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The Gulf South Clinical Trials Network was created to bring access to the latest advancements in cancer to your community. If a trial is available in a surrounding parish or county, it will appear first, followed by trials available in the rest of the region. To learn more about a trial or your eligibility, select “contact us” for your preferred location, and someone will be in touch with you soon.

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- IRB - National Cancer Institute - Central IRB
- 71 Trials Available
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TRIAL NUMBER: WF-2303CD

Title: Understanding and Enhancing Health-Related Social Needs (HRSN) Screening Among Community Oncology Practices

Purpose: This study evaluates health related social needs screening processes in community oncology clinics.
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: EA8212

Title: A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)

Purpose: The study hypothesis is that BCG naïve non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical Gemcitabine + Docetaxel (GEMDOCE) will result in a non-inferior event-free survival (EFS) compared to standard treatment with intravesical BCG. The purpose of this study is to test whether Gemcitabine + Docetaxel is a better or worse treatment than the usual BCG therapy approach. The primary objective of this study is to determine the event free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer patients treated with intravesical BCG vs Gemcitabine + Docetaxel. Secondary objectives are as follows: to compare changes in cancer-specific and bladder cancer-specific QOL from baseline to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE, to determine the cystectomy free survival (CFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, to determine the progression free survival (PFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, and to determine the safety and toxicity of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.
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: 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: A012103

Title: OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy

Purpose: The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. 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. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.

TRIAL NUMBER: EA1211

Title: Interim FDG-PET/CT for PreDIcting REsponse of HER2+ Breast Cancer to Neoadjuvant Therapy: DIRECT Trial

Purpose: This phase II trial tests how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT imaging and helps to identify areas of active cancer. PET and CT are imaging techniques that make detailed, computerized pictures of areas inside the body. The use of FDG-PET/CT may help doctors better decide if a patient needs more or less treatment before surgery in order to get the best response. This study evaluates whether FDG-PET/CT is useful in predicting a patient's response to standard of care chemotherapy.

TRIAL NUMBER: EAQ221CD

Title: Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP)

Purpose: This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called WiseBag along with text message reminders for missed or extra medication events, to enhanced usual care (EUC), where patients only use the Wisebag, to monitor medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor. To ensure CDK4/6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule. Forgetfulness was the most common reason reported for medication non adherence. Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor.

TRIAL NUMBER: EAY191-N2

Title: A ComboMATCH Treatment Trial EAY191-N2: Phase 2 Trial of Fulvestrant and Binimetinib in Patients With Hormone Receptor-Positive Metastatic Breast Cancer With a Frameshift or Nonsense Mutation or Genomic Deletion in NF1

Purpose: This ComboMATCH phase II trial compares the usual treatment alone (fulvestrant) to using binimetinib plus the usual treatment in patients with hormone receptor positive breast cancer that has spread to other places in the body (metastatic) and has an NF1 genetic change. Fulvestrant is a hormonal therapy that binds to estrogen receptors in tumor cells, resulting in estrogen receptor destruction and decreased estrogen binding, which may inhibit the growth of estrogen-sensitive tumor cells. Binimetinib is a targeted therapy that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition of binimetinib to fulvestrant in breast cancers with an NF1 genetic change could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression) as compared to fulvestrant alone.
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: NRG-BR009

Title: A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET)

Purpose: This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

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: S2206

Title: Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) Plus Chemotherapy Versus Chemotherapy Alone for MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer

Purpose: This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint Ultrahigh (MP2) stage II-III hormone receptor positive, HER2 negative breast 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 paclitaxel, doxorubicin, and cyclophosphamide 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. There is some evidence from previous clinical trials that people who have a MammaPrint Ultrahigh Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer.

TRIAL NUMBER: S2212

Title: Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study

Purpose: This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.

TRIAL NUMBER: URCC-18007

Title: RANDOMIZED PLACEBO CONTROLLED TRIAL OF BUPROPION FOR CANCER RELATED FATIGUE

Purpose: AIMS/OBJECTIVES 2.1 Primary Aim is to determine the efficacy of bupropion versus placebo in reducing fatigue in a double-blinded, placebo-controlled, randomized clinical trial of breast cancer survivors with fatigue Primary Hypothesis: Bupropion will be associated with greater improvements in fatigue than placebo. 2.2 Secondary Aim 1 is to assess the efficacy of bupropion versus placebo on depression and quality of life in breast cancer survivors with fatigue Secondary Hypothesis 1a: Bupropion will be associated with greater improvements in depression and quality of life than placebo. Secondary Hypothesis 1b: The beneficial effects of bupropion on fatigue will be independent of its effects on depression. 2.3 Secondary Aim 2 is to assess the tolerability of bupropion in breast cancer survivors with fatigue Secondary Hypothesis 2: Adherence, incidence of CTCAE grade 2 or above toxicity, self-reported insomnia, and early discontinuation will be similar between the bupropion and placebo groups. 2.4 Exploratory Aim 1 is to assess the efficacy of bupropion versus placebo on symptomatology and cognition in breast cancer survivors with fatigue Exploratory Hypothesis 1a: Bupropion will be associated with greater improvements in depression and quality of life than placebo. 2.5 Exploratory Aim 2 is to explore the effects of bupropion on putative mechanisms of cancer-related fatigue Exploratory Hypothesis 2a: The relationship between group assignment and reductions in fatigue will be mediated by cytokines and cortisol slope. Exploratory Hypothesis 2b: The relationship between bupropion metabolites and fatigue in the bupropion group will be mediated by cytokines and cortisol slope. 2.5 Exploratory Aim 3 is to explore associations of CYP2B6 genotype with bupropion metabolism and changes in fatigue Exploratory Hypothesis 3: Bupropion metabolism and improvements in fatigue will be greater in patients with no copies of the reduced-function *6 allele (i.e., normal metabolizers) compared to patients with one or two copies of the *6 allele (i.e., reduced metabolizers). We will also compare associations of CYP2B6 genotype and tolerability. Since little previous data exists on CYP2B6 genotype and bupropion tolerability, no hypotheses are offered.

TRIAL NUMBER: ACNS2021

Title: A Phase 2 Trial of Chemotherapy Followed by Response-Based Whole Ventricular &Amp; Spinal Canal Irradiation (WVSCI) for Patients With Localized Non-Germinomatous Central Nervous System Germ Cell Tumor

Purpose: This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patient's response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, 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. Radiation therapy uses high energy x-rays or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT.

TRIAL NUMBER: A212102

Title: BLINDED REFERENCE SET FOR MULTICANCER EARLY DETECTION BLOOD TESTS

Purpose:

PRIMARY OBJECTIVE:

I. To provide a blinded reference set of cancer versus (vs.) non-cancer blood samples that will be used to validate assays for inclusion in a prospective clinical trial focused on utility of blood-based multi-cancer early detection.

SECONDARY OBJECTIVES:

I. Evaluate test performance at the time of initial cancer diagnosis by tumor type.

II. Evaluate test performance at the time of initial cancer diagnosis by clinical stage.

OUTLINE:

Participants complete a questionnaire at baseline. Participants undergo collection of blood samples at registration and at 12 months after registration. Patients with a cancer diagnosis may undergo collection of tissue samples at registration and 12 months after registration.

After completion of study, participants are followed up at 1 year.

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: A022101

Title: A PRAGMATIC RANDOMIZED PHASE III TRIAL EVALUATING TOTAL ABLATIVE THERAPY FOR PATIENTS WITH LIMITED METASTATIC COLORECTAL CANCER: EVALUATING RADIATION, ABLATION, AND SURGERY [ERASUR]

Purpose:
PRIMARY OBJECTIVE:

I. To evaluate and compare overall survival (OS) (measured from time of randomization) in patients with newly diagnosed oligometastatic colorectal cancer (oCRC) treated with total ablative therapy (TAT) in addition to standard of care (SOC) systemic therapy versus SOC systemic therapy.

SECONDARY OBJECTIVES:

I. To evaluate and compare event-free survival (EFS) (measured from time of randomization) between the two treatment arms.

II. To assess the adverse events (AE) profile within each of the two treatment arms.

III. To evaluate the time to local recurrence (TLR) (measured from completion of TAT) in patients with newly diagnosed oCRC treated with TAT + SOC systemic therapy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients undergo TAT on study, consisting of SABR with or without surgical resection and/or microwave ablation. Patients also receive SOC chemotherapy on study. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT scans throughout the trial.

ARM 2: Patients receive SOC chemotherapy on study. Patients also undergo Patients also undergo CT or MRI or PET/CT scans throughout the trial.

TRIAL NUMBER: A022104

Title: The Janus Rectal Cancer Trial: A Randomized Phase II Trial Testing The Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients With Locally Advanced Rectal Cancer

Purpose: This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) 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. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.

TRIAL NUMBER: NRG-GI004

Title: COLORECTAL CANCER METASTATIC dMMR IMMUNO-THERAPY (COMMIT) STUDY: A RANDOMIZED PHASE III STUDY OF mFOLFOX6/BEVACIZUMAB COMBINATION CHEMOTHERAPY WITH OR WITHOUT ATEZOLIZUMAB OR ATEZOLIZUMAB MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH DEFICIENT DNA MISMATCH REPOAR (dMMR) METASTATIC COLORECTAL CANCER

Purpose: PRIMARY OBJECTIVES:
I. To determine the efficacy, based on progression-free survival (PFS), of fluorouracil, oxaliplatin, and leucovorin calcium (mFOLFOX6)/bevacizumab plus atezolizumab (combination) and atezolizumab (single agent) as compared to mFOLFOX6/bevacizumab (control).
SECONDARY OBJECTIVES:
I. To compare the overall survival (OS). II. To compare the objective response rates (ORR) per RECIST 1.1. III. To determine the safety profiles of the combination of mFOLFOX6/bevacizumab/atezolizumab and atezolizumab monotherapy in patients with microsatellite instability-high metastatic colorectal cancer (MSI-H mCRC).
IV. To compare the surgical conversion rate. V. To compare disease control rate (complete response [CR] + partial response [PR] + stable disease [SD]) at 12 months.
VI. To determine the duration of response and stable disease. VII. To determine the progression-free survival (PFS) by retrospective central independent scan review.
TERTIARY OBJECTIVES:
I. To compare the health-related quality of life and patient-reported symptoms. II. To bank tissue and blood samples for other future correlative studies from patients enrolled on the study.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on day 1, oxaliplatin IV over 2 hours on day 1 of courses 1-10, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1 and 2. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 2 weeks for up to 48 courses in the absence of disease progression or unacceptable toxicity.
ARM III: Patients receive atezolizumab IV over 30-60 minutes on day 1. Courses with repeat every 2 weeks for up to 48 courses in the absence of disease progression or unacceptable toxicity. Patients also received bevacizumab IV over 30-90 minutes on day 1, oxaliplatin IV over 2 hours on day 1 courses 1-10, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 8 weeks for 18 months, and then every 12 weeks for up to 5 years.

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: WF-1806

Title: MYOPENIA AND MECHANISMS OF CHEMOTHERAPY TOXICITY IN OLDER ADULTS WITH COLORECTAL CANCER: THE M&M STUDY

Purpose:
Primary Outcome Measures :
1. Number of Chemotherapy Toxicities (Grade 3 - 5) [ Time Frame: Up to 6 months (after initiation of chemotherapy) ]
  Chemotoxicity will be measured after initiation of chemotherapy using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Secondary Outcome Measures :
1. Overall Survival [ Time Frame: 1 year ]
  Participants will be followed for the duration of the study with each participant followed for at least one year after diagnosis, to determine vital status. Loss-to-follow-up will be minimized by asking participating sites to provide date of last contact every 3 months.
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: S2303

Title: Randomized Phase II/III Trial of 2nd Line Nivolumab + Paclitaxel + Ramucirumab Versus Paclitaxel + Ramucirumab in Patients With PD-L1 CPS >/= 1 Advanced Gastric and Esophageal Adenocarcinoma (PARAMMUNE)

Purpose: This phase II/III trial compares the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab to paclitaxel and ramucirumab alone in treating patients with gastric or esophageal adenocarcinoma that that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Adding nivolumab to ramucirumab and paclitaxel may work better to treat patients with advanced stomach or esophageal cancer.

TRIAL NUMBER: A022102

Title: Randomized Phase III Trial of mFOLFIRINOX vs. FOLFOX With Nivolumab for First-Line Treatment of Metastatic HER2- Gastroesophageal Adenocarcinoma

Purpose: This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. The usual approach for patients is treatment with FOLFOX chemotherapy. Chemotherapy drugs 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. Fluorouracil stops cells from making DNA and it may kill tumor cells. Leucovorin is used with fluorouracil to enhance the effects of the drug. Oxaliplatin works by killing, stopping, or slowing the growth of tumor cells. Some patients also receive an immunotherapy drug, nivolumab, in addition to FOLFOX chemotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill tumor cells. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers.
TRIAL NUMBER: NRG-CC008

Title: A NON-RANDOMIZED PROSPECTIVE CLINICAL TRIAL COMPARING THE NON-INFERIORITY OF SALPINGECTOMY TO SALPINGO-OOPHORECTOMY TO REDUCE THE RISK OF OVARIAN CANCER AMONG BRCA1 CARRIERS [SOROCk]

Purpose:
Primary Outcome Measures :
1. Time to development of incident high-grade serous carcinomas (HGSC), specifically ovarian, primary peritoneal, or fallopian tube cancers [ Time Frame: Up to 20 years ]
  Will be assessed using a stratified log rank test, stratifying for age. The effects of other covariates, such as familial history of gynecologic cancer, time to crossover for bilateral salpingectomy (BLS) patients, and age at study entry, will be adjusted for in Cox proportional hazard models. Patients who crossover will be analyzed according to the initial surgery received at study enrollment as this will reflect actual practice.
Secondary Outcome Measures :
1. Health-related quality of life (QOL) [ Time Frame: Up to 24 months post-surgery ]
  Will be measured by the Functional Assessment of Cancer Therapy - Endocrine Symptom (FACT-ES). The FACT total score (calculated from the physical, functional, social and emotional well-being subscales) and ES subscale will be assessed. Higher scores indicate better QOL for the FACT-ES and better functioning for the FSFI total score.
2. Estrogen deprivation symptoms [ Time Frame: Up to 24 months post-surgery ]
  Will be measured by the FACT-ES. The FACT total score (calculated from the physical, functional, social and emotional well-being subscales) and ES subscale will be assessed. Higher scores indicate better QOL for the FACT-ES and better functioning for the FSFI total score.
3. Sexual dysfunction [ Time Frame: Up to 24 months post-surgery ]
  Will be measured by the Female Sexual Function Index (FSFI). Higher scores indicate better functioning for the FSFI total score.
4. Menopausal symptoms [ Time Frame: Up to 24 months post-surgery ]
  Will be measured by the Menopausal Symptom Checklist (MSCL).
5. Cancer distress [ Time Frame: Up to 24 months post-surgery ]
  Will be measured by the Impact of Events Scale (IES).
6. Medical decision making [ Time Frame: Up to 24 months post-surgery ]
  Will be measured by the Shared Decision Making Questionnaire (SDM-Q-9) to determin factors associated with the risk of reducing surgical treatment choice. The SDM-Q-9 total score at each time point of collection will be compared between arms using a t-test with a significance level of 0.05. A linear model will be used to assess the association of the SDM-Q-9 total score with treatment arm and patient characteristics such as age and race.
7. Medical decision making [ Time Frame: Up to 24 months post-surgery ]
  Will be measured by the Decisional Regret Scale to determine factor associated with the risk of reducing surgical treatment choice. The Decisional Regret Scale total score at each time point of collection will be compared between arms using a t-test with a significance level of 0.05. A linear model will be used to assess the association of the Decisional Regret Scale total score with treatment arm and patient characteristics such as age, race, crossover from BLS arm, and hysterectomy status.
8. Incidence of adverse events [ Time Frame: Up to 24 months post-surgery ]
  Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Counts and frequencies will be provided for the worst grade adverse event (AE) experienced by the patient by treatment arm. The distribution of AE grade in the BLS arm will be compared to the BSO arm using a chi-square test, or Fisher's exact test if cell frequencies are < 5, at the one-sided 0.05 significance level.
Other Outcome Measures:
1. Cost effectiveness [ Time Frame: Up to 24 months post-surgery ]
  Will be measured by European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L). A Markov model will be used to model cost.
2. Sexual dysfunction by PROMIS screener [ Time Frame: Up to 20 years ]
  Will be measured by selected Patient-Reported Outcomes Measurement Information System (PROMIS) screener. Each item will be analyzed separately and compared between treatment arms using a chi-square test.
3. Section dysfunction by PROMIS external sexual function items [ Time Frame: Up to 20 years ]
  Will be measured by selected PROMIS external sexual function items. Each item will be analyzed separately and compared between treatment arms using a chi-square test.
4. Correlation between Health related (HR)-QOL and patient reported symptoms. [ Time Frame: Up to 24 months post-surgery ]
  Will examine the correlation between HR-QOL, as measured by the FACT, with menopausal symptoms, as measured by the MCL, sexual dysfunction, as measured by FSFI, and PROMIS screener and external sexual function items and cancer distress as measured by the IES. Pearson correlation coefficients will be used for correlating the FACT total score with the FSFI overall score and IES total distress score. Spearman correlation coefficients will be used to assess the correlation between FACT total score and the MSCL symptoms, FSFI, and PROMIS items.
TRIAL NUMBER: NRG-CC010

Title: A Phase III Trial of the Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Endometrial Cancer

Purpose:

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: NRG-GY026

Title: A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined With Either Trastuzumab and Hyaluronidase-Oysk (HERCEPTIN HYLECTA) or Pertuzumab, Trastuzumab, and Hyaluronidase-Zzxf (PHESGO) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma

Purpose: This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab or pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer, so that these medications will have a greater effect. Hyaluronidase also allows trastuzumab and trastuzumab/pertuzumab to be given by injection under the skin and shortens their administration time compared to trastuzumab or pertuzumab alone. Paclitaxel is a taxane and in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving Herceptin Hylecta or Phesgo in combination with paclitaxel and carboplatin may shrink the tumor and prevent the cancer from coming back in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma.

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: EA3161

Title: A PHASE II/III RANDOMIZED STUDY OF MAINTENANCE NIVOLUMAB VERSUS OBSERVATION IN PATIENTS WITH LOCALLY ADVANCED, INTERMEDIATE RISK HPV POSITIVE OPCA

Purpose: Primary Outcome Measures :
Progression-free survival (PFS) (Phase II) [ Time Frame: From randomization to date of progression, second primary tumor from the head and neck region, or death, assessed up to 24 months ] Progression will be defined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Log rank test will be used to compare PFS and OS. Both phase II and phase III analyses will be intent-to-treat analysis, and analysis will be stratified on stratification factors collected at the time of randomization. As patients on the observation arm are allowed to cross-over to the nivolumab arm upon progression, an overall survival analysis using inverse probability censoring weights (IPCW, Robins et. al, 2000) will also be considered. Kaplan-Meier method and Cox regression will be used for the survival outcome analyses.
Overall survival (OS) (Phase III) [ Time Frame: From randomization to death, assessed up to 24 months ] Log rank test will be used to compare PFS and OS. Both phase II and phase III analyses will be intent-to-treat analysis, and analysis will be stratified on stratification factors collected at the time of randomization. As patients on the observation arm are allowed to cross-over to the nivolumab arm upon progression, an overall survival analysis using inverse probability censoring weights (IPCW, Robins et. al, 2000) will also be considered. Kaplan-Meier method and Cox regression will be used for the survival outcome analyses.
Negative (standardized qualitative) 12 week post therapy (cisplatin + radiation therapy [RT]) FDG positron emission tomography/computed tomography (PET/CT) associated with OS for patients who have a PET/CT [ Time Frame: At 12 weeks ] Logrank tests and input hazard rates will be used.
Negative (standardized qualitative) 12 week post therapy (cisplatin + RT) FDG PET/CT associated with PFS for patients who have a PET/CT [ Time Frame: At 12 weeks ] Logrank tests and input hazard rates will be used.

Secondary Outcome Measures :
Prognostic effect of baseline PD-L1 expression (positive versus [vs.] negative) on OS and PFS [ Time Frame: Baseline up to 10 years ] Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
Prognostic effect of baseline saliva and/or plasma human papillomavirus (HPV) status (positive vs. negative) on OS and PFS [ Time Frame: Baseline up to 10 years ] Saliva and plasma HPV status at 12 weeks and 9 months following completion of concurrent therapy will also be analyzed regarding effect on outcome. Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
Prognostic value of maximum standardized uptake value (SUVmax) of primary tumor or neck nodal metastasis of baseline FDG PET/CT for OS [ Time Frame: Baseline up to 10 years ] Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
Prognostic value of SUVmax of primary tumor or neck nodal metastasis of baseline FDG PET/CT for PFS [ Time Frame: Baseline up to 10 years ] Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
SUVmax of primary tumor or nodal metastasis of baseline FDG PET/CT with PD-L1 expression (positive vs. negative) [ Time Frame: Baseline up to 10 years ] Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
Post therapy (cisplatin + RT) FDG PET/CT with saliva or plasma levels of HPV deoxyribonucleic acid (DNA) [ Time Frame: Up to 9 months post-therapy ] Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
PET based therapy response assessment compared to RECIST 1.1 assessment for patients who have a PET/CT scan at 12 weeks [ Time Frame: At 12 weeks post chemoradiation therapy ] Kappa statistics will be applied to evaluate the agreement between PET based therapy response assessment (Hopkins criteria) and RECIST 1.1 assessment at 12 weeks post chemoradiation therapy.
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: RTOG-1216

Title: RANDOMIZED PHASE II/III TRIAL OF ADJUVANT RADIATION THERAPY WITH CISPLATIN, DOCETAXEL-CETUXIMAB, OR CISPLATIN-ATEZOLIZUMAB IN PATHOLOGIC HIGH-RISK SQUAMOUS CELL CANCER OF THE HEAD AND NECK

Purpose:
Primary Outcome Measures :
1. Disease-free survival (DFS) (Phase II) [ Time Frame: From date of randomization until date of local-regional recurrence, distant metastasis or death due to any cause, assessed up to 7 years ]
  Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a one-sided log rank test.
2. Overall survival (OS) (Phase III) [ Time Frame: From date of randomization to death due to any cause, assessed up to 7 years ]
  Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a one-sided log rank test. Multivariate analysis will be performed using the Cox proportional hazards model.
Secondary Outcome Measures :
1. Local-regional failure (LRF) [ Time Frame: From date of randomization until date of local-regional recurrence, assessed up to 7 years ]
  The cumulative incidence method will be used to estimate rates, and the failure rates for the experimental arms will be compared against the control using a failure-specific log rank test.
2. Distant metastasis (DM) [ Time Frame: From date of randomization to date of distant metastasis, assessed up to 7 years ]
  The cumulative incidence method will be used to estimate rates, and the failure rates for the experimental arms will be compared against the control using a failure-specific log rank test.
3. Toxicity [ Time Frame: From start of treatment to death or last follow-up ]
  Adverse events (AEs) will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0. Rates of grade 3+ adverse events overall will be compared between arms by Chi-square test, or Fisher's exact test.
4. Patient-reported outcome, symptom burden [ Time Frame: Time from randomization to a first recovery within at least one MID unit of total symptom severity compared to the baseline (reference) score ]
  Time to recovery of baseline total symptom severity from the MD Anderson Symptom Inventory - Head and Neck (MDASI-HN). The cumulative incidence method will be used to estimate the event rates, and the event rates between arms will be compared using a cause-specific log rank test. The Fine-Gray subdistribution hazards model may be applied to further explore outcomes by treatment arm and other covariates.
5. Quality of life [ Time Frame: Baseline and 1 year post radiation therapy (RT) ]
  Quality of life change from baseline at 1-year post RT, as measured by the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N) Trial Outcome Index (TOI). FACT TOI is a validated efficient summary index of physical/functional outcomes, and disease site-specific items, which is highly reliable and sensitive to change in performance status rating. A constrained longitudinal data analysis model will be fitted with all the time points (discrete), the treatment factor and its interaction. The secondary non-inferiority patient-reported outcome (PRO) hypothesis will be tested using a confidence interval approach.
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: 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: NRG-LU008

Title: Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally Advanced Non-Small Cell Lung Cancer

Purpose: This phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT) to standard treatment (image guided radiation therapy [IGRT] and chemotherapy followed by immunotherapy with durvalumab) versus standard treatment alone in treating patients with non-small cell lung cancer that cannot be treated by surgery (inoperable). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. IGRT is a type of radiation that uses a computer to create picture of the tumor, to help guide the radiation beam during therapy, making it more accurate and causing less damage to healthy tissue. Standard chemotherapy used in this trial consists of combinations of the following drugs: cisplatin, carboplatin, paclitaxel, pemetrexed, and etoposide. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It works by stopping the growth and spread of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by blocking the action of a certain substance in the body that may help tumor cells multiply. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Immunotherapy with durvalumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Adding SBRT to the standard treatment of IGRT with chemotherapy and immunotherapy may be more effective at treating patients with inoperable non-small cell lung cancer than giving the standard treatment alone.

TRIAL NUMBER: S1800D

Title: A Phase II/III Study of N-803 (ALT-803) plus Pembrolizumab versus Standard of Care in Participants with Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated with Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study)

Purpose: This phase II/III Lung-MAP trial studies how well immunotherapy treatment with N-803 (ALT-803) and pembrolizumab working in treating patients with non-small cell lung cancer that has spread to other places in the body (advanced). Natural killer cells, part of our immune system, are always on alert and ready to defend our bodies from many kinds of infection or rogue cells, such as those that cause cancer. N-803 (ALT-803) may activate natural killer cells so that they can stimulate an immune response to help fight 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. Giving N-803 (ALT-803) and pembrolizumab may help shrink and stabilize lung cancer or prevent it from returning.
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: S1914

Title: A RANDOMIZED PHASE III TRIAL OF INDUCTION/CONSOLIDATION ATEZOLIZUMAB (NSC #783608) + SBRT VERSUS SBRT ALONE IN HIGH RISK, EARLY STAGE NSCLC

Purpose:
Primary Outcome Measures :
1. Overall survival [ Time Frame: 3 years ]
  Will compare overall survival between patients with inoperable, T1, T2, limited T3, N0M0 (early stage) non-small cell lung cancer randomized to stereotactic body radiation therapy with or without atezolizumab. Will be evaluated using the method of Kaplan-Meier. For point estimates at landmark times, the associated 95% confidence interval (CI) will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios for these outcomes will be estimated using a Cox Proportional Hazards regression model and estimated using a stratified Cox regression model.
Secondary Outcome Measures :
1. Progression free survival [ Time Frame: 5 years ]
  Will be evaluated using the method of Kaplan-Meier. For point estimates at landmark times, the associated 95% CI will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios for these outcomes will be estimated using a Cox Proportional Hazards regression model and estimated using a stratified Cox regression model.
2. Incidence of adverse events [ Time Frame: 5 years ]
TRIAL NUMBER: S1929

Title: Phase II Randomized Study of Maintenance Atezolizumab Versus Atezolizumab in Combination with Talazoparib in Patients with SLFN11 Positive Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Purpose:
Primary Outcome Measures :
1. Progression free survival [ Time Frame: From the date of maintenance randomization to the date of first document of progression or symptomatic deterioration, or death due to any cause, assessed up to 18 months ]
  Analysis will be done using a 1-sided 10% level stratified log-rank test. Will be estimated using the Kaplan-Meier method. Associated confidence intervals around the median will be performed using the Brookmeyer-Crowley method.
Secondary Outcome Measures : Overall survival [ Time Frame: From the date of maintenance randomization until death from any cause, with participants last known to be alive censored at the date of last contact, assessed up to 3 years from randomization ]
Will be estimated using the Kaplan-Meier method. Associated confidence intervals around the median will be performed using the Brookmeyer-Crowley method.
TRIAL NUMBER: EA6194

Title: Phase II Randomized Study of Neoadjuvant Pembrolizumab Alone or in Combination With CMP-001 in Patients With Operable Melanoma: Efficacy and Biomarker Study

Purpose: This phase II trial studies the effect of pembrolizumab alone or in combination with CMP-001 in treating patients with melanoma that can be treated by surgery (operable). 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. Immunotherapy with CMP-001 may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. The addition of CMP-001 to pembrolizumab could improve the ability of the immune system to shrink tumors and to prevent them from returning.

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: WF-1901

Title: Internet-delivered Management of Pain Among Cancer Treatment Survivors (IMPACTS)

Purpose:
To determine whether an Internet-based pain coping skills program plus enhanced usual care, compared to enhanced usual care alone, yields significant improvements in the co-primary outcomes of pain severity (as measured by the Brief Pain Inventory (BPI)) and pain interference (also measured by the BPI) from baseline to the post-intervention assessment for cancer survivors with persistent pain.

This is a parallel group randomized controlled, prospective study that examines the effect of an Internet-based pain coping skills program on pain severity and pain interference among adult cancer survivors experiencing persistent cancer-related pain. The study also explores the effects of an Internet-based pain coping skills program on opioid/analgesic medication use, health-related quality of life, pain management self-efficacy and various other factors relevant among populations with persistent pain (i.e., fatigue, sleep, emotional distress, positive affect, pain impact, perceived cognitive problems, and cognitive performance), as well as qualitative assessments of participants experiences with pain and the intervention. A total of 456 participants will be enrolled (228 per arm) and randomized into the internet program arm (plus enhanced usual care) or Enhanced Usual Care alone.

Each participant will be enrolled in the study for 9 months (from randomization at week 0 to the final follow-up assessment at week 34).

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: EAA181

Title: Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation

Purpose:
Primary Outcome Measures :
1. Consolidation overall survival [ Time Frame: Time from Step 2 randomization at the start of consolidation to death or to the 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 treatment hazard ratio (bortezomib, daratumumab and hyaluronidase-fihj (daratumumab), lenalidomide and dexamethasone [Btz-DRd] then daratumumab, lenalidomide and dexamethasone [DRd] then daratumumab and lenalidomide [DR]).
Secondary Outcome Measures :
1. Consolidation progression-free survival [ Time Frame: Time from Step 2 randomization at the start of consolidation until the earlier of progression or death due to any cause, assessed up to 15 years ]
  Patients alive without disease progression will be censored at date of last disease evaluation. Only deaths that occur within 3 months of the last disease evaluation are considered events.
2. Incidence of adverse events [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
3. Incidence of grade 3 or higher non-hematologic adverse events [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
4. Incidence of grade 3 or higher adverse events [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
5. Best response [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
6. FACT-Ntx TOI recovery rate (Patient reported outcome [PRO]) [ Time Frame: From end of induction through consolidation up to 1 year of maintenance, up to 21 weeks ]
  Defined as the proportion of patients with the FACT-Ntx TOI score returning to baseline level reached at consolidation randomization after experiencing a MID decrease while on up to 1 year of maintenance.
Other Outcome Measures:
1. Change in Functional Assessment of Cancer Therapy - Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) score (Patient reported outcome) [ Time Frame: From end of induction to after completion of 9 cycles of consolidation, a period of approximately 36 weeks (9 months) ]
  Calculated as the difference after completion of 9 cycles of consolidation therapy from end of induction. Scores can range from a minimum of 0 and a maximum of 44. A higher score on this assessment means a worse outcome.
2. Levels and changes of FACT-General (G) (physical well-being [PWB] + functional well-being [FWB]) score (PRO) [ Time Frame: From the end of induction through 1 year of maintenance, 21 weeks ]
  The FACT-G is a single outcome measure made up of the PWB and FWB components. Scores range from a minimum of 0 and a maximum of 56. For this assessment, a higher score means a better outcome.
3. Presence, frequency, interference, amount and/or severity of select PRO- Common Terminology Criteria for Adverse Events (CTCAEs) (PRO) [ Time Frame: Up to 15 years ]
  Presence, frequency, interference, amount and/or severity of select PRO-CTCAEs tabulated at each measurement.
4. Comparison of selected PRO-CTCAEs with provider obtained assessment of same CTCAE items (PRO) [ Time Frame: Up to 15 years ]
5. 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).
6. 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: A211901

Title: Reaching Rural Cancer Survivors Who Smoke Using Text-Based Cessation Interventions

Purpose: This phase III trial compares the effect of text-based cessation intervention to a manual in helping rural cancer patients who smoke, quit. Text-based scheduled gradual reduction may reduce the frequency of cigarette use to zero and may be effective in quitting smoking.

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-19178

Title: Optimizing Functional Outcomes of Older Cancer Survivors after Chemotherapy: The GEM-S Study

Purpose: This phase III trial compares the effect of geriatric evaluation and management with survivorship health education (GEMS) to usual care on patient-reported physical function in older survivors of cancer. Survivorship care for older adults of cancer usually consists of getting advice from their doctor. This advice may include how to do their daily activities, so they are less tired or how to manage multiple diseases, or long-term side effects from treatment. GEMS may help improve the physical ability to perform activities of daily living, mental well-being, and memory in older survivors of cancer after chemotherapy. This study may help doctors learn if including GEMS in their practices improves physical, mental and memory functions in their patients. The study may also help to understand how such care affects cancer patients and their caregivers' quality of life.

TRIAL NUMBER: URCC-19185

Title: Multicenter Randomized Controlled Trial Comparing Brief Behavioral Therapy for Cancer Related Insomnia (BBT-CI) and Healthy Eating Education Learning (HEAL)

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: NRG-CC012CD

Title: Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment

Purpose: In this clinical trial, symptom monitoring (interactive voice response [IVR] is compared to automated telephone symptom management [ATSM] and telephone interpersonal counseling [TIPC]) for reducing symptom burden and psychological distress (depressive and anxiety symptoms) among people receiving oral anti-cancer treatment. Symptoms are the number one driver of treatment interruptions and unscheduled health services use. To reduce the risk of these events, symptom monitoring and management are necessary. However, these services are not implemented routinely, especially in the community oncology settings. Further, depressive and anxiety symptoms are a key barrier to enacting symptom self-management strategies. IVR is a form of symptom monitoring where patients, when called, enter their symptom ratings over the phone. Their symptom summary is sent to their provider, and patients may be advised to reach out to their oncology provider, based on their symptoms. The ATSM intervention combines IVR assessments with a Symptom Management and Survivorship educational handbook with self-management strategies. Patients receiving ATSM enter their symptom ratings over the phone and have their symptoms reported to their provider, but patients are also directed to the handbook for strategies to manage elevated symptoms. Patients receiving ATSM who report being anxious, discouraged, or sad will also receive TIPC, which targets psychological distress and its connection to social support and interpersonal communication. Information gathered from this study may help researchers learn more about the best ways to manage patient symptoms and improve patient outcomes.
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: A021806

Title: A PHASE III TRIAL OF PERIOPERATIVE VERSUS ADJUVANT CHEMOTHERAPY FOR RESECTABLE PANCREATIC CANCER

Purpose:
Primary Outcome Measures :
1. Overall survival (OS) [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Overall survival is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. The treatment arms will be compared using a stratified Cox regression model, and hazard ratios from each arm will be estimated.
Secondary Outcome Measures :
1. Disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Disease-free survival (DFS) is defined as the time from randomization to the date of progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, whichever occurs first. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
2. Time to locoregional recurrence (TLR) [ Time Frame: Time between randomization and locoregional recurrence after resection, assessed up to 6 years. ]
  Time to locoregional recurrence (TLR) is defined as the time from randomization to the date of locoregional recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
3. Time to distant metastases (TDM) [ Time Frame: Time between randomization and metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection, assessed up to 6 years. ]
  Time to distant metastases (TDM) is defined as the time from randomization to the date of metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
4. R0 resection rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients with negative resection margins after undergoing surgery.
5. Rate of unresectability [ Time Frame: At time of surgery or planned time of surgery. ]
  The rate (percentage) of patients who cannot undergo surgery due to adverse events, progressive disease, death, poor performance, or patient/physician decision, are deemed unresectable before surgery, or resection was not performed during surgery.
6. Pathologic complete response (pCR) rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients who achieve a pathologic complete response (pCR) confirmed by histopathologic review of the surgical specimen.
7. Incidence of adverse events (AEs), assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 (v5.0) [ Time Frame: Up to 2 years. ]
  The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns within treatment arms and during the following three time points: during perioperative chemotherapy, surgical complications during surgery and post-operative period for 30 days, and during adjuvant chemotherapy.
8. Fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (modified [m]FOLFIRINOX) dose intensity delivered [ Time Frame: 8 months ]
  Dose intensity is defined as the percentage of total cumulative dose the patient received divided by the total dose planned per protocol times 100.
9. Fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (modified [m]FOLFIRINOX) number of cycles received [ Time Frame: 8 months ]
  The number of cycles received is defined as the total number of cycles that the participant received at least one dose of any agent in mFOLFIRINOX.
10. Quality of life as assessed by the physical functioning, nausea/vomiting, and diarrhea subscales in the Quality of Life Questionnaire-Core 30 (QLQ-C30) [ Time Frame: 8 weeks ]
  Quality of Life Questionnaire-Core 30 (QLQ-C30) is a 30-item questionnaire to assess the overall quality of life in cancer patients. QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning, greater occurrence of nausea/vomiting, and greater occurrence of diarrhea.
11. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for overall survival (OS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
12. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for disease-free survival (DFS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
13. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on the risk of grade 3+ adverse event associated with chemotherapy [ Time Frame: Up to 2 years. ]
  Multivariate Logistic models will be fit for the binary endpoint of grade 3+ adverse event (patient experiences at least one grade 3 or higher adverse event during treatment)
14. The ability of computed tomography (CT)-based radiomics to distinguish post-neoadjuvant chemotherapy (NAC) fibrosis from viable tumor as measured by comparison to histological evaluation [ Time Frame: At time of surgery. ]
  Comparison between computed tomography (CT)-based radiomics and histological tumor fibrosis proportions will be measured using Spearman's rank correlation coefficient.
15. Computed tomography (CT)-based radiomics as non-invasive predictors of overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards model will be fit for overall survival (OS) endpoint (defined above) with covariates chosen from all available radiomics features using the least absolute shrinkage and selection operator (LASSO) method with 10-fold cross-validation (CV) and additionally adjusted for clinically important confounders. After the final model is selected the area under the receiver operating characteristic curve (AUC) will be reported to indicate the prediction performance of the radiomics model.
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: NRG-GU013

Title: The Phase III 'High Five Trial' Five Fraction Radiation for High-Risk Prostate Cancer

Purpose: This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.

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: S2210

Title: A Phase II Study of Neoadjuvant Carboplatin for Localized, High Risk Prostate Cancer With Germline BRCA1/2 Mutations

Purpose: This phase II trial tests how well carboplatin before surgery works in treating patients with high-risk prostate cancer and an inherited BRCA1 or BRCA2 gene mutation. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping, or slowing the growth of tumor cells. Giving carboplatin before surgery may shrink tumors in patients with high-risk prostate cancer with BRCA1 and BRCA2 gene mutations.

TRIAL NUMBER: CCTG-CO32

Title: A Phase 3 Randomized Trial Of Neoadjuvant Chemotherapy, Excision And Observation Versus Chemoradiotherapy For Early Rectal Cancer

Purpose: This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?

TRIAL NUMBER: NRG-GU012

Title: Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)

Purpose: This phase II trial tests whether the addition of radiation to the primary tumor, typically given with stereotactic ablative radiation therapy (SABR), in combination with standard of care immunotherapy improves outcomes in patients with renal cell cancer that is not recommended for surgery and has spread to other places in the body (metastatic). Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses of radiation over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, avelumab, 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. Axitinib, cabozantinib, and lenvatinib are in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving SABR in combination with standard of care immunotherapy may help shrink or stabilize the cancer in patients with renal cell cancer.

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: S2200

Title: A Phase II Randomized Trial of Cabozantinib (NSC #761968) With or Without Atezolizumab (NSC #783608) in Patients With Advanced Papillary Renal Cell Carcinoma (PAPMET2)

Purpose: This phase II trial tests whether cabozantinib with or without atezolizumab works to shrink tumors in patients with papillary kidney cancer that has spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 cabozantinib with atezolizumab may prevent papillary kidney cancer from growing or spreading compared to cabozantinib alone.

TRIAL NUMBER: EAY191

Title: Molecular Analysis for Combination Therapy Choice (ComboMATCH)

Purpose: This ComboMATCH patient registration trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.
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: A032103

Title: MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcer

Purpose: This phase II/III trial tests the role of DNA released from tumor cells into the blood in guiding the use of immunotherapy (nivolumab alone or with relatlimab) after surgical removal of the bladder for bladder cancer treatment. DNA is material found inside all of our cells that acts as a blueprint for how cells function. Tumor cells often have abnormal DNA that looks different than DNA in normal cells. A new test called Signatera has been developed that can detect bladder cancer DNA in the blood which might indicate the presence of bladder tumor cells somewhere in the body. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if the Signatera test can better identify which patients need an additional treatment with immunotherapy to help prevent bladder cancer from coming back after surgery.

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.

LA029 - University Medical Center
Orleans Parish
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TRIAL NUMBER: WF-2303CD

Title: Understanding and Enhancing Health-Related Social Needs (HRSN) Screening Among Community Oncology Practices

Purpose: This study evaluates health related social needs screening processes in community oncology clinics.

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 :

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).
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 :

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).
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).
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.
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.
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.
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: 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: GCAR-7213

Title: GBM AGILE: Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM

Purpose:

Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. Its goals are to identify effective therapies for glioblastoma and match effective therapies with patient subtypes. Bayesian response adaptive randomization is used within subtypes of the disease to assign participants to Arms based on their performance. The primary endpoint is overall survival (OS).

GBM AGILE is designed to efficiently evaluate therapies. The trial will be conducted under a single Master Investigational New Drug Application/Clinical Trial Application and Master Protocol, allowing multiple drugs and drug combinations from different pharmaceutical companies to be evaluated simultaneously. The plan is to add experimental therapies as new information about promising new drugs are identified and remove therapies as they complete their evaluation.

TRIAL NUMBER: 01-PS-001

Title: Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I (B-STRONGER-I)

Purpose:

Primary objective: Evaluate the correlation of MRD detection by NeXT Personal CTA to pathological Complete Response (pCR) after neoadjuvant chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC)

Secondary: Evaluate the trajectory of changes in MRD detected by NeXT Personal CTA during neoadjuvant chemotherapy (NAC) to pathological Complete Response (pCR) or non pCR in stage IIII triple negative breast cancer (TNBC) by using logistical regression, slope and change in MRD level between different timepoints.

Exploratory analyses: NeXT Personal CTA clinical accuracy may be evaluated as compared to other MRD clinically available tests. Stratification based on NAC therapy regimen, genomic profiles and biomarker analysis.

TRIAL NUMBER: A012103

Title: OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy

Purpose: The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. 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. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.

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: EAQ221CD

Title: Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP)

Purpose: This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called WiseBag along with text message reminders for missed or extra medication events, to enhanced usual care (EUC), where patients only use the Wisebag, to monitor medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor. To ensure CDK4/6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule. Forgetfulness was the most common reason reported for medication non adherence. Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor.

TRIAL NUMBER: MicroRNA

Title: MicroRNAs as a Prognostic Marker for Breast Cancer

Purpose:

The purpose of this study is to investigate the quantity and expression level of microRNA, a small

non-coding RNA, in breast cancer tissues and bio-fluids (plasma and serum).

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 :

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 :

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)
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
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)
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)
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: NRG-BR009

Title: A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET)

Purpose: This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

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: S2212

Title: Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study

Purpose: This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.

TRIAL NUMBER: EVOLVE - D7984C00002

Title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women with High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy (eVOLVE-Cervical)

Purpose:

This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to

explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018

stage IIIC to IVA cervical cancer with lymph node involvement) who have not progressed

following platinum-based CCRT.

TRIAL NUMBER: GOG-3043 ROCC

Title: A Phase III Randomized Controlled Trial of Robotic Versus Open Radical Hysterectomy for Cervical Cancer (ROCC)

Purpose: This is a Phase III randomized controlled trial to compare survival for patients who undergi robotic assisted laparoscopy versus open radical hysterectomy and lymph node assessment for the treatment of early stage cervical cancer.

TRIAL NUMBER: MK-2870-020-00/GOG-3101-ENGOT-cx20

Title: A Phase 3 Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Patients with Recurrent or Metastatic Cervical Cancer (TroFuse-020/GOG-3101/ENGOT-cx20)

Purpose:

TRIAL NUMBER: OU-SCC-STAR

Title: Phase II Trial of Niraparib in Combination with Dostarlimab in Patients with Recurrent or Progressive Cervix Cancer (STAR)

Purpose:

Primary Outcome Measures :

Proportion of patients with response to treatment [ Time Frame: 1 year ]
The proportion of patients treated with Niraparib and dostarlimab who achieve CR or PR, evaluated using RECIST v1.1

Secondary Outcome Measures :

Number of patients who experience toxicity [ Time Frame: 2 years ]
To determine the nature and degree of toxicity in combination of Niraparib and dostarlimab
Duration of patients with response [ Time Frame: up to 5 years ]
To estimate the duration of response of patients treated with combination of Niraparib and dostarlimab
Progression free survival [ Time Frame: up to 5 years ]
To estimate the progression free survival of patients treated with combination of Niraparib and dostarlimab
Overall survival [ Time Frame: up to 5 years ]
To estimate the overall survival of patients treated with combination of Niraparib and dostarlimab

TRIAL NUMBER: A212102

Title: BLINDED REFERENCE SET FOR MULTICANCER EARLY DETECTION BLOOD TESTS

Purpose:

PRIMARY OBJECTIVE:

I. To provide a blinded reference set of cancer versus (vs.) non-cancer blood samples that will be used to validate assays for inclusion in a prospective clinical trial focused on utility of blood-based multi-cancer early detection.

SECONDARY OBJECTIVES:

I. Evaluate test performance at the time of initial cancer diagnosis by tumor type.

II. Evaluate test performance at the time of initial cancer diagnosis by clinical stage.

OUTLINE:

Participants complete a questionnaire at baseline. Participants undergo collection of blood samples at registration and at 12 months after registration. Patients with a cancer diagnosis may undergo collection of tissue samples at registration and 12 months after registration.

After completion of study, participants are followed up at 1 year.

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: A022101

Title: A PRAGMATIC RANDOMIZED PHASE III TRIAL EVALUATING TOTAL ABLATIVE THERAPY FOR PATIENTS WITH LIMITED METASTATIC COLORECTAL CANCER: EVALUATING RADIATION, ABLATION, AND SURGERY [ERASUR]

Purpose:

PRIMARY OBJECTIVE:

I. To evaluate and compare overall survival (OS) (measured from time of randomization) in patients with newly diagnosed oligometastatic colorectal cancer (oCRC) treated with total ablative therapy (TAT) in addition to standard of care (SOC) systemic therapy versus SOC systemic therapy.

SECONDARY OBJECTIVES:

I. To evaluate and compare event-free survival (EFS) (measured from time of randomization) between the two treatment arms.

II. To assess the adverse events (AE) profile within each of the two treatment arms.

III. To evaluate the time to local recurrence (TLR) (measured from completion of TAT) in patients with newly diagnosed oCRC treated with TAT + SOC systemic therapy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients undergo TAT on study, consisting of SABR with or without surgical resection and/or microwave ablation. Patients also receive SOC chemotherapy on study. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT scans throughout the trial.

ARM 2: Patients receive SOC chemotherapy on study. Patients also undergo Patients also undergo CT or MRI or PET/CT scans throughout the trial.

TRIAL NUMBER: A022104

Title: The Janus Rectal Cancer Trial: A Randomized Phase II Trial Testing The Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients With Locally Advanced Rectal Cancer

Purpose: This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) 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. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.

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: A022102

Title: Randomized Phase III Trial of mFOLFIRINOX vs. FOLFOX With Nivolumab for First-Line Treatment of Metastatic HER2- Gastroesophageal Adenocarcinoma

Purpose: This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. The usual approach for patients is treatment with FOLFOX chemotherapy. Chemotherapy drugs 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. Fluorouracil stops cells from making DNA and it may kill tumor cells. Leucovorin is used with fluorouracil to enhance the effects of the drug. Oxaliplatin works by killing, stopping, or slowing the growth of tumor cells. Some patients also receive an immunotherapy drug, nivolumab, in addition to FOLFOX chemotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill tumor cells. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers.

TRIAL NUMBER: ACR-368-201/GOG-3082

Title: A Phase 1b/2 Basket Study of ACR-368 as Monotherapy and in Combination With Gemcitabine in Adult Subjects With Platinum-Resistant Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma Based on Acrivon OncoSignature® Status

Purpose: This is an open label Phase 1b/2 study to evaluate the efficacy and safety of ACR-368 as monotherapy or in combination with low dose gemcitabine in participants with platinum-resistant ovarian carcinoma, endometrial adenocarcinoma, and urothelial carcinoma based on Acrivon's OncoSignature® test status.

TRIAL NUMBER: DURAFAK

Title: A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) Plus Defactinib (FAK Inhibitor) in Recurrent Gynecological Cancers (DURAFAK)

Purpose: The purpose of this research is to test the effectiveness and safety of the study drugs (VS-6766 and defactinib), and see what effects (good and bad) these drugs have on the patients with endometrioid cancer, mucinous ovarian cancer, high-grade serous ovarian cancer, or cervical cancer.

TRIAL NUMBER: GOG-3068/HOTT

Title: GOG-3068: A Phase III Randomized Trial of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Cisplatin Versus no HIPEC at the Time of Optimal Interval Cytoreductive Surgery Followed by Niraparib Maintenance in Patients With Newly Diagnosed Stage III and IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (Heated Ovarian Treatment Trial)

Purpose: Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 3-4 cycles). Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study.

TRIAL NUMBER: GOG-3088

Title: A Randomized Phase II Study of Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma

Purpose: This is a clinical trial to test letrozole in patients with uterine leiomyosarcoma. The main question is will treatment with letrozole extend progression-free survival in patients. Patients will receive 2/5 mg of letrozole daily.

TRIAL NUMBER: IMGN853-0421

Title: Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FR?-positive Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Chemotherapy Plus Bevacizumab

Purpose: GLORIOSA is a Phase 3 multicenter, open label study designed to evaluate the safety and efficacy of Mirvetuximab Soravtansine in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FR?) expression.

TRIAL NUMBER: MK-2870-005/ENGOT-en23/GOG-3095

Title: A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy (MK-2870-005/ENGOT-en23/GOG-3095)

Purpose: The primary objectives of this study are to compare MK-2870 to Treatment of Physician's Choice (TPC) with respect to progression-free survival (PFS) per RECIST 1.1, as assessed by blinded independent central review (BICR), and overall survival (OS). The primary hypotheses are that MK-2870 is superior to TPC with respect to PFS per RECIST 1.1, as assessed by BICR, and that MK-2870 is superior to TPC with respect to OS.

TRIAL NUMBER: NRG-CC008

Title: A NON-RANDOMIZED PROSPECTIVE CLINICAL TRIAL COMPARING THE NON-INFERIORITY OF SALPINGECTOMY TO SALPINGO-OOPHORECTOMY TO REDUCE THE RISK OF OVARIAN CANCER AMONG BRCA1 CARRIERS [SOROCk]

Purpose:

Primary Outcome Measures :

Time to development of incident high-grade serous carcinomas (HGSC), specifically ovarian, primary peritoneal, or fallopian tube cancers [ Time Frame: Up to 20 years ]
Will be assessed using a stratified log rank test, stratifying for age. The effects of other covariates, such as familial history of gynecologic cancer, time to crossover for bilateral salpingectomy (BLS) patients, and age at study entry, will be adjusted for in Cox proportional hazard models. Patients who crossover will be analyzed according to the initial surgery received at study enrollment as this will reflect actual practice.

Secondary Outcome Measures :

Health-related quality of life (QOL) [ Time Frame: Up to 24 months post-surgery ]
Will be measured by the Functional Assessment of Cancer Therapy - Endocrine Symptom (FACT-ES). The FACT total score (calculated from the physical, functional, social and emotional well-being subscales) and ES subscale will be assessed. Higher scores indicate better QOL for the FACT-ES and better functioning for the FSFI total score.
Estrogen deprivation symptoms [ Time Frame: Up to 24 months post-surgery ]
Will be measured by the FACT-ES. The FACT total score (calculated from the physical, functional, social and emotional well-being subscales) and ES subscale will be assessed. Higher scores indicate better QOL for the FACT-ES and better functioning for the FSFI total score.
Sexual dysfunction [ Time Frame: Up to 24 months post-surgery ]
Will be measured by the Female Sexual Function Index (FSFI). Higher scores indicate better functioning for the FSFI total score.
Menopausal symptoms [ Time Frame: Up to 24 months post-surgery ]
Will be measured by the Menopausal Symptom Checklist (MSCL).
Cancer distress [ Time Frame: Up to 24 months post-surgery ]
Will be measured by the Impact of Events Scale (IES).
Medical decision making [ Time Frame: Up to 24 months post-surgery ]
Will be measured by the Shared Decision Making Questionnaire (SDM-Q-9) to determin factors associated with the risk of reducing surgical treatment choice. The SDM-Q-9 total score at each time point of collection will be compared between arms using a t-test with a significance level of 0.05. A linear model will be used to assess the association of the SDM-Q-9 total score with treatment arm and patient characteristics such as age and race.
Medical decision making [ Time Frame: Up to 24 months post-surgery ]
Will be measured by the Decisional Regret Scale to determine factor associated with the risk of reducing surgical treatment choice. The Decisional Regret Scale total score at each time point of collection will be compared between arms using a t-test with a significance level of 0.05. A linear model will be used to assess the association of the Decisional Regret Scale total score with treatment arm and patient characteristics such as age, race, crossover from BLS arm, and hysterectomy status.
Incidence of adverse events [ Time Frame: Up to 24 months post-surgery ]
Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Counts and frequencies will be provided for the worst grade adverse event (AE) experienced by the patient by treatment arm. The distribution of AE grade in the BLS arm will be compared to the BSO arm using a chi-square test, or Fisher's exact test if cell frequencies are < 5, at the one-sided 0.05 significance level.

Other Outcome Measures:

Cost effectiveness [ Time Frame: Up to 24 months post-surgery ]
Will be measured by European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L). A Markov model will be used to model cost.
Sexual dysfunction by PROMIS screener [ Time Frame: Up to 20 years ]
Will be measured by selected Patient-Reported Outcomes Measurement Information System (PROMIS) screener. Each item will be analyzed separately and compared between treatment arms using a chi-square test.
Section dysfunction by PROMIS external sexual function items [ Time Frame: Up to 20 years ]
Will be measured by selected PROMIS external sexual function items. Each item will be analyzed separately and compared between treatment arms using a chi-square test.
Correlation between Health related (HR)-QOL and patient reported symptoms. [ Time Frame: Up to 24 months post-surgery ]
Will examine the correlation between HR-QOL, as measured by the FACT, with menopausal symptoms, as measured by the MCL, sexual dysfunction, as measured by FSFI, and PROMIS screener and external sexual function items and cancer distress as measured by the IES. Pearson correlation coefficients will be used for correlating the FACT total score with the FSFI overall score and IES total distress score. Spearman correlation coefficients will be used to assess the correlation between FACT total score and the MSCL symptoms, FSFI, and PROMIS items.

TRIAL NUMBER: NRG-CC010

Title: A Phase III Trial of the Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Endometrial Cancer

Purpose:

TRIAL NUMBER: NRG-GY026

Title: A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined With Either Trastuzumab and Hyaluronidase-Oysk (HERCEPTIN HYLECTA) or Pertuzumab, Trastuzumab, and Hyaluronidase-Zzxf (PHESGO) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma

Purpose: This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab or pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer, so that these medications will have a greater effect. Hyaluronidase also allows trastuzumab and trastuzumab/pertuzumab to be given by injection under the skin and shortens their administration time compared to trastuzumab or pertuzumab alone. Paclitaxel is a taxane and in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving Herceptin Hylecta or Phesgo in combination with paclitaxel and carboplatin may shrink the tumor and prevent the cancer from coming back in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma.

TRIAL NUMBER: Pro00103465

Title: EMCT2 - ENDOMETRIAL CANCER MOLECULARLY TARGETED THERAPY CONSORTIUM

Purpose:

The Endometrial Cancer Molecularly Targeted Therapy Consortium is a multi-institutional consortium to develop a data and tissue repository to confirm and support the use of tumor alterations and biomarkers to direct biologic therapies and potentially enhance survival outcomes in women with endometrial cancer.

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: VS-6766-301/GOG-3097/ENGOT-ov81/NCRI

Title: A Phase 3, Randomized, Open-Label Study of Combination Therapy With Avutometinib Plus Defactinib Versus Investigator's Choice of Treatment in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 301)

Purpose:

This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.

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: EA3161

Title: A PHASE II/III RANDOMIZED STUDY OF MAINTENANCE NIVOLUMAB VERSUS OBSERVATION IN PATIENTS WITH LOCALLY ADVANCED, INTERMEDIATE RISK HPV POSITIVE OPCA

Purpose: Primary Outcome Measures :
Progression-free survival (PFS) (Phase II) [ Time Frame: From randomization to date of progression, second primary tumor from the head and neck region, or death, assessed up to 24 months ] Progression will be defined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Log rank test will be used to compare PFS and OS. Both phase II and phase III analyses will be intent-to-treat analysis, and analysis will be stratified on stratification factors collected at the time of randomization. As patients on the observation arm are allowed to cross-over to the nivolumab arm upon progression, an overall survival analysis using inverse probability censoring weights (IPCW, Robins et. al, 2000) will also be considered. Kaplan-Meier method and Cox regression will be used for the survival outcome analyses.
Overall survival (OS) (Phase III) [ Time Frame: From randomization to death, assessed up to 24 months ] Log rank test will be used to compare PFS and OS. Both phase II and phase III analyses will be intent-to-treat analysis, and analysis will be stratified on stratification factors collected at the time of randomization. As patients on the observation arm are allowed to cross-over to the nivolumab arm upon progression, an overall survival analysis using inverse probability censoring weights (IPCW, Robins et. al, 2000) will also be considered. Kaplan-Meier method and Cox regression will be used for the survival outcome analyses.
Negative (standardized qualitative) 12 week post therapy (cisplatin + radiation therapy [RT]) FDG positron emission tomography/computed tomography (PET/CT) associated with OS for patients who have a PET/CT [ Time Frame: At 12 weeks ] Logrank tests and input hazard rates will be used.
Negative (standardized qualitative) 12 week post therapy (cisplatin + RT) FDG PET/CT associated with PFS for patients who have a PET/CT [ Time Frame: At 12 weeks ] Logrank tests and input hazard rates will be used.

Secondary Outcome Measures :
Prognostic effect of baseline PD-L1 expression (positive versus [vs.] negative) on OS and PFS [ Time Frame: Baseline up to 10 years ] Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
Prognostic effect of baseline saliva and/or plasma human papillomavirus (HPV) status (positive vs. negative) on OS and PFS [ Time Frame: Baseline up to 10 years ] Saliva and plasma HPV status at 12 weeks and 9 months following completion of concurrent therapy will also be analyzed regarding effect on outcome. Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
Prognostic value of maximum standardized uptake value (SUVmax) of primary tumor or neck nodal metastasis of baseline FDG PET/CT for OS [ Time Frame: Baseline up to 10 years ] Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
Prognostic value of SUVmax of primary tumor or neck nodal metastasis of baseline FDG PET/CT for PFS [ Time Frame: Baseline up to 10 years ] Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
SUVmax of primary tumor or nodal metastasis of baseline FDG PET/CT with PD-L1 expression (positive vs. negative) [ Time Frame: Baseline up to 10 years ] Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
Post therapy (cisplatin + RT) FDG PET/CT with saliva or plasma levels of HPV deoxyribonucleic acid (DNA) [ Time Frame: Up to 9 months post-therapy ] Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
PET based therapy response assessment compared to RECIST 1.1 assessment for patients who have a PET/CT scan at 12 weeks [ Time Frame: At 12 weeks post chemoradiation therapy ] Kappa statistics will be applied to evaluate the agreement between PET based therapy response assessment (Hopkins criteria) and RECIST 1.1 assessment at 12 weeks post chemoradiation therapy.

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 :

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

Secondary Outcome Measures :

Locoregional Failure Rates [ Time Frame: Up to 9 years ]
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).
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.
Incidence of late toxicity [ Time Frame: Up to 9 years ]
Measured by CTCAE v5.0.
Hearing loss [ Time Frame: At 6 months post-radiation therapy ]
Measured by Hearing Handicap Inventory for Adults-Screening.

TRIAL NUMBER: RTOG-1216

Title: RANDOMIZED PHASE II/III TRIAL OF ADJUVANT RADIATION THERAPY WITH CISPLATIN, DOCETAXEL-CETUXIMAB, OR CISPLATIN-ATEZOLIZUMAB IN PATHOLOGIC HIGH-RISK SQUAMOUS CELL CANCER OF THE HEAD AND NECK

Purpose:

Primary Outcome Measures :

Disease-free survival (DFS) (Phase II) [ Time Frame: From date of randomization until date of local-regional recurrence, distant metastasis or death due to any cause, assessed up to 7 years ]
Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a one-sided log rank test.
Overall survival (OS) (Phase III) [ Time Frame: From date of randomization to death due to any cause, assessed up to 7 years ]
Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a one-sided log rank test. Multivariate analysis will be performed using the Cox proportional hazards model.

Secondary Outcome Measures :

Local-regional failure (LRF) [ Time Frame: From date of randomization until date of local-regional recurrence, assessed up to 7 years ]
The cumulative incidence method will be used to estimate rates, and the failure rates for the experimental arms will be compared against the control using a failure-specific log rank test.
Distant metastasis (DM) [ Time Frame: From date of randomization to date of distant metastasis, assessed up to 7 years ]
The cumulative incidence method will be used to estimate rates, and the failure rates for the experimental arms will be compared against the control using a failure-specific log rank test.
Toxicity [ Time Frame: From start of treatment to death or last follow-up ]
Adverse events (AEs) will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0. Rates of grade 3+ adverse events overall will be compared between arms by Chi-square test, or Fisher's exact test.
Patient-reported outcome, symptom burden [ Time Frame: Time from randomization to a first recovery within at least one MID unit of total symptom severity compared to the baseline (reference) score ]
Time to recovery of baseline total symptom severity from the MD Anderson Symptom Inventory - Head and Neck (MDASI-HN). The cumulative incidence method will be used to estimate the event rates, and the event rates between arms will be compared using a cause-specific log rank test. The Fine-Gray subdistribution hazards model may be applied to further explore outcomes by treatment arm and other covariates.
Quality of life [ Time Frame: Baseline and 1 year post radiation therapy (RT) ]
Quality of life change from baseline at 1-year post RT, as measured by the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N) Trial Outcome Index (TOI). FACT TOI is a validated efficient summary index of physical/functional outcomes, and disease site-specific items, which is highly reliable and sensitive to change in performance status rating. A constrained longitudinal data analysis model will be fitted with all the time points (discrete), the treatment factor and its interaction. The secondary non-inferiority patient-reported outcome (PRO) hypothesis will be tested using a confidence interval approach.

TRIAL NUMBER: A081801

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

Purpose:

Primary Outcome Measures :

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.
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 :

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 ]
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 ]
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.
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.
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: 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: NRG-LU008

Title: Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally Advanced Non-Small Cell Lung Cancer

Purpose: This phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT) to standard treatment (image guided radiation therapy [IGRT] and chemotherapy followed by immunotherapy with durvalumab) versus standard treatment alone in treating patients with non-small cell lung cancer that cannot be treated by surgery (inoperable). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. IGRT is a type of radiation that uses a computer to create picture of the tumor, to help guide the radiation beam during therapy, making it more accurate and causing less damage to healthy tissue. Standard chemotherapy used in this trial consists of combinations of the following drugs: cisplatin, carboplatin, paclitaxel, pemetrexed, and etoposide. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It works by stopping the growth and spread of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by blocking the action of a certain substance in the body that may help tumor cells multiply. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Immunotherapy with durvalumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Adding SBRT to the standard treatment of IGRT with chemotherapy and immunotherapy may be more effective at treating patients with inoperable non-small cell lung cancer than giving the standard treatment alone.

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 :

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 :

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.
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.
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.
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.
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.
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: 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-19185

Title: Multicenter Randomized Controlled Trial Comparing Brief Behavioral Therapy for Cancer Related Insomnia (BBT-CI) and Healthy Eating Education Learning (HEAL)

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: NRG-CC012CD

Title: Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment

Purpose: In this clinical trial, symptom monitoring (interactive voice response [IVR] is compared to automated telephone symptom management [ATSM] and telephone interpersonal counseling [TIPC]) for reducing symptom burden and psychological distress (depressive and anxiety symptoms) among people receiving oral anti-cancer treatment. Symptoms are the number one driver of treatment interruptions and unscheduled health services use. To reduce the risk of these events, symptom monitoring and management are necessary. However, these services are not implemented routinely, especially in the community oncology settings. Further, depressive and anxiety symptoms are a key barrier to enacting symptom self-management strategies. IVR is a form of symptom monitoring where patients, when called, enter their symptom ratings over the phone. Their symptom summary is sent to their provider, and patients may be advised to reach out to their oncology provider, based on their symptoms. The ATSM intervention combines IVR assessments with a Symptom Management and Survivorship educational handbook with self-management strategies. Patients receiving ATSM enter their symptom ratings over the phone and have their symptoms reported to their provider, but patients are also directed to the handbook for strategies to manage elevated symptoms. Patients receiving ATSM who report being anxious, discouraged, or sad will also receive TIPC, which targets psychological distress and its connection to social support and interpersonal communication. Information gathered from this study may help researchers learn more about the best ways to manage patient symptoms and improve patient outcomes.

TRIAL NUMBER: A021806

Title: A PHASE III TRIAL OF PERIOPERATIVE VERSUS ADJUVANT CHEMOTHERAPY FOR RESECTABLE PANCREATIC CANCER

Purpose:

Primary Outcome Measures :

Overall survival (OS) [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
Overall survival is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. The treatment arms will be compared using a stratified Cox regression model, and hazard ratios from each arm will be estimated.

Secondary Outcome Measures :

Disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
Disease-free survival (DFS) is defined as the time from randomization to the date of progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, whichever occurs first. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Time to locoregional recurrence (TLR) [ Time Frame: Time between randomization and locoregional recurrence after resection, assessed up to 6 years. ]
Time to locoregional recurrence (TLR) is defined as the time from randomization to the date of locoregional recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Time to distant metastases (TDM) [ Time Frame: Time between randomization and metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection, assessed up to 6 years. ]
Time to distant metastases (TDM) is defined as the time from randomization to the date of metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
R0 resection rate [ Time Frame: At time of surgery. ]
The rate (percentage) of patients with negative resection margins after undergoing surgery.
Rate of unresectability [ Time Frame: At time of surgery or planned time of surgery. ]
The rate (percentage) of patients who cannot undergo surgery due to adverse events, progressive disease, death, poor performance, or patient/physician decision, are deemed unresectable before surgery, or resection was not performed during surgery.
Pathologic complete response (pCR) rate [ Time Frame: At time of surgery. ]
The rate (percentage) of patients who achieve a pathologic complete response (pCR) confirmed by histopathologic review of the surgical specimen.
Incidence of adverse events (AEs), assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 (v5.0) [ Time Frame: Up to 2 years. ]
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns within treatment arms and during the following three time points: during perioperative chemotherapy, surgical complications during surgery and post-operative period for 30 days, and during adjuvant chemotherapy.
Fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (modified [m]FOLFIRINOX) dose intensity delivered [ Time Frame: 8 months ]
Dose intensity is defined as the percentage of total cumulative dose the patient received divided by the total dose planned per protocol times 100.
Fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (modified [m]FOLFIRINOX) number of cycles received [ Time Frame: 8 months ]
The number of cycles received is defined as the total number of cycles that the participant received at least one dose of any agent in mFOLFIRINOX.
Quality of life as assessed by the physical functioning, nausea/vomiting, and diarrhea subscales in the Quality of Life Questionnaire-Core 30 (QLQ-C30) [ Time Frame: 8 weeks ]
Quality of Life Questionnaire-Core 30 (QLQ-C30) is a 30-item questionnaire to assess the overall quality of life in cancer patients. QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning, greater occurrence of nausea/vomiting, and greater occurrence of diarrhea.
Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
Multivariate Cox proportional hazards models will be fit for overall survival (OS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
Multivariate Cox proportional hazards models will be fit for disease-free survival (DFS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on the risk of grade 3+ adverse event associated with chemotherapy [ Time Frame: Up to 2 years. ]
Multivariate Logistic models will be fit for the binary endpoint of grade 3+ adverse event (patient experiences at least one grade 3 or higher adverse event during treatment)
The ability of computed tomography (CT)-based radiomics to distinguish post-neoadjuvant chemotherapy (NAC) fibrosis from viable tumor as measured by comparison to histological evaluation [ Time Frame: At time of surgery. ]
Comparison between computed tomography (CT)-based radiomics and histological tumor fibrosis proportions will be measured using Spearman's rank correlation coefficient.
Computed tomography (CT)-based radiomics as non-invasive predictors of overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
Multivariate Cox proportional hazards model will be fit for overall survival (OS) endpoint (defined above) with covariates chosen from all available radiomics features using the least absolute shrinkage and selection operator (LASSO) method with 10-fold cross-validation (CV) and additionally adjusted for clinically important confounders. After the final model is selected the area under the receiver operating characteristic curve (AUC) will be reported to indicate the prediction performance of the radiomics model.

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: URCC-22053

Title: High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients

Purpose: This phase III trial tests whether high-dose vitamin D works in treating androgen-deprivation therapy (ADT)-induced bone loss in patients with prostate cancer who are undergoing androgen-deprivation therapy. Vitamins are substances that the body needs to grow and develop normally. Vitamin D helps the body absorb calcium. Calcium is one of the main building blocks of bone. A lack of vitamin D can lead to bone diseases such as osteoporosis or rickets. This trial may help researcher determine if high-dose vitamin D helps keep bones strong, lowers number of falls, and lessens fatigue in men getting androgen-deprivation therapy.

TRIAL NUMBER: CCTG-CO32

Title: A Phase 3 Randomized Trial Of Neoadjuvant Chemotherapy, Excision And Observation Versus Chemoradiotherapy For Early Rectal Cancer

Purpose: This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?

TRIAL NUMBER: NRG-GU012

Title: Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)

Purpose: This phase II trial tests whether the addition of radiation to the primary tumor, typically given with stereotactic ablative radiation therapy (SABR), in combination with standard of care immunotherapy improves outcomes in patients with renal cell cancer that is not recommended for surgery and has spread to other places in the body (metastatic). Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses of radiation over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, avelumab, 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. Axitinib, cabozantinib, and lenvatinib are in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving SABR in combination with standard of care immunotherapy may help shrink or stabilize the cancer in patients with renal cell cancer.

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: S2200

Title: A Phase II Randomized Trial of Cabozantinib (NSC #761968) With or Without Atezolizumab (NSC #783608) in Patients With Advanced Papillary Renal Cell Carcinoma (PAPMET2)

Purpose: This phase II trial tests whether cabozantinib with or without atezolizumab works to shrink tumors in patients with papillary kidney cancer that has spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 cabozantinib with atezolizumab may prevent papillary kidney cancer from growing or spreading compared to cabozantinib alone.

TRIAL NUMBER: JCXH-211-IV-101

Title: A Phase 1/2 Open-Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of JCXH-211-IV Monotherapy and in Combination With Pembrolizumab in Patients with Advanced Solid Tumors

Purpose:

This is a Phase 1/2 open label study to evaluate the safety, tolerability, and preliminary efficacy of JCXH-211-IV monotherapy and in combination with pembrolizumab in patients with locally advanced/metastatic, relapsed, or refractory solid tumors who failed at least 1 line of SOC therapies. SOC therapies, when appropriate, include FDA approved immunotherapy or targeted therapy or chemotherapy, or a combination of them.

TRIAL NUMBER: NB004-01

Title: A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB004 Administered as Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors

Purpose: This is a Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB004 Administered as Monotherapy or Combination Therapy in Subjects with Advanced Solid Tumors

TRIAL NUMBER: OP-3136-101

Title: A Phase 1 First-in-Human, Open-Label, Multicenter Study of OP-3136 in Adult Participants with Advanced or Metastatic Solid Tumors

Purpose:

TRIAL NUMBER: SHR-A1904-I-104

Title: AN OPEN-LABEL, SINGLE-ARM, MULTI-CENTER PHASE I/IIA CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS

Purpose: The study (dose escalation/expansion) is being conducted to assess the safety and tolerability of SHR-A1904 in subjects with advanced solid tumors, and to determine maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D), to assess preliminary efficacy of SHR-A1904, pharmacokinetic (PK) profile and immunogenicity of SHR-A1904 in subjects with advanced solid tumors.

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.

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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: A012103

Title: OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy

Purpose: The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. 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. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.
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: NRG-BR009

Title: A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET)

Purpose: This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

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: 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: 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: 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: MK-2870-005/ENGOT-en23/GOG-3095

Title: A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy (MK-2870-005/ENGOT-en23/GOG-3095)

Purpose: The primary objectives of this study are to compare MK-2870 to Treatment of Physician's Choice (TPC) with respect to progression-free survival (PFS) per RECIST 1.1, as assessed by blinded independent central review (BICR), and overall survival (OS). The primary hypotheses are that MK-2870 is superior to TPC with respect to PFS per RECIST 1.1, as assessed by BICR, and that MK-2870 is superior to TPC with respect to OS.

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: EA3161

Title: A PHASE II/III RANDOMIZED STUDY OF MAINTENANCE NIVOLUMAB VERSUS OBSERVATION IN PATIENTS WITH LOCALLY ADVANCED, INTERMEDIATE RISK HPV POSITIVE OPCA

Purpose: Primary Outcome Measures :
Progression-free survival (PFS) (Phase II) [ Time Frame: From randomization to date of progression, second primary tumor from the head and neck region, or death, assessed up to 24 months ] Progression will be defined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Log rank test will be used to compare PFS and OS. Both phase II and phase III analyses will be intent-to-treat analysis, and analysis will be stratified on stratification factors collected at the time of randomization. As patients on the observation arm are allowed to cross-over to the nivolumab arm upon progression, an overall survival analysis using inverse probability censoring weights (IPCW, Robins et. al, 2000) will also be considered. Kaplan-Meier method and Cox regression will be used for the survival outcome analyses.
Overall survival (OS) (Phase III) [ Time Frame: From randomization to death, assessed up to 24 months ] Log rank test will be used to compare PFS and OS. Both phase II and phase III analyses will be intent-to-treat analysis, and analysis will be stratified on stratification factors collected at the time of randomization. As patients on the observation arm are allowed to cross-over to the nivolumab arm upon progression, an overall survival analysis using inverse probability censoring weights (IPCW, Robins et. al, 2000) will also be considered. Kaplan-Meier method and Cox regression will be used for the survival outcome analyses.
Negative (standardized qualitative) 12 week post therapy (cisplatin + radiation therapy [RT]) FDG positron emission tomography/computed tomography (PET/CT) associated with OS for patients who have a PET/CT [ Time Frame: At 12 weeks ] Logrank tests and input hazard rates will be used.
Negative (standardized qualitative) 12 week post therapy (cisplatin + RT) FDG PET/CT associated with PFS for patients who have a PET/CT [ Time Frame: At 12 weeks ] Logrank tests and input hazard rates will be used.

Secondary Outcome Measures :
Prognostic effect of baseline PD-L1 expression (positive versus [vs.] negative) on OS and PFS [ Time Frame: Baseline up to 10 years ] Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
Prognostic effect of baseline saliva and/or plasma human papillomavirus (HPV) status (positive vs. negative) on OS and PFS [ Time Frame: Baseline up to 10 years ] Saliva and plasma HPV status at 12 weeks and 9 months following completion of concurrent therapy will also be analyzed regarding effect on outcome. Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
Prognostic value of maximum standardized uptake value (SUVmax) of primary tumor or neck nodal metastasis of baseline FDG PET/CT for OS [ Time Frame: Baseline up to 10 years ] Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
Prognostic value of SUVmax of primary tumor or neck nodal metastasis of baseline FDG PET/CT for PFS [ Time Frame: Baseline up to 10 years ] Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
SUVmax of primary tumor or nodal metastasis of baseline FDG PET/CT with PD-L1 expression (positive vs. negative) [ Time Frame: Baseline up to 10 years ] Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
Post therapy (cisplatin + RT) FDG PET/CT with saliva or plasma levels of HPV deoxyribonucleic acid (DNA) [ Time Frame: Up to 9 months post-therapy ] Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
PET based therapy response assessment compared to RECIST 1.1 assessment for patients who have a PET/CT scan at 12 weeks [ Time Frame: At 12 weeks post chemoradiation therapy ] Kappa statistics will be applied to evaluate the agreement between PET based therapy response assessment (Hopkins criteria) and RECIST 1.1 assessment at 12 weeks post chemoradiation therapy.

TRIAL NUMBER: AALL1732

Title: A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Purpose:
This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase 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. This trial will also study the outcomes of patients with mixed phenotype acute leukemia (MPAL) and disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy.

The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, in order to classify patients into post-consolidation treatment groups. On the second part of this study, patients will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab. Other aims of this study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.

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: 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: 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: 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: 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-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: 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: URCC-22053

Title: High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients

Purpose: This phase III trial tests whether high-dose vitamin D works in treating androgen-deprivation therapy (ADT)-induced bone loss in patients with prostate cancer who are undergoing androgen-deprivation therapy. Vitamins are substances that the body needs to grow and develop normally. Vitamin D helps the body absorb calcium. Calcium is one of the main building blocks of bone. A lack of vitamin D can lead to bone diseases such as osteoporosis or rickets. This trial may help researcher determine if high-dose vitamin D helps keep bones strong, lowers number of falls, and lessens fatigue in men getting androgen-deprivation therapy.

TRIAL NUMBER: NRG-GU012

Title: Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)

Purpose: This phase II trial tests whether the addition of radiation to the primary tumor, typically given with stereotactic ablative radiation therapy (SABR), in combination with standard of care immunotherapy improves outcomes in patients with renal cell cancer that is not recommended for surgery and has spread to other places in the body (metastatic). Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses of radiation over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, avelumab, 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. Axitinib, cabozantinib, and lenvatinib are in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving SABR in combination with standard of care immunotherapy may help shrink or stabilize the cancer in patients with renal cell cancer.

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: 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.
- LA066 - Touro Infirmary
- Orleans Parish
- 3 Trials Available
- CONTACT US
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: NRG-GU012

Title: Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)

Purpose: This phase II trial tests whether the addition of radiation to the primary tumor, typically given with stereotactic ablative radiation therapy (SABR), in combination with standard of care immunotherapy improves outcomes in patients with renal cell cancer that is not recommended for surgery and has spread to other places in the body (metastatic). Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses of radiation over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, avelumab, 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. Axitinib, cabozantinib, and lenvatinib are in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving SABR in combination with standard of care immunotherapy may help shrink or stabilize the cancer in patients with renal cell cancer.

TRIAL NUMBER: S2200

Title: A Phase II Randomized Trial of Cabozantinib (NSC #761968) With or Without Atezolizumab (NSC #783608) in Patients With Advanced Papillary Renal Cell Carcinoma (PAPMET2)

Purpose: This phase II trial tests whether cabozantinib with or without atezolizumab works to shrink tumors in patients with papillary kidney cancer that has spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 cabozantinib with atezolizumab may prevent papillary kidney cancer from growing or spreading compared to cabozantinib alone.
- LA124 - LSU Healthcare Network /Metairie Multi-Specialty Clinic
- Jefferson Parish
- 10 Trials Available
- CONTACT US
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: 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: 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: 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: 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-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: 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: NRG-GU012

Title: Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)

Purpose: This phase II trial tests whether the addition of radiation to the primary tumor, typically given with stereotactic ablative radiation therapy (SABR), in combination with standard of care immunotherapy improves outcomes in patients with renal cell cancer that is not recommended for surgery and has spread to other places in the body (metastatic). Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses of radiation over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, avelumab, 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. Axitinib, cabozantinib, and lenvatinib are in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving SABR in combination with standard of care immunotherapy may help shrink or stabilize the cancer in patients with renal cell cancer.

TRIAL NUMBER: S2200

Title: A Phase II Randomized Trial of Cabozantinib (NSC #761968) With or Without Atezolizumab (NSC #783608) in Patients With Advanced Papillary Renal Cell Carcinoma (PAPMET2)

Purpose: This phase II trial tests whether cabozantinib with or without atezolizumab works to shrink tumors in patients with papillary kidney cancer that has spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 cabozantinib with atezolizumab may prevent papillary kidney cancer from growing or spreading compared to cabozantinib alone.

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.
- LA045 - East Jefferson General Hospital
- Jefferson Parish
- 11 Trials Available
- CONTACT US
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: 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: 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-CC010

Title: A Phase III Trial of the Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Endometrial Cancer

Purpose:
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: 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-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: 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: NRG-GU012

Title: Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)

Purpose: This phase II trial tests whether the addition of radiation to the primary tumor, typically given with stereotactic ablative radiation therapy (SABR), in combination with standard of care immunotherapy improves outcomes in patients with renal cell cancer that is not recommended for surgery and has spread to other places in the body (metastatic). Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses of radiation over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, avelumab, 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. Axitinib, cabozantinib, and lenvatinib are in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving SABR in combination with standard of care immunotherapy may help shrink or stabilize the cancer in patients with renal cell cancer.

TRIAL NUMBER: S2200

Title: A Phase II Randomized Trial of Cabozantinib (NSC #761968) With or Without Atezolizumab (NSC #783608) in Patients With Advanced Papillary Renal Cell Carcinoma (PAPMET2)

Purpose: This phase II trial tests whether cabozantinib with or without atezolizumab works to shrink tumors in patients with papillary kidney cancer that has spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 cabozantinib with atezolizumab may prevent papillary kidney cancer from growing or spreading compared to cabozantinib alone.

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.
- LA099 - Ochsner LSU Health-Cancer Treatment Center
- 2 Trials Available
- CONTACT US
TRIAL NUMBER: EA8212

Title: A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)

Purpose: The study hypothesis is that BCG naïve non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical Gemcitabine + Docetaxel (GEMDOCE) will result in a non-inferior event-free survival (EFS) compared to standard treatment with intravesical BCG. The purpose of this study is to test whether Gemcitabine + Docetaxel is a better or worse treatment than the usual BCG therapy approach. The primary objective of this study is to determine the event free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer patients treated with intravesical BCG vs Gemcitabine + Docetaxel. Secondary objectives are as follows: to compare changes in cancer-specific and bladder cancer-specific QOL from baseline to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE, to determine the cystectomy free survival (CFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, to determine the progression free survival (PFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, and to determine the safety and toxicity of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.

TRIAL NUMBER: EAQ221CD

Title: Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP)

Purpose: This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called WiseBag along with text message reminders for missed or extra medication events, to enhanced usual care (EUC), where patients only use the Wisebag, to monitor medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor. To ensure CDK4/6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule. Forgetfulness was the most common reason reported for medication non adherence. Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor.
- IRB - National Cancer Institute Pediatric Central IRB
- 24 Trials Available
- CONTACT US
TRIAL NUMBER: AOST2031

Title: A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Purpose: This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.
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: ACCL2031

Title: A Phase 3 Randomized, Placebo-Controlled Trial Evaluating Memantine for Neurocognitive Protection in Children Undergoing Cranial Radiotherapy as Part of Treatment for Primary Central Nervous System Tumors

Purpose: This phase III trial compares memantine to usual treatment in treating patients with brain tumors that are newly diagnosed or has come back (recurrent). Memantine may block receptors (parts of nerve cells) in the brain known to contribute to a decline in cognitive function. Giving memantine may make a difference in cognitive function (attention, memory, or other thought processes) in children and adolescents receiving brain radiation therapy to treat a primary brain tumor.

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: The purpose of this study is to understand who chooses to participate in clinical trials; and the reasons individuals/families choose not to participate in clinical trials. This information will help researchers design future studies and attempt to address the reasons people do not participate, especially young adults and teenagers, older people and minorities. In addition, personal and medical information will be collected to help understand differences in treatment and treatment outcomes among these populations.
TRIAL NUMBER: ACNS1833

Title: A PHASE 3 RANDOMIZED NON-INFERIORITY STUDY OF CARBOPLATIN AND VINCRISTINE VERSUS SELUMETINIB (NSC# 748727, IND# 77782) IN NEWLY DIAGNOSED OR PREVIOUSLY UNTREATED LOW-GRADE GLIOMA (LGG) NOT ASSOCIATED WITH BRAFV600E MUTATIONS OR SYSTEMIC NEUROFIBROMATOSIS TYPE 1 (NF1)

Purpose:
Primary Outcome Measures :
1. Event-free survival (EFS) [ Time Frame: Time from randomization to the first occurrence of clinical or radiographic disease progression, disease recurrence, second malignant neoplasm, or death from any cause, assessed up to 10 years ]
  Will estimate the hazard ratio based on a stratified Cox proportional hazards model and use Kaplan Meier (KM) methods to visualize and summarize the data.
Secondary Outcome Measures :
1. Radiographic tumor response rate [ Time Frame: Up to 10 years ]
  Will summarize the radiologic response rates per arm and test for a difference between the 2 arms using an exact binomial test.
2. Overall survival (OS) [ Time Frame: Time from randomization until death from any cause or until the time of last follow-up for patients who are alive at time of analysis ]
  Will also use the KM methods, log-rank tests, and Cox proportional hazards models to determine whether there is a difference in OS between the 2 arms.
3. Proportion of patients who experience an improvement in visual acuity (VA) [ Time Frame: After first 12 months of treatment ]
  The vision-based analyses will be conducted both on a per-subject and per-eye basis. For the per subject analyses, will use an exact binomial test to compare the difference in the proportion of subjects in each arm that show improvement in VA after 12 months of treatment using a 1-sided test with 10% type 1 error. For the secondary per eye analyses, will use repeated measures approaches to account for within patient correlations. Will consider changes between baseline and 12-month time points for this analysis.
4. Motor function assessment [ Time Frame: At baseline and after 48 weeks of therapy ]
  The Vineland scale will be used to assess motor and coordination deficits. Will compare the magnitudes of change from baseline between the 2 treatment arms and provide a 90% 2-sided confidence interval for this difference.
5. Change in parent and patient-reported quality of life (QOL) over time [ Time Frame: Baseline and at 9 months after treatment initiation ]
  QOL will be measured via the validated PedsQL Generic Module (for children 2-21 years old). Primary analysis will be based on a 2-sample t-test comparing change in the QOL score between 9 months and baseline for the 2 arms, as planned. If the change scores are skewed or do not otherwise meet the t-test assumptions, non-parametric alternatives may be employed for analysis.
Other Outcome Measures:
1. PedsQL Generic module [ Time Frame: At baseline, 9 months, and 30 months, and 60 months after treatment initiation ]
  For all measures, scores for each domain at each time point, as well as change in scores between time points, will be summarized and examined by descriptive statistics and appropriate plots.
2. Neurocognitive function [ Time Frame: At baseline, 9 months, and 30 months, and 60 months after treatment initiation ]
  Assessed by Children's Oncology Group (COG) Standardized Neuropsychological & Behavioral Battery.
3. Neurocognitive function [ Time Frame: At baseline, 9 months, and 30 months, and 60 months after treatment initiation ]
  Assessed by Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2).
TRIAL NUMBER: AALL1732

Title: A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Purpose:
This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase 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. This trial will also study the outcomes of patients with mixed phenotype acute leukemia (MPAL) and disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy.

The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, in order to classify patients into post-consolidation treatment groups. On the second part of this study, patients will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab. Other aims of this study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.

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: 9442/4941L

Title: National Wilms Tumor Late Effects Study

Purpose: The purpose of this study is to learn more about the possible causes of Wilms tumor and the effects of successful treatment for Wilms tumor, and to serve as a resource for Wilms tumor patients and their families. Information will be collected from participants in order to determine if they or their offspring are at risk for adverse medical conditions. If there is more than one case of Wilms tumor in a given family, geneticists working on this protocol will attempt to estimate heritability and recurrence risks to better understand the possible long-term effects of treatment for Wilms tumor. The information from this study will be collected and stored in a large computer database at the National Wilms Tumor Data and Statistical Center (NWTS).

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: AALL1621

Title: A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518, IND#133494) in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B- ALL)

Purpose:
Primary Outcome Measures :
1. Morphologic response (complete response [CR]+ incomplete hematologic recovery [CRi]) following one cycle of treatment with inotuzumab ozogamicin (Cohort 1) [ Time Frame: Up to 28 days ]
  The response rate will be estimated using the proportion of eligible/evaluable patients with CR/CRi response. A one-sided lower 95% Agresti-Coull confidence limit will be calculated.
Secondary Outcome Measures :
1. Morphologic response (CR + CRi) following 2 cycles of inotuzumab ozogamicin therapy (Cohort1) [ Time Frame: Up to 56 days ]
  The response rate will be estimated using the proportion of eligible/evaluable patients with CR/CRi response.
2. Incidence of dose-limiting toxicities at recommended phase II dose (RP2D) (Cohort 1) [ Time Frame: During Cycle 1, up to 42 days ]
  Evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity tables will be constructed to summarize the observed incidence by type of toxicity and grade. For a given reporting period, a patient will be counted only once for a given toxicity for the worst grade of that toxicity reported for that patient.
3. Level of minimal residual disease (MRD) assessed in bone marrow by flow cytometry (Cohort 1 and 2) [ Time Frame: Up to 2 cycles ]
  MRD negativity rates (< 0.01% detectable leukemia cells) will be estimated.
4. Incidence of adverse events of sinusoidal obstruction syndrome (SOS) of liver (Cohort 1 and 2) [ Time Frame: Up to 1 year from last dose of Inotuzumab ozogamicin ]
  Evaluated according to NCI CTCAE version 5.0. The incidence of SOS of the liver in patients during inotuzumab ozogamicin therapy and following subsequent treatment including myeloablative hematopoietic cell transplantation (HSCT) will be described.
5. Event free survival (EFS) (Cohort 1) [ Time Frame: From study entry to first event (induction failure, induction death, relapse, second malignancy, remission death), or date of last follow-up for event free subjects, assessed up to 5 years ]
  Standard errors and confidence intervals for EFS will be calculated using Peto's method.
6. Overall survival (Cohort 1) [ Time Frame: From the time from study entry to death or date of last follow-up, assessed up to 3 years ]
  OS will be estimated using Kaplan Meier approach.
7. Duration of CR, CRi (Cohort 1) [ Time Frame: Up to 3 years ]
  Among responding patients, three-year complete continuous response will also be estimated using duration of CR/CRi for the overall responding group and stratified by whether or not the patients proceed to HSCT.
8. Pharmacokinetic (PK) parameters, i.e., inotuzumab ozogamicin trough levels (Cohort 1) [ Time Frame: Cycles 1 and 2 (each cycle is 28 days) ]
  Inotuzumab ozogamicin trough levels (ng/mL) will be determined in serum by validated, high sensitivity liquid chromatography-mass spectrometry (LCMS) assays. Descriptive summary statistics will be provided for the trough levels at scheduled visits for Cycles 1 and 2.
9. Immunogenicity (Cohort 1) [ Time Frame: Cycles 1 and 2 ]
  Enhanced chemiluminescence (ECL) and cell-based assays will be used to detect anti-drug antibodies and neutralizing antibodies to inotuzumab ozogamicin in serum. Inotuzumab ozogamicin trough levels will be compared between patients with and without antibodies.
10. Incidence of dose-limiting toxicities at the selected dose level of inotuzumab ozogamicin in combination with the augmented modified Berlin-Frankfurt-Munster (mBFM) consolidation chemotherapy (Cohort 2) [ Time Frame: Up to cycle 1 (each cycle is 36 days) ]
  Evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity tables will be constructed to summarize the observed incidence by type of toxicity and grade. For a given reporting period, a patient will be counted only once for a given toxicity for the worst grade of that toxicity reported for that patient.
Other Outcome Measures:
1. Changes in CD22 surface expression (Cohorts 1 and 2) [ Time Frame: Baseline, post Cycle 1, and at time of relapse ]
  Exploratory analysis of CD22 will focus primarily on the comparison of paired pre-treatment and post-treatment samples at the following times, 1) End of cycle 1 and 2) at relapse to evaluate for changes in CD22 expression pre and post-inotuzumab ozogamicin. Specifically, samples will be evaluated for change in CD22 expression that occurs over time to study the role of CD22 expression as it relates to resistance to therapy or mechanism for relapse. Correlation between changes in CD22 expression and patient's clinical response to inotuzumab ozogamicin as well as cytogenetic/molecular features will be described, in particular to explore the association of CD22-negative subpopulations in patients with KMT2A-rearranged acute lymphoblastic leukemia (ALL).
2. Change in CD22 site density (Cohorts 1 and 2) [ Time Frame: Baseline, post Cycle 1, and at time of relapse ]
  Exploratory analysis of CD22 will focus primarily on the comparison of paired pre-treatment and post-treatment samples at the following times, 1) End of cycle 1 and 2) at relapse to evaluate for changes in CD22 site density pre and post-inotuzumab ozogamicin. Samples will be evaluated for any change in CD22 site density that occurs over time and to evaluate for the emergence of a CD22 "dim" or "negative" population to study the role of CD22 site density as it relates to resistance to therapy or mechanism for relapse. Correlation between changes in CD22 site density and patient's clinical response to inotuzumab ozogamicin as well as cytogenetic/molecular features will be described, in particular to explore the association of CD22-negative subpopulations in patients with KMT2A-rearranged acute lymphoblastic leukemia (ALL).
3. Leukemic blast CD22 splice variants (Cohorts 1 and 2) [ Time Frame: Baseline, post-Cycle 1, and at time of relapse ]
  Will be analyzed by ribonucleic acid-sequencing (RNA-Seq). The MAJIQ and VOILA software will be used to identify splicing variations in CD22 from RNA Seq and to quantitate the percent spliced in (PSI) of the alternative exons. CD22 protein levels will be determined by immunoblotting of whole cell protein lysates using several anti-CD22 antibodies recognizing either extracellular or intracellular domains. Both protein sizes and preservation of individual epitopes will be assessed and correlated with alterations in exon inclusion.
4. Intracellular signaling pathways in leukemic blasts treated with inotuzumab ozogamicin (Cohorts 1 and 2) [ Time Frame: Baseline up to 5 years ]
  Peripheral blood samples will be evaluated by comprehensive protein profiling using CyTOF panels for the two major areas of analyses, surface immunophenotyping to assess the developmental stage of both normal and abnormal B cells and measure their responses to inotuzumab ozogamicin , as well as intracellular epitopes to assess the cellular consequences of treatment with inotuzumab ozogamicin. Exploratory analysis will be performed using Cytobank software tools (viSNE, SPADE and CITRUS) for subpopulations clustering, dimensionality reduction and hierarchical organization.
5. Changes in peripheral blood absolute B cell numbers and maturation of developing B cell populations with inotuzumab ozogamicin therapy (Cohorts 1 and 2) [ Time Frame: Baseline up to 5 years ]
  Descriptive statistics will be used to characterize patterns of B-cell development including selective loss of subsets. Changes in B cell number and subsets will be described, and exploratory analysis will be conducted to assess their correlation with clinical features including immunoglobulin levels, occurrence of infections, and need for intravenous immunoglobulin (IVIG) replacement during inotuzumab ozogamicin therapy.
6. Level of MRD by next-generation high-throughput sequencing (HTS) techniques (Cohorts 1 and 2) [ Time Frame: Up to 2 cycles ]
  Compared to MRD measured by flow cytometry. MRD levels at each bone marrow evaluation time point will be measured by standard flow cytometry (MRD-negative defined as < 0.01% or 1 leukemic cell in 10-4 nucleated cells). At the end of cycles 1 and 2, MRD will also be assessed by HTS. The correlation between the measurements with each technique will be described and the sensitivity of flow-based MRD methodology in the setting of CD22-targeted therapy will be explored.
7. Serum levels of candidate SOS biomarkers Ang2 and L ficolin (Cohorts 1 and 2) [ Time Frame: Up to 12 months from last dose of inotuzumab ozogamicin ]
  Correlated with clinical development of SOS. Descriptive statistics will be used to characterize clinical features of patients experiencing SOS. L-ficolin and Ang2 absolute levels and change in level over time with inotuzumab ozogamicin exposure will be evaluated and correlated with development of SOS. Biomarker levels will be compared using simple comparative statistics between subgroups.
8. Incidence of SOS in patients who receive prophylaxis with ursodeoxycholic acid (UDCA) during inotuzumab ozogamicin therapy (Cohorts 1 and 2) [ Time Frame: Up to 12 months from last dose of inotuzumab ozogamicin ]
  Descriptive statistics will be used to characterize clinical features of patients experiencing SOS, potential clinical risk factors, and the impact of ursodeoxycholic acid prophylaxis.
9. Interaction between CAR- T therapy and inotuzumab ozogamicin (Cohorts 1 and 2) [ Time Frame: Up to 5 years ]
  Will be evaluated by incidence of hematologic DLT in patients with CAR-T therapy prior to inotuzumab ozogamicin, incidence of post-inotuzumab ozogamicin CAR-T therapy, time to CAR-T therapy after inotuzumab ozogamicin, and B-cell recovery prior to CAR-T therapy after inotuzumab ozogamicin. Will be summarized using descriptive statistics.
10. Morphologic response (CR/CRi) (Cohort 2) [ Time Frame: Up to 2 cycles (each cycle is 36 days) ]
  Will be estimated using the proportion of eligible/evaluable patients with CR/CRi response. Analysis will be mostly descriptive.
TRIAL NUMBER: ACCL1931

Title: A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy

Purpose: This phase III trial compares the effect of adding levocarnitine to chemotherapy versus chemotherapy alone in protecting the liver in patients with leukemia and lymphoma. Standard of care chemotherapy treatment for leukemia and lymphoma includes a type of chemotherapy named asparaginase, given either as the drug pegaspargase, or a similar drug, calaspargase pegol. This type of chemotherapy can cause severe liver damage. Levocarnitine is a drug used to provide extra carnitine, a naturally occurring nutrient that is part of a typical diet and is also made by the body. Carnitine is important to keep the liver healthy and may be able to prevent damage to the liver from chemotherapy and other drugs. Taking levocarnitine may reduce the rate of severe liver damage caused by asparaginase chemotherapy in patients with leukemia and lymphoma.

TRIAL NUMBER: APAL2020SC

Title: Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias

Purpose: This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat may provide information about the patient's leukemia that is important when deciding how to best treat it, and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults.

TRIAL NUMBER: ASCT2031

Title: A Multi-Center, Phase 3, Randomized Trial of Matched Unrelated Donor (MUD) Versus HLA-Haploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) With Acute Leukemia or Myelodysplastic Syndrome (MDS)

Purpose: This phase III trial compares hematopoietic (stem) cell transplantation (HCT) using mismatched related donors (haploidentical [haplo]) versus matched unrelated donors (MUD) in treating children, adolescents, and young adults with acute leukemia or myelodysplastic syndrome (MDS). HCT is considered standard of care treatment for patients with high-risk acute leukemia and MDS. In HCT, patients are given very high doses of chemotherapy or radiation therapy, which is intended to kill cancer cells that may be resistant to more standard doses of chemotherapy; unfortunately, this also destroys the normal cells in the bone marrow, including stem cells. After the treatment, patients must have a healthy supply of stem cells reintroduced or transplanted. The transplanted cells then reestablish the blood cell production process in the bone marrow. The healthy stem cells may come from the blood or bone marrow of a related or unrelated donor. If patients do not have a matched related donor, doctors do not know what the next best donor choice is or if a haplo related donor or matched unrelated donor (MUD) is better. This trial may help researchers understand whether a haplo related donor or a MUD HCT for children with acute leukemia or MDS is better or if there is no difference at all.

TRIAL NUMBER: AHOD2131

Title: A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy With Immuno-Oncology Therapy for Children and Adults With Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma

Purpose: This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, 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 doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride 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. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone.

TRIAL NUMBER: ANHL1931

Title: A Randomized Phase 3 Trial of Nivolumab (NSC# 748726) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma

Purpose: This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs 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. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.

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: 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: 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: 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: 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: ACNS1831

Title: A Phase 3 Randomized Study of Selumetinib (IND # 77782) versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)

Purpose:
Primary Outcome Measures :
1. Event-free survival (EFS) [ Time Frame: From randomization to the first occurrence of any of the following events: clinical or radiographic disease progression, disease recurrence, second malignant neoplasm, or death from any cause, assessed up to 3 years after accrual completion ]
  EFS is defined as time from randomization to the first occurrence of any of the following events: clinical or radiographic disease progression, disease recurrence, second malignant neoplasm, or death from any cause. Patients who are event-free will be censored at the time of last follow-up. Hazard ratio based on a stratified Cox proportional hazards model will be reported, along with a 90% confidence interval.
2. Number of participants with visual acuity (VA) improvement per arm [ Time Frame: Baseline and end of about 12 months of treatment ]
  VA will be assessed using Teller acuity cards (TAC). A significant improvement in VA will be defined as a decrease of >= 0.2 logMAR (corrected for age) from baseline (pre-treatment baseline) to end of about 12 months of treatment. The primary analysis will be based on per subject outcome (rather than per eye).
Secondary Outcome Measures :
1. Radiographic tumor response rate [ Time Frame: Assessed up to 3 years after accrual completion ]
  Tumors will be classified into complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD). Radiologic response rates will be summarized per arm and be tested for a difference between the two arms using an exact binomial test.
2. Overall survival (OS) [ Time Frame: From randomization until death from any cause or till the time of last follow-up for patients who are alive at the time of analysis, assessed up to 3 years after accrual completion ]
  OS is defined as the time from randomization until death from any cause or till the time of last follow-up for patients who are alive at the time of analysis. Hazard ratio will be reported, along with a 90% confidence interval.
3. Change in VA using HOTV letter acuity testing [ Time Frame: Baseline and end of about 12 months of treatment ]
  HOTV is a recognition acuity measure. It will be conducted on patients who are developmentally able to perform this testing.
4. Change in motor function [ Time Frame: Baseline and approximately 12 months of treatment ]
  The Vineland-3 Motor Scale from the Comprehensive Parent Rating Form will be used to assess motor deficits. Change in Vineland motor scale from baseline to about 12 months of treatment will be compared between two treatment arms.
5. Change in quality of life (QOL) as measured by Pain and Hurt subscale score [ Time Frame: Baseline and 12 months of treatment ]
  QOL will be assessed by Pediatric Quality of Life (PedsQL) Generic and Brain Tumor modules. Analysis will be based on a 2-sample t-test comparing change in Pain and Hurt subscale score from baseline to 12 months for the two arms.
6. Change in quality of life (QOL) as measured by Movement and Balance subscale score [ Time Frame: Baseline and 12 months of treatment ]
  QOL will be assessed by Pediatric Quality of Life (PedsQL) Generic and Brain Tumor modules. Analysis will be based on a 2-sample t-test comparing change in Movement and Balance subscale score from baseline to 12 months for the two arms.
7. Change in executive function as measured by BRIEF Cognitive Regulation Index (CRI) [ Time Frame: Baseline and 24 months of treatment ]
  Executive function will be measured by age-appropriate Behavior Rating Inventory of Executive Function (BRIEF) questionnaire. Analysis will be based on a 2-sample t-test comparing change in the designated score from baseline to 24 months for the two arms.
8. Change in neurocognitive function as measured by Cogstate composite score [ Time Frame: Baseline and 24 months of treatment ]
  Neurocognitive function will be measured by a computerized battery (Cogstate) testing. Analysis will be based on a 2-sample t-test comparing change in Cogstate composite score from baseline to 24 months for the two arms.
Other Outcome Measures:
1. Change in circumpapillary retinal nerve fiber layer (cpRNFL) thickness by treatment arm [ Time Frame: Baseline and 12 months ]
  cpRNFL thickness is a measure of optical coherence tomography (OCT). This assessment will be conducted in a subgroup of consenting patients with optic pathway gliomas (OPGs) treated at select COG institutions with the expertise to utilize this technology. Analysis will be conducted on a per-eye basis.
2. cpRNFL thickness at baseline by visual acuity (VA) treatment response [ Time Frame: Baseline and 12 months ]
  Data will be analyzed on a per-eye basis. Children with OPGs will be classified into decline in VA versus (vs.) stable/improved VA, depending on VA treatment response at 12 months. cpRNFL thickness prior to treatment initiation will be compared.
3. cpRNFL thickness change over time by visual acuity (VA) treatment response [ Time Frame: Baseline and 12 months ]
  Data will be analyzed on a per-eye basis. Children with OPGs will be classified into decline in VA vs. stable/improved VA, depending on VA treatment response at 12 months. cpRNFL thickness change over time will be compared.
4. Change in macular ganglion cell - inner plexiform layer (GCIPL) thickness by treatment arm [ Time Frame: Baseline and 12 months ]
  GCIPL thickness is another measure of optical coherence tomography (OCT). This assessment will be conducted in a subgroup of consenting patients with optic pathway gliomas (OPGs) treated at select COG institutions with the expertise to utilize this technology. Analysis will be conducted on a per-eye basis.
5. GCIPL thickness at baseline by visual acuity (VA) treatment response [ Time Frame: Baseline and 12 months ]
  Data will be analyzed on a per-eye basis. Children with OPGs will be classified into decline in VA vs. stable/improved VA, depending on VA treatment response at 12 months. GCIPL thickness prior to treatment initiation will be compared.
6. GCIPL thickness change over time by visual acuity (VA) treatment response [ Time Frame: Baseline and 12 months ]
  Data will be analyzed on a per-eye basis. Children with OPGs will be classified into decline in VA vs. stable/improved VA, depending on VA treatment response at 12 months. GCIPL thickness change over time will be compared.
7. Novel semi-automated volumetric magnetic resonance imaging (MRI) measure at 3 months [ Time Frame: 3 months on study ]
  Optic pathway tumors will be classified into progressive disease (PD), stable disease (SD), partial response (PR), and complete response (CR) using novel semi-automated volumetric MRI measurements. This assessment will include patients with OPGs consenting to volumetric MRI study.
8. Percent change in tumor size between volumetric measure and traditional 2-dimentional (2-D) measure at 3 months [ Time Frame: 3 months on study ]
  This assessment includes participants with OPGs consenting to volumetric MRI study.
9. Novel semi-automated volumetric MRI measure at 6 months [ Time Frame: 6 months on study ]
  Optic pathway tumors will be classified into progressive disease (PD), stable disease (SD), partial response (PR), and complete response (CR) using novel semi-automated volumetric MRI measurements. This assessment will include patients with OPGs consenting to volumetric MRI study.
10. Percent change in tumor size between volumetric measure and traditional 2-dimentional (2-D) measure at 6 months [ Time Frame: 6 months on study ]
  This assessment includes participants with OPGs consenting to volumetric MRI study.
11. Novel semi-automated volumetric MRI measure at 9 months [ Time Frame: 9 months on study ]
  Optic pathway tumors will be classified into progressive disease (PD), stable disease (SD), partial response (PR), and complete response (CR) using novel semi-automated volumetric MRI measurements. This assessment will include patients with OPGs consenting to volumetric MRI study.
12. Percent change in tumor size between volumetric measure and traditional 2-dimentional (2-D) measure at 9 months [ Time Frame: 9 months on study ]
  This assessment includes participants with OPGs consenting to volumetric MRI study.
13. Novel semi-automated volumetric MRI measure at 12 months [ Time Frame: 12 months on study ]
  Optic pathway tumors will be classified into progressive disease (PD), stable disease (SD), partial response (PR), and complete response (CR) using novel semi-automated volumetric MRI measurements. This assessment will include patients with OPGs consenting to volumetric MRI study.
14. Percent change in tumor size between volumetric measure and traditional 2-dimentional (2-D) measure at 12 months [ Time Frame: 12 months on study ]
  This assessment includes participants with OPGs consenting to volumetric MRI study.
15. Novel semi-automated volumetric MRI measure at 15 months [ Time Frame: 15 months on study ]
  Optic pathway tumors will be classified into progressive disease (PD), stable disease (SD), partial response (PR), and complete response (CR) using novel semi-automated volumetric MRI measurements. This assessment will include patients with OPGs consenting to volumetric MRI study.
16. Percent change in tumor size between volumetric measure and traditional 2-dimentional (2-D) measure at 15 months [ Time Frame: 15 months on study ]
  This assessment includes participants with OPGs consenting to volumetric MRI study.
17. Tumor and blood banking [ Time Frame: Up to 10 years ]
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.
TRIAL NUMBER: APEC1621 (Master)

Title: NCI-COG PEDIATRIC MATCH (MOLECULAR ANALYSIS FOR THERAPY CHOICE) MASTER VERSION CONTROL PROTOCOL

Purpose:
- LA004 - Children's Hospital
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TRIAL NUMBER: AOST2031

Title: A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Purpose: This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.
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: ACCL2031

Title: A Phase 3 Randomized, Placebo-Controlled Trial Evaluating Memantine for Neurocognitive Protection in Children Undergoing Cranial Radiotherapy as Part of Treatment for Primary Central Nervous System Tumors

Purpose: This phase III trial compares memantine to usual treatment in treating patients with brain tumors that are newly diagnosed or has come back (recurrent). Memantine may block receptors (parts of nerve cells) in the brain known to contribute to a decline in cognitive function. Giving memantine may make a difference in cognitive function (attention, memory, or other thought processes) in children and adolescents receiving brain radiation therapy to treat a primary brain tumor.

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: 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: The purpose of this study is to understand who chooses to participate in clinical trials; and the reasons individuals/families choose not to participate in clinical trials. This information will help researchers design future studies and attempt to address the reasons people do not participate, especially young adults and teenagers, older people and minorities. In addition, personal and medical information will be collected to help understand differences in treatment and treatment outcomes among these populations.
TRIAL NUMBER: ACNS1833

Title: A PHASE 3 RANDOMIZED NON-INFERIORITY STUDY OF CARBOPLATIN AND VINCRISTINE VERSUS SELUMETINIB (NSC# 748727, IND# 77782) IN NEWLY DIAGNOSED OR PREVIOUSLY UNTREATED LOW-GRADE GLIOMA (LGG) NOT ASSOCIATED WITH BRAFV600E MUTATIONS OR SYSTEMIC NEUROFIBROMATOSIS TYPE 1 (NF1)

Purpose:
Primary Outcome Measures :
1. Event-free survival (EFS) [ Time Frame: Time from randomization to the first occurrence of clinical or radiographic disease progression, disease recurrence, second malignant neoplasm, or death from any cause, assessed up to 10 years ]
  Will estimate the hazard ratio based on a stratified Cox proportional hazards model and use Kaplan Meier (KM) methods to visualize and summarize the data.
Secondary Outcome Measures :
1. Radiographic tumor response rate [ Time Frame: Up to 10 years ]
  Will summarize the radiologic response rates per arm and test for a difference between the 2 arms using an exact binomial test.
2. Overall survival (OS) [ Time Frame: Time from randomization until death from any cause or until the time of last follow-up for patients who are alive at time of analysis ]
  Will also use the KM methods, log-rank tests, and Cox proportional hazards models to determine whether there is a difference in OS between the 2 arms.
3. Proportion of patients who experience an improvement in visual acuity (VA) [ Time Frame: After first 12 months of treatment ]
  The vision-based analyses will be conducted both on a per-subject and per-eye basis. For the per subject analyses, will use an exact binomial test to compare the difference in the proportion of subjects in each arm that show improvement in VA after 12 months of treatment using a 1-sided test with 10% type 1 error. For the secondary per eye analyses, will use repeated measures approaches to account for within patient correlations. Will consider changes between baseline and 12-month time points for this analysis.
4. Motor function assessment [ Time Frame: At baseline and after 48 weeks of therapy ]
  The Vineland scale will be used to assess motor and coordination deficits. Will compare the magnitudes of change from baseline between the 2 treatment arms and provide a 90% 2-sided confidence interval for this difference.
5. Change in parent and patient-reported quality of life (QOL) over time [ Time Frame: Baseline and at 9 months after treatment initiation ]
  QOL will be measured via the validated PedsQL Generic Module (for children 2-21 years old). Primary analysis will be based on a 2-sample t-test comparing change in the QOL score between 9 months and baseline for the 2 arms, as planned. If the change scores are skewed or do not otherwise meet the t-test assumptions, non-parametric alternatives may be employed for analysis.
Other Outcome Measures:
1. PedsQL Generic module [ Time Frame: At baseline, 9 months, and 30 months, and 60 months after treatment initiation ]
  For all measures, scores for each domain at each time point, as well as change in scores between time points, will be summarized and examined by descriptive statistics and appropriate plots.
2. Neurocognitive function [ Time Frame: At baseline, 9 months, and 30 months, and 60 months after treatment initiation ]
  Assessed by Children's Oncology Group (COG) Standardized Neuropsychological & Behavioral Battery.
3. Neurocognitive function [ Time Frame: At baseline, 9 months, and 30 months, and 60 months after treatment initiation ]
  Assessed by Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2).
TRIAL NUMBER: AALL1732

Title: A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Purpose:
This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase 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. This trial will also study the outcomes of patients with mixed phenotype acute leukemia (MPAL) and disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy.

The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, in order to classify patients into post-consolidation treatment groups. On the second part of this study, patients will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab. Other aims of this study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.

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: 9442/4941L

Title: National Wilms Tumor Late Effects Study

Purpose: The purpose of this study is to learn more about the possible causes of Wilms tumor and the effects of successful treatment for Wilms tumor, and to serve as a resource for Wilms tumor patients and their families. Information will be collected from participants in order to determine if they or their offspring are at risk for adverse medical conditions. If there is more than one case of Wilms tumor in a given family, geneticists working on this protocol will attempt to estimate heritability and recurrence risks to better understand the possible long-term effects of treatment for Wilms tumor. The information from this study will be collected and stored in a large computer database at the National Wilms Tumor Data and Statistical Center (NWTS).

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: AALL1621

Title: A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518, IND#133494) in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B- ALL)

Purpose:
Primary Outcome Measures :
1. Morphologic response (complete response [CR]+ incomplete hematologic recovery [CRi]) following one cycle of treatment with inotuzumab ozogamicin (Cohort 1) [ Time Frame: Up to 28 days ]
  The response rate will be estimated using the proportion of eligible/evaluable patients with CR/CRi response. A one-sided lower 95% Agresti-Coull confidence limit will be calculated.
Secondary Outcome Measures :
1. Morphologic response (CR + CRi) following 2 cycles of inotuzumab ozogamicin therapy (Cohort1) [ Time Frame: Up to 56 days ]
  The response rate will be estimated using the proportion of eligible/evaluable patients with CR/CRi response.
2. Incidence of dose-limiting toxicities at recommended phase II dose (RP2D) (Cohort 1) [ Time Frame: During Cycle 1, up to 42 days ]
  Evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity tables will be constructed to summarize the observed incidence by type of toxicity and grade. For a given reporting period, a patient will be counted only once for a given toxicity for the worst grade of that toxicity reported for that patient.
3. Level of minimal residual disease (MRD) assessed in bone marrow by flow cytometry (Cohort 1 and 2) [ Time Frame: Up to 2 cycles ]
  MRD negativity rates (< 0.01% detectable leukemia cells) will be estimated.
4. Incidence of adverse events of sinusoidal obstruction syndrome (SOS) of liver (Cohort 1 and 2) [ Time Frame: Up to 1 year from last dose of Inotuzumab ozogamicin ]
  Evaluated according to NCI CTCAE version 5.0. The incidence of SOS of the liver in patients during inotuzumab ozogamicin therapy and following subsequent treatment including myeloablative hematopoietic cell transplantation (HSCT) will be described.
5. Event free survival (EFS) (Cohort 1) [ Time Frame: From study entry to first event (induction failure, induction death, relapse, second malignancy, remission death), or date of last follow-up for event free subjects, assessed up to 5 years ]
  Standard errors and confidence intervals for EFS will be calculated using Peto's method.
6. Overall survival (Cohort 1) [ Time Frame: From the time from study entry to death or date of last follow-up, assessed up to 3 years ]
  OS will be estimated using Kaplan Meier approach.
7. Duration of CR, CRi (Cohort 1) [ Time Frame: Up to 3 years ]
  Among responding patients, three-year complete continuous response will also be estimated using duration of CR/CRi for the overall responding group and stratified by whether or not the patients proceed to HSCT.
8. Pharmacokinetic (PK) parameters, i.e., inotuzumab ozogamicin trough levels (Cohort 1) [ Time Frame: Cycles 1 and 2 (each cycle is 28 days) ]
  Inotuzumab ozogamicin trough levels (ng/mL) will be determined in serum by validated, high sensitivity liquid chromatography-mass spectrometry (LCMS) assays. Descriptive summary statistics will be provided for the trough levels at scheduled visits for Cycles 1 and 2.
9. Immunogenicity (Cohort 1) [ Time Frame: Cycles 1 and 2 ]
  Enhanced chemiluminescence (ECL) and cell-based assays will be used to detect anti-drug antibodies and neutralizing antibodies to inotuzumab ozogamicin in serum. Inotuzumab ozogamicin trough levels will be compared between patients with and without antibodies.
10. Incidence of dose-limiting toxicities at the selected dose level of inotuzumab ozogamicin in combination with the augmented modified Berlin-Frankfurt-Munster (mBFM) consolidation chemotherapy (Cohort 2) [ Time Frame: Up to cycle 1 (each cycle is 36 days) ]
  Evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity tables will be constructed to summarize the observed incidence by type of toxicity and grade. For a given reporting period, a patient will be counted only once for a given toxicity for the worst grade of that toxicity reported for that patient.
Other Outcome Measures:
1. Changes in CD22 surface expression (Cohorts 1 and 2) [ Time Frame: Baseline, post Cycle 1, and at time of relapse ]
  Exploratory analysis of CD22 will focus primarily on the comparison of paired pre-treatment and post-treatment samples at the following times, 1) End of cycle 1 and 2) at relapse to evaluate for changes in CD22 expression pre and post-inotuzumab ozogamicin. Specifically, samples will be evaluated for change in CD22 expression that occurs over time to study the role of CD22 expression as it relates to resistance to therapy or mechanism for relapse. Correlation between changes in CD22 expression and patient's clinical response to inotuzumab ozogamicin as well as cytogenetic/molecular features will be described, in particular to explore the association of CD22-negative subpopulations in patients with KMT2A-rearranged acute lymphoblastic leukemia (ALL).
2. Change in CD22 site density (Cohorts 1 and 2) [ Time Frame: Baseline, post Cycle 1, and at time of relapse ]
  Exploratory analysis of CD22 will focus primarily on the comparison of paired pre-treatment and post-treatment samples at the following times, 1) End of cycle 1 and 2) at relapse to evaluate for changes in CD22 site density pre and post-inotuzumab ozogamicin. Samples will be evaluated for any change in CD22 site density that occurs over time and to evaluate for the emergence of a CD22 "dim" or "negative" population to study the role of CD22 site density as it relates to resistance to therapy or mechanism for relapse. Correlation between changes in CD22 site density and patient's clinical response to inotuzumab ozogamicin as well as cytogenetic/molecular features will be described, in particular to explore the association of CD22-negative subpopulations in patients with KMT2A-rearranged acute lymphoblastic leukemia (ALL).
3. Leukemic blast CD22 splice variants (Cohorts 1 and 2) [ Time Frame: Baseline, post-Cycle 1, and at time of relapse ]
  Will be analyzed by ribonucleic acid-sequencing (RNA-Seq). The MAJIQ and VOILA software will be used to identify splicing variations in CD22 from RNA Seq and to quantitate the percent spliced in (PSI) of the alternative exons. CD22 protein levels will be determined by immunoblotting of whole cell protein lysates using several anti-CD22 antibodies recognizing either extracellular or intracellular domains. Both protein sizes and preservation of individual epitopes will be assessed and correlated with alterations in exon inclusion.
4. Intracellular signaling pathways in leukemic blasts treated with inotuzumab ozogamicin (Cohorts 1 and 2) [ Time Frame: Baseline up to 5 years ]
  Peripheral blood samples will be evaluated by comprehensive protein profiling using CyTOF panels for the two major areas of analyses, surface immunophenotyping to assess the developmental stage of both normal and abnormal B cells and measure their responses to inotuzumab ozogamicin , as well as intracellular epitopes to assess the cellular consequences of treatment with inotuzumab ozogamicin. Exploratory analysis will be performed using Cytobank software tools (viSNE, SPADE and CITRUS) for subpopulations clustering, dimensionality reduction and hierarchical organization.
5. Changes in peripheral blood absolute B cell numbers and maturation of developing B cell populations with inotuzumab ozogamicin therapy (Cohorts 1 and 2) [ Time Frame: Baseline up to 5 years ]
  Descriptive statistics will be used to characterize patterns of B-cell development including selective loss of subsets. Changes in B cell number and subsets will be described, and exploratory analysis will be conducted to assess their correlation with clinical features including immunoglobulin levels, occurrence of infections, and need for intravenous immunoglobulin (IVIG) replacement during inotuzumab ozogamicin therapy.
6. Level of MRD by next-generation high-throughput sequencing (HTS) techniques (Cohorts 1 and 2) [ Time Frame: Up to 2 cycles ]
  Compared to MRD measured by flow cytometry. MRD levels at each bone marrow evaluation time point will be measured by standard flow cytometry (MRD-negative defined as < 0.01% or 1 leukemic cell in 10-4 nucleated cells). At the end of cycles 1 and 2, MRD will also be assessed by HTS. The correlation between the measurements with each technique will be described and the sensitivity of flow-based MRD methodology in the setting of CD22-targeted therapy will be explored.
7. Serum levels of candidate SOS biomarkers Ang2 and L ficolin (Cohorts 1 and 2) [ Time Frame: Up to 12 months from last dose of inotuzumab ozogamicin ]
  Correlated with clinical development of SOS. Descriptive statistics will be used to characterize clinical features of patients experiencing SOS. L-ficolin and Ang2 absolute levels and change in level over time with inotuzumab ozogamicin exposure will be evaluated and correlated with development of SOS. Biomarker levels will be compared using simple comparative statistics between subgroups.
8. Incidence of SOS in patients who receive prophylaxis with ursodeoxycholic acid (UDCA) during inotuzumab ozogamicin therapy (Cohorts 1 and 2) [ Time Frame: Up to 12 months from last dose of inotuzumab ozogamicin ]
  Descriptive statistics will be used to characterize clinical features of patients experiencing SOS, potential clinical risk factors, and the impact of ursodeoxycholic acid prophylaxis.
9. Interaction between CAR- T therapy and inotuzumab ozogamicin (Cohorts 1 and 2) [ Time Frame: Up to 5 years ]
  Will be evaluated by incidence of hematologic DLT in patients with CAR-T therapy prior to inotuzumab ozogamicin, incidence of post-inotuzumab ozogamicin CAR-T therapy, time to CAR-T therapy after inotuzumab ozogamicin, and B-cell recovery prior to CAR-T therapy after inotuzumab ozogamicin. Will be summarized using descriptive statistics.
10. Morphologic response (CR/CRi) (Cohort 2) [ Time Frame: Up to 2 cycles (each cycle is 36 days) ]
  Will be estimated using the proportion of eligible/evaluable patients with CR/CRi response. Analysis will be mostly descriptive.
TRIAL NUMBER: ACCL1931

Title: A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy

Purpose: This phase III trial compares the effect of adding levocarnitine to chemotherapy versus chemotherapy alone in protecting the liver in patients with leukemia and lymphoma. Standard of care chemotherapy treatment for leukemia and lymphoma includes a type of chemotherapy named asparaginase, given either as the drug pegaspargase, or a similar drug, calaspargase pegol. This type of chemotherapy can cause severe liver damage. Levocarnitine is a drug used to provide extra carnitine, a naturally occurring nutrient that is part of a typical diet and is also made by the body. Carnitine is important to keep the liver healthy and may be able to prevent damage to the liver from chemotherapy and other drugs. Taking levocarnitine may reduce the rate of severe liver damage caused by asparaginase chemotherapy in patients with leukemia and lymphoma.

TRIAL NUMBER: APAL2020SC

Title: Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias

Purpose: This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat may provide information about the patient's leukemia that is important when deciding how to best treat it, and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults.

TRIAL NUMBER: ASCT2031

Title: A Multi-Center, Phase 3, Randomized Trial of Matched Unrelated Donor (MUD) Versus HLA-Haploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) With Acute Leukemia or Myelodysplastic Syndrome (MDS)

Purpose: This phase III trial compares hematopoietic (stem) cell transplantation (HCT) using mismatched related donors (haploidentical [haplo]) versus matched unrelated donors (MUD) in treating children, adolescents, and young adults with acute leukemia or myelodysplastic syndrome (MDS). HCT is considered standard of care treatment for patients with high-risk acute leukemia and MDS. In HCT, patients are given very high doses of chemotherapy or radiation therapy, which is intended to kill cancer cells that may be resistant to more standard doses of chemotherapy; unfortunately, this also destroys the normal cells in the bone marrow, including stem cells. After the treatment, patients must have a healthy supply of stem cells reintroduced or transplanted. The transplanted cells then reestablish the blood cell production process in the bone marrow. The healthy stem cells may come from the blood or bone marrow of a related or unrelated donor. If patients do not have a matched related donor, doctors do not know what the next best donor choice is or if a haplo related donor or matched unrelated donor (MUD) is better. This trial may help researchers understand whether a haplo related donor or a MUD HCT for children with acute leukemia or MDS is better or if there is no difference at all.

TRIAL NUMBER: AHOD2131

Title: A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy With Immuno-Oncology Therapy for Children and Adults With Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma

Purpose: This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, 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 doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride 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. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone.

TRIAL NUMBER: ANHL1931

Title: A Randomized Phase 3 Trial of Nivolumab (NSC# 748726) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma

Purpose: This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs 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. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.

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: 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: 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: ACNS1831

Title: A Phase 3 Randomized Study of Selumetinib (IND # 77782) versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)

Purpose:
Primary Outcome Measures :
1. Event-free survival (EFS) [ Time Frame: From randomization to the first occurrence of any of the following events: clinical or radiographic disease progression, disease recurrence, second malignant neoplasm, or death from any cause, assessed up to 3 years after accrual completion ]
  EFS is defined as time from randomization to the first occurrence of any of the following events: clinical or radiographic disease progression, disease recurrence, second malignant neoplasm, or death from any cause. Patients who are event-free will be censored at the time of last follow-up. Hazard ratio based on a stratified Cox proportional hazards model will be reported, along with a 90% confidence interval.
2. Number of participants with visual acuity (VA) improvement per arm [ Time Frame: Baseline and end of about 12 months of treatment ]
  VA will be assessed using Teller acuity cards (TAC). A significant improvement in VA will be defined as a decrease of >= 0.2 logMAR (corrected for age) from baseline (pre-treatment baseline) to end of about 12 months of treatment. The primary analysis will be based on per subject outcome (rather than per eye).
Secondary Outcome Measures :
1. Radiographic tumor response rate [ Time Frame: Assessed up to 3 years after accrual completion ]
  Tumors will be classified into complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD). Radiologic response rates will be summarized per arm and be tested for a difference between the two arms using an exact binomial test.
2. Overall survival (OS) [ Time Frame: From randomization until death from any cause or till the time of last follow-up for patients who are alive at the time of analysis, assessed up to 3 years after accrual completion ]
  OS is defined as the time from randomization until death from any cause or till the time of last follow-up for patients who are alive at the time of analysis. Hazard ratio will be reported, along with a 90% confidence interval.
3. Change in VA using HOTV letter acuity testing [ Time Frame: Baseline and end of about 12 months of treatment ]
  HOTV is a recognition acuity measure. It will be conducted on patients who are developmentally able to perform this testing.
4. Change in motor function [ Time Frame: Baseline and approximately 12 months of treatment ]
  The Vineland-3 Motor Scale from the Comprehensive Parent Rating Form will be used to assess motor deficits. Change in Vineland motor scale from baseline to about 12 months of treatment will be compared between two treatment arms.
5. Change in quality of life (QOL) as measured by Pain and Hurt subscale score [ Time Frame: Baseline and 12 months of treatment ]
  QOL will be assessed by Pediatric Quality of Life (PedsQL) Generic and Brain Tumor modules. Analysis will be based on a 2-sample t-test comparing change in Pain and Hurt subscale score from baseline to 12 months for the two arms.
6. Change in quality of life (QOL) as measured by Movement and Balance subscale score [ Time Frame: Baseline and 12 months of treatment ]
  QOL will be assessed by Pediatric Quality of Life (PedsQL) Generic and Brain Tumor modules. Analysis will be based on a 2-sample t-test comparing change in Movement and Balance subscale score from baseline to 12 months for the two arms.
7. Change in executive function as measured by BRIEF Cognitive Regulation Index (CRI) [ Time Frame: Baseline and 24 months of treatment ]
  Executive function will be measured by age-appropriate Behavior Rating Inventory of Executive Function (BRIEF) questionnaire. Analysis will be based on a 2-sample t-test comparing change in the designated score from baseline to 24 months for the two arms.
8. Change in neurocognitive function as measured by Cogstate composite score [ Time Frame: Baseline and 24 months of treatment ]
  Neurocognitive function will be measured by a computerized battery (Cogstate) testing. Analysis will be based on a 2-sample t-test comparing change in Cogstate composite score from baseline to 24 months for the two arms.
Other Outcome Measures:
1. Change in circumpapillary retinal nerve fiber layer (cpRNFL) thickness by treatment arm [ Time Frame: Baseline and 12 months ]
  cpRNFL thickness is a measure of optical coherence tomography (OCT). This assessment will be conducted in a subgroup of consenting patients with optic pathway gliomas (OPGs) treated at select COG institutions with the expertise to utilize this technology. Analysis will be conducted on a per-eye basis.
2. cpRNFL thickness at baseline by visual acuity (VA) treatment response [ Time Frame: Baseline and 12 months ]
  Data will be analyzed on a per-eye basis. Children with OPGs will be classified into decline in VA versus (vs.) stable/improved VA, depending on VA treatment response at 12 months. cpRNFL thickness prior to treatment initiation will be compared.
3. cpRNFL thickness change over time by visual acuity (VA) treatment response [ Time Frame: Baseline and 12 months ]
  Data will be analyzed on a per-eye basis. Children with OPGs will be classified into decline in VA vs. stable/improved VA, depending on VA treatment response at 12 months. cpRNFL thickness change over time will be compared.
4. Change in macular ganglion cell - inner plexiform layer (GCIPL) thickness by treatment arm [ Time Frame: Baseline and 12 months ]
  GCIPL thickness is another measure of optical coherence tomography (OCT). This assessment will be conducted in a subgroup of consenting patients with optic pathway gliomas (OPGs) treated at select COG institutions with the expertise to utilize this technology. Analysis will be conducted on a per-eye basis.
5. GCIPL thickness at baseline by visual acuity (VA) treatment response [ Time Frame: Baseline and 12 months ]
  Data will be analyzed on a per-eye basis. Children with OPGs will be classified into decline in VA vs. stable/improved VA, depending on VA treatment response at 12 months. GCIPL thickness prior to treatment initiation will be compared.
6. GCIPL thickness change over time by visual acuity (VA) treatment response [ Time Frame: Baseline and 12 months ]
  Data will be analyzed on a per-eye basis. Children with OPGs will be classified into decline in VA vs. stable/improved VA, depending on VA treatment response at 12 months. GCIPL thickness change over time will be compared.
7. Novel semi-automated volumetric magnetic resonance imaging (MRI) measure at 3 months [ Time Frame: 3 months on study ]
  Optic pathway tumors will be classified into progressive disease (PD), stable disease (SD), partial response (PR), and complete response (CR) using novel semi-automated volumetric MRI measurements. This assessment will include patients with OPGs consenting to volumetric MRI study.
8. Percent change in tumor size between volumetric measure and traditional 2-dimentional (2-D) measure at 3 months [ Time Frame: 3 months on study ]
  This assessment includes participants with OPGs consenting to volumetric MRI study.
9. Novel semi-automated volumetric MRI measure at 6 months [ Time Frame: 6 months on study ]
  Optic pathway tumors will be classified into progressive disease (PD), stable disease (SD), partial response (PR), and complete response (CR) using novel semi-automated volumetric MRI measurements. This assessment will include patients with OPGs consenting to volumetric MRI study.
10. Percent change in tumor size between volumetric measure and traditional 2-dimentional (2-D) measure at 6 months [ Time Frame: 6 months on study ]
  This assessment includes participants with OPGs consenting to volumetric MRI study.
11. Novel semi-automated volumetric MRI measure at 9 months [ Time Frame: 9 months on study ]
  Optic pathway tumors will be classified into progressive disease (PD), stable disease (SD), partial response (PR), and complete response (CR) using novel semi-automated volumetric MRI measurements. This assessment will include patients with OPGs consenting to volumetric MRI study.
12. Percent change in tumor size between volumetric measure and traditional 2-dimentional (2-D) measure at 9 months [ Time Frame: 9 months on study ]
  This assessment includes participants with OPGs consenting to volumetric MRI study.
13. Novel semi-automated volumetric MRI measure at 12 months [ Time Frame: 12 months on study ]
  Optic pathway tumors will be classified into progressive disease (PD), stable disease (SD), partial response (PR), and complete response (CR) using novel semi-automated volumetric MRI measurements. This assessment will include patients with OPGs consenting to volumetric MRI study.
14. Percent change in tumor size between volumetric measure and traditional 2-dimentional (2-D) measure at 12 months [ Time Frame: 12 months on study ]
  This assessment includes participants with OPGs consenting to volumetric MRI study.
15. Novel semi-automated volumetric MRI measure at 15 months [ Time Frame: 15 months on study ]
  Optic pathway tumors will be classified into progressive disease (PD), stable disease (SD), partial response (PR), and complete response (CR) using novel semi-automated volumetric MRI measurements. This assessment will include patients with OPGs consenting to volumetric MRI study.
16. Percent change in tumor size between volumetric measure and traditional 2-dimentional (2-D) measure at 15 months [ Time Frame: 15 months on study ]
  This assessment includes participants with OPGs consenting to volumetric MRI study.
17. Tumor and blood banking [ Time Frame: Up to 10 years ]
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.
- LA017 - LSU HSC - Shreveport University Health - FWCC
- Caddo Parish
- 8 Trials Available
- CONTACT US
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: EAQ221CD

Title: Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP)

Purpose: This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called WiseBag along with text message reminders for missed or extra medication events, to enhanced usual care (EUC), where patients only use the Wisebag, to monitor medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor. To ensure CDK4/6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule. Forgetfulness was the most common reason reported for medication non adherence. Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor.
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: S2206

Title: Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) Plus Chemotherapy Versus Chemotherapy Alone for MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer

Purpose: This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint Ultrahigh (MP2) stage II-III hormone receptor positive, HER2 negative breast 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 paclitaxel, doxorubicin, and cyclophosphamide 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. There is some evidence from previous clinical trials that people who have a MammaPrint Ultrahigh Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast 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: 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: EAA181

Title: Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation

Purpose:
Primary Outcome Measures :
1. Consolidation overall survival [ Time Frame: Time from Step 2 randomization at the start of consolidation to death or to the 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 treatment hazard ratio (bortezomib, daratumumab and hyaluronidase-fihj (daratumumab), lenalidomide and dexamethasone [Btz-DRd] then daratumumab, lenalidomide and dexamethasone [DRd] then daratumumab and lenalidomide [DR]).
Secondary Outcome Measures :
1. Consolidation progression-free survival [ Time Frame: Time from Step 2 randomization at the start of consolidation until the earlier of progression or death due to any cause, assessed up to 15 years ]
  Patients alive without disease progression will be censored at date of last disease evaluation. Only deaths that occur within 3 months of the last disease evaluation are considered events.
2. Incidence of adverse events [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
3. Incidence of grade 3 or higher non-hematologic adverse events [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
4. Incidence of grade 3 or higher adverse events [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
5. Best response [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
6. FACT-Ntx TOI recovery rate (Patient reported outcome [PRO]) [ Time Frame: From end of induction through consolidation up to 1 year of maintenance, up to 21 weeks ]
  Defined as the proportion of patients with the FACT-Ntx TOI score returning to baseline level reached at consolidation randomization after experiencing a MID decrease while on up to 1 year of maintenance.
Other Outcome Measures:
1. Change in Functional Assessment of Cancer Therapy - Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) score (Patient reported outcome) [ Time Frame: From end of induction to after completion of 9 cycles of consolidation, a period of approximately 36 weeks (9 months) ]
  Calculated as the difference after completion of 9 cycles of consolidation therapy from end of induction. Scores can range from a minimum of 0 and a maximum of 44. A higher score on this assessment means a worse outcome.
2. Levels and changes of FACT-General (G) (physical well-being [PWB] + functional well-being [FWB]) score (PRO) [ Time Frame: From the end of induction through 1 year of maintenance, 21 weeks ]
  The FACT-G is a single outcome measure made up of the PWB and FWB components. Scores range from a minimum of 0 and a maximum of 56. For this assessment, a higher score means a better outcome.
3. Presence, frequency, interference, amount and/or severity of select PRO- Common Terminology Criteria for Adverse Events (CTCAEs) (PRO) [ Time Frame: Up to 15 years ]
  Presence, frequency, interference, amount and/or severity of select PRO-CTCAEs tabulated at each measurement.
4. Comparison of selected PRO-CTCAEs with provider obtained assessment of same CTCAE items (PRO) [ Time Frame: Up to 15 years ]
5. 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).
6. 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: 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).
- LA068 - Ochsner LSU Health Monroe Medical Center
- Ouchita
- 7 Trials Available
- CONTACT US
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: EAQ221CD

Title: Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP)

Purpose: This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called WiseBag along with text message reminders for missed or extra medication events, to enhanced usual care (EUC), where patients only use the Wisebag, to monitor medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor. To ensure CDK4/6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule. Forgetfulness was the most common reason reported for medication non adherence. Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor.

TRIAL NUMBER: S2206

Title: Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) Plus Chemotherapy Versus Chemotherapy Alone for MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer

Purpose: This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint Ultrahigh (MP2) stage II-III hormone receptor positive, HER2 negative breast 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 paclitaxel, doxorubicin, and cyclophosphamide 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. There is some evidence from previous clinical trials that people who have a MammaPrint Ultrahigh Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast 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: 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: EAA181

Title: Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation

Purpose:
Primary Outcome Measures :
1. Consolidation overall survival [ Time Frame: Time from Step 2 randomization at the start of consolidation to death or to the 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 treatment hazard ratio (bortezomib, daratumumab and hyaluronidase-fihj (daratumumab), lenalidomide and dexamethasone [Btz-DRd] then daratumumab, lenalidomide and dexamethasone [DRd] then daratumumab and lenalidomide [DR]).
Secondary Outcome Measures :
1. Consolidation progression-free survival [ Time Frame: Time from Step 2 randomization at the start of consolidation until the earlier of progression or death due to any cause, assessed up to 15 years ]
  Patients alive without disease progression will be censored at date of last disease evaluation. Only deaths that occur within 3 months of the last disease evaluation are considered events.
2. Incidence of adverse events [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
3. Incidence of grade 3 or higher non-hematologic adverse events [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
4. Incidence of grade 3 or higher adverse events [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
5. Best response [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
6. FACT-Ntx TOI recovery rate (Patient reported outcome [PRO]) [ Time Frame: From end of induction through consolidation up to 1 year of maintenance, up to 21 weeks ]
  Defined as the proportion of patients with the FACT-Ntx TOI score returning to baseline level reached at consolidation randomization after experiencing a MID decrease while on up to 1 year of maintenance.
Other Outcome Measures:
1. Change in Functional Assessment of Cancer Therapy - Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) score (Patient reported outcome) [ Time Frame: From end of induction to after completion of 9 cycles of consolidation, a period of approximately 36 weeks (9 months) ]
  Calculated as the difference after completion of 9 cycles of consolidation therapy from end of induction. Scores can range from a minimum of 0 and a maximum of 44. A higher score on this assessment means a worse outcome.
2. Levels and changes of FACT-General (G) (physical well-being [PWB] + functional well-being [FWB]) score (PRO) [ Time Frame: From the end of induction through 1 year of maintenance, 21 weeks ]
  The FACT-G is a single outcome measure made up of the PWB and FWB components. Scores range from a minimum of 0 and a maximum of 56. For this assessment, a higher score means a better outcome.
3. Presence, frequency, interference, amount and/or severity of select PRO- Common Terminology Criteria for Adverse Events (CTCAEs) (PRO) [ Time Frame: Up to 15 years ]
  Presence, frequency, interference, amount and/or severity of select PRO-CTCAEs tabulated at each measurement.
4. Comparison of selected PRO-CTCAEs with provider obtained assessment of same CTCAE items (PRO) [ Time Frame: Up to 15 years ]
5. 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).
6. 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: 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).
- LA007 - Ochsner Medical Center Jefferson
- Orleans Parish
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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: A012103

Title: OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy

Purpose: The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. 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. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.

TRIAL NUMBER: EAQ221CD

Title: Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP)

Purpose: This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called WiseBag along with text message reminders for missed or extra medication events, to enhanced usual care (EUC), where patients only use the Wisebag, to monitor medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor. To ensure CDK4/6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule. Forgetfulness was the most common reason reported for medication non adherence. Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor.

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: NRG-BR009

Title: A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET)

Purpose: This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

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: A022104

Title: The Janus Rectal Cancer Trial: A Randomized Phase II Trial Testing The Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients With Locally Advanced Rectal Cancer

Purpose: This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) 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. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.

TRIAL NUMBER: S2303

Title: Randomized Phase II/III Trial of 2nd Line Nivolumab + Paclitaxel + Ramucirumab Versus Paclitaxel + Ramucirumab in Patients With PD-L1 CPS >/= 1 Advanced Gastric and Esophageal Adenocarcinoma (PARAMMUNE)

Purpose: This phase II/III trial compares the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab to paclitaxel and ramucirumab alone in treating patients with gastric or esophageal adenocarcinoma that that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Adding nivolumab to ramucirumab and paclitaxel may work better to treat patients with advanced stomach or esophageal cancer.

TRIAL NUMBER: AALL1732

Title: A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Purpose:
This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase 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. This trial will also study the outcomes of patients with mixed phenotype acute leukemia (MPAL) and disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy.

The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, in order to classify patients into post-consolidation treatment groups. On the second part of this study, patients will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab. Other aims of this study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.

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-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: 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: ACCL1931

Title: A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy

Purpose: This phase III trial compares the effect of adding levocarnitine to chemotherapy versus chemotherapy alone in protecting the liver in patients with leukemia and lymphoma. Standard of care chemotherapy treatment for leukemia and lymphoma includes a type of chemotherapy named asparaginase, given either as the drug pegaspargase, or a similar drug, calaspargase pegol. This type of chemotherapy can cause severe liver damage. Levocarnitine is a drug used to provide extra carnitine, a naturally occurring nutrient that is part of a typical diet and is also made by the body. Carnitine is important to keep the liver healthy and may be able to prevent damage to the liver from chemotherapy and other drugs. Taking levocarnitine may reduce the rate of severe liver damage caused by asparaginase chemotherapy in patients with leukemia and lymphoma.

TRIAL NUMBER: APAL2020SC

Title: Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias

Purpose: This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat may provide information about the patient's leukemia that is important when deciding how to best treat it, and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults.

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: 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: 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: S2302

Title: Pragmatica-Lung: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) Plus Pembrolizumab (MK-3475; NSC 776864) Versus Standard of Care for Participants Previously Treated With Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer

Purpose: This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. 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. Chemotherapy drugs 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. This trial may help doctors find out if giving ramucirumab with pembrolizumab is more effective at treating patients with stage IV or recurrent non-small cell lung cancer than standard chemotherapy.

TRIAL NUMBER: AHOD2131

Title: A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy With Immuno-Oncology Therapy for Children and Adults With Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma

Purpose: This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, 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 doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride 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. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone.

TRIAL NUMBER: ANHL1931

Title: A Randomized Phase 3 Trial of Nivolumab (NSC# 748726) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma

Purpose: This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs 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. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.

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: 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: 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: 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: 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: 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: 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: 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: WF-1901

Title: Internet-delivered Management of Pain Among Cancer Treatment Survivors (IMPACTS)

Purpose:
To determine whether an Internet-based pain coping skills program plus enhanced usual care, compared to enhanced usual care alone, yields significant improvements in the co-primary outcomes of pain severity (as measured by the Brief Pain Inventory (BPI)) and pain interference (also measured by the BPI) from baseline to the post-intervention assessment for cancer survivors with persistent pain.

This is a parallel group randomized controlled, prospective study that examines the effect of an Internet-based pain coping skills program on pain severity and pain interference among adult cancer survivors experiencing persistent cancer-related pain. The study also explores the effects of an Internet-based pain coping skills program on opioid/analgesic medication use, health-related quality of life, pain management self-efficacy and various other factors relevant among populations with persistent pain (i.e., fatigue, sleep, emotional distress, positive affect, pain impact, perceived cognitive problems, and cognitive performance), as well as qualitative assessments of participants experiences with pain and the intervention. A total of 456 participants will be enrolled (228 per arm) and randomized into the internet program arm (plus enhanced usual care) or Enhanced Usual Care alone.

Each participant will be enrolled in the study for 9 months (from randomization at week 0 to the final follow-up assessment at week 34).

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: A211901

Title: Reaching Rural Cancer Survivors Who Smoke Using Text-Based Cessation Interventions

Purpose: This phase III trial compares the effect of text-based cessation intervention to a manual in helping rural cancer patients who smoke, quit. Text-based scheduled gradual reduction may reduce the frequency of cigarette use to zero and may be effective in quitting smoking.

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: A021806

Title: A PHASE III TRIAL OF PERIOPERATIVE VERSUS ADJUVANT CHEMOTHERAPY FOR RESECTABLE PANCREATIC CANCER

Purpose:
Primary Outcome Measures :
1. Overall survival (OS) [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Overall survival is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. The treatment arms will be compared using a stratified Cox regression model, and hazard ratios from each arm will be estimated.
Secondary Outcome Measures :
1. Disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Disease-free survival (DFS) is defined as the time from randomization to the date of progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, whichever occurs first. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
2. Time to locoregional recurrence (TLR) [ Time Frame: Time between randomization and locoregional recurrence after resection, assessed up to 6 years. ]
  Time to locoregional recurrence (TLR) is defined as the time from randomization to the date of locoregional recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
3. Time to distant metastases (TDM) [ Time Frame: Time between randomization and metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection, assessed up to 6 years. ]
  Time to distant metastases (TDM) is defined as the time from randomization to the date of metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
4. R0 resection rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients with negative resection margins after undergoing surgery.
5. Rate of unresectability [ Time Frame: At time of surgery or planned time of surgery. ]
  The rate (percentage) of patients who cannot undergo surgery due to adverse events, progressive disease, death, poor performance, or patient/physician decision, are deemed unresectable before surgery, or resection was not performed during surgery.
6. Pathologic complete response (pCR) rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients who achieve a pathologic complete response (pCR) confirmed by histopathologic review of the surgical specimen.
7. Incidence of adverse events (AEs), assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 (v5.0) [ Time Frame: Up to 2 years. ]
  The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns within treatment arms and during the following three time points: during perioperative chemotherapy, surgical complications during surgery and post-operative period for 30 days, and during adjuvant chemotherapy.
8. Fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (modified [m]FOLFIRINOX) dose intensity delivered [ Time Frame: 8 months ]
  Dose intensity is defined as the percentage of total cumulative dose the patient received divided by the total dose planned per protocol times 100.
9. Fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (modified [m]FOLFIRINOX) number of cycles received [ Time Frame: 8 months ]
  The number of cycles received is defined as the total number of cycles that the participant received at least one dose of any agent in mFOLFIRINOX.
10. Quality of life as assessed by the physical functioning, nausea/vomiting, and diarrhea subscales in the Quality of Life Questionnaire-Core 30 (QLQ-C30) [ Time Frame: 8 weeks ]
  Quality of Life Questionnaire-Core 30 (QLQ-C30) is a 30-item questionnaire to assess the overall quality of life in cancer patients. QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning, greater occurrence of nausea/vomiting, and greater occurrence of diarrhea.
11. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for overall survival (OS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
12. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for disease-free survival (DFS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
13. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on the risk of grade 3+ adverse event associated with chemotherapy [ Time Frame: Up to 2 years. ]
  Multivariate Logistic models will be fit for the binary endpoint of grade 3+ adverse event (patient experiences at least one grade 3 or higher adverse event during treatment)
14. The ability of computed tomography (CT)-based radiomics to distinguish post-neoadjuvant chemotherapy (NAC) fibrosis from viable tumor as measured by comparison to histological evaluation [ Time Frame: At time of surgery. ]
  Comparison between computed tomography (CT)-based radiomics and histological tumor fibrosis proportions will be measured using Spearman's rank correlation coefficient.
15. Computed tomography (CT)-based radiomics as non-invasive predictors of overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards model will be fit for overall survival (OS) endpoint (defined above) with covariates chosen from all available radiomics features using the least absolute shrinkage and selection operator (LASSO) method with 10-fold cross-validation (CV) and additionally adjusted for clinically important confounders. After the final model is selected the area under the receiver operating characteristic curve (AUC) will be reported to indicate the prediction performance of the radiomics model.
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: URCC-22053

Title: High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients

Purpose: This phase III trial tests whether high-dose vitamin D works in treating androgen-deprivation therapy (ADT)-induced bone loss in patients with prostate cancer who are undergoing androgen-deprivation therapy. Vitamins are substances that the body needs to grow and develop normally. Vitamin D helps the body absorb calcium. Calcium is one of the main building blocks of bone. A lack of vitamin D can lead to bone diseases such as osteoporosis or rickets. This trial may help researcher determine if high-dose vitamin D helps keep bones strong, lowers number of falls, and lessens fatigue in men getting androgen-deprivation therapy.

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: EAY191

Title: Molecular Analysis for Combination Therapy Choice (ComboMATCH)

Purpose: This ComboMATCH patient registration trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.

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)

TRIAL NUMBER: A032103

Title: MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcer

Purpose: This phase II/III trial tests the role of DNA released from tumor cells into the blood in guiding the use of immunotherapy (nivolumab alone or with relatlimab) after surgical removal of the bladder for bladder cancer treatment. DNA is material found inside all of our cells that acts as a blueprint for how cells function. Tumor cells often have abnormal DNA that looks different than DNA in normal cells. A new test called Signatera has been developed that can detect bladder cancer DNA in the blood which might indicate the presence of bladder tumor cells somewhere in the body. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if the Signatera test can better identify which patients need an additional treatment with immunotherapy to help prevent bladder cancer from coming back after surgery.

IRB - LSU Health Sciences Center - New Orleans IRB
11 Trials Available
CONTACT US

TRIAL NUMBER: 01-PS-001

Title: Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I (B-STRONGER-I)

Purpose:

TRIAL NUMBER: DARE

TRIAL NUMBER: GOG-3043 ROCC

Title: A Phase III Randomized Controlled Trial of Robotic Versus Open Radical Hysterectomy for Cervical Cancer (ROCC)

TRIAL NUMBER: OU-SCC-STAR

Title: Phase II Trial of Niraparib in Combination with Dostarlimab in Patients with Recurrent or Progressive Cervix Cancer (STAR)

Purpose:

Primary Outcome Measures :

Proportion of patients with response to treatment [ Time Frame: 1 year ]
The proportion of patients treated with Niraparib and dostarlimab who achieve CR or PR, evaluated using RECIST v1.1

Secondary Outcome Measures :

Number of patients who experience toxicity [ Time Frame: 2 years ]
To determine the nature and degree of toxicity in combination of Niraparib and dostarlimab
Duration of patients with response [ Time Frame: up to 5 years ]
To estimate the duration of response of patients treated with combination of Niraparib and dostarlimab
Progression free survival [ Time Frame: up to 5 years ]
To estimate the progression free survival of patients treated with combination of Niraparib and dostarlimab
Overall survival [ Time Frame: up to 5 years ]
To estimate the overall survival of patients treated with combination of Niraparib and dostarlimab

TRIAL NUMBER: DURAFAK

Title: A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) Plus Defactinib (FAK Inhibitor) in Recurrent Gynecological Cancers (DURAFAK)

TRIAL NUMBER: GOG-3068/HOTT

TRIAL NUMBER: MK-2870-005/ENGOT-en23/GOG-3095

TRIAL NUMBER: Pro00103465

Title: EMCT2 - ENDOMETRIAL CANCER MOLECULARLY TARGETED THERAPY CONSORTIUM

TRIAL NUMBER: SISTER

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

Purpose:

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: LSU-LCMC Cancer Center Biobank

Title: LSU-LCMC Cancer Center Biobank

Purpose:

TRIAL NUMBER: NB004-01

- LA014 - CHRISTUS Highland Medical Center
- 6 Trials Available
- CONTACT US
TRIAL NUMBER: A012103

Title: OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy

Purpose: The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. 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. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.

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: 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: 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)
- LA140 - Louisiana Hematology Oncology Associates
- 2 Trials Available
- CONTACT US
TRIAL NUMBER: A012103

Title: OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy

Purpose: The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. 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. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.

TRIAL NUMBER: EAQ221CD

Title: Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP)

Purpose: This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called WiseBag along with text message reminders for missed or extra medication events, to enhanced usual care (EUC), where patients only use the Wisebag, to monitor medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor. To ensure CDK4/6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule. Forgetfulness was the most common reason reported for medication non adherence. Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor.
- LA035 - MBP Cancer Center
- East Feliciana Parish
- 13 Trials Available
- CONTACT US
TRIAL NUMBER: A012103

Title: OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy

Purpose: The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. 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. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.

TRIAL NUMBER: EAQ221CD

Title: Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP)

Purpose: This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called WiseBag along with text message reminders for missed or extra medication events, to enhanced usual care (EUC), where patients only use the Wisebag, to monitor medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor. To ensure CDK4/6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule. Forgetfulness was the most common reason reported for medication non adherence. Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor.

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-1806

Title: MYOPENIA AND MECHANISMS OF CHEMOTHERAPY TOXICITY IN OLDER ADULTS WITH COLORECTAL CANCER: THE M&M STUDY

Purpose:
Primary Outcome Measures :
1. Number of Chemotherapy Toxicities (Grade 3 - 5) [ Time Frame: Up to 6 months (after initiation of chemotherapy) ]
  Chemotoxicity will be measured after initiation of chemotherapy using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Secondary Outcome Measures :
1. Overall Survival [ Time Frame: 1 year ]
  Participants will be followed for the duration of the study with each participant followed for at least one year after diagnosis, to determine vital status. Loss-to-follow-up will be minimized by asking participating sites to provide date of last contact every 3 months.
TRIAL NUMBER: NRG-GY003

Title: Phase II Randomized Trial of Nivolumab With or Without Ipilimumab in Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Purpose: This phase II trial studies how well nivolumab works with or without ipilimumab in treating patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer that has not responded after prior treatment (persistent) or has come back (recurrent). Monoclonal antibodies, such as nivolumab and ipilimumab, may block tumor growth in different ways by targeting certain cells.
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: 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: S1914

Title: A RANDOMIZED PHASE III TRIAL OF INDUCTION/CONSOLIDATION ATEZOLIZUMAB (NSC #783608) + SBRT VERSUS SBRT ALONE IN HIGH RISK, EARLY STAGE NSCLC

Purpose:
Primary Outcome Measures :
1. Overall survival [ Time Frame: 3 years ]
  Will compare overall survival between patients with inoperable, T1, T2, limited T3, N0M0 (early stage) non-small cell lung cancer randomized to stereotactic body radiation therapy with or without atezolizumab. Will be evaluated using the method of Kaplan-Meier. For point estimates at landmark times, the associated 95% confidence interval (CI) will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios for these outcomes will be estimated using a Cox Proportional Hazards regression model and estimated using a stratified Cox regression model.
Secondary Outcome Measures :
1. Progression free survival [ Time Frame: 5 years ]
  Will be evaluated using the method of Kaplan-Meier. For point estimates at landmark times, the associated 95% CI will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios for these outcomes will be estimated using a Cox Proportional Hazards regression model and estimated using a stratified Cox regression model.
2. Incidence of adverse events [ Time Frame: 5 years ]
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: A021806

Title: A PHASE III TRIAL OF PERIOPERATIVE VERSUS ADJUVANT CHEMOTHERAPY FOR RESECTABLE PANCREATIC CANCER

Purpose:
Primary Outcome Measures :
1. Overall survival (OS) [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Overall survival is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. The treatment arms will be compared using a stratified Cox regression model, and hazard ratios from each arm will be estimated.
Secondary Outcome Measures :
1. Disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Disease-free survival (DFS) is defined as the time from randomization to the date of progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, whichever occurs first. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
2. Time to locoregional recurrence (TLR) [ Time Frame: Time between randomization and locoregional recurrence after resection, assessed up to 6 years. ]
  Time to locoregional recurrence (TLR) is defined as the time from randomization to the date of locoregional recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
3. Time to distant metastases (TDM) [ Time Frame: Time between randomization and metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection, assessed up to 6 years. ]
  Time to distant metastases (TDM) is defined as the time from randomization to the date of metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
4. R0 resection rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients with negative resection margins after undergoing surgery.
5. Rate of unresectability [ Time Frame: At time of surgery or planned time of surgery. ]
  The rate (percentage) of patients who cannot undergo surgery due to adverse events, progressive disease, death, poor performance, or patient/physician decision, are deemed unresectable before surgery, or resection was not performed during surgery.
6. Pathologic complete response (pCR) rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients who achieve a pathologic complete response (pCR) confirmed by histopathologic review of the surgical specimen.
7. Incidence of adverse events (AEs), assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 (v5.0) [ Time Frame: Up to 2 years. ]
  The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns within treatment arms and during the following three time points: during perioperative chemotherapy, surgical complications during surgery and post-operative period for 30 days, and during adjuvant chemotherapy.
8. Fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (modified [m]FOLFIRINOX) dose intensity delivered [ Time Frame: 8 months ]
  Dose intensity is defined as the percentage of total cumulative dose the patient received divided by the total dose planned per protocol times 100.
9. Fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (modified [m]FOLFIRINOX) number of cycles received [ Time Frame: 8 months ]
  The number of cycles received is defined as the total number of cycles that the participant received at least one dose of any agent in mFOLFIRINOX.
10. Quality of life as assessed by the physical functioning, nausea/vomiting, and diarrhea subscales in the Quality of Life Questionnaire-Core 30 (QLQ-C30) [ Time Frame: 8 weeks ]
  Quality of Life Questionnaire-Core 30 (QLQ-C30) is a 30-item questionnaire to assess the overall quality of life in cancer patients. QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning, greater occurrence of nausea/vomiting, and greater occurrence of diarrhea.
11. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for overall survival (OS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
12. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for disease-free survival (DFS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
13. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on the risk of grade 3+ adverse event associated with chemotherapy [ Time Frame: Up to 2 years. ]
  Multivariate Logistic models will be fit for the binary endpoint of grade 3+ adverse event (patient experiences at least one grade 3 or higher adverse event during treatment)
14. The ability of computed tomography (CT)-based radiomics to distinguish post-neoadjuvant chemotherapy (NAC) fibrosis from viable tumor as measured by comparison to histological evaluation [ Time Frame: At time of surgery. ]
  Comparison between computed tomography (CT)-based radiomics and histological tumor fibrosis proportions will be measured using Spearman's rank correlation coefficient.
15. Computed tomography (CT)-based radiomics as non-invasive predictors of overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards model will be fit for overall survival (OS) endpoint (defined above) with covariates chosen from all available radiomics features using the least absolute shrinkage and selection operator (LASSO) method with 10-fold cross-validation (CV) and additionally adjusted for clinically important confounders. After the final model is selected the area under the receiver operating characteristic curve (AUC) will be reported to indicate the prediction performance of the radiomics model.
TRIAL NUMBER: NRG-GU013

Title: The Phase III 'High Five Trial' Five Fraction Radiation for High-Risk Prostate Cancer

Purpose: This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.

TRIAL NUMBER: NRG-GU012

Title: Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)

Purpose: This phase II trial tests whether the addition of radiation to the primary tumor, typically given with stereotactic ablative radiation therapy (SABR), in combination with standard of care immunotherapy improves outcomes in patients with renal cell cancer that is not recommended for surgery and has spread to other places in the body (metastatic). Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses of radiation over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, avelumab, 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. Axitinib, cabozantinib, and lenvatinib are in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving SABR in combination with standard of care immunotherapy may help shrink or stabilize the cancer in patients with renal cell cancer.
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TRIAL NUMBER: A012103

Title: OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy

Purpose: The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. 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. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.

TRIAL NUMBER: EAQ221CD

Title: Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP)

Purpose: This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called WiseBag along with text message reminders for missed or extra medication events, to enhanced usual care (EUC), where patients only use the Wisebag, to monitor medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor. To ensure CDK4/6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule. Forgetfulness was the most common reason reported for medication non adherence. Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor.

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: 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-1806

Title: MYOPENIA AND MECHANISMS OF CHEMOTHERAPY TOXICITY IN OLDER ADULTS WITH COLORECTAL CANCER: THE M&M STUDY

Purpose:
Primary Outcome Measures :
1. Number of Chemotherapy Toxicities (Grade 3 - 5) [ Time Frame: Up to 6 months (after initiation of chemotherapy) ]
  Chemotoxicity will be measured after initiation of chemotherapy using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Secondary Outcome Measures :
1. Overall Survival [ Time Frame: 1 year ]
  Participants will be followed for the duration of the study with each participant followed for at least one year after diagnosis, to determine vital status. Loss-to-follow-up will be minimized by asking participating sites to provide date of last contact every 3 months.
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: 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: S1914

Title: A RANDOMIZED PHASE III TRIAL OF INDUCTION/CONSOLIDATION ATEZOLIZUMAB (NSC #783608) + SBRT VERSUS SBRT ALONE IN HIGH RISK, EARLY STAGE NSCLC

Purpose:
Primary Outcome Measures :
1. Overall survival [ Time Frame: 3 years ]
  Will compare overall survival between patients with inoperable, T1, T2, limited T3, N0M0 (early stage) non-small cell lung cancer randomized to stereotactic body radiation therapy with or without atezolizumab. Will be evaluated using the method of Kaplan-Meier. For point estimates at landmark times, the associated 95% confidence interval (CI) will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios for these outcomes will be estimated using a Cox Proportional Hazards regression model and estimated using a stratified Cox regression model.
Secondary Outcome Measures :
1. Progression free survival [ Time Frame: 5 years ]
  Will be evaluated using the method of Kaplan-Meier. For point estimates at landmark times, the associated 95% CI will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios for these outcomes will be estimated using a Cox Proportional Hazards regression model and estimated using a stratified Cox regression model.
2. Incidence of adverse events [ Time Frame: 5 years ]
TRIAL NUMBER: A021806

Title: A PHASE III TRIAL OF PERIOPERATIVE VERSUS ADJUVANT CHEMOTHERAPY FOR RESECTABLE PANCREATIC CANCER

Purpose:
Primary Outcome Measures :
1. Overall survival (OS) [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Overall survival is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. The treatment arms will be compared using a stratified Cox regression model, and hazard ratios from each arm will be estimated.
Secondary Outcome Measures :
1. Disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Disease-free survival (DFS) is defined as the time from randomization to the date of progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, whichever occurs first. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
2. Time to locoregional recurrence (TLR) [ Time Frame: Time between randomization and locoregional recurrence after resection, assessed up to 6 years. ]
  Time to locoregional recurrence (TLR) is defined as the time from randomization to the date of locoregional recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
3. Time to distant metastases (TDM) [ Time Frame: Time between randomization and metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection, assessed up to 6 years. ]
  Time to distant metastases (TDM) is defined as the time from randomization to the date of metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
4. R0 resection rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients with negative resection margins after undergoing surgery.
5. Rate of unresectability [ Time Frame: At time of surgery or planned time of surgery. ]
  The rate (percentage) of patients who cannot undergo surgery due to adverse events, progressive disease, death, poor performance, or patient/physician decision, are deemed unresectable before surgery, or resection was not performed during surgery.
6. Pathologic complete response (pCR) rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients who achieve a pathologic complete response (pCR) confirmed by histopathologic review of the surgical specimen.
7. Incidence of adverse events (AEs), assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 (v5.0) [ Time Frame: Up to 2 years. ]
  The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns within treatment arms and during the following three time points: during perioperative chemotherapy, surgical complications during surgery and post-operative period for 30 days, and during adjuvant chemotherapy.
8. Fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (modified [m]FOLFIRINOX) dose intensity delivered [ Time Frame: 8 months ]
  Dose intensity is defined as the percentage of total cumulative dose the patient received divided by the total dose planned per protocol times 100.
9. Fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (modified [m]FOLFIRINOX) number of cycles received [ Time Frame: 8 months ]
  The number of cycles received is defined as the total number of cycles that the participant received at least one dose of any agent in mFOLFIRINOX.
10. Quality of life as assessed by the physical functioning, nausea/vomiting, and diarrhea subscales in the Quality of Life Questionnaire-Core 30 (QLQ-C30) [ Time Frame: 8 weeks ]
  Quality of Life Questionnaire-Core 30 (QLQ-C30) is a 30-item questionnaire to assess the overall quality of life in cancer patients. QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning, greater occurrence of nausea/vomiting, and greater occurrence of diarrhea.
11. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for overall survival (OS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
12. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for disease-free survival (DFS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
13. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on the risk of grade 3+ adverse event associated with chemotherapy [ Time Frame: Up to 2 years. ]
  Multivariate Logistic models will be fit for the binary endpoint of grade 3+ adverse event (patient experiences at least one grade 3 or higher adverse event during treatment)
14. The ability of computed tomography (CT)-based radiomics to distinguish post-neoadjuvant chemotherapy (NAC) fibrosis from viable tumor as measured by comparison to histological evaluation [ Time Frame: At time of surgery. ]
  Comparison between computed tomography (CT)-based radiomics and histological tumor fibrosis proportions will be measured using Spearman's rank correlation coefficient.
15. Computed tomography (CT)-based radiomics as non-invasive predictors of overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards model will be fit for overall survival (OS) endpoint (defined above) with covariates chosen from all available radiomics features using the least absolute shrinkage and selection operator (LASSO) method with 10-fold cross-validation (CV) and additionally adjusted for clinically important confounders. After the final model is selected the area under the receiver operating characteristic curve (AUC) will be reported to indicate the prediction performance of the radiomics model.
TRIAL NUMBER: NRG-GU012

Title: Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)

Purpose: This phase II trial tests whether the addition of radiation to the primary tumor, typically given with stereotactic ablative radiation therapy (SABR), in combination with standard of care immunotherapy improves outcomes in patients with renal cell cancer that is not recommended for surgery and has spread to other places in the body (metastatic). Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses of radiation over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, avelumab, 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. Axitinib, cabozantinib, and lenvatinib are in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving SABR in combination with standard of care immunotherapy may help shrink or stabilize the cancer in patients with renal cell cancer.
- LA046 - Medical Center of Baton Rouge
- East Feliciana Parish
- 12 Trials Available
- CONTACT US
TRIAL NUMBER: A012103

Title: OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy

Purpose: The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. 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. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.

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: 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: 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: 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: 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: 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: S2302

Title: Pragmatica-Lung: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) Plus Pembrolizumab (MK-3475; NSC 776864) Versus Standard of Care for Participants Previously Treated With Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer

Purpose: This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. 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. Chemotherapy drugs 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. This trial may help doctors find out if giving ramucirumab with pembrolizumab is more effective at treating patients with stage IV or recurrent non-small cell lung cancer than standard chemotherapy.
TRIAL NUMBER: A021806

Title: A PHASE III TRIAL OF PERIOPERATIVE VERSUS ADJUVANT CHEMOTHERAPY FOR RESECTABLE PANCREATIC CANCER

Purpose:
Primary Outcome Measures :
1. Overall survival (OS) [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Overall survival is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. The treatment arms will be compared using a stratified Cox regression model, and hazard ratios from each arm will be estimated.
Secondary Outcome Measures :
1. Disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Disease-free survival (DFS) is defined as the time from randomization to the date of progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, whichever occurs first. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
2. Time to locoregional recurrence (TLR) [ Time Frame: Time between randomization and locoregional recurrence after resection, assessed up to 6 years. ]
  Time to locoregional recurrence (TLR) is defined as the time from randomization to the date of locoregional recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
3. Time to distant metastases (TDM) [ Time Frame: Time between randomization and metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection, assessed up to 6 years. ]
  Time to distant metastases (TDM) is defined as the time from randomization to the date of metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
4. R0 resection rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients with negative resection margins after undergoing surgery.
5. Rate of unresectability [ Time Frame: At time of surgery or planned time of surgery. ]
  The rate (percentage) of patients who cannot undergo surgery due to adverse events, progressive disease, death, poor performance, or patient/physician decision, are deemed unresectable before surgery, or resection was not performed during surgery.
6. Pathologic complete response (pCR) rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients who achieve a pathologic complete response (pCR) confirmed by histopathologic review of the surgical specimen.
7. Incidence of adverse events (AEs), assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 (v5.0) [ Time Frame: Up to 2 years. ]
  The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns within treatment arms and during the following three time points: during perioperative chemotherapy, surgical complications during surgery and post-operative period for 30 days, and during adjuvant chemotherapy.
8. Fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (modified [m]FOLFIRINOX) dose intensity delivered [ Time Frame: 8 months ]
  Dose intensity is defined as the percentage of total cumulative dose the patient received divided by the total dose planned per protocol times 100.
9. Fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (modified [m]FOLFIRINOX) number of cycles received [ Time Frame: 8 months ]
  The number of cycles received is defined as the total number of cycles that the participant received at least one dose of any agent in mFOLFIRINOX.
10. Quality of life as assessed by the physical functioning, nausea/vomiting, and diarrhea subscales in the Quality of Life Questionnaire-Core 30 (QLQ-C30) [ Time Frame: 8 weeks ]
  Quality of Life Questionnaire-Core 30 (QLQ-C30) is a 30-item questionnaire to assess the overall quality of life in cancer patients. QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning, greater occurrence of nausea/vomiting, and greater occurrence of diarrhea.
11. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for overall survival (OS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
12. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for disease-free survival (DFS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
13. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on the risk of grade 3+ adverse event associated with chemotherapy [ Time Frame: Up to 2 years. ]
  Multivariate Logistic models will be fit for the binary endpoint of grade 3+ adverse event (patient experiences at least one grade 3 or higher adverse event during treatment)
14. The ability of computed tomography (CT)-based radiomics to distinguish post-neoadjuvant chemotherapy (NAC) fibrosis from viable tumor as measured by comparison to histological evaluation [ Time Frame: At time of surgery. ]
  Comparison between computed tomography (CT)-based radiomics and histological tumor fibrosis proportions will be measured using Spearman's rank correlation coefficient.
15. Computed tomography (CT)-based radiomics as non-invasive predictors of overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards model will be fit for overall survival (OS) endpoint (defined above) with covariates chosen from all available radiomics features using the least absolute shrinkage and selection operator (LASSO) method with 10-fold cross-validation (CV) and additionally adjusted for clinically important confounders. After the final model is selected the area under the receiver operating characteristic curve (AUC) will be reported to indicate the prediction performance of the radiomics model.
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)
- LA134 - Ochsner High Grove
- East Feliciana Parish
- 10 Trials Available
- CONTACT US
TRIAL NUMBER: A012103

Title: OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy

Purpose: The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. 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. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.

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: 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: 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: 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: 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: A021806

Title: A PHASE III TRIAL OF PERIOPERATIVE VERSUS ADJUVANT CHEMOTHERAPY FOR RESECTABLE PANCREATIC CANCER

Purpose:
Primary Outcome Measures :
1. Overall survival (OS) [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Overall survival is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. The treatment arms will be compared using a stratified Cox regression model, and hazard ratios from each arm will be estimated.
Secondary Outcome Measures :
1. Disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Disease-free survival (DFS) is defined as the time from randomization to the date of progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, whichever occurs first. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
2. Time to locoregional recurrence (TLR) [ Time Frame: Time between randomization and locoregional recurrence after resection, assessed up to 6 years. ]
  Time to locoregional recurrence (TLR) is defined as the time from randomization to the date of locoregional recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
3. Time to distant metastases (TDM) [ Time Frame: Time between randomization and metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection, assessed up to 6 years. ]
  Time to distant metastases (TDM) is defined as the time from randomization to the date of metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
4. R0 resection rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients with negative resection margins after undergoing surgery.
5. Rate of unresectability [ Time Frame: At time of surgery or planned time of surgery. ]
  The rate (percentage) of patients who cannot undergo surgery due to adverse events, progressive disease, death, poor performance, or patient/physician decision, are deemed unresectable before surgery, or resection was not performed during surgery.
6. Pathologic complete response (pCR) rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients who achieve a pathologic complete response (pCR) confirmed by histopathologic review of the surgical specimen.
7. Incidence of adverse events (AEs), assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 (v5.0) [ Time Frame: Up to 2 years. ]
  The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns within treatment arms and during the following three time points: during perioperative chemotherapy, surgical complications during surgery and post-operative period for 30 days, and during adjuvant chemotherapy.
8. Fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (modified [m]FOLFIRINOX) dose intensity delivered [ Time Frame: 8 months ]
  Dose intensity is defined as the percentage of total cumulative dose the patient received divided by the total dose planned per protocol times 100.
9. Fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (modified [m]FOLFIRINOX) number of cycles received [ Time Frame: 8 months ]
  The number of cycles received is defined as the total number of cycles that the participant received at least one dose of any agent in mFOLFIRINOX.
10. Quality of life as assessed by the physical functioning, nausea/vomiting, and diarrhea subscales in the Quality of Life Questionnaire-Core 30 (QLQ-C30) [ Time Frame: 8 weeks ]
  Quality of Life Questionnaire-Core 30 (QLQ-C30) is a 30-item questionnaire to assess the overall quality of life in cancer patients. QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning, greater occurrence of nausea/vomiting, and greater occurrence of diarrhea.
11. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for overall survival (OS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
12. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for disease-free survival (DFS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
13. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on the risk of grade 3+ adverse event associated with chemotherapy [ Time Frame: Up to 2 years. ]
  Multivariate Logistic models will be fit for the binary endpoint of grade 3+ adverse event (patient experiences at least one grade 3 or higher adverse event during treatment)
14. The ability of computed tomography (CT)-based radiomics to distinguish post-neoadjuvant chemotherapy (NAC) fibrosis from viable tumor as measured by comparison to histological evaluation [ Time Frame: At time of surgery. ]
  Comparison between computed tomography (CT)-based radiomics and histological tumor fibrosis proportions will be measured using Spearman's rank correlation coefficient.
15. Computed tomography (CT)-based radiomics as non-invasive predictors of overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards model will be fit for overall survival (OS) endpoint (defined above) with covariates chosen from all available radiomics features using the least absolute shrinkage and selection operator (LASSO) method with 10-fold cross-validation (CV) and additionally adjusted for clinically important confounders. After the final model is selected the area under the receiver operating characteristic curve (AUC) will be reported to indicate the prediction performance of the radiomics model.
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: A012103

Title: OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy

Purpose: The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. 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. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.

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: 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-1806

Title: MYOPENIA AND MECHANISMS OF CHEMOTHERAPY TOXICITY IN OLDER ADULTS WITH COLORECTAL CANCER: THE M&M STUDY

Purpose:
Primary Outcome Measures :
1. Number of Chemotherapy Toxicities (Grade 3 - 5) [ Time Frame: Up to 6 months (after initiation of chemotherapy) ]
  Chemotoxicity will be measured after initiation of chemotherapy using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Secondary Outcome Measures :
1. Overall Survival [ Time Frame: 1 year ]
  Participants will be followed for the duration of the study with each participant followed for at least one year after diagnosis, to determine vital status. Loss-to-follow-up will be minimized by asking participating sites to provide date of last contact every 3 months.
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: 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: NRG-LU002

Title: MAINTENANCE SYSTEMIC THERAPY VERSUS CONSOLIDATIVE STEREOTACTIC BODY RADIATION THERAPY (SBRT) PLUS MAINTENANCE SYSTEMIC THERAPY FOR LIMITED METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC): A RANDOMIZED PHASE II/III TRIAL

Purpose: (Arm 1): Maintenance systemic therapy should begin within 2 weeks of randomization. (Arm 2): Radiation should begin within 2 weeks of randomization, and maintenance systemic therapy should begin within 2 weeks of the completion of radiation.
TRIAL NUMBER: A021806

Title: A PHASE III TRIAL OF PERIOPERATIVE VERSUS ADJUVANT CHEMOTHERAPY FOR RESECTABLE PANCREATIC CANCER

Purpose:
Primary Outcome Measures :
1. Overall survival (OS) [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Overall survival is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. The treatment arms will be compared using a stratified Cox regression model, and hazard ratios from each arm will be estimated.
Secondary Outcome Measures :
1. Disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Disease-free survival (DFS) is defined as the time from randomization to the date of progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, whichever occurs first. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
2. Time to locoregional recurrence (TLR) [ Time Frame: Time between randomization and locoregional recurrence after resection, assessed up to 6 years. ]
  Time to locoregional recurrence (TLR) is defined as the time from randomization to the date of locoregional recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
3. Time to distant metastases (TDM) [ Time Frame: Time between randomization and metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection, assessed up to 6 years. ]
  Time to distant metastases (TDM) is defined as the time from randomization to the date of metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
4. R0 resection rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients with negative resection margins after undergoing surgery.
5. Rate of unresectability [ Time Frame: At time of surgery or planned time of surgery. ]
  The rate (percentage) of patients who cannot undergo surgery due to adverse events, progressive disease, death, poor performance, or patient/physician decision, are deemed unresectable before surgery, or resection was not performed during surgery.
6. Pathologic complete response (pCR) rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients who achieve a pathologic complete response (pCR) confirmed by histopathologic review of the surgical specimen.
7. Incidence of adverse events (AEs), assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 (v5.0) [ Time Frame: Up to 2 years. ]
  The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns within treatment arms and during the following three time points: during perioperative chemotherapy, surgical complications during surgery and post-operative period for 30 days, and during adjuvant chemotherapy.
8. Fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (modified [m]FOLFIRINOX) dose intensity delivered [ Time Frame: 8 months ]
  Dose intensity is defined as the percentage of total cumulative dose the patient received divided by the total dose planned per protocol times 100.
9. Fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (modified [m]FOLFIRINOX) number of cycles received [ Time Frame: 8 months ]
  The number of cycles received is defined as the total number of cycles that the participant received at least one dose of any agent in mFOLFIRINOX.
10. Quality of life as assessed by the physical functioning, nausea/vomiting, and diarrhea subscales in the Quality of Life Questionnaire-Core 30 (QLQ-C30) [ Time Frame: 8 weeks ]
  Quality of Life Questionnaire-Core 30 (QLQ-C30) is a 30-item questionnaire to assess the overall quality of life in cancer patients. QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning, greater occurrence of nausea/vomiting, and greater occurrence of diarrhea.
11. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for overall survival (OS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
12. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for disease-free survival (DFS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
13. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on the risk of grade 3+ adverse event associated with chemotherapy [ Time Frame: Up to 2 years. ]
  Multivariate Logistic models will be fit for the binary endpoint of grade 3+ adverse event (patient experiences at least one grade 3 or higher adverse event during treatment)
14. The ability of computed tomography (CT)-based radiomics to distinguish post-neoadjuvant chemotherapy (NAC) fibrosis from viable tumor as measured by comparison to histological evaluation [ Time Frame: At time of surgery. ]
  Comparison between computed tomography (CT)-based radiomics and histological tumor fibrosis proportions will be measured using Spearman's rank correlation coefficient.
15. Computed tomography (CT)-based radiomics as non-invasive predictors of overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards model will be fit for overall survival (OS) endpoint (defined above) with covariates chosen from all available radiomics features using the least absolute shrinkage and selection operator (LASSO) method with 10-fold cross-validation (CV) and additionally adjusted for clinically important confounders. After the final model is selected the area under the receiver operating characteristic curve (AUC) will be reported to indicate the prediction performance of the radiomics model.
- LA135 - Terrebonne General Medical Center
- Terrebonne Parish
- 8 Trials Available
- CONTACT US
TRIAL NUMBER: A012103

Title: OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy

Purpose: The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. 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. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.

TRIAL NUMBER: EAQ221CD

Title: Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP)

Purpose: This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called WiseBag along with text message reminders for missed or extra medication events, to enhanced usual care (EUC), where patients only use the Wisebag, to monitor medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor. To ensure CDK4/6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule. Forgetfulness was the most common reason reported for medication non adherence. Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor.

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-1806

Title: MYOPENIA AND MECHANISMS OF CHEMOTHERAPY TOXICITY IN OLDER ADULTS WITH COLORECTAL CANCER: THE M&M STUDY

Purpose:
Primary Outcome Measures :
1. Number of Chemotherapy Toxicities (Grade 3 - 5) [ Time Frame: Up to 6 months (after initiation of chemotherapy) ]
  Chemotoxicity will be measured after initiation of chemotherapy using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Secondary Outcome Measures :
1. Overall Survival [ Time Frame: 1 year ]
  Participants will be followed for the duration of the study with each participant followed for at least one year after diagnosis, to determine vital status. Loss-to-follow-up will be minimized by asking participating sites to provide date of last contact every 3 months.
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: 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: A021806

Title: A PHASE III TRIAL OF PERIOPERATIVE VERSUS ADJUVANT CHEMOTHERAPY FOR RESECTABLE PANCREATIC CANCER

Purpose:
Primary Outcome Measures :
1. Overall survival (OS) [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Overall survival is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. The treatment arms will be compared using a stratified Cox regression model, and hazard ratios from each arm will be estimated.
Secondary Outcome Measures :
1. Disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Disease-free survival (DFS) is defined as the time from randomization to the date of progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, whichever occurs first. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
2. Time to locoregional recurrence (TLR) [ Time Frame: Time between randomization and locoregional recurrence after resection, assessed up to 6 years. ]
  Time to locoregional recurrence (TLR) is defined as the time from randomization to the date of locoregional recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
3. Time to distant metastases (TDM) [ Time Frame: Time between randomization and metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection, assessed up to 6 years. ]
  Time to distant metastases (TDM) is defined as the time from randomization to the date of metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
4. R0 resection rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients with negative resection margins after undergoing surgery.
5. Rate of unresectability [ Time Frame: At time of surgery or planned time of surgery. ]
  The rate (percentage) of patients who cannot undergo surgery due to adverse events, progressive disease, death, poor performance, or patient/physician decision, are deemed unresectable before surgery, or resection was not performed during surgery.
6. Pathologic complete response (pCR) rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients who achieve a pathologic complete response (pCR) confirmed by histopathologic review of the surgical specimen.
7. Incidence of adverse events (AEs), assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 (v5.0) [ Time Frame: Up to 2 years. ]
  The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns within treatment arms and during the following three time points: during perioperative chemotherapy, surgical complications during surgery and post-operative period for 30 days, and during adjuvant chemotherapy.
8. Fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (modified [m]FOLFIRINOX) dose intensity delivered [ Time Frame: 8 months ]
  Dose intensity is defined as the percentage of total cumulative dose the patient received divided by the total dose planned per protocol times 100.
9. Fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (modified [m]FOLFIRINOX) number of cycles received [ Time Frame: 8 months ]
  The number of cycles received is defined as the total number of cycles that the participant received at least one dose of any agent in mFOLFIRINOX.
10. Quality of life as assessed by the physical functioning, nausea/vomiting, and diarrhea subscales in the Quality of Life Questionnaire-Core 30 (QLQ-C30) [ Time Frame: 8 weeks ]
  Quality of Life Questionnaire-Core 30 (QLQ-C30) is a 30-item questionnaire to assess the overall quality of life in cancer patients. QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning, greater occurrence of nausea/vomiting, and greater occurrence of diarrhea.
11. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for overall survival (OS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
12. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for disease-free survival (DFS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
13. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on the risk of grade 3+ adverse event associated with chemotherapy [ Time Frame: Up to 2 years. ]
  Multivariate Logistic models will be fit for the binary endpoint of grade 3+ adverse event (patient experiences at least one grade 3 or higher adverse event during treatment)
14. The ability of computed tomography (CT)-based radiomics to distinguish post-neoadjuvant chemotherapy (NAC) fibrosis from viable tumor as measured by comparison to histological evaluation [ Time Frame: At time of surgery. ]
  Comparison between computed tomography (CT)-based radiomics and histological tumor fibrosis proportions will be measured using Spearman's rank correlation coefficient.
15. Computed tomography (CT)-based radiomics as non-invasive predictors of overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards model will be fit for overall survival (OS) endpoint (defined above) with covariates chosen from all available radiomics features using the least absolute shrinkage and selection operator (LASSO) method with 10-fold cross-validation (CV) and additionally adjusted for clinically important confounders. After the final model is selected the area under the receiver operating characteristic curve (AUC) will be reported to indicate the prediction performance of the radiomics model.
- MS017 - Gulfport Memorial Hospital
- 12 Trials Available
- CONTACT US
TRIAL NUMBER: EAQ221CD

Title: Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP)

Purpose: This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called WiseBag along with text message reminders for missed or extra medication events, to enhanced usual care (EUC), where patients only use the Wisebag, to monitor medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor. To ensure CDK4/6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule. Forgetfulness was the most common reason reported for medication non adherence. Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor.

TRIAL NUMBER: EAY191-N2

Title: A ComboMATCH Treatment Trial EAY191-N2: Phase 2 Trial of Fulvestrant and Binimetinib in Patients With Hormone Receptor-Positive Metastatic Breast Cancer With a Frameshift or Nonsense Mutation or Genomic Deletion in NF1

Purpose: This ComboMATCH phase II trial compares the usual treatment alone (fulvestrant) to using binimetinib plus the usual treatment in patients with hormone receptor positive breast cancer that has spread to other places in the body (metastatic) and has an NF1 genetic change. Fulvestrant is a hormonal therapy that binds to estrogen receptors in tumor cells, resulting in estrogen receptor destruction and decreased estrogen binding, which may inhibit the growth of estrogen-sensitive tumor cells. Binimetinib is a targeted therapy that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition of binimetinib to fulvestrant in breast cancers with an NF1 genetic change could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression) as compared to fulvestrant alone.
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-18007

Title: RANDOMIZED PLACEBO CONTROLLED TRIAL OF BUPROPION FOR CANCER RELATED FATIGUE

Purpose: AIMS/OBJECTIVES 2.1 Primary Aim is to determine the efficacy of bupropion versus placebo in reducing fatigue in a double-blinded, placebo-controlled, randomized clinical trial of breast cancer survivors with fatigue Primary Hypothesis: Bupropion will be associated with greater improvements in fatigue than placebo. 2.2 Secondary Aim 1 is to assess the efficacy of bupropion versus placebo on depression and quality of life in breast cancer survivors with fatigue Secondary Hypothesis 1a: Bupropion will be associated with greater improvements in depression and quality of life than placebo. Secondary Hypothesis 1b: The beneficial effects of bupropion on fatigue will be independent of its effects on depression. 2.3 Secondary Aim 2 is to assess the tolerability of bupropion in breast cancer survivors with fatigue Secondary Hypothesis 2: Adherence, incidence of CTCAE grade 2 or above toxicity, self-reported insomnia, and early discontinuation will be similar between the bupropion and placebo groups. 2.4 Exploratory Aim 1 is to assess the efficacy of bupropion versus placebo on symptomatology and cognition in breast cancer survivors with fatigue Exploratory Hypothesis 1a: Bupropion will be associated with greater improvements in depression and quality of life than placebo. 2.5 Exploratory Aim 2 is to explore the effects of bupropion on putative mechanisms of cancer-related fatigue Exploratory Hypothesis 2a: The relationship between group assignment and reductions in fatigue will be mediated by cytokines and cortisol slope. Exploratory Hypothesis 2b: The relationship between bupropion metabolites and fatigue in the bupropion group will be mediated by cytokines and cortisol slope. 2.5 Exploratory Aim 3 is to explore associations of CYP2B6 genotype with bupropion metabolism and changes in fatigue Exploratory Hypothesis 3: Bupropion metabolism and improvements in fatigue will be greater in patients with no copies of the reduced-function *6 allele (i.e., normal metabolizers) compared to patients with one or two copies of the *6 allele (i.e., reduced metabolizers). We will also compare associations of CYP2B6 genotype and tolerability. Since little previous data exists on CYP2B6 genotype and bupropion tolerability, no hypotheses are offered.

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: 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: 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: EAA181

Title: Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation

Purpose:
Primary Outcome Measures :
1. Consolidation overall survival [ Time Frame: Time from Step 2 randomization at the start of consolidation to death or to the 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 treatment hazard ratio (bortezomib, daratumumab and hyaluronidase-fihj (daratumumab), lenalidomide and dexamethasone [Btz-DRd] then daratumumab, lenalidomide and dexamethasone [DRd] then daratumumab and lenalidomide [DR]).
Secondary Outcome Measures :
1. Consolidation progression-free survival [ Time Frame: Time from Step 2 randomization at the start of consolidation until the earlier of progression or death due to any cause, assessed up to 15 years ]
  Patients alive without disease progression will be censored at date of last disease evaluation. Only deaths that occur within 3 months of the last disease evaluation are considered events.
2. Incidence of adverse events [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
3. Incidence of grade 3 or higher non-hematologic adverse events [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
4. Incidence of grade 3 or higher adverse events [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
5. Best response [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
6. FACT-Ntx TOI recovery rate (Patient reported outcome [PRO]) [ Time Frame: From end of induction through consolidation up to 1 year of maintenance, up to 21 weeks ]
  Defined as the proportion of patients with the FACT-Ntx TOI score returning to baseline level reached at consolidation randomization after experiencing a MID decrease while on up to 1 year of maintenance.
Other Outcome Measures:
1. Change in Functional Assessment of Cancer Therapy - Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) score (Patient reported outcome) [ Time Frame: From end of induction to after completion of 9 cycles of consolidation, a period of approximately 36 weeks (9 months) ]
  Calculated as the difference after completion of 9 cycles of consolidation therapy from end of induction. Scores can range from a minimum of 0 and a maximum of 44. A higher score on this assessment means a worse outcome.
2. Levels and changes of FACT-General (G) (physical well-being [PWB] + functional well-being [FWB]) score (PRO) [ Time Frame: From the end of induction through 1 year of maintenance, 21 weeks ]
  The FACT-G is a single outcome measure made up of the PWB and FWB components. Scores range from a minimum of 0 and a maximum of 56. For this assessment, a higher score means a better outcome.
3. Presence, frequency, interference, amount and/or severity of select PRO- Common Terminology Criteria for Adverse Events (CTCAEs) (PRO) [ Time Frame: Up to 15 years ]
  Presence, frequency, interference, amount and/or severity of select PRO-CTCAEs tabulated at each measurement.
4. Comparison of selected PRO-CTCAEs with provider obtained assessment of same CTCAE items (PRO) [ Time Frame: Up to 15 years ]
5. 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).
6. 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: 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: 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: EAY191

Title: Molecular Analysis for Combination Therapy Choice (ComboMATCH)

Purpose: This ComboMATCH patient registration trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.
- LA126 - CHRISTUS Saint Patrick Hospital
- 2 Trials Available
- CONTACT US
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: 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.
- LA024 - Ochsner Health Center-Summa
- East Feliciana Parish
- 6 Trials Available
- CONTACT US
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: 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: 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: 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: 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)
- LA130 - Ochsner Hematology Oncology North Shore - Covington (West Region)
- 5 Trials Available
- CONTACT US
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: A022104

Title: The Janus Rectal Cancer Trial: A Randomized Phase II Trial Testing The Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients With Locally Advanced Rectal Cancer

Purpose: This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) 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. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.
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: 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).
- IRB - WCG/ADVARRA/EXTERNAL CIRB
- 16 Trials Available
- CONTACT US
TRIAL NUMBER: OP-1250-301/OPERA-01

Title: A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)

Purpose: This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on at least one endocrine therapy in combination with a CDK4/6 inhibitor.

TRIAL NUMBER: EVOLVE - D7984C00002

Title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women with High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy (eVOLVE-Cervical)

Purpose:
This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to

explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018

stage IIIC to IVA cervical cancer with lymph node involvement) who have not progressed

following platinum-based CCRT.

TRIAL NUMBER: MK-2870-020-00/GOG-3101-ENGOT-cx20

Title: A Phase 3 Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Patients with Recurrent or Metastatic Cervical Cancer (TroFuse-020/GOG-3101/ENGOT-cx20)

Purpose:

TRIAL NUMBER: ACR-368-201/GOG-3082

Title: A Phase 1b/2 Basket Study of ACR-368 as Monotherapy and in Combination With Gemcitabine in Adult Subjects With Platinum-Resistant Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma Based on Acrivon OncoSignature® Status

Purpose: This is an open label Phase 1b/2 study to evaluate the efficacy and safety of ACR-368 as monotherapy or in combination with low dose gemcitabine in participants with platinum-resistant ovarian carcinoma, endometrial adenocarcinoma, and urothelial carcinoma based on Acrivon's OncoSignature® test status.

TRIAL NUMBER: ENGOT-EN20/GOG-3083/XPORT-EC-042

Title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

Purpose: The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v 1.1]) after completing at least 12 weeks of platinum-based therapy. A total of 220 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.

TRIAL NUMBER: GOG-3068/HOTT

Title: GOG-3068: A Phase III Randomized Trial of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Cisplatin Versus no HIPEC at the Time of Optimal Interval Cytoreductive Surgery Followed by Niraparib Maintenance in Patients With Newly Diagnosed Stage III and IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (Heated Ovarian Treatment Trial)

Purpose: Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 3-4 cycles). Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study.

TRIAL NUMBER: GOG-3088

Title: A Randomized Phase II Study of Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma

Purpose: This is a clinical trial to test letrozole in patients with uterine leiomyosarcoma. The main question is will treatment with letrozole extend progression-free survival in patients. Patients will receive 2/5 mg of letrozole daily.

TRIAL NUMBER: IMGN853-0421

Title: Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FR?-positive Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Chemotherapy Plus Bevacizumab

Purpose: GLORIOSA is a Phase 3 multicenter, open label study designed to evaluate the safety and efficacy of Mirvetuximab Soravtansine in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FR?) expression.

TRIAL NUMBER: VS-6766-301/GOG-3097/ENGOT-ov81/NCRI

Title: A Phase 3, Randomized, Open-Label Study of Combination Therapy With Avutometinib Plus Defactinib Versus Investigator's Choice of Treatment in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 301)

Purpose:

This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.

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: CIBI363A202

Title: A Phase 2, Open-label, Multicenter Study of IBI363 (PD1-IL2m) in Subjects With Advanced Solid Malignancies

Purpose: This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies.

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: JCXH-211-IV-101

Title: A Phase 1/2 Open-Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of JCXH-211-IV Monotherapy and in Combination With Pembrolizumab in Patients with Advanced Solid Tumors

Purpose:
This is a Phase 1/2 open label study to evaluate the safety, tolerability, and preliminary efficacy of JCXH-211-IV monotherapy and in combination with pembrolizumab in patients with locally advanced/metastatic, relapsed, or refractory solid tumors who failed at least 1 line of SOC therapies. SOC therapies, when appropriate, include FDA approved immunotherapy or targeted therapy or chemotherapy, or a combination of them.

TRIAL NUMBER: OP-3136-101

Title: A Phase 1 First-in-Human, Open-Label, Multicenter Study of OP-3136 in Adult Participants with Advanced or Metastatic Solid Tumors

Purpose:

TRIAL NUMBER: SHR-A1904-I-104

Title: AN OPEN-LABEL, SINGLE-ARM, MULTI-CENTER PHASE I/IIA CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS

Purpose: The study (dose escalation/expansion) is being conducted to assess the safety and tolerability of SHR-A1904 in subjects with advanced solid tumors, and to determine maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D), to assess preliminary efficacy of SHR-A1904, pharmacokinetic (PK) profile and immunogenicity of SHR-A1904 in subjects with advanced solid tumors.

TRIAL NUMBER: STX-478-101

Title: First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

Purpose:
Study STX-478-101 is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 in participants with advanced solid tumors with P13Ka mutations.

Part 1 will evaluate STX-478 as monotherapy in participants with advanced solid tumors. Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in participants with hormone receptor positive (HR+) breast cancer. Part 3 will evaluate STX-478 as combination therapy with fulvestrant and a CDK4/6 Inhibitor (either Ribociclib or Palbociclib) in participants with HR+ breast cancer.

Each study part will include a 28-day screening period, followed by treatment with STX-478 monotherapy or combination therapy.
- LA026 - Woman's Hospital
- East Feliciana Parish
- 2 Trials Available
- CONTACT US
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: 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.
- LA073 - West Jefferson Medical Center
- Jefferson Parish
- 7 Trials Available
- CONTACT US
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: 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: NRG-CC008

Title: A NON-RANDOMIZED PROSPECTIVE CLINICAL TRIAL COMPARING THE NON-INFERIORITY OF SALPINGECTOMY TO SALPINGO-OOPHORECTOMY TO REDUCE THE RISK OF OVARIAN CANCER AMONG BRCA1 CARRIERS [SOROCk]

Purpose:
Primary Outcome Measures :
1. Time to development of incident high-grade serous carcinomas (HGSC), specifically ovarian, primary peritoneal, or fallopian tube cancers [ Time Frame: Up to 20 years ]
  Will be assessed using a stratified log rank test, stratifying for age. The effects of other covariates, such as familial history of gynecologic cancer, time to crossover for bilateral salpingectomy (BLS) patients, and age at study entry, will be adjusted for in Cox proportional hazard models. Patients who crossover will be analyzed according to the initial surgery received at study enrollment as this will reflect actual practice.
Secondary Outcome Measures :
1. Health-related quality of life (QOL) [ Time Frame: Up to 24 months post-surgery ]
  Will be measured by the Functional Assessment of Cancer Therapy - Endocrine Symptom (FACT-ES). The FACT total score (calculated from the physical, functional, social and emotional well-being subscales) and ES subscale will be assessed. Higher scores indicate better QOL for the FACT-ES and better functioning for the FSFI total score.
2. Estrogen deprivation symptoms [ Time Frame: Up to 24 months post-surgery ]
  Will be measured by the FACT-ES. The FACT total score (calculated from the physical, functional, social and emotional well-being subscales) and ES subscale will be assessed. Higher scores indicate better QOL for the FACT-ES and better functioning for the FSFI total score.
3. Sexual dysfunction [ Time Frame: Up to 24 months post-surgery ]
  Will be measured by the Female Sexual Function Index (FSFI). Higher scores indicate better functioning for the FSFI total score.
4. Menopausal symptoms [ Time Frame: Up to 24 months post-surgery ]
  Will be measured by the Menopausal Symptom Checklist (MSCL).
5. Cancer distress [ Time Frame: Up to 24 months post-surgery ]
  Will be measured by the Impact of Events Scale (IES).
6. Medical decision making [ Time Frame: Up to 24 months post-surgery ]
  Will be measured by the Shared Decision Making Questionnaire (SDM-Q-9) to determin factors associated with the risk of reducing surgical treatment choice. The SDM-Q-9 total score at each time point of collection will be compared between arms using a t-test with a significance level of 0.05. A linear model will be used to assess the association of the SDM-Q-9 total score with treatment arm and patient characteristics such as age and race.
7. Medical decision making [ Time Frame: Up to 24 months post-surgery ]
  Will be measured by the Decisional Regret Scale to determine factor associated with the risk of reducing surgical treatment choice. The Decisional Regret Scale total score at each time point of collection will be compared between arms using a t-test with a significance level of 0.05. A linear model will be used to assess the association of the Decisional Regret Scale total score with treatment arm and patient characteristics such as age, race, crossover from BLS arm, and hysterectomy status.
8. Incidence of adverse events [ Time Frame: Up to 24 months post-surgery ]
  Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Counts and frequencies will be provided for the worst grade adverse event (AE) experienced by the patient by treatment arm. The distribution of AE grade in the BLS arm will be compared to the BSO arm using a chi-square test, or Fisher's exact test if cell frequencies are < 5, at the one-sided 0.05 significance level.
Other Outcome Measures:
1. Cost effectiveness [ Time Frame: Up to 24 months post-surgery ]
  Will be measured by European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L). A Markov model will be used to model cost.
2. Sexual dysfunction by PROMIS screener [ Time Frame: Up to 20 years ]
  Will be measured by selected Patient-Reported Outcomes Measurement Information System (PROMIS) screener. Each item will be analyzed separately and compared between treatment arms using a chi-square test.
3. Section dysfunction by PROMIS external sexual function items [ Time Frame: Up to 20 years ]
  Will be measured by selected PROMIS external sexual function items. Each item will be analyzed separately and compared between treatment arms using a chi-square test.
4. Correlation between Health related (HR)-QOL and patient reported symptoms. [ Time Frame: Up to 24 months post-surgery ]
  Will examine the correlation between HR-QOL, as measured by the FACT, with menopausal symptoms, as measured by the MCL, sexual dysfunction, as