm with descriptive statistics and graphically over time. Patients will be classified into dichotomous groups based on a 75% relative dose intensity cutoff (< 75% vs >= 75% represents poor vs good treatment adherence). The proportion of patients with poor lenalidomide treatment adherence will be compared between arms using the Fisher's exact test. In addition, multi-variable logistic regression analysis will be conducted to identify the baseline factors associated with calculated good treatment adherence.
    Relative dose intensity calculated as the dose intensity divided by planned dose intensity [ Time Frame: Up to 24 months ] Dose intensity will be calculated overall and by cycle. Data will be summarized by treatment arm with descriptive statistics and graphically over time. Patients will be classified into dichotomous groups based on a 75% relative dose intensity cutoff (< 75% vs >= 75% represents poor vs good treatment adherence). The proportion of patients with poor lenalidomide treatment adherence will be compared between arms using the Fisher's exact test. In addition, multi-variable logistic regression analysis will be conducted to identify the baseline factors associated with calculated good treatment adherence.
    Duration of treatment [ Time Frame: From randomization to date off treatment, or censored at the date of last treatment, assessed up to 24 months ] Treatment duration in each arm will be estimated using Kaplan-Meier methods and compared between arms with the log-rank test.
    Time to progression [ Time Frame: From randomization to progression, or censored at date of last disease evaluation, assessed up to 15 years ] Will be estimated using the Kaplan-Meier method.
    Presence, frequency, interference, amount and/or severity of select patient reported outcomes (PRO)-CTCAEs [ Time Frame: Assessed at each treatment cycle, from cycle 1 of treatment to end of treatment, up to 24 cycles of treatment (each cycle is 28 days) ] Descriptive statistics (mean, standard deviation, median, range) will be used to summarize selected PRO-CTCAEs tabulated at each cycle overall and by arm. Will map PRO-CTCAEs with provider reported adverse events (AEs) and evaluate differences in incidence and worst severity. Items correspond to 5 attributes measured [frequency (F), severity (S), interference (I), presence/absence (P) and amount (A)] based on multiple choice questions. Response for each attribute except P which is binary is on a 5-point Likert scale with 5 indicating 'almost constantly' frequency, 'very severe' severity, 'very much' amount or 'very much' interference. An overall PRO-CTCAE score will be calculated at each time point.
    Overall PRO-CTCAE score [ Time Frame: Up to 15 years ] Defined as the sum of item scores on all symptomatic adverse events (AEs). Descriptive statistics will be used to summarize selected PRO-CTCAEs tabulated at each cycle overall and by arm. Will map PRO-CTCAEs with provider reported AEs and evaluate differences in incidence and worst severity. An overall PRO-CTCAE score will be calculated at each time point.
    Adherence Starts with Knowledge (ASK)-12 scores [ Time Frame: At 7, 13, and 19 cycles of treatment (each cycle is 28 days) ] Descriptive statistics will be used to summarize ASK-12 scores tabulated at cycles 7, 13 and 19 overall and by arm. Differences between arms will be evaluated based a t-test (or Wilcoxon rank sum test). Patients will also be classified into high versus low likelihood of medication adherence groups according to tertile distributions (lowest tertile vs second and top). Association between likelihood of medication adherence and calculated treatment adherence dichotomous groups will be evaluated in patients with both ASK-12 and treatment data at cycles 7, 13 and 19 post randomization. In addition, multivariable logistic regression analysis will be conducted to identify the baseline factors associated with low likelihood of medication adherence.
    PRO compliance rate [ Time Frame: Up to 15 years ] Defined as the proportion of patients who submit the given PRO instrument among those eligible at each time point which excludes those missing by design (due to death or disease progression, early treatment discontinuation).
    PRO completion rate [ Time Frame: Up to 15 years ] Defined as the proportion of patients who complete given PRO instrument based on the instrument's scoring system among those eligible at each time point.

    TRIAL NUMBER: ANBL1821

    Title: A PHASE 2 RANDOMIZED STUDY OF IRINOTECAN/TEMOZOLOMIDE/DINUTUXIMAB WITH OR WITHOUT EFLORNITHINE (DFMO) (IND#141913) IN CHILDREN WITH RELAPSED, REFRACTORY OR PROGRESSIVE NEUROBLASTOMA

    Purpose:

    Primary Outcome Measures :
    1. Response rate [ Time Frame: Up to the first 6 cycles of treatment ]
      Responders are defined as patients who achieve a >= minor response (MR) per the International Neuroblastoma Response Criteria (INRC) as their best overall response by the end of 6 cycles. The response rate to treatment will be calculated among all eligible patients, including placement of a 95% confidence interval on the response rate.


    Secondary Outcome Measures :
    1. Progression-free survival (PFS) [ Time Frame: Up to 5 years ]
      Kaplan-Meier method will be used to estimate progression-free survival (PFS). PFS time will be calculated from the time of randomization to the occurrence of relapse, progressive disease, or death. Patients without a PFS event will be censored at the time of last follow-up.

    2. Overall survival (OS) [ Time Frame: Up to 5 years ]
      Kaplan-Meier method will be used to estimate overall survival (OS). OS time will be calculated from the time of randomization to the occurrence of death. Patients still alive will be censored at the time of last follow-up.

    3. Incidence of adverse events >= Grade 3 (Regimen B) [ Time Frame: Up to 5 years ]
      The percentage of patients on Regimen B with at least one Grade 3 or higher toxicity will be calculated, assessed with Common Terminology Criteria for Adverse Events version 5.0.


    Other Outcome Measures:
    1. Immune and cytokine profiles [ Time Frame: Up to 6 cycles ]
      Will be assessed by exploring the relationship between response (responder versus [vs.] non-responder) after 6 cycles on Regimen B with serum cytokine levels (IL1, IL6, tumor necrosis factor [TNF]-alpha, IFN-gamma, etc.), tumor resident immune cells (natural killer [NK] cells, tumor-associated macrophages [TAMS], tumor infiltrating lymphocyte [TILS]), and critical immune cell suppressing proteins (B7H3, PDL-1) using Fisher's exact test for categorical and Wilcoxon rank-sum test for continuous factors.

    2. GD2 levels in tumor cells from bone marrow samples [ Time Frame: Up to 5 years ]
      Will be correlated with response (responder vs. non-responder) after 6 cycles using Fisher?s exact test for categorical and the Wilcoxon rank-sum test for continuous factors.

    3. Patient reported pain and opiate usage [ Time Frame: Up to 5 years ]
      The occurrence of pain on each regimen as reported by patient report and opiate use will be descriptively summarized. Descriptive and summary statistics will be used to describe the scores from the Faces Pain Scale-Revised during the dinutuximab infusion and on day 1 with irinotecan and temozolomide alone for each arm separately. Confidence intervals will be constructed for the mean and frequency estimates. The day 1 patient reported outcome data are expected to be similar between the 2 regimens, while differences during or after completion of treatment may be observed.

    TRIAL NUMBER: NRG-GU002

    Title: NRG-GU002: PHASE II-III TRIAL OF ADJUVANT RADIOTHERAPY AND ANDROGEN DEPRIVATION FOLLOWING RADICAL PROSTATECTOMY WITH OR WITHOUT ADJUVANT DOCETAXEL

    Purpose: This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.

    TRIAL NUMBER: AREN1721

    Title: A RANDOMIZED PHASE 2 TRIAL OF AXITINIB/NIVOLUMAB COMBINATION THERAPY VS. SINGLE AGENT AXITINIB OR NIVOLUMAB FOR THE TREATMENT OF TFE/TRANSLOCATION RENAL CELL CARCINOMA (tRCC) ACROSS ALL AGE GROUPS

    Purpose:

    Primary Outcome Measures :
    1. Progression free survival [ Time Frame: From initiation of treatment assessed up to 4 years ]

    Other Outcome Measures:
    1. Translocation morphology renal cell carcinoma clinical behavior [ Time Frame: Up to 4 years ]
      Will list and summarize the frequency of site(s) of disease at presentation (including extent of lymph node involvement), site(s) of relapse, surgical practices on protocol therapy, and radiotherapy practices on protocol therapy.

    2. Type of antitumor immune response and stability of T cell activation [ Time Frame: Baseline up to 4 years ]
      Will summarize the levels of analytes and tumor expression before and after treatment and evaluate the changes due to treatment after logarithmic transformation using the paired t-test. Analytes include myeloid derived stem cells: CD45, CD11b, CD33, CD14, CD15, HLA-DR, viability, stain 1; regulatory T cells: viability, CD45, CE4, CD3, CD24, FoxP3; CD8 T cells (CD45, CD8, CD3); CD8 phenotype and activation and exhaustion (CD69, CD38, PD1, CD244, TIM3). Tumor expression of PDL-1, PD1, CD3, CD4 and CD8 will be assessed using TFE renal cell carcinoma samples from the study and scored for intensity (0 - 3).

    TRIAL NUMBER: S1400F

    Title: A PHASE II STUDY OF MEDI4736 (DURVALUMAB) PLUS TREMELIMUMAB AS THERAPY FOR PATIENTS WITH PREVIOUSLY TREATED ANTI-PD-1/PD-L1 RESISTANT STAGE IV SQUAMOUS CELL LUNG CANCER (LUNG-MAP NON-MATCH SUB-STUDY)

    Purpose: Primary Outcome Measures: Investigator-assessed progression-free survival as defined by Response Evaluation Criteria in Solid Tumors 1.1 (Design #1, Phase II) [ Time Frame: From date of sub-study registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 18 months since completion of accrual ] A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to investigator-assessed progression-free survival, comparing the two treatment arms.
    Investigator-assessed progression-free survival in patients with advanced stage refractory squamous cell carcinoma of the lung randomized to receive investigational therapy vs standard therapy (Design #2,Phase III,Option for Biomarker-driven sub-studies) [ Time Frame: Up to 3 years ] Estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median investigator-assessed progression-free survival. A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to progression free survival comparing the two treatment arms at the levels specified.
    Less than 33% improvement in median investigator-assessed progression-free survival as defined as Response Evaluation Criteria in Solid Tumors 1.1 (Design #1, Phase III) [ Time Frame: From date of sub-study registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 18 months since completion of accrual ] A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to investigator-assessed progression-free survival, comparing the two treatment arms. A Cox PH model will be used to estimate the hazard ratios and associated confidence intervals.
    Objective response rate (confirmed and unconfirmed, complete and partial) (Design #2, Phase II, Option for Biomarker-driven Sub-studies) [ Time Frame: Up to 3 years ] The investigational therapy arm will be judged to have provided sufficient evidence to proceed to the Phase III component if the objective response rate is at least 25%. Response rates and associated confidence intervals will be calculated.
    Objective response rate (confirmed and unconfirmed, complete and partial) in patients treated with investigational non-match therapy with advanced stage refractory squamous cell carcinoma of the lung (Design #2, Option for Non-Match Sub-Studies) [ Time Frame: Up to 3 years ] Response rates and associated confidence intervals will be calculated.
    Overall survival (Design #1, Phase III) [ Time Frame: From date of sub-study registration (or date of screening registration if patient never enrolls in a sub-study) to date of death due to any cause, assessed up to 3 years ] A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to overall survival, comparing the two treatment arms. A Cox PH model will be used to estimate the hazard ratios and associated confidence intervals.
    Overall survival in patients with advanced stage refractory squamous cell carcinoma of the lung randomized to receive investigational therapy versus standard therapy (Design #2, Phase III, Option for Biomarker-driven Sub-studies) [ Time Frame: Up to 3 years ] The Brookmeyer-Crowley method will be used to calculate confidence intervals for median overall survival. A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to overall survival comparing the two treatment arms at the levels specified.

    Secondary Outcome Measures: Duration of response among patients who achieve a complete response or partial response by Response Evaluation Criteria in Solid Tumors 1.1 (Design #2, Phase II, Option for Biomarker-driven Sub-studies and Design #2, Option for Non-Match Sub-studies) [ Time Frame: Up to 3 years ] Estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median duration of response.
    Frequency and severity of toxicities associated with investigational therapy versus standard therapy (Design #2, Phase III, Option for Biomarker-driven Sub-studies) [ Time Frame: Up to 3 years ] Analysis of toxicities will be performed using a chi-square or Fisher?s exact test, as appropriate.
    Investigator-assessed progression-free survival, censoring patients with symptomatic deterioration at the time of symptomatic deterioration (Design #1, Phase III) [ Time Frame: From date of sub-study registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 3 years ] Descriptive data will be presented.
    Overall survival with investigational therapy (Design #2, Phase II, Option for Biomarker-driven Sub-studies and Design #2, Option for Non-Match Sub-studies) [ Time Frame: Up to 3 years ] A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to overall survival comparing the two treatment arms at the levels specified. A Cox PH model will be used to estimate the hazard ratios and associated confidence intervals.
    Progression free survival with investigational therapy (Design #2, Phase II, Option for Biomarker-driven Sub-studies and Design #2, Option for Non-Match Sub-studies) [ Time Frame: Up to 3 years ] A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to progression free survival comparing the two treatment arms at the levels specified. A Cox PH model will be used to estimate the hazard ratios and associated confidence intervals.
    Response rate (confirmed and unconfirmed) in patients with measurable disease as defined by Response Evaluation Criteria in Solid Tumors 1.1 (Design #1, Phase II and III) [ Time Frame: Up to 3 years ] Analysis will be performed using a chi squared or Fisher?s exact test, as appropriate. Response proportions will be compared using a 1-sided Fisher?s exact test at the 0.001 level.
    Response rates (confirmed and unconfirmed, complete and partial) among patients randomized to receive investigational therapy versus standard therapy (Design #2, Phase III, Option for Biomarker-driven Sub-studies) [ Time Frame: Up to 3 years ] Analysis of response rates will be performed using a chi-square or Fisher?s exact test, as appropriate.
    Severity of toxicities associated with investigational therapy versus standard therapy (Design #2, Phase II, Option for Biomarker-driven Sub-studies and Design #2, Option for Non-Match Sub-studies) [ Time Frame: Up to 3 years ] Analysis of toxicities will be performed using a chi-square or Fisher?s exact test, as appropriate.
    Toxicity frequencies, monitored using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Design #1, Phase II and III) [ Time Frame: Up to 3 years ] Analysis will be performed using a chi squared or Fisher?s exact test, as appropriate.

    Other Outcome Measures: Screen success rate, monitored by the percentage of screened patients that register to a therapeutic sub-study [ Time Frame: Up to 3 years ] Descriptive data will be presented.
    Treatment arm randomization acceptance rate, monitored by the percentage of patients that receive at least one dose of the treatment they are randomized to (Design #1) [ Time Frame: Up to 3 years ] Descriptive data will be presented.

    Estimated Enrollment: 10000 Actual Study Start Date: June 16, 2014 Estimated Study Completion Date: April 1, 2022 Estimated Primary Completion Date: April 1, 2022 (Final data collection date for primary outcome measure)

    TRIAL NUMBER: APEC1621J

    Title: NCI-COG PEDIATRIC MATCH (MOLECULAR ANALYSIS FOR THERAPY CHOICE)- PHASE 2 SUBPROTOCOL OF BVD-523FB (ULIXERTINIB) IN PATIENTS WITH TUMORS HARBORING ACTIVATING MAPK PATHWAY MUTATIONS

    Purpose: Primary Outcome Measures : Objective response rate (ORR = complete response [CR] + partial response [PR]) in pediatric patients treated with BVD-523FB (ulixertinib) [ Time Frame: Up to 2 years ] Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method

    Secondary Outcome Measures : Progression free survival (PFS) in pediatric patients treated with ulixertinib [ Time Frame: From initiation of treatment to disease progression, disease recurrence, or death from any cause assessed up to 2 years ] PFS along with the confidence intervals will be estimated using the Kaplan-Meier method.
    Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events version 5.0 [ Time Frame: Up to 2 years ] Toxicity tables will be constructed to summarize the observed incidence by type of toxicity and grade. A patient will be counted only once for a given toxicity for the worst grade of that toxicity reported for that patient. Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen.
    Preliminary estimates of the pharmacokinetics of ulixertinib in children and adolescents with relapsed or refractory cancer [ Time Frame: Pre-dose and 1, 2, 4, and 6-8 hours after dose on course 1, day 1; and pre-dose on course 1, day 2, and course 1, day 15 ] Will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).

    Other Outcome Measures: Other biomarkers as predictors of response to ulixertinib and whether tumors that harbor different mutations or fusions will demonstrate differential response to treatment [ Time Frame: Up to 2 years ] Will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.
    Profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA) [ Time Frame: Up to 2 years ] Will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.

    TRIAL NUMBER: A091605

    Title: A RANDOMIZED PHASE II STUDY OF ANTI-PD1 ANTIBODY [MK-3475 (PEMBROLIZUMAB)] ALONE VERSUS ANTI-PD1 ANTIBODY PLUS STEREOTACTIC BODY RADIATION THERAPY IN ADVANCED MERKEL CELL CARCINOMA

    Purpose: This randomized phase II trial studies how well pembrolizumab with or without stereotactic body radiation therapy works in treating patients with merkel cell cancer that has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving pembrolizumab with stereotactic body radiation therapy may work better in treating patients with merkel cell cancer.

    TRIAL NUMBER: A091802

    Title: Phase II Randomized Trial of Avelumab Plus Cetuximab Versus Avelumab Alone in Advanced Cutaneous Squamous Cell Carcinoma of the Skin (cSCC)

    Purpose: This phase II trial studies how well avelumab with or without cetuximab work in treating patients with skin squamous cell cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as avelumab and cetuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.


    TRIAL NUMBER: A031501

    Title: PHASE III RANDOMIZED ADJUVANT STUDY OF MK-3475 (PEMBROLIZUMAB) IN MUSCLE INVASIVE AND LOCALLY ADVANCED UROTHELIAL CARCINOMA (AMBASSADOR) VERSUS OBSERVATION

    Purpose: Primary Outcome Measures: Disease-free survival [ Time Frame: From randomization to the first metastatic recurrence (presence of any recurrent disease), or death, whichever occurs first, assessed up to 5 years ] The stratified proportional hazards model will be the primary analysis. The hazard ratio and its 95% confidence interval from the stratified Cox model with a single treatment covariate will be reported. The unstratified hazard ratio will also be presented.
    Overall survival [ Time Frame: From randomization to the date of death from any cause, assessed up to 5 years ] The stratified proportional hazards model will be the primary analysis. The hazard ratio and its 95% confidence interval from the stratified Cox model with a single treatment covariate will be reported. The unstratified hazard ratio will also be presented.

    Secondary Outcome Measures: Disease-free survival in PD-L1 positive and negative patients [ Time Frame: From randomization to the first metastatic recurrence (presence of any recurrent disease), or death, whichever occurs first, assessed up to 5 years ] The stratified proportional hazards model will be the primary analysis. The hazard ratio and its 95% confidence interval from the stratified Cox model with a single treatment covariate will be reported. The unstratified hazard ratio will also be presented.
    Overall survival in PD-L1 positive and negative patients [ Time Frame: From randomization to the date of death from any cause, assessed up to 5 years ] The stratified proportional hazards model will be the primary analysis. The hazard ratio and its 95% confidence interval from the stratified Cox model with a single treatment covariate will be reported. The unstratified hazard ratio will also be presented.

    Estimated Enrollment: 739 Actual Study Start Date: September 21, 2017 Estimated Study Completion Date: February 28, 2019 Estimated Primary Completion Date: February 28, 2019 (Final data collection date for primary outcome measure)

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    TRIAL NUMBER: ACNS1931

    Title: A Phase 3 Study of Selumetinib (NSC# 748727, IND# 77782) or Selumetinib in Combination with Vinblastine for non-NF1, non-TSC Patients with Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 Mutations

    Purpose:

    Primary Outcome Measures :
    1. Maximum tolerated dose/recommended phase II dose (MTD/RP2D) of selumetinib and vinblastine combination (feasibility) [ Time Frame: 1 month post enrollment ]
      The MTD is empirically defined as the highest dose level at which 6 patients have been treated with at most one patient experiencing a dose-limiting toxicity (DLT) and the next higher dose level has been determined to be too toxic.

    2. Event-free survival (efficacy) [ Time Frame: Up to 5 years after enrollment ]
      Will use Kaplan-Meier (KM) methods and stratified log-rank tests to estimate EFS per arm and compare the EFS outcome between the two arms to assess difference in efficacy. EFS is defined as the interval from randomization to the first occurrence of clinical or radiographic disease progression, disease recurrence, subsequent malignant neoplasm, or death from any cause. Patients who are event-free will be censored at the time of last follow-up.


    Secondary Outcome Measures :
    1. Radiographic tumor response rate (efficacy) [ Time Frame: Up to 2 years after enrollment ]
      Will summarize the radiologic response rates (complete response [CR] or partial response [PR] per arm and test for a difference between the 2 arms using an exact binomial test. PR is defined as greater than or equal to 50% reduction in target lesion size by bi-dimensional measurement on T2/FLAIR, as compared with the baseline measurements, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 8 weeks. CR must also be sustained for at least 8 weeks and requires complete disappearance of the target lesion on T2/FLAIR imaging (if enhancement had been present, it must have resolved completely); No new lesions, no new T2/FLAIR abnormalities, and no new or increased enhancement; Patients must be off corticosteroids or only on physiological replacement doses; and Patients should be stable or improved clinically.

    2. Overall survival (OS) (efficacy) [ Time Frame: Up to 5 years after enrollment ]
      Will use the KM methods to estimate OS for each treatment arm and use stratified log-rank tests to determine whether there is a difference in OS between the 2 arms. OS is defined as the interval from randomization to death from any cause or to the time of last follow-up for patients who are alive at the time of analysis

    3. EFS by BRAF Status [ Time Frame: Up to 5 years after enrollment ]
      Will use KM methods to estimate the difference in EFS and between patients with BRAF rearranged LGG and patients with non-BRAF rearranged LGG after treatment with selumetinib + vinblastine versus single-agent selumetinib. EFS is defined as the interval from randomization to the first occurrence of clinical or radiographic disease progression, disease recurrence, subsequent malignant neoplasm, or death from any cause. Patients who are event-free will be censored at the time of last follow-up

    4. Incidence of adverse events (feasibility) [ Time Frame: Up to 5 years ]
      Toxicities will be summarized by dose level and by attribution to vinblastine versus selumetinib during the feasibility component.

    5. Incidence of adverse events (efficacy) [ Time Frame: Up to 5 years ]
      Reported toxicities will be summarized per arm for the efficacy component.

    6. Quality of life (QOL) [ Time Frame: Baseline to cycle 7 day 1 ]
      Will use 2-sample 2-sided t-tests to compare the change from baseline in the PedsQL? Generic Module Total Scale Score between the two treatment arms at Cycle 7 Day 1 for both patient and parent-proxy report.

    7. Visual outcome comparison [ Time Frame: 12 months after enrollment ]
      Will use an exact binomial test to compare the difference in the proportion of subjects in each arm that show improvement in visual acuity per Teller Acuity assessment after 12 months of treatment using a 1-sided test with 10% type 1 error.

    TRIAL NUMBER: CHDCP-001

    Title: DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)

    Purpose:

    TRIAL NUMBER: ANBL1531

    Title: ANBL1531, A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)

    Purpose: ANBL1531 is a COG group-wide Phase III study for patients between 1-30 years of age with neuroblastoma or ganglioneuroblastoma (nodular). In this study, researchers want to find out if we can improve the treatment for subjects with high-risk NBL by adding the experimental drug 131I-MIBG or the experimental drug crizotinib to COG recommended therapy. (Subjects are people who agree to take part in this study). 131I-MIBG is an experimental anticancer drug that has not been approved by the Food and Drug Administration (FDA) for use in treating high-risk NBL. 131I-MIBG has been used to treat NBL that did not respond to standard therapy or that has come back. 131I-MIBG has been shown to be well tolerated in children with cancer. Crizotinib is an experimental anticancer drug that has not been approved by the FDA for use in treating high-risk NBL. Crizotinib has been approved by the FDA for use in treating adults with certain types of lung cancer that has spread. Crizotinib has been welltolerated in children and adults with cancer. Crizotinib will only be used in subjects whose tumor shows changes (mutations or increased number of copies) in a gene called ALK. Changes in the ALK gene are only found in 10-15% of children with high-risk NBL. The overall goals of this study are to: • Compare the effects, good and/or bad, of the experimental drug 131I-MIBG added to current COG recommended therapy to the effects of current COG recommended therapy without the experimental drug 131I-MIBG. • Compare the effects, good and/or bad, of the experimental drug crizotinib added to current COG recommended therapy to the effects of current COG recommended therapy without the experimental drug crizotinib. Another goal of this study is to: • Evaluate the effects, good and/or bad, of using the experimental drug 131I-MIBG and reducing the number of stem cell transplants from 2 to 1 by giving the drugs BuMel during Consolidation therapy. The goal for subjects in Arm D of this study is: • To see if subjects with a tumor that is 123I-MIBG non-avid and does not have changes in the ALK gene have better outcomes than those with 123I-MIBG avid NBL when treated with COG recommended therapy for high-risk neuroblastoma. An 123I-MIBG avid tumor means that the tumor took up 123I-MIBG during a scan. An 123IMIBG non-avid tumor means that the tumor did not take up 123I-MIBG during a scan. The goal for subjects in Arm E of this study is: • To see if subjects with a tumor that shows changes in the ALK gene will have improved outcomes when the experimental drug crizotinib is added to COG recommended therapy for high-risk neuroblastoma. Each subject on the ANBL1531 study will have genetic tests done on his/her tumor tissue. The tumor tissue will be tested for changes to a gene called ALK. The experimental drug crizotinib may be effective against tumors with ALK gene changes.

    TRIAL NUMBER: APEC14B1

    Title: Project: Every Child for Younger Patients With Cancer

    Purpose: This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

    TRIAL NUMBER: COG-AALL1731

    Title: A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy)

    Purpose:

    Primary Outcome Measures :
    1. Post-Consolidation disease free survival (DFS) with addition of 2 cycle of blinatumomab in patients with standard risk (SR) B-lymphoblastic leukemia (B-ALL) and higher risk features, and patients with standard risk average (SR-Avg) B-ALL [ Time Frame: 5 years ]
      Efficacy design and standard survival analysis methods used to detect improvement in post-Consolidation DFS due to the addition of 2 cycles of blinatumomab to standard therapy in patients with SR B-ALL and higher risk features, and patients with SR-Avg B-ALL who are negative for minimal residual disease (MRD) by flow cytometry but have detectable or indeterminate MRD as measured by high-throughput sequencing (HTS) at end of induction (EOI), and patients with double trisomy of chromosomes 4 and 10 (DT) with MRD (flow) 0.01% - <0.1%.

    2. DFS in boys in the SR-favorable subset of SR B-ALL [ Time Frame: 5 years ]
      Time from end of consolidation to first event (relapse, second malignant neoplasm, remission, death) or censored at date of last contact for those who are disease-free.


    Secondary Outcome Measures :
    1. DFS for patients with SR-Avg B-ALL who are negative for MRD measured by flow cytometry and HTS at EOI when treated with standard chemotherapy with a treatment duration of 2 years from the start of interim maintenance (IM)1, regardless of sex [ Time Frame: 5 years ]
      Time from end of consolidation to first event (relapse, second malignant neoplasm, remission, death) or censored at date of last contact for those who are disease-free.

    2. DFS for patients with standard-risk favorable (SR-Fav) B-ALL [ Time Frame: 5 years ]
      Time from end of consolidation to first event (relapse, second malignant neoplasm, remission, death) or censored at date of last contact for those who are disease-free.

    3. Treatment-related mortality in Down syndrome high risk (DS-high) patients after replacement of intensive elements of standard chemotherapy (omission of anthracyclines in induction, omission of the second month of DI) with 3 cycles of blinatumomab [ Time Frame: 5 years ]
    4. DFS of DS-High B-ALL patients when intensive elements of chemotherapy are replaced with 3 cycles of blinatumomab [ Time Frame: 5 years ]
      Time from end of consolidation to first event (relapse, second malignant neoplasm, remission, death) or censored at date of last contact for those who are disease-free.

    5. DFS of patients with localized B-lymphoblastic lymphoma receiving standard risk acute lymphoblastic leukemia therapy [ Time Frame: 5 years ]
      Time from end of consolidation to first event (relapse, second malignant neoplasm, remission, death) or censored at date of last contact for those who are disease-free.

    6. Neurocognitive functioning [ Time Frame: Baseline to 2 years after IM1 ]
      Compare the change in neurocognitive functioning, as measured by the CogState Cognitive Composite, from baseline to end-of-therapy among patients with ALL ages 4-< 10 years at the time of diagnosis between children from poor families (defined as presence of household material hardship (HMH), including either food, housing or energy insecurity) and non-poor families (absence of HMH).

    7. Caregiver burden and patient/proxy-reported symptoms among those enrolled in HMH [ Time Frame: Baseline to 2 years after IM1 ]
      Compare the demands and work limitations on caregivers of children with ALL receiving chemotherapy versus chemotherapy with the addition of blinatumomab and to compare the change in the demands and work limitations over time, measured by the Care of My Child with Cancer questionnaire and the Caregiver Work Limitations questionnaire during post-Induction therapy. Patient/proxy reported symptoms measured by Memorial Symptom Assessment Scale.


    Other Outcome Measures:
    1. Adaptive and innate immune functions and host genetic factors associated with severe infectious complications in children with DS B-ALL [ Time Frame: 5 years ]
      FlowSom high resolution clustering approach to identify cellular subsets and/or activation states (endophenotypes) that distinguish cases from controls. Conduct a genome-wide assessment using a case-control approach comparing those who develop grade 4-5 microbiologically documented infections (cases) compared to those who do not (controls).

    2. Neurocognitive, functional, and quality of life outcomes in patients with DS and ALL [ Time Frame: 5 years ]
      Measured by caregiver (parent/legal guardian) questionnaires.

    3. Prevalence of minimal marrow disease (MMD) in B-LLy [ Time Frame: 5 years ]
      Correlate MMD at diagnosis with outcome in patients with B-LLy.

    TRIAL NUMBER: S1826

    Title: A PHASE III, RANDOMIZED STUDY OF NIVOLUMAB (OPDIVO) PLUS AVD OR BRENTUXIMAB VEDOTIN (ADCETRIS) PLUS AVD IN PATIENTS (AGE >/= 12 YEARS) WITH NEWLY DIAGNOSED ADVANCED STAGE CLASSICAL HODGKIN LYMPHOMA

    Purpose:

    Primary Outcome Measures :
    1. Progression free survival (PFS) [ Time Frame: From date of registration to date of first observation of progressive disease according to the 2014 Lugano classification, or death due to any cause, assessed at 2 years ]
      Will test the null hypothesis (HR=1) for PFS using stratified log-rank test with a one-sided alpha of 0.021. The analysis will be based on modified intent-to-treat and will include all eligible patients as randomized regardless of treatment received. The one-sided alpha of .021 will control of the overall type-one error of the study (including the 2 interim superiority analyses) to be less than .025.


    Secondary Outcome Measures :
    1. Overall survival [ Time Frame: 2 years ]
    2. Event-free survival (EFS) [ Time Frame: From date of registration to date of first occurrence of EFS event, assessed at 2 years ]
      Will be estimated using Kaplan-Meier method and compared between treatment arms using cox regression model.

    3. Metabolic complete response rate [ Time Frame: Up to 10 years ]
      Defined using 2014 Lugano classification.

    4. Incidence of adverse events [ Time Frame: Up to 10 years ]
      Toxicity will be evaluated using Common Terminology Criteria of Adverse Events (CTCAE) version 5 items. Treatment-related toxicities between arms will be compared using Fisher's exact test stratified by age groups. Targeted patient-reported toxicities also will be collected at each time point using the Patient Reported Outcome (PRO)-CTCAE for patients 18 years and older and from youth 12-17 years, using the Pediatric (Ped) PRO-CTCAE

    TRIAL NUMBER: AGCT1531

    Title: A PHASE 3 STUDY OF ACTIVE SURVEILLANCE FOR LOW RISK AND A RANDOMIZED TRIAL OF CARBOPLATIN VS. CISPLATIN FOR STANDARD RISK PEDIATRIC AND ADULT PATIENTS WITH GERM CELL TUMORS

    Purpose: Primary Outcome Measures:
    EFS [ Time Frame: The time from study entry to the date of death, date of disease progression or recurrence, date of second malignant neoplasm or date of last contact and ascertained as alive, whichever comes first, assessed up to 5 years ] Overall survival (OS) [ Time Frame: The time from randomization to date of date of death or date of last follow-up and ascertained as alive, assessed up to 8 years ] A 1-sided lower 85% confidence limit for the 2-year survival will be constructed, and if this confidence limit is greater than 0.95, it will be concluded that the strategy provides sufficient OS.

    Secondary Outcome Measures:
    Content validity and understandability of AYA-Hearing Screen assessed by questionnaire [ Time Frame: Baseline ] Incidence of ototoxicity [ Time Frame: 4 weeks after the last dose of platin therapy ] Will compare the proportion of patients who demonstrate hearing loss according to the International Society of Pediatric Oncology criteria.
    Novel genetic variants associated with an increased risk of platinum-associated ototoxicity as determined by standard audiology [ Time Frame: Up to 10 years ] For each candidate gene, will perform an exact two-sided test for the equality of binomial proportions for the event - patient has the candidate gene. The two groups compared will be defined by the presence of SHL. Will use the Bonferroni correction to control experiment-wise error and designate the result as significant if the observed p-value is less than or equal to 0.0025.
    Utility of the 4-miRNA panel as markers diagnostic of MGCTs [ Time Frame: Up to 10 years ] Will use categorical data methods and estimate the probability of demonstrating an elevated miRNA value as the proportion of patients who have the particular miRNA elevated.
    Utility of the 4-miRNA panel as markers diagnostic of MGCTs [ Time Frame: Up to 10 years ] Will compare the diagnostic sensitivity of serum markers, particularly elevated alpha-fetoprotein, to that of elevated microRNA for each of the microRNAs, as well as the characteristic any microRNA elevated. Will perform McNemar's test. The result for each serum evaluation (elevated or not elevated) for each sample on which both serum marker and microRNA evaluation are obtained will be cross tabulated and the p-value associated with McNemar's test calculated. A p-value of 0.05 or less will be considered evidence of differential sensitivity.

    Other Outcome Measures:
    Activation of protein signaling pathway [ Time Frame: Up to 10 years ] Will assess the relationship between pathway activation, including EGFR, MAP Kinase and P3K and risk for disease progression. Tumor materials will be evaluated for the activation of specific pathways, including the three mentioned above. The effect of pathway activation, coded as yes vs. no, on the cause-specific hazard of EFS component disease progression will be estimated by relative risk regression considering other EFS events as censoring events. Will use the Benjamini and Hochberg procedure to control the false discovery rate.
    Binomial data [ Time Frame: Up to 10 years ] Will use repeated measures binomial data as the initial approach to investigating this exploratory aim. Each biomarker will be examined individually. The predictor variables will be the measured value of particular novel biomarker and randomized treatment regimen. The response variable will be the occurrence of grade 3 or higher nephrotoxicity during the next treatment cycle. Will use logistic regression with a shared random frailty for outcomes for the same individual, when the subject's biomarkers are evaluated more than once during protocol therapy and the particular toxicity type is revers
    Incidence of kidney dysfunction [ Time Frame: 12-16 weeks after the last dose of platin therapy ] Two patient characteristics will be used to measure kidney dysfunction: (1) the presence of Grade 1 or greater elevation of serum creatinine; and a second measure that is more sensitive for damage to the renal endothelium (2) albuminuria.
    Incidence of self-reported peripheral neuropathy assessed by the 11-item Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale [ Time Frame: Up to 12 months ] Will compare the characteristics obtained at the start of chemotherapy of patients from the relevant groups who contribute to the patient reported outcome analyses with those who do not to investigate whether the measured group may not be representative of the study population. Will also conduct other sensitivity analysis as appropriate to assess the effects of missing data on the analysis for this aim.
    Incidence of self-reported peripheral neuropathy assessed by the 11-item Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale [ Time Frame: Up to 12 months ] Will compare self-reported peripheral neuropathy and other patient-reported outcomes between children, adolescents and young adults with standard risk germ cell tumors treated with carboplatin-based chemotherapy as compared to cisplatin based chemotherapy.
    Prognostic effects of the marker defined by microRNA signature present or high values of alpha-fetoprotein or beta-HCG [ Time Frame: Up to 10 years ] Will be assessed using a proportional approach. EFS from time of enrollment will be used for markers that are obtained at enrollment. EFS post complete evaluation of marker decline will be used for markers where the characteristic is the change in a putative marker.
    Prognostic significance of the 4-miRNA panel [ Time Frame: Up to 10 years ] Will be assessed using time-dependent covariate analysis.

    TRIAL NUMBER: APEC1621A

    Title: Pediatric MATCH: Trk Inhibitor LOXO-101 in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions

    Purpose: This phase II trial studies Trk inhibitor LOXO-101 in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that have spread to other places in the body and have come back or do not respond to treatment. Trk inhibitor LOXO-101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth

    TRIAL NUMBER: APEC1621B

    Title: Pediatric MATCH: Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations

    Purpose: This phase II trial studies how well erdafitinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have spread to other places in the body and have come back or do not respond to treatment with FGFR mutations. Erdafitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621C

    Title: Pediatric MATCH: Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations

    Purpose: This phase II trial studies how well tazemetostat works in treating patients with solid tumors, non-hodgkin lymphoma, or histiocytic disorders that have spread to other places in the body and have come back or do not respond to treatment and have EZH2, SMARCB1, or SMARCA4 gene mutations. Tazemetostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621D

    Title: Pediatric MATCH: PI3K/mTOR Inhibitor LY3023414 in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations

    Purpose: This phase II trial studies how well PI3K/mTOR inhibitor LY3023414 works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with TSC or PI3K/MTOR mutations that have spread to other places in the body and have come back or do not respond to treatment. PI3K/mTOR inhibitor LY3023414 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621E

    Title: Pediatric MATCH: Selumetinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating MAPK Pathway Mutations

    Purpose: This phase II trial studies how well selumetinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with MAPK pathway activation mutations that have spread to other places in the body and have come back or do not respond to treatment. Selumetinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621F

    Title: Pediatric MATCH: Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations

    Purpose: This phase II trial studies how well ensartinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that have come back or do not respond to treatment and have spread to other places in the body. Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    TRIAL NUMBER: APEC1621SC

    Title: Pediatric MATCH: Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders

    Purpose: This screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.

    TRIAL NUMBER: ARST1921

    Title: A Safety, Pharmacokinetic and Efficacy Study of a ?-Secretase Inhibitor, Nirogacestat (PF-03084014; IND# 146375), in Children and Adolescents with Progressive, Surgically Unresectable Desmoid Tumors

    Purpose:

    Primary Outcome Measures :
    1. Progression-free survival (PFS) [ Time Frame: From initiation of treatment to occurrence of disease progression or death from any cause, assessed up to 2 years ]
      Will be estimated using the Kaplan-Meier method with the 95% confidence interval estimated by the Peto-Peto method.

    2. Incidence of adverse events [ Time Frame: Up to 2 years ]
      Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0. All grade 3 or above toxicities deemed related to study drug will be summarized. All grade 1 and 2 toxicities observed in > 5% of participants and deemed related to study drug will be reported.

    3. Pharmacokinetic (PK) parameter: systemic exposure [ Time Frame: Up to Cycle 3 (each cycle lasts 28 days) ]
      PK parameters of nirogacestat will be defined to quantify systemic exposure, drug clearance, terminal half-life and other pharmacokinetic characteristics. These PK parameters will be summarized with descriptive statistics, including means, medians, ranges, and standard deviations.

    4. Pharmacokinetic (PK) parameter: drug clearance [ Time Frame: Up to Cycle 3 (each cycle lasts 28 days) ]
      PK parameters of nirogacestat will be defined to quantify systemic exposure, drug clearance, terminal half-life and other pharmacokinetic characteristics. These PK parameters will be summarized with descriptive statistics, including means, medians, ranges, and standard deviations.

    5. Pharmacokinetic (PK) parameter: half-life [ Time Frame: Up to Cycle 3 (each cycle lasts 28 days) ]
      PK parameters of nirogacestat will be defined to quantify systemic exposure, drug clearance, terminal half-life and other pharmacokinetic characteristics. These PK parameters will be summarized with descriptive statistics, including means, medians, ranges, and standard deviations.


    Secondary Outcome Measures :
    1. Objective response rate [ Time Frame: Up to 24 months ]
      Defined by the rate of a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.


    Other Outcome Measures:
    1. CTNNB1 and APC gene mutations and genomic signatures [ Time Frame: Up to 2 years ]
      The chi-square test will be used to assess the correlation of CTNNB1 and APC gene mutations and genomic signatures with tumor response, and the long-rank test will be used to assess the correlation of CTNNB1 and APC gene mutations and genomic signatures with PFS.

    2. Changes in the levels of each of the lymphocyte subsets and immunoglobulins [ Time Frame: Up to 2 years ]
      Lymphocyte subsets include CD3 (total T cells), CD3+CD4+ (T helper cells), CD3+CD8+ (T cytotoxic cells), CD4:CD8 ratio, CD3+HLA-DR+ (activated T cells) percentages and absolute counts. The chi-square test will be used to assess the correlation of the levels of lymphocyte and immunoglobulin with tumor response, and the Cox regression will be used to assess the correlation of the levels of lymphocyte and immunoglobulin with PFS.

    3. Response assessments by the RECIST criteria [ Time Frame: Up to cycle 24 ]
    4. Response assessment by the World Health Organization (WHO) criteria [ Time Frame: Up to cycle 24 ]
    5. Patient reported outcomes (PROs) [ Time Frame: Up to 2 years ]
      The chi-square test will be used to assess the correlation of PROs summary scores with tumor response, and the Cox regression will be used to assess the correlation of PROs summary scores with PFS. Correlation between PRO summary scores using Patient Reported Outcomes Measurement Information System (PROMIS) and GOunder/DTRF DEsmoid Symptom/Impact Scale (GODDESS) will be assessed by performing inferences on the Pearson correlation coefficients.

    TRIAL NUMBER: ALTE2031

    Title: StepByStep: A Randomized Trial of a Mobile Health and Social Media Physical Activity Intervention among Adolescent and Young Adult Childhood Cancer Survivors

    Purpose: This phase III trial compares a multi-component mobile health and social media physical activity intervention versus wearing a physical activity tracker alone among adolescent and young adult childhood cancer survivors. Regular physical activity helps maintain healthy weight, energy levels, and health. Adolescents and young adults who complete treatment for cancer are often less active. They may gain weight and have more health problems compared to people the same age who have not had treatment for cancer. Comparing the 2 programs will help researchers learn how to increase physical activity levels over time and also how changes in physical activity levels affect health and quality of life over time.

    TRIAL NUMBER: AREN1921

    Title: Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

    Purpose:

    Primary Outcome Measures :
    1. Event-free survival (EFS) [ Time Frame: From study entry to the earliest of relapse or disease progression, second malignant neoplasm, or death from any cause, assessed up to 5 years after study enrollment ]
      For Strata 1-3, the primary analysis of EFS will consist of a one-sample, one-sided log rank test versus a historical control cohort (or representative distribution) with stratum-specific type I error levels. For Stratum 4, the primary analysis of EFS is descriptive, but with a desired level of precision to estimate 4-year EFS at the time of the final analysis (2 years after the last patient enrolls).


    Secondary Outcome Measures :
    1. Overall survival (OS) [ Time Frame: From study entry to death due to any cause, assessed up to 5 years after study enrollment ]
      For each stratum, OS will be estimated at the same time as the conclusive (interim or final) analysis and reported descriptively with 95% pointwise confidence bands.


    Other Outcome Measures:
    1. Incidence of grade 3-5 renal toxicity [ Time Frame: Up to 30 weeks on average for Stratum 4 only ]
      Incidence of grade 3-5 renal toxicity during protocol therapy will be monitored for Stratum 4 as part of a prospective safety monitoring plan. At the time of final study analysis, renal toxicity will be described by factors including age, relapse risk group, and timing and association (descriptive) with the exploratory renal toxicity biomarkers.

    2. Collection of blood and urine samples [ Time Frame: Up to 42 weeks on average for Strata 1-3 and up to 30 weeks on average for Stratum 4 ]
      For all Strata 1-4, serial blood and urine samples will be collected (during protocol therapy, at the end of protocol therapy, and at first relapse) and banked for future analysis such as evaluation of minimal residual disease by assessing levels of circulating tumor-derived deoxyribonucleic acid.

    3. p53 biomarker analysis [ Time Frame: Based on tissue collected at diagnosis (Strata 1 and 2 only), with outcomes collected up to 5 years after study entry ]
      For patients with diffuse anaplastic Wilms tumors (DAWT) (Strata 1 and 2), p53 from diagnostic tissue will be assessed, and rates of p53 mutations described overall and within each stratum. Degree of anaplasia as a predictor of p53 mutation status will be analyzed in logistic regression models, and association of p53 status with EFS and OS will be analyzed in Cox regression models, stratified by disease stage. Possible interactions between p53 mutation status and degree of anaplasia in outcome models will be explored.

    4. EFS for patients with gross total disease resection [ Time Frame: From study entry to the earliest of relapse or disease progression, second malignant neoplasm, or death from any cause, assessed up to 5 years after study enrollment ]
      EFS will be described for newly diagnosed disease stage 2-4 DAWT patients (Strata 1 and 2) and relapsed favorable histology Wilms tumors (FHWT) patients (Strata 3 and 4) who have gross total disease resection prior to enrollment or at the time of delayed nephrectomy following adjuvant chemotherapy. Kaplan-Meier curves will be reported by strata with 95% confidence bands. Potential prognostic factors for these patients will be explored in Cox regression models.

    5. OS for patients with gross total disease resection [ Time Frame: From study entry to death due to any cause, assessed up to 5 years after study entry ]
      OS will be described for newly diagnosed disease stage 2-4 DAWT patients (Strata 1 and 2) and relapsed FHWT patients (Strata 3 and 4) who have gross total disease resection prior to enrollment or at the time of delayed nephrectomy following adjuvant chemotherapy. Kaplan-Meier curves will be reported by strata with 95% confidence bands. Potential prognostic factors for these patients will be explored in Cox regression models.

    6. Association of the number of nodes examined with EFS and OS [ Time Frame: Nodal information from upfront or delayed nephrectomy, with outcomes collected for up to 5 years after study entry ]
      The number of lymph nodes examined at the time of primary nephrectomy and number of positive nodes will be collected for all DAWT patients who enroll to Strata 1 or 2. The association of the number of nodes examined with EFS and OS will be explored in Cox regression models stratified by disease stage. For each of these analyses, association will be expressed either as a single hazard ratio if the effect is found to be linear, or as continuous functions on the hazard ratio scale if the effect is found to be non-linear. Similar models will be fit to examine the association between ratio of positive nodes to nodes examined and outcomes. Confidence intervals or bands will be reported for all quantities.

    • West Jefferson Medical Center
    • Jefferson Davis Parish
    • 5 Trials Available
    • CONTACT US

    TRIAL NUMBER: CG01 GBM

    Title: Standard Chemotherapy versus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients with Recurrent Glioblastoma Multiforme (GBM)

    Purpose:

    The purpose of this clinical study is to confirm the utility of chemosensitivity tumor testing on cancer stem cells (ChemoID) as a predictor of clinical response in poor prognosis malignant brain tumors such as recurrent glioblastoma (GBM).

    This study is designed as a parallel group randomized controlled clinical trial to determine if recurrent Glioblastoma (GBM) patients treated with drugs predicted by the ChemoID assay will have better outcomes than patients treated with standard-of-care control therapy chosen by the Physician.

    Upon obtaining informed consent, all eligible participants affected by recurrent GBM will have a tumor biopsy to undergo ChemoID drug response testing with multiple FDA-approved chemotherapeutic agents.

    Eligible participants will be randomized to a standard treatment arm with control treatment (chemotherapy chosen by the Physician from a provided list), or to a study arm of FDA-approved drugs selected by the ChemoID drug response assay.

    TRIAL NUMBER: N0577

    Title: N0577 (CODEL): Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

    Purpose: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.

    TRIAL NUMBER: Southeastern Study of Cancer and the Environment

    Title: Southeastern Study of Cancer and the Environment

    Purpose: STUDY PURPOSE - The purpose of the research is to provide new information on genetic and environmental risk factors for adult-onset glioma and meningioma. Such information is relevant to prevention and treatment. STUDY DESIGN – The study is a multi-institutional, clinic-based case-control study of genetic and environmental risk factors for adult-onset brain tumors (glioma and meningioma). Cases (brain tumor patients) will be identified at leading brain tumor treatment centers and several neurosurgical/neuro-oncology practices in the southeastern US. Community controls will be identified by a survey research firm (SDR Sampling Services - Atlanta, Georgia) with individual matching on age, gender, zipcode and season of enrollment. The second control group, consisting of friends, relatives and other associates of the case, will be matched on age and gender.

    TRIAL NUMBER: WF-1801

    Title: A Single Arm, Pilot Study of Ramipril for Preventing Radiation-Induced Cognitive Decline in Glioblastoma (GBM) Patients Receiving Brain Radiotherapy

    Purpose: This study is to determine if an oral drug called Ramipril can lower the chance of memory loss in patients with glioblastoma getting chemoradiation. Patients will take Ramipril during chemoradiation and continue until 4 months post-treatment. Memory loss will be assessed using several neurocognitive tests throughout the duration of the study.

    TRIAL NUMBER: DCP-001

    Title: DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)

    Purpose: The protocol is not a scientific study; rather, a method to implement the screening tool and allow the collection and analyses of expanded data with informed consent. Investigators also enroll patients into NCI-treatment trials. The tool, based on a screening log successfully used within the NCI Community Cancer Centers Program (NCCCP), has been streamlined and integrated into the sites’ workflow by using OPEN. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. Also missing from the existing data is the context of care, within the communities themselves where most cancer and at risk of cancer patients receive care which is the focus of NCORP. The profile of patients accrued to NCI-sponsored clinical trials lacks both racial/ethnic and socioeconomic diversity. Accrued patients tend to be insured, highly educated and of higher socioeconomic means. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. NCORP's clinical trials portfolio includes cancer control, prevention, screening, symptom science, and cancer care delivery research.

    • Culicchia Neurological Clinic LLC
    • Jefferson Davis Parish
    • 4 Trials Available
    • CONTACT US

    TRIAL NUMBER: CG01 GBM

    Title: Standard Chemotherapy versus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients with Recurrent Glioblastoma Multiforme (GBM)

    Purpose:

    The purpose of this clinical study is to confirm the utility of chemosensitivity tumor testing on cancer stem cells (ChemoID) as a predictor of clinical response in poor prognosis malignant brain tumors such as recurrent glioblastoma (GBM).

    This study is designed as a parallel group randomized controlled clinical trial to determine if recurrent Glioblastoma (GBM) patients treated with drugs predicted by the ChemoID assay will have better outcomes than patients treated with standard-of-care control therapy chosen by the Physician.

    Upon obtaining informed consent, all eligible participants affected by recurrent GBM will have a tumor biopsy to undergo ChemoID drug response testing with multiple FDA-approved chemotherapeutic agents.

    Eligible participants will be randomized to a standard treatment arm with control treatment (chemotherapy chosen by the Physician from a provided list), or to a study arm of FDA-approved drugs selected by the ChemoID drug response assay.

    TRIAL NUMBER: Southeastern Study of Cancer and the Environment

    Title: Southeastern Study of Cancer and the Environment

    Purpose: STUDY PURPOSE - The purpose of the research is to provide new information on genetic and environmental risk factors for adult-onset glioma and meningioma. Such information is relevant to prevention and treatment. STUDY DESIGN – The study is a multi-institutional, clinic-based case-control study of genetic and environmental risk factors for adult-onset brain tumors (glioma and meningioma). Cases (brain tumor patients) will be identified at leading brain tumor treatment centers and several neurosurgical/neuro-oncology practices in the southeastern US. Community controls will be identified by a survey research firm (SDR Sampling Services - Atlanta, Georgia) with individual matching on age, gender, zipcode and season of enrollment. The second control group, consisting of friends, relatives and other associates of the case, will be matched on age and gender.

    TRIAL NUMBER: WF-1801

    Title: A Single Arm, Pilot Study of Ramipril for Preventing Radiation-Induced Cognitive Decline in Glioblastoma (GBM) Patients Receiving Brain Radiotherapy

    Purpose: This study is to determine if an oral drug called Ramipril can lower the chance of memory loss in patients with glioblastoma getting chemoradiation. Patients will take Ramipril during chemoradiation and continue until 4 months post-treatment. Memory loss will be assessed using several neurocognitive tests throughout the duration of the study.

    TRIAL NUMBER: DCP-001

    Title: DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)

    Purpose: The protocol is not a scientific study; rather, a method to implement the screening tool and allow the collection and analyses of expanded data with informed consent. Investigators also enroll patients into NCI-treatment trials. The tool, based on a screening log successfully used within the NCI Community Cancer Centers Program (NCCCP), has been streamlined and integrated into the sites’ workflow by using OPEN. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. Also missing from the existing data is the context of care, within the communities themselves where most cancer and at risk of cancer patients receive care which is the focus of NCORP. The profile of patients accrued to NCI-sponsored clinical trials lacks both racial/ethnic and socioeconomic diversity. Accrued patients tend to be insured, highly educated and of higher socioeconomic means. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. NCORP's clinical trials portfolio includes cancer control, prevention, screening, symptom science, and cancer care delivery research.

    • LSU HSC - Shreveport University Health - FWCC
    • Caddo Parish
    • 19 Trials Available
    • CONTACT US

    TRIAL NUMBER: A011202

    Title: A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (CT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy

    Purpose: Study Outline: All patients will undergo surgery to identify sentinel lymph node(s). If a lymph node (sentinel or non-sentinel) is determined to be positive on intra-operative pathology the patient will be registered/randomized intra-operatively. Patients who do not have a sentinel lymph node identified will not be registered/randomized to the study. Patients whose sentinel lymph node status is cannot be/is not determined intra- operatively, and have not undergone ALND, but had at least one lymph node (sentinel or non-sentinel) found to be positive on final pathology review will be registered/randomized post-operatively. Patients whose sentinel lymph node status is found to be negative intra-operatively and have not undergone ALND, but had at least one lymph node (sentinel or non-sentinel) found to be positive on final pathology review will be registered/randomized post-operatively. ALND is not to be performed prior to registration/randomization. Patients who are determined to have negative lymph nodes on final pathology will not be registered/randomized, but can be offered participation in another cooperative group trial. The primary and secondary objectives of the study are described below. Please see the "Arms" section for a detailed description of the treatment regimens. Primary Objective: To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive SLN(s) after completion of neoadjuvant chemotherapy Secondary Objectives: To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of the incidence of invasive loco-regional recurrences in patients with a positive SLN(s) after completion of neoadjuvant chemotherapy To obtain an estimate of the distribution of residual disease burden scores for each treatment arm To estimate the distribution of overall survival for each treatment arm Patients may receive adjuvant and ancillary therapy as appropriate per the protocol. Adjuvant Therapy: Adjuvant endocrine therapy: Patients with hormone receptor (ER and/or PR) positive disease should receive a minimum of 5 years of standard endocrine therapy (experimental agents/regimens are not permitted). Endocrine therapy should begin following completion of neoadjuvant chemotherapy and surgery, either before, during or after radiation therapy at the discretion of the oncologist. Selection of the agents is at the treating physician's discretion. Patients with HER 2 positive disease should complete a total of one year of trastuzumab therapy (over the neoadjuvant and adjuvant period). Chemotherapy, biologic therapy or vaccine therapy in the adjuvant setting is not allowed. Patients who wish to receive any of these therapies after surgery must go off study at the time of their initiation. Ancillary Therapy: Patients should receive full supportive care, including transfusions of blood and blood products, erythropoetin (unless otherwise specified in the protocol), antibiotics, antiemetics, etc. when appropriate. Patients are followed up for 5 years after completion of radiation therapy.

    TRIAL NUMBER: A011801

    Title: T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial

    Purpose: This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.

    TRIAL NUMBER: A211601

    Title: EVALUATION OF MAMMOGRAPHIC BREAST DENSITY EFFECT OF ASPIRIN: A COMPANION STUDY TO ALLIANCE STUDY A011502

    Purpose: Primary Outcome Measures : Mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms [ Time Frame: At 1 year post-registration to A011502 ] The 1-year mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms will be compared. Analysis of covariance (ANCOVA) adjusting for baseline MPD will be used to compare MPD at 1 year between the arms. After adjusting for the baseline MPD, it will be concluded that the 1-year MPD is statistically different between the two arms if the corresponding two-sided p-value is less than 0.05. If normality of the primary variable is questionable, then variable transformation or nonparametric Wilcoxon rank-sum test on simple change MPD values may be considered as alternative approaches. A subsequent exploratory analysis will include all patients with an MPD computed at baseline (regardless of that baseline value) and at 1-year post-baseline.

    Secondary Outcome Measures : Mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms [ Time Frame: At 2 years post-registration to A011502 ] The 2-year mammographic breast density in the contralateral (unaffected) breast between the two arms for those patients with a baseline mammographic percent density (MPD) >= 25% and a 2-year post-baseline MPD will be compared. ANCOVA will be used to compare MPD between the arms. The corresponding test for the between-arm difference in MPD at 2-years will also be carried out at the 0.05 significance level.

    TRIAL NUMBER: EA1151

    Title: Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer

    Purpose: This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.

    TRIAL NUMBER: NRG-BR003

    Title: A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel With or Without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

    Purpose: This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.

    TRIAL NUMBER: NRG-BR007

    Title: NRG-BR007: A PHASE III CLINICAL TRIAL EVALUATING DE-ESCALATION OF BREAST RADIATION FOR CONSERVATIVE TREATMENT OF STAGE I, HORMONE SENSITIVE, HER2-NEGATIVE, ONCOTYPE RECURRENCE SCORE ? 18 BREAST CANCER (DEBRA*) * DE-escalation of Breast RAdiation (DEBRA)

    Purpose:

    Primary Outcome Measures :
    1. Time to invasive or noninvasive IBTR. [ Time Frame: 5 years ]
      Time from randomization to any invasive or noninvasive IBTR or last follow-up (expressed as % IBTR-free)


    Secondary Outcome Measures :
    1. Percent of women with an intact index breast at report of the primary endpoint inclusive of salvage second breast conservation procedures. [ Time Frame: Through study completion, an average of 15 years. ]
      Time from randomization to any breast procedure after the initial surgery or last follow-up (expressed as % with intact index breast)

    2. Time from randomization to the first occurrence of invasive ipsilateral breast tumor recurrence. [ Time Frame: 5 years ]
      Time from randomization to any invasive IBTR or last follow-up (expressed as percentage of invasive IBTR-free

    3. Time from randomization to diagnosis of a local, regional or distant recurrence as a first cancer event. [ Time Frame: 5 years ]
      Time from randomization to any breast cancer recurrence at a local, regional or distant site or last follow-up (expressed as percentage of recurrence-free)

    4. Time from randomization to the first distant cancer event (either a recurrence or a secondary primary cancer). [ Time Frame: 5 years ]
      Time from randomization to any cancer occurring at a distant site or last follow-up (expressed as percentage of distant disease-free)

    5. Time from randomization to any death. [ Time Frame: 5 years ]
      Time from randomization to any death or last follow-up (expressed as percent surviving)

    TRIAL NUMBER: S1703

    Title: S1703; Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored with Serum Tumor Marker Directed Disease Monitoring (STMDDM) versus Usual Care in Patients with Metastatic Hormone Receptor Positive Breast Cancer

    Purpose: To assess whether patients with HER-2 negative, hormone receptor positive, metastatic breast cancer who are monitored with serum tumor marker directed disease monitoring (STMDDM) have non-inferior overall survival compared to patients monitored with usual care.

    TRIAL NUMBER: URCC-16070

    Title: Netupitant/Palonosetron Hydrochloride and Dexamethasone With or Without Prochlorperazine or Olanzapine in Improving Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer

    Purpose: This randomized phase III trial studies how well netupitant/palonosetron hydrochloride and dexamethasone with prochlorperazine or olanzapine work compared to netupitant/palonosetron hydrochloride and dexamethasone in improving chemotherapy-induced nausea and vomiting in patients with breast cancer. Antiemetic drugs, such as prochlorperazine and olanzapine, may help lessen nausea and vomiting in patients with breast cancer treated with chemotherapy.

    TRIAL NUMBER: DCP-001

    Title: DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)

    Purpose: The protocol is not a scientific study; rather, a method to implement the screening tool and allow the collection and analyses of expanded data with informed consent. Investigators also enroll patients into NCI-treatment trials. The tool, based on a screening log successfully used within the NCI Community Cancer Centers Program (NCCCP), has been streamlined and integrated into the sites’ workflow by using OPEN. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. Also missing from the existing data is the context of care, within the communities themselves where most cancer and at risk of cancer patients receive care which is the focus of NCORP. The profile of patients accrued to NCI-sponsored clinical trials lacks both racial/ethnic and socioeconomic diversity. Accrued patients tend to be insured, highly educated and of higher socioeconomic means. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. NCORP's clinical trials portfolio includes cancer control, prevention, screening, symptom science, and cancer care delivery research.

    TRIAL NUMBER: URCC-13059

    Title: A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy for Advanced Cancer: Reducing Chemotherapy Toxicity in Older Patients.

    Purpose: This cluster randomized clinical trial compares a geriatric assessment intervention with usual care for reducing chemotherapy toxicity in older patients with cancer that has spread to other places in the body. A geriatric assessment may identify risk factors for chemotherapy toxicity and may improve outcomes for older patients with advanced cancer.

    TRIAL NUMBER: A151216

    Title: Genetic Testing For Patients with Resectable or Resected Lung Cancer: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

    Purpose: PRIMARY OBJECTIVES:
    I. To centrally genotype resected lung adenocarcinomas for epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma receptor tyrosine kinase (ALK) rearrangements to facilitate accrual to randomized adjuvant studies.
    II. To obtain clinically annotated tumor tissue and patient-matched non-malignant deoxyribonucleic acid (DNA) from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow clinically annotated advanced genomic analyses in concert with the National Cancer Institute (NCI) Center for Cancer Genomics (CCG).
    SECONDARY OBJECTIVES:
    I. To characterize the natural history of EGFR and ALK wild-type lung cancers to allow subsequent development of targeted therapies against genotype-defined sub-populations in the adjuvant and recurrent settings.
    II. To cross-validate local genotyping assays for EGFR and ALK with a central reference standard.
    TERTIARY OBJECTIVES:
    I. To study the genomic evolution of lung cancers by comparing genomic characteristics at resection and at recurrence.
    OUTLINE:
    Patients undergo collection of blood and tissue samples for EGFR and ALK testing via direct sequencing and fluorescence in situ hybridization (FISH). Patients that have had surgery prior to pre-registration will submit samples from the previous surgery for testing.
    After completion of study, patients that are not enrolled on either A081105 or E4512 are followed up every 6 months for 5 years.

    TRIAL NUMBER: A171901

    Title: Older Non-Small Cell Lung Cancer Patients (>/= 70 Years of Age) Treated With First-Line MK-3475 (Pembrolizumab)+/- Chemotherapy (Oncologist's/Patient's Choice)

    Purpose: This trial studies the side effects of pembrolizumab with or without chemotherapy in treating patients with stage IV non-small cell lung cancer that has come back (recurrent) and has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with or without chemotherapy may shrink the tumor in older patients with non-small cell lung cancer.

    TRIAL NUMBER: E4512

    Title: A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

    Purpose: PRIMARY OBJECTIVES:
    I. To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) over placebo for patients with stage IB >= 4 cm, II and IIIA, anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following surgical resection.
    SECONDARY OBJECTIVES:
    I. To evaluate and compare disease-free survival (DFS) associated with crizotinib and placebo.
    II. To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting.
    III. To collect tumor tissue and blood specimens for future research.
    OUTLINE: Patients are randomized to 1 of 2 treatment arms.
    ARM A: Patients receive crizotinib orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    ARM B: Patients receive placebo PO BID on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for 5 years.

    TRIAL NUMBER: WF20817CD

    Title: IMPLEMENTATION OF SMOKING CESSATION SERVICES WITHIN NCI NCORP COMMUNITY SITES WITH ORGANIZED LUNG

    Purpose: Evaluate a multi-faceted training program to improve short-term smoking cessation rates (<14 days post-visit) and short (3 months) and sustained abstinence (6 months) among 1,114 enrolled smokers who present for LDCT lung cancer screening in 26 community-based practices.

    TRIAL NUMBER: EA6141

    Title: Randomized Phase II/III Study of Nivolumab Plus Ipilimumab Plus Sargramostim Versus Nivolumab Plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma

    Purpose: PRIMARY OBJECTIVES:
    I. To compare the overall survival (OS) of nivolumab/ipilimumab/GM-CSF (sargramostim) versus nivolumab/ipilimumab.
    SECONDARY OBJECTIVES:
    I. To evaluate progression free survival (PFS) of patients treated with nivolumab/ipilimumab/GM-CSF versus nivolumab/ipilimumab.
    II. To assess for differences in tolerability, specifically the rate of grade III or higher adverse events, between nivolumab/ipilimumab/GM-CSF versus nivolumab/ipilimumab.
    III. To explore comparisons of immune-related response criteria to standard criteria as endpoint evaluations.
    OUTLINE: Patients are randomized to 1 of 2 treatment arms.
    ARM I: INDUCTION THERAPY: Patients receive nivolumab intravenously (IV) over 60 minutes on day 1, ipilimumab IV over 90 minutes on day 1, and sargramostim subcutaneously (SC) on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
    MAINTENANCE THERAPY: Patients receive nivolumab and sargramostim as in Induction therapy. Patients with partial response (PR), stable disease (SD), or complete response (CR) at 24 weeks may continue maintenance therapy in the absence of disease progression or unacceptable toxicity.
    ARM II: INDUCTION THERAPY: Patients receive nivolumab and ipilimumab as in Arm I. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
    MAINTENANCE THERAPY: Patients receive nivolumab as in Induction therapy. Patients with PR, SD, or CR at 24 weeks may continue maintenance therapy in the absence of disease progression or unacceptable toxicity.
    After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

    TRIAL NUMBER: E3A06

    Title: Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma

    Purpose: This randomized phase II/III trial studies how well lenalidomide works and compares it to observation in treating patients with asymptomatic high-risk asymptomatic (smoldering) multiple myeloma. Biological therapies such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether lenalidomide is effective in treating patients with high-risk smoldering multiple myeloma than observation alone.

    TRIAL NUMBER: EAA173

    Title: DARATUMUMAB TO ENHANCE THERAPEUTIC EFFECTIVENESS OF REVLIMID IN SMOLDERING MYELOMA (DETER-SMM)

    Purpose: Primary Outcome Measures :
    Overall survival (OS) [ Time Frame: From randomization to death due to any cause, or censored at date last known alive, assessed up to 15 years ] Will be estimated using the Kaplan-Meier (KM) method and compared using a stratified log-rank test. Stratified cox proportional hazards regression will produce a treatment hazard ratio estimate.
    Functional Assessment of Cancer Therapy-General (FACT-G) score [ Time Frame: Baseline to 24 cycles of treatment (each cycle is 28 days) ] A general effect size measure of half standard deviation will be used to establish the minimally important difference. Descriptive statistics (mean, standard deviation [SD], median, range) will be used to evaluate the distribution of levels and changes for the set of health-related quality of life (QOL) evaluations. Levels and changes will also be assessed graphically. Changes from baseline will be analyzed using linear mixed models based on restricted maximum likelihood estimation with covariance matrix maximizing Akaike information criteria. Models with treatment, assessment time, and treatment by assessment time interaction with and without other predictors will be fit. If there is substantial missingness, will analyze the data according to the methods described in Schluchter and Schluchter, Greene and Beck.

    Secondary Outcome Measures :
    Progression-free survival (PFS) [ Time Frame: From randomization until disease progression or death due to any cause, or censored at date of last disease evaluation, assessed up to 15 years ] Will be estimated using the KM method and compared using a stratified log-rank test. Stratified cox proportional hazards regression will produce a treatment hazard ratio estimate.
    Best response on treatment based on International Myeloma Working Group (IMWG) criteria [ Time Frame: At 12 and 24 months ] Response will be tabulated by category. Response rates of very good partial response (VGPR) or better and partial response (PR) or better will be compared using the Fisher's exact test. Ineligible patients are excluded from the analysis and unevaluable patients are counted in the denominator.
    Incidence of adverse events by worst grade and type for treated patients determined using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: Up to 28 days post-treatment ] Will monitor the toxicities experienced by all treated patients. Will compare rates of worst grade 3 or higher non-hematologic treatment-related events using the Fisher's exact test.
    Incidence of grade 3 or higher infusion-related reactions over course 1 determined based on CTCAE [ Time Frame: During cycle 1 of treatment (each cycle is 28 days) ] Will monitor the toxicities experienced by all treated patients. Will compare rates of worst grade 3 or higher non-hematologic treatment-related events using the Fisher's exact test.
    Stem cell (SC) mobilization failure [ Time Frame: After 4 to 6 cycles of treatment (each cycle is 28 days) ] Defined as not collecting a minimum of 5x10^6 CD34 cells per kilogram weight. SC mobilization and type of growth factor support will be summarized overall and by treatment arm with descriptive statistics.
    Early SC mobilization feasibility [ Time Frame: Up to 6 cycles of treatment (each cycle is 28 days) ] Defined as the proportion of patients less than 65 years of age treated for 6 courses who opt for SC mobilization. SC mobilization and type of growth factor support will be summarized overall and by treatment arm with descriptive statistics.
    Type of growth factor support [ Time Frame: During 4 to 6 cycles of treatment (each cycle is 28 days) ] SC mobilization and type of growth factor support will be summarized overall and by treatment arm with descriptive statistics.
    Change in FACT-G score [ Time Frame: From treatment end to 6 months post-treatment ] A general effect size measure of half standard deviation will be used to establish the minimally important difference. Descriptive statistics (mean, SD, median, range) will be used to evaluate the distribution of levels and changes for the set of health-related QOL evaluations. Levels and changes will also be assessed graphically. Changes from baseline will be analyzed using linear mixed models based on restricted maximum likelihood estimation with covariance matrix maximizing Akaike information criteria. Models with treatment, assessment time, and treatment by assessment time interaction with and without other predictors will be fit. If there is substantial missingness, will analyze the data according to the methods described in Schluchter and Schluchter, Greene and Beck.
    Levels of FACT-G score at each assessment time point [ Time Frame: From baseline, at 3, f7, 13, 19 cycles of treatment, and early discontinuation of treatment, assessed up to 24 cycles of treatment (each cycle is 28 days) ] A general effect size measure of half standard deviation will be used to establish the minimally important difference. Descriptive statistics (mean, SD, median, range) will be used to evaluate the distribution of levels and changes for the set of health-related QOL evaluations. Levels and changes will also be assessed graphically. Changes from baseline will be analyzed using linear mixed models based on restricted maximum likelihood estimation with covariance matrix maximizing Akaike information criteria. Models with treatment, assessment time, and treatment by assessment time interaction with and without other predictors will be fit. If there is substantial missingness, will analyze the data according to the methods described in Schluchter and Schluchter, Greene and Beck.
    Time to worsening of FACT-G [ Time Frame: From baseline until a decrease of 9 points, or censored at date of last assessment, assessed up to 6 months post-treatment ] Will be analyzed with Kaplan-Meier methods and Cox regression with the related treatment arm as the only factor. Correlation between time to worsening of symptoms with PFS and OS will be assessed with Kendall's Tau adjusted for censored observations.

    Other Outcome Measures:
    Cumulative dose calculated as the sum of all doses taken across all cycles [ Time Frame: Up to 24 months ] Cumulative dose will be calculated overall and by cycle. Data will be summarized by treatment arm with descriptive statistics and graphically over time. Patients will be classified into dichotomous groups based on a 75% relative dose intensity cutoff (< 75% versus [vs] >= 75% represents poor vs good treatment adherence). The proportion of patients with poor lenalidomide treatment adherence will be compared between arms using the Fisher's exact test. In addition, multi-variable logistic regression analysis will be conducted to identify the baseline factors associated with calculated good treatment adherence.
    Dose intensity calculated as cumulative dose received divided by treatment duration [ Time Frame: Up to 24 months ] Dose intensity will be calculated overall and by cycle. Data will be summarized by treatment arm with descriptive statistics and graphically over time. Patients will be classified into dichotomous groups based on a 75% relative dose intensity cutoff (< 75% vs >= 75% represents poor vs good treatment adherence). The proportion of patients with poor lenalidomide treatment adherence will be compared between arms using the Fisher's exact test. In addition, multi-variable logistic regression analysis will be conducted to identify the baseline factors associated with calculated good treatment adherence.
    Relative dose intensity calculated as the dose intensity divided by planned dose intensity [ Time Frame: Up to 24 months ] Dose intensity will be calculated overall and by cycle. Data will be summarized by treatment arm with descriptive statistics and graphically over time. Patients will be classified into dichotomous groups based on a 75% relative dose intensity cutoff (< 75% vs >= 75% represents poor vs good treatment adherence). The proportion of patients with poor lenalidomide treatment adherence will be compared between arms using the Fisher's exact test. In addition, multi-variable logistic regression analysis will be conducted to identify the baseline factors associated with calculated good treatment adherence.
    Duration of treatment [ Time Frame: From randomization to date off treatment, or censored at the date of last treatment, assessed up to 24 months ] Treatment duration in each arm will be estimated using Kaplan-Meier methods and compared between arms with the log-rank test.
    Time to progression [ Time Frame: From randomization to progression, or censored at date of last disease evaluation, assessed up to 15 years ] Will be estimated using the Kaplan-Meier method.
    Presence, frequency, interference, amount and/or severity of select patient reported outcomes (PRO)-CTCAEs [ Time Frame: Assessed at each treatment cycle, from cycle 1 of treatment to end of treatment, up to 24 cycles of treatment (each cycle is 28 days) ] Descriptive statistics (mean, standard deviation, median, range) will be used to summarize selected PRO-CTCAEs tabulated at each cycle overall and by arm. Will map PRO-CTCAEs with provider reported adverse events (AEs) and evaluate differences in incidence and worst severity. Items correspond to 5 attributes measured [frequency (F), severity (S), interference (I), presence/absence (P) and amount (A)] based on multiple choice questions. Response for each attribute except P which is binary is on a 5-point Likert scale with 5 indicating 'almost constantly' frequency, 'very severe' severity, 'very much' amount or 'very much' interference. An overall PRO-CTCAE score will be calculated at each time point.
    Overall PRO-CTCAE score [ Time Frame: Up to 15 years ] Defined as the sum of item scores on all symptomatic adverse events (AEs). Descriptive statistics will be used to summarize selected PRO-CTCAEs tabulated at each cycle overall and by arm. Will map PRO-CTCAEs with provider reported AEs and evaluate differences in incidence and worst severity. An overall PRO-CTCAE score will be calculated at each time point.
    Adherence Starts with Knowledge (ASK)-12 scores [ Time Frame: At 7, 13, and 19 cycles of treatment (each cycle is 28 days) ] Descriptive statistics will be used to summarize ASK-12 scores tabulated at cycles 7, 13 and 19 overall and by arm. Differences between arms will be evaluated based a t-test (or Wilcoxon rank sum test). Patients will also be classified into high versus low likelihood of medication adherence groups according to tertile distributions (lowest tertile vs second and top). Association between likelihood of medication adherence and calculated treatment adherence dichotomous groups will be evaluated in patients with both ASK-12 and treatment data at cycles 7, 13 and 19 post randomization. In addition, multivariable logistic regression analysis will be conducted to identify the baseline factors associated with low likelihood of medication adherence.
    PRO compliance rate [ Time Frame: Up to 15 years ] Defined as the proportion of patients who submit the given PRO instrument among those eligible at each time point which excludes those missing by design (due to death or disease progression, early treatment discontinuation).
    PRO completion rate [ Time Frame: Up to 15 years ] Defined as the proportion of patients who complete given PRO instrument based on the instrument's scoring system among those eligible at each time point.

    TRIAL NUMBER: S1803

    Title: S1803; Phase III Study of Daratumumab/rHuPH20 (NSC- 810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)

    Purpose: Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years.

    TRIAL NUMBER: A191402CD

    Title: Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer

    Purpose: This randomized phase III trial studies how well decision aids work in improving knowledge in patients with newly diagnosed prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.

    • Ochsner LSU Health Monroe Medical Center
    • Ouchita
    • 9 Trials Available
    • CONTACT US

    TRIAL NUMBER: A211601

    Title: EVALUATION OF MAMMOGRAPHIC BREAST DENSITY EFFECT OF ASPIRIN: A COMPANION STUDY TO ALLIANCE STUDY A011502

    Purpose: Primary Outcome Measures : Mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms [ Time Frame: At 1 year post-registration to A011502 ] The 1-year mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms will be compared. Analysis of covariance (ANCOVA) adjusting for baseline MPD will be used to compare MPD at 1 year between the arms. After adjusting for the baseline MPD, it will be concluded that the 1-year MPD is statistically different between the two arms if the corresponding two-sided p-value is less than 0.05. If normality of the primary variable is questionable, then variable transformation or nonparametric Wilcoxon rank-sum test on simple change MPD values may be considered as alternative approaches. A subsequent exploratory analysis will include all patients with an MPD computed at baseline (regardless of that baseline value) and at 1-year post-baseline.

    Secondary Outcome Measures : Mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms [ Time Frame: At 2 years post-registration to A011502 ] The 2-year mammographic breast density in the contralateral (unaffected) breast between the two arms for those patients with a baseline mammographic percent density (MPD) >= 25% and a 2-year post-baseline MPD will be compared. ANCOVA will be used to compare MPD between the arms. The corresponding test for the between-arm difference in MPD at 2-years will also be carried out at the 0.05 significance level.

    TRIAL NUMBER: NRG-BR003

    Title: A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel With or Without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

    Purpose: This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.

    TRIAL NUMBER: S1703

    Title: S1703; Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored with Serum Tumor Marker Directed Disease Monitoring (STMDDM) versus Usual Care in Patients with Metastatic Hormone Receptor Positive Breast Cancer

    Purpose: To assess whether patients with HER-2 negative, hormone receptor positive, metastatic breast cancer who are monitored with serum tumor marker directed disease monitoring (STMDDM) have non-inferior overall survival compared to patients monitored with usual care.

    TRIAL NUMBER: DCP-001

    Title: DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)

    Purpose: The protocol is not a scientific study; rather, a method to implement the screening tool and allow the collection and analyses of expanded data with informed consent. Investigators also enroll patients into NCI-treatment trials. The tool, based on a screening log successfully used within the NCI Community Cancer Centers Program (NCCCP), has been streamlined and integrated into the sites’ workflow by using OPEN. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. Also missing from the existing data is the context of care, within the communities themselves where most cancer and at risk of cancer patients receive care which is the focus of NCORP. The profile of patients accrued to NCI-sponsored clinical trials lacks both racial/ethnic and socioeconomic diversity. Accrued patients tend to be insured, highly educated and of higher socioeconomic means. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial influences affecting clinical trial participation. NCORP's clinical trials portfolio includes cancer control, prevention, screening, symptom science, and cancer care delivery research.

    TRIAL NUMBER: URCC-13059

    Title: A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy for Advanced Cancer: Reducing Chemotherapy Toxicity in Older Patients.

    Purpose: This cluster randomized clinical trial compares a geriatric assessment intervention with usual care for reducing chemotherapy toxicity in older patients with cancer that has spread to other places in the body. A geriatric assessment may identify risk factors for chemotherapy toxicity and may improve outcomes for older patients with advanced cancer.

    TRIAL NUMBER: A151216

    Title: Genetic Testing For Patients with Resectable or Resected Lung Cancer: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

    Purpose: PRIMARY OBJECTIVES:
    I. To centrally genotype resected lung adenocarcinomas for epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma receptor tyrosine kinase (ALK) rearrangements to facilitate accrual to randomized adjuvant studies.
    II. To obtain clinically annotated tumor tissue and patient-matched non-malignant deoxyribonucleic acid (DNA) from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow clinically annotated advanced genomic analyses in concert with the National Cancer Institute (NCI) Center for Cancer Genomics (CCG).
    SECONDARY OBJECTIVES:
    I. To characterize the natural history of EGFR and ALK wild-type lung cancers to allow subsequent development of targeted therapies against genotype-defined sub-populations in the adjuvant and recurrent settings.
    II. To cross-validate local genotyping assays for EGFR and ALK with a central reference standard.
    TERTIARY OBJECTIVES:
    I. To study the genomic evolution of lung cancers by comparing genomic characteristics at resection and at recurrence.
    OUTLINE:
    Patients undergo collection of blood and tissue samples for EGFR and ALK testing via direct sequencing and fluorescence in situ hybridization (FISH). Patients that have had surgery prior to pre-registration will submit samples from the previous surgery for testing.
    After completion of study, patients that are not enrolled on either A081105 or E4512 are followed up every 6 months for 5 years.

    TRIAL NUMBER: E4512

    Title: A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

    Purpose: PRIMARY OBJECTIVES:
    I. To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) over placebo for patients with stage IB >= 4 cm, II and IIIA, anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following surgical resection.
    SECONDARY OBJECTIVES:
    I. To evaluate and compare disease-free survival (DFS) associated with crizotinib and placebo.
    II. To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting.
    III. To collect tumor tissue and blood specimens for future research.
    OUTLINE: Patients are randomized to 1 of 2 treatment arms.
    ARM A: Patients receive crizotinib orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    ARM B: Patients receive placebo PO BID on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for 5 years.

    TRIAL NUMBER: E3A06

    Title: Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma

    Purpose: This randomized phase II/III trial studies how well lenalidomide works and compares it to observation in treating patients with asymptomatic high-risk asymptomatic (smoldering) multiple myeloma. Biological therapies such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether lenalidomide is effective in treating patients with high-risk smoldering multiple myeloma than observation alone.

    TRIAL NUMBER: EAA173

    Title: DARATUMUMAB TO ENHANCE THERAPEUTIC EFFECTIVENESS OF REVLIMID IN SMOLDERING MYELOMA (DETER-SMM)

    Purpose: Primary Outcome Measures :
    Overall survival (OS) [ Time Frame: From randomization to death due to any cause, or censored at date last known alive, assessed up to 15 years ] Will be estimated using the Kaplan-Meier (KM) method and compared using a stratified log-rank test. Stratified cox proportional hazards regression will produce a treatment hazard ratio estimate.
    Functional Assessment of Cancer Therapy-General (FACT-G) score [ Time Frame: Baseline to 24 cycles of treatment (each cycle is 28 days) ] A general effect size measure of half standard deviation will be used to establish the minimally important difference. Descriptive statistics (mean, standard deviation [SD], median, range) will be used to evaluate the distribution of levels and changes for the set of health-related quality of life (QOL) evaluations. Levels and changes will also be assessed graphically. Changes from baseline will be analyzed using linear mixed models based on restricted maximum likelihood estimation with covariance matrix maximizing Akaike information criteria. Models with treatment, assessment time, and treatment by assessment time interaction with and without other predictors will be fit. If there is substantial missingness, will analyze the data according to the methods described in Schluchter and Schluchter, Greene and Beck.

    Secondary Outcome Measures :
    Progression-free survival (PFS) [ Time Frame: From randomization until disease progression or death due to any cause, or censored at date of last disease evaluation, assessed up to 15 years ] Will be estimated using the KM method and compared using a stratified log-rank test. Stratified cox proportional hazards regression will produce a treatment hazard ratio estimate.
    Best response on treatment based on International Myeloma Working Group (IMWG) criteria [ Time Frame: At 12 and 24 months ] Response will be tabulated by category. Response rates of very good partial response (VGPR) or better and partial response (PR) or better will be compared using the Fisher's exact test. Ineligible patients are excluded from the analysis and unevaluable patients are counted in the denominator.
    Incidence of adverse events by worst grade and type for treated patients determined using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: Up to 28 days post-treatment ] Will monitor the toxicities experienced by all treated patients. Will compare rates of worst grade 3 or higher non-hematologic treatment-related events using the Fisher's exact test.
    Incidence of grade 3 or higher infusion-related reactions over course 1 determined based on CTCAE [ Time Frame: During cycle 1 of treatment (each cycle is 28 days) ] Will monitor the toxicities experienced by all treated patients. Will compare rates of worst grade 3 or higher non-hematologic treatment-related events using the Fisher's exact test.
    Stem cell (SC) mobilization failure [ Time Frame: After 4 to 6 cycles of treatment (each cycle is 28 days) ] Defined as not collecting a minimum of 5x10^6 CD34 cells per kilogram weight. SC mobilization and type of growth factor support will be summarized overall and by treatment arm with descriptive statistics.
    Early SC mobilization feasibility [ Time Frame: Up to 6 cycles of treatment (each cycle is 28 days) ] Defined as the proportion of patients less than 65 years of age treated for 6 courses who opt for SC mobilization. SC mobilization and type of growth factor support will be summarized overall and by treatment arm with descriptive statistics.
    Type of growth factor support [ Time Frame: During 4 to 6 cycles of treatment (each cycle is 28 days) ] SC mobilization and type of growth factor support will be summarized overall and by treatment arm with descriptive statistics.
    Change in FACT-G score [ Time Frame: From treatment end to 6 months post-treatment ] A general effect size measure of half standard deviation will be used to establish the minimally important difference. Descriptive statistics (mean, SD, median, range) will be used to evaluate the distribution of levels and changes for the set of health-related QOL evaluations. Levels and changes will also be assessed graphically. Changes from baseline will be analyzed using linear mixed models based on restricted maximum likelihood estimation with covariance matrix maximizing Akaike information criteria. Models with treatment, assessment time, and treatment by assessment time interaction with and without other predictors will be fit. If there is substantial missingness, will analyze the data according to the methods described in Schluchter and Schluchter, Greene and Beck.
    Levels of FACT-G score at each assessment time point [ Time Frame: From baseline, at 3, f7, 13, 19 cycles of treatment, and early discontinuation of treatment, assessed up to 24 cycles of treatment (each cycle is 28 days) ] A general effect size measure of half standard deviation will be used to establish the minimally important difference. Descriptive statistics (mean, SD, median, range) will be used to evaluate the distribution of levels and changes for the set of health-related QOL evaluations. Levels and changes will also be assessed graphically. Changes from baseline will be analyzed using linear mixed models based on restricted maximum likelihood estimation with covariance matrix maximizing Akaike information criteria. Models with treatment, assessment time, and treatment by assessment time interaction with and without other predictors will be fit. If there is substantial missingness, will analyze the data according to the methods described in Schluchter and Schluchter, Greene and Beck.
    Time to worsening of FACT-G [ Time Frame: From baseline until a decrease of 9 points, or censored at date of last assessment, assessed up to 6 months post-treatment ] Will be analyzed with Kaplan-Meier methods and Cox regression with the related treatment arm as the only factor. Correlation between time to worsening of symptoms with PFS and OS will be assessed with Kendall's Tau adjusted for censored observations.

    Other Outcome Measures:
    Cumulative dose calculated as the sum of all doses taken across all cycles [ Time Frame: Up to 24 months ] Cumulative dose will be calculated overall and by cycle. Data will be summarized by treatment arm with descriptive statistics and graphically over time. Patients will be classified into dichotomous groups based on a 75% relative dose intensity cutoff (< 75% versus [vs] >= 75% represents poor vs good treatment adherence). The proportion of patients with poor lenalidomide treatment adherence will be compared between arms using the Fisher's exact test. In addition, multi-variable logistic regression analysis will be conducted to identify the baseline factors associated with calculated good treatment adherence.
    Dose intensity calculated as cumulative dose received divided by treatment duration [ Time Frame: Up to 24 months ] Dose intensity will be calculated overall and by cycle. Data will be summarized by treatment arm with descriptive statistics and graphically over time. Patients will be classified into dichotomous groups based on a 75% relative dose intensity cutoff (< 75% vs >= 75% represents poor vs good treatment adherence). The proportion of patients with poor lenalidomide treatment adherence will be compared between arms using the Fisher's exact test. In addition, multi-variable logistic regression analysis will be conducted to identify the baseline factors associated with calculated good treatment adherence.
    Relative dose intensity calculated as the dose intensity divided by planned dose intensity [ Time Frame: Up to 24 months ] Dose intensity will be calculated overall and by cycle. Data will be summarized by treatment arm with descriptive statistics and graphically over time. Patients will be classified into dichotomous groups based on a 75% relative dose intensity cutoff (< 75% vs >= 75% represents poor vs good treatment adherence). The proportion of patients with poor lenalidomide treatment adherence will be compared between arms using the Fisher's exact test. In addition, multi-variable logistic regression analysis will be conducted to identify the baseline factors associated with calculated good treatment adherence.
    Duration of treatment [ Time Frame: From randomization to date off treatment, or censored at the date of last treatment, assessed up to 24 months ] Treatment duration in each arm will be estimated using Kaplan-Meier methods and compared between arms with the log-rank test.
    Time to progression [ Time Frame: From randomization to progression, or censored at date of last disease evaluation, assessed up to 15 years ] Will be estimated using the Kaplan-Meier method.
    Presence, frequency, interference, amount and/or severity of select patient reported outcomes (PRO)-CTCAEs [ Time Frame: Assessed at each treatment cycle, from cycle 1 of treatment to end of treatment, up to 24 cycles of treatment (each cycle is 28 days) ] Descriptive statistics (mean, standard deviation, median, range) will be used to summarize selected PRO-CTCAEs tabulated at each cycle overall and by arm. Will map PRO-CTCAEs with provider reported adverse events (AEs) and evaluate differences in incidence and worst severity. Items correspond to 5 attributes measured [frequency (F), severity (S), interference (I), presence/absence (P) and amount (A)] based on multiple choice questions. Response for each attribute except P which is binary is on a 5-point Likert scale with 5 indicating 'almost constantly' frequency, 'very severe' severity, 'very much' amount or 'very much' interference. An overall PRO-CTCAE score will be calculated at each time point.
    Overall PRO-CTCAE score [ Time Frame: Up to 15 years ] Defined as the sum of item scores on all symptomatic adverse events (AEs). Descriptive statistics will be used to summarize selected PRO-CTCAEs tabulated at each cycle overall and by arm. Will map PRO-CTCAEs with provider reported AEs and evaluate differences in incidence and worst severity. An overall PRO-CTCAE score will be calculated at each time point.
    Adherence Starts with Knowledge (ASK)-12 scores [ Time Frame: At 7, 13, and 19 cycles of treatment (each cycle is 28 days) ] Descriptive statistics will be used to summarize ASK-12 scores tabulated at cycles 7, 13 and 19 overall and by arm. Differences between arms will be evaluated based a t-test (or Wilcoxon rank sum test). Patients will also be classified into high versus low likelihood of medication adherence groups according to tertile distributions (lowest tertile vs second and top). Association between likelihood of medication adherence and calculated treatment adherence dichotomous groups will be evaluated in patients with both ASK-12 and treatment data at cycles 7, 13 and 19 post randomization. In addition, multivariable logistic regression analysis will be conducted to identify the baseline factors associated with low likelihood of medication adherence.
    PRO compliance rate [ Time Frame: Up to 15 years ] Defined as the proportion of patients who submit the given PRO instrument among those eligible at each time point which excludes those missing by design (due to death or disease progression, early treatment discontinuation).
    PRO completion rate [ Time Frame: Up to 15 years ] Defined as the proportion of patients who complete given PRO instrument based on the instrument's scoring system among those eligible at each time point.

    • LSU Health Sciences Center - New Orleans IRB
    • 7 Trials Available
    • CONTACT US

    TRIAL NUMBER: DARE

    Title: A RANDOMIZED, PHASE II TRIAL OF CIRCULATING TUMOR DNAGUIDED SECOND LINE ADJUVANT THERAPY FOR HIGH RESIDUAL RISK, STAGE II-III, ESTROGEN RECEPTOR POSITIVE, HER2 NEGATIVE BREAST CANCER (DARE)

    Purpose: To assess if (i) the incidence of ctDNA positivity in stage II/III R+/HER2- breast cancer patients who are receiving standard of care adjuvant endocrine therapy, (ii) and assess if treatment with palbociclib and fulvestrant improves relapse-free survival (RFS) compared to continued standard of care adjuvant endocrine therapy for stage II/III, ER+/HER2- breast cancer in patients with detectable circulating tumor DNA (ctDNA) in their blood without imaging evidence of metastatic disease. 

    TRIAL NUMBER: Iovance Biotherapeutics C-145-04

    Title: A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic, or Persistent Cervical Carcinoma

    Purpose: Prospective, multicenter, single-arm, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145) followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma

    TRIAL NUMBER: SISTER

    Title: Social Interventions for Support during Treatment for Endometrial Cancer and Recurrence (SISTER): a multi-site randomized controlled trial

    Purpose:

    Aim 1: To determine whether -- and to what extent -- 2 virtual evidenced-based interventions ? (1) facilitated support group and (2) 1:1 peer support compared to receipt of usual care improve recommended treatment completion among Black people with high-risk EC.

    Aim 2: To compare the effectiveness of virtual evidenced-based interventions on level of social isolation during cancer treatment among Black people with high-risk EC.

    TRIAL NUMBER: MK-2140-003

    Title: A Phase 2/3 Multicenter, Open-label, Randomized, Active-Control Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

    Purpose: The purpose of this Phase 2/3, randomized, multisite, open-label, dose confirmation, and expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in combination with standard of care options for the treatment of rrDLBCL. This study will be divided into 2 parts: Dose Confirmation (Part 1) and Safety Run-in and Efficacy Expansion (Part 2) and will enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx with respect to progression-free survival (PFS) per Lugano response criteria by blinded independent review committee (BICR); and that ZV in combination with bendamustine rituximab (BR) is superior to BR with respect to PFS per Lugano response criteria by BICR.


    TRIAL NUMBER: COVID-19 Biospecimen

    Title: COVID-19 Biospecimen Collection

    Purpose:

    TRIAL NUMBER: RTOG-3506

    Title: RTOG 3506; A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery (STEEL)

    Purpose: Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive disease features will receive salvage radiation therapy and standard androgen deprivation therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free survival when enhanced ADT is used compared to standard ADT.

    TRIAL NUMBER: DF1001-001

    Title: DF1001-001: A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

    Purpose: DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cells activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express human epidermal growth factor receptor 2 (HER2). The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having either selected solid tumors, or solid tumors expressing high levels of HER2. A combination therapy cohort of DF1001 and pembrolizumab will also be opened for enrollment. 

    • CHRISTUS Highland Medical Center
    • 6 Trials Available
    • CONTACT US

    TRIAL NUMBER: EA1131

    Title: A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Observation in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy

    Purpose: The purpose of this study is to compare the IDFS in TNBC patients with residual basal-like disease after neoadjuvant chemotherapy who are randomized to post-preoperative platinum based chemotherapy with those who are randomized to observation. At present, upon completion of neoadjuvant therapy, the standard of care for patients with TNBC (who have no clinical evidence of metastatic disease after surgical excision of the cancer regardless of burden of residual disease) is observation, since there is no additional therapies available with proven impact. This study could provide a possible alternative treatment, which makes it appropriate for the population.

    TRIAL NUMBER: NRG-BR003

    Title: A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel With or Without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

    Purpose: This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.

    TRIAL NUMBER: WF-97116

    Title: Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil - WF 97116

    Purpose: This study is to compare the safety and effects of donepezil (Aricept) or if it decreases memory loss after receiving chemotherapy for breast cancer.

    TRIAL NUMBER: A151216

    Title: Genetic Testing For Patients with Resectable or Resected Lung Cancer: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

    Purpose: PRIMARY OBJECTIVES:
    I. To centrally genotype resected lung adenocarcinomas for epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma receptor tyrosine kinase (ALK) rearrangements to facilitate accrual to randomized adjuvant studies.
    II. To obtain clinically annotated tumor tissue and patient-matched non-malignant deoxyribonucleic acid (DNA) from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow clinically annotated advanced genomic analyses in concert with the National Cancer Institute (NCI) Center for Cancer Genomics (CCG).
    SECONDARY OBJECTIVES:
    I. To characterize the natural history of EGFR and ALK wild-type lung cancers to allow subsequent development of targeted therapies against genotype-defined sub-populations in the adjuvant and recurrent settings.
    II. To cross-validate local genotyping assays for EGFR and ALK with a central reference standard.
    TERTIARY OBJECTIVES:
    I. To study the genomic evolution of lung cancers by comparing genomic characteristics at resection and at recurrence.
    OUTLINE:
    Patients undergo collection of blood and tissue samples for EGFR and ALK testing via direct sequencing and fluorescence in situ hybridization (FISH). Patients that have had surgery prior to pre-registration will submit samples from the previous surgery for testing.
    After completion of study, patients that are not enrolled on either A081105 or E4512 are followed up every 6 months for 5 years.

    TRIAL NUMBER: E4512

    Title: A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

    Purpose: PRIMARY OBJECTIVES:
    I. To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) over placebo for patients with stage IB >= 4 cm, II and IIIA, anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following surgical resection.
    SECONDARY OBJECTIVES:
    I. To evaluate and compare disease-free survival (DFS) associated with crizotinib and placebo.
    II. To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting.
    III. To collect tumor tissue and blood specimens for future research.
    OUTLINE: Patients are randomized to 1 of 2 treatment arms.
    ARM A: Patients receive crizotinib orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    ARM B: Patients receive placebo PO BID on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for 5 years.

    TRIAL NUMBER: A031501

    Title: PHASE III RANDOMIZED ADJUVANT STUDY OF MK-3475 (PEMBROLIZUMAB) IN MUSCLE INVASIVE AND LOCALLY ADVANCED UROTHELIAL CARCINOMA (AMBASSADOR) VERSUS OBSERVATION

    Purpose: Primary Outcome Measures: Disease-free survival [ Time Frame: From randomization to the first metastatic recurrence (presence of any recurrent disease), or death, whichever occurs first, assessed up to 5 years ] The stratified proportional hazards model will be the primary analysis. The hazard ratio and its 95% confidence interval from the stratified Cox model with a single treatment covariate will be reported. The unstratified hazard ratio will also be presented.
    Overall survival [ Time Frame: From randomization to the date of death from any cause, assessed up to 5 years ] The stratified proportional hazards model will be the primary analysis. The hazard ratio and its 95% confidence interval from the stratified Cox model with a single treatment covariate will be reported. The unstratified hazard ratio will also be presented.

    Secondary Outcome Measures: Disease-free survival in PD-L1 positive and negative patients [ Time Frame: From randomization to the first metastatic recurrence (presence of any recurrent disease), or death, whichever occurs first, assessed up to 5 years ] The stratified proportional hazards model will be the primary analysis. The hazard ratio and its 95% confidence interval from the stratified Cox model with a single treatment covariate will be reported. The unstratified hazard ratio will also be presented.
    Overall survival in PD-L1 positive and negative patients [ Time Frame: From randomization to the date of death from any cause, assessed up to 5 years ] The stratified proportional hazards model will be the primary analysis. The hazard ratio and its 95% confidence interval from the stratified Cox model with a single treatment covariate will be reported. The unstratified hazard ratio will also be presented.

    Estimated Enrollment: 739 Actual Study Start Date: September 21, 2017 Estimated Study Completion Date: February 28, 2019 Estimated Primary Completion Date: February 28, 2019 (Final data collection date for primary outcome measure)

    • Ochsner Hematology Oncology North Shore - Covington (West Region)
    • 4 Trials Available
    • CONTACT US

    TRIAL NUMBER: EA1131

    Title: A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Observation in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy

    Purpose: The purpose of this study is to compare the IDFS in TNBC patients with residual basal-like disease after neoadjuvant chemotherapy who are randomized to post-preoperative platinum based chemotherapy with those who are randomized to observation. At present, upon completion of neoadjuvant therapy, the standard of care for patients with TNBC (who have no clinical evidence of metastatic disease after surgical excision of the cancer regardless of burden of residual disease) is observation, since there is no additional therapies available with proven impact. This study could provide a possible alternative treatment, which makes it appropriate for the population.

    TRIAL NUMBER: S1501

    Title: PROSPECTIVE EVALUATION OF CARVEDILOL IN PREVENTION OF CARDIAC TOXICITY IN PATIENTS WITH METASTATIC HER-2+ BREAST CANCER, PHASE III

    Purpose: Primary Objective To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy. Secondary Objectives a. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of predefined subsequent cardiac events in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy. b. To evaluate if prophylactic carvedilol compared with no intervention results in a longer time to first interruption of trastuzumab?based HER-2 targeted therapy due to either cardiac dysfunction or events. c. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction OR events in this population. d. To establish and prospectively collect a predefined panel of baseline core cardiovascular measures and develop a predictive model of cardiac dysfunction (see Section 11.2). e. To evaluate the rate of cardiac dysfunction in an observational arm consisting of individuals otherwise eligible for the study except for use of beta blockers, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitors for other medical reasons.

    TRIAL NUMBER: A151216

    Title: Genetic Testing For Patients with Resectable or Resected Lung Cancer: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

    Purpose: PRIMARY OBJECTIVES:
    I. To centrally genotype resected lung adenocarcinomas for epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma receptor tyrosine kinase (ALK) rearrangements to facilitate accrual to randomized adjuvant studies.
    II. To obtain clinically annotated tumor tissue and patient-matched non-malignant deoxyribonucleic acid (DNA) from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow clinically annotated advanced genomic analyses in concert with the National Cancer Institute (NCI) Center for Cancer Genomics (CCG).
    SECONDARY OBJECTIVES:
    I. To characterize the natural history of EGFR and ALK wild-type lung cancers to allow subsequent development of targeted therapies against genotype-defined sub-populations in the adjuvant and recurrent settings.
    II. To cross-validate local genotyping assays for EGFR and ALK with a central reference standard.
    TERTIARY OBJECTIVES:
    I. To study the genomic evolution of lung cancers by comparing genomic characteristics at resection and at recurrence.
    OUTLINE:
    Patients undergo collection of blood and tissue samples for EGFR and ALK testing via direct sequencing and fluorescence in situ hybridization (FISH). Patients that have had surgery prior to pre-registration will submit samples from the previous surgery for testing.
    After completion of study, patients that are not enrolled on either A081105 or E4512 are followed up every 6 months for 5 years.

    TRIAL NUMBER: E4512

    Title: A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

    Purpose: PRIMARY OBJECTIVES:
    I. To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) over placebo for patients with stage IB >= 4 cm, II and IIIA, anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following surgical resection.
    SECONDARY OBJECTIVES:
    I. To evaluate and compare disease-free survival (DFS) associated with crizotinib and placebo.
    II. To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting.
    III. To collect tumor tissue and blood specimens for future research.
    OUTLINE: Patients are randomized to 1 of 2 treatment arms.
    ARM A: Patients receive crizotinib orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    ARM B: Patients receive placebo PO BID on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for 5 years.

    • Ochsner Medical Center Kenner
    • 14 Trials Available
    • CONTACT US

    TRIAL NUMBER: EA1131

    Title: A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Observation in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy

    Purpose: The purpose of this study is to compare the IDFS in TNBC patients with residual basal-like disease after neoadjuvant chemotherapy who are randomized to post-preoperative platinum based chemotherapy with those who are randomized to observation. At present, upon completion of neoadjuvant therapy, the standard of care for patients with TNBC (who have no clinical evidence of metastatic disease after surgical excision of the cancer regardless of burden of residual disease) is observation, since there is no additional therapies available with proven impact. This study could provide a possible alternative treatment, which makes it appropriate for the population.

    TRIAL NUMBER: NSABP B-51

    Title: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

    Purpose: This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer

    TRIAL NUMBER: S1418

    Title: A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer With ? 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy

    Purpose: This randomized phase III trial studies how well pembrolizumab works in treating triple-negative breast cancer. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

    TRIAL NUMBER: A021502

    Title: Randomized Trial of Standard Chemotherapy Alone or Combined With Atezolizumab as Adjuvant Therapy for Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair

    Purpose: This randomized phase III trial studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy with atezolizumab may work better than combination chemotherapy alone in treating patients with colon cancer.

    TRIAL NUMBER: EA2174

    Title: A PHASE II/III STUDY OF PERI-OPERATIVE NIVOLUMAB AND IPILIMUMAB IN PATIENTS WITH LOCOREGIONAL ESOPHAGEAL AND GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA

    Purpose: Primary Outcome Measures : Pathologic complete response (Step I) [ Time Frame: Up to 5 weeks ] The study with compare the pathologic complete response of Arm A and Arm B using a one-sided 0.10 level chi-squared test for proportions.
    Disease-free survival (DFS) (Step 2) [ Time Frame: From the adjuvant treatment randomization assessed for up to 7 years ] DFS measured from the adjuvant treatment randomization will be the endpoint of the adjuvant portion of the study and to achieve the desired power it is expected that patients will be followed for an additional year post completion of accrual to the adjuvant portion. The DFS comparison will be between patients randomized to Arm C (nivolumab) versus Arm D (nivolumab plus ipilimumab) using a one-sided 0.10 level stratified log rank test.

    Secondary Outcome Measures : Incidence of adverse events [ Time Frame: Up to 7 years ] Graded according to Common Terminology Criteria for Adverse Events version 5.0. Toxicity will be evaluated among all treated patients regardless of eligibility and interim analyses of toxicity are performed twice yearly. The study will have sufficient precision to provide 95% confidence intervals on toxicity
    Overall survival [ Time Frame: From the time of first randomization up to 7 years ] Analyses will be descriptive in nature and will not follow any formal interim monitoring.
    DFS [ Time Frame: From the time of first randomization up to 7 years ] The DFS comparison will be between patients randomized to Arm C (nivolumab) versus Arm D (nivolumab plus ipilimumab) using a one-sided 0.10 level stratified log rank test.

    Other Outcome Measures: Percent change in mean volumetric apparent diffusion coefficient (ADC) [ Time Frame: Baseline to mid-treatment ] The study will assess the area under the receiver operating characteristic curve of the changes of apparent diffusion coefficient (ADC) value.

    TRIAL NUMBER: S0820

    Title: A DOUBLE BLIND PLACEBO-CONTROLLED TRIAL OF EFLORNITHINE AND SULINDAC TO PREVENT RECURRENCE OF HIGH RISK ADENOMAS AND SECOND PRIMARY COLORECTAL CANCERS IN PATIENTS WITH STAGE 0-III COLON CANCER, PHASE III

    Purpose: The purpose of this study is to assess whether eflornithine 500 mg or sulindac 150 mg are effective in reducing the 3-year event rate of high risk adenoma or second primary colorectal cancer in Stage 0, I II and III colon cancer patients. The primary hypothesis will test the main effect of each agent, as well as the comparison of placebo alone to the combination of sulindac and eflornithine.

    TRIAL NUMBER: EA2142

    Title: Randomized Phase II Study of Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced G3 Non-small Cell Gastroenteropancreatic Neuroendocrine Carcinomas

    Purpose: This randomized phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, capecitabine, cisplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Certain types of neuroendocrine carcinomas may respond better to treatments other than the current standard treatment of cisplatin and etoposide. It is not yet known whether temozolomide and capecitabine may work better than cisplatin and etoposide in treating patients with this type of neuroendocrine carcinoma, called non-small cell neuroendocrine carcinoma.

    TRIAL NUMBER: A041701

    Title: A Randomized Phase II/III Study of Conventional Chemotherapy +/- Uproleselan (GMI-1271) in Older Adults With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy

    Purpose: This phase II/III trial studies how well daunorubicin and cytarabine with or without uproleselan works in treating older adult patients with acute myeloid leukemia receiving intensive induction chemotherapy. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Uproleselan may prevent cancer from returning or getting worse. Giving daunorubicin and cytarabine with uproleselan may work better in treating patients with acute myeloid leukemia compared to daunorubicin and cytarabine alone.

    TRIAL NUMBER: A151216

    Title: Genetic Testing For Patients with Resectable or Resected Lung Cancer: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

    Purpose: PRIMARY OBJECTIVES:
    I. To centrally genotype resected lung adenocarcinomas for epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma receptor tyrosine kinase (ALK) rearrangements to facilitate accrual to randomized adjuvant studies.
    II. To obtain clinically annotated tumor tissue and patient-matched non-malignant deoxyribonucleic acid (DNA) from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow clinically annotated advanced genomic analyses in concert with the National Cancer Institute (NCI) Center for Cancer Genomics (CCG).
    SECONDARY OBJECTIVES:
    I. To characterize the natural history of EGFR and ALK wild-type lung cancers to allow subsequent development of targeted therapies against genotype-defined sub-populations in the adjuvant and recurrent settings.
    II. To cross-validate local genotyping assays for EGFR and ALK with a central reference standard.
    TERTIARY OBJECTIVES:
    I. To study the genomic evolution of lung cancers by comparing genomic characteristics at resection and at recurrence.
    OUTLINE:
    Patients undergo collection of blood and tissue samples for EGFR and ALK testing via direct sequencing and fluorescence in situ hybridization (FISH). Patients that have had surgery prior to pre-registration will submit samples from the previous surgery for testing.
    After completion of study, patients that are not enrolled on either A081105 or E4512 are followed up every 6 months for 5 years.

    TRIAL NUMBER: E4512

    Title: A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

    Purpose: PRIMARY OBJECTIVES:
    I. To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) over placebo for patients with stage IB >= 4 cm, II and IIIA, anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following surgical resection.
    SECONDARY OBJECTIVES:
    I. To evaluate and compare disease-free survival (DFS) associated with crizotinib and placebo.
    II. To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting.
    III. To collect tumor tissue and blood specimens for future research.
    OUTLINE: Patients are randomized to 1 of 2 treatment arms.
    ARM A: Patients receive crizotinib orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    ARM B: Patients receive placebo PO BID on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for 5 years.

    TRIAL NUMBER: EA6134

    Title: A Randomized Phase III Trial of Dabrafenib + Trametinib Followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab Followed by Dabrafenib + Trametinib at Progression in Patients With Advanced BRAFV600 Mutant Melanoma

    Purpose: This randomized phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III-IV melanoma that contains a mutation known as v-raf murine sarcoma viral oncogene homolog B V600 (BRAFV600) and cannot be removed by surgery. Ipilimumab and nivolumab may block tumor growth by targeting certain cells. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.

    TRIAL NUMBER: EAY131

    Title: EAY131: Molecular Analysis for Therapy Choice (NCI-MATCH)

    Purpose: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

    TRIAL NUMBER: S1609

    Title: SWOG 1609: DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors Treatment with Ipilimumab and Nivolumab for Rare Cancers

    Purpose: Both Ipilimumab and Nivolumab have already been FDA-approved to treat other cancers. However, Ipilimumab and Nivolumab are investigational and not FDA-approved for use in combination in treating rare cancers or cancers of unknown primary origin.

    TRIAL NUMBER: A191402CD

    Title: Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer

    Purpose: This randomized phase III trial studies how well decision aids work in improving knowledge in patients with newly diagnosed prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.

    • Ochsner Hematology Oncology North Shore - Slidell (East Region)
    • 4 Trials Available
    • CONTACT US

    TRIAL NUMBER: EA1131

    Title: A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Observation in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy

    Purpose: The purpose of this study is to compare the IDFS in TNBC patients with residual basal-like disease after neoadjuvant chemotherapy who are randomized to post-preoperative platinum based chemotherapy with those who are randomized to observation. At present, upon completion of neoadjuvant therapy, the standard of care for patients with TNBC (who have no clinical evidence of metastatic disease after surgical excision of the cancer regardless of burden of residual disease) is observation, since there is no additional therapies available with proven impact. This study could provide a possible alternative treatment, which makes it appropriate for the population.

    TRIAL NUMBER: S1501

    Title: PROSPECTIVE EVALUATION OF CARVEDILOL IN PREVENTION OF CARDIAC TOXICITY IN PATIENTS WITH METASTATIC HER-2+ BREAST CANCER, PHASE III

    Purpose: Primary Objective To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy. Secondary Objectives a. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of predefined subsequent cardiac events in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy. b. To evaluate if prophylactic carvedilol compared with no intervention results in a longer time to first interruption of trastuzumab?based HER-2 targeted therapy due to either cardiac dysfunction or events. c. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction OR events in this population. d. To establish and prospectively collect a predefined panel of baseline core cardiovascular measures and develop a predictive model of cardiac dysfunction (see Section 11.2). e. To evaluate the rate of cardiac dysfunction in an observational arm consisting of individuals otherwise eligible for the study except for use of beta blockers, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitors for other medical reasons.

    TRIAL NUMBER: A151216

    Title: Genetic Testing For Patients with Resectable or Resected Lung Cancer: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

    Purpose: PRIMARY OBJECTIVES:
    I. To centrally genotype resected lung adenocarcinomas for epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma receptor tyrosine kinase (ALK) rearrangements to facilitate accrual to randomized adjuvant studies.
    II. To obtain clinically annotated tumor tissue and patient-matched non-malignant deoxyribonucleic acid (DNA) from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow clinically annotated advanced genomic analyses in concert with the National Cancer Institute (NCI) Center for Cancer Genomics (CCG).
    SECONDARY OBJECTIVES:
    I. To characterize the natural history of EGFR and ALK wild-type lung cancers to allow subsequent development of targeted therapies against genotype-defined sub-populations in the adjuvant and recurrent settings.
    II. To cross-validate local genotyping assays for EGFR and ALK with a central reference standard.
    TERTIARY OBJECTIVES:
    I. To study the genomic evolution of lung cancers by comparing genomic characteristics at resection and at recurrence.
    OUTLINE:
    Patients undergo collection of blood and tissue samples for EGFR and ALK testing via direct sequencing and fluorescence in situ hybridization (FISH). Patients that have had surgery prior to pre-registration will submit samples from the previous surgery for testing.
    After completion of study, patients that are not enrolled on either A081105 or E4512 are followed up every 6 months for 5 years.

    TRIAL NUMBER: E4512

    Title: A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

    Purpose: PRIMARY OBJECTIVES:
    I. To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) over placebo for patients with stage IB >= 4 cm, II and IIIA, anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following surgical resection.
    SECONDARY OBJECTIVES:
    I. To evaluate and compare disease-free survival (DFS) associated with crizotinib and placebo.
    II. To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting.
    III. To collect tumor tissue and blood specimens for future research.
    OUTLINE: Patients are randomized to 1 of 2 treatment arms.
    ARM A: Patients receive crizotinib orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    ARM B: Patients receive placebo PO BID on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for 5 years.

    • MBP Cancer Center
    • East Feliciana Parish
    • 13 Trials Available
    • CONTACT US

    TRIAL NUMBER: EA1131

    Title: A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Observation in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy

    Purpose: The purpose of this study is to compare the IDFS in TNBC patients with residual basal-like disease after neoadjuvant chemotherapy who are randomized to post-preoperative platinum based chemotherapy with those who are randomized to observation. At present, upon completion of neoadjuvant therapy, the standard of care for patients with TNBC (who have no clinical evidence of metastatic disease after surgical excision of the cancer regardless of burden of residual disease) is observation, since there is no additional therapies available with proven impact. This study could provide a possible alternative treatment, which makes it appropriate for the population.

    TRIAL NUMBER: EA1151

    Title: Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer

    Purpose: This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.

    TRIAL NUMBER: DCP-001

    Title: DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)

    Purpose: The protocol is not a scientific study; rather, a method to implement the screening tool and allow the collection and analyses of expanded data with informed consent. Investigators also enroll patients into NCI-treatment trials. The tool, based on a screening log successfully used within the NCI Community Cancer Centers Program (NCCCP), has been streamlined and integrated into the sites’ workflow by using OPEN. The NCI Community Oncology Research Program (NCORP), a network of diverse community oncology practices, provides an opportunity to collect this important but missing clinical trials screening and expanded demographics in order to better understand the complex and multi-factorial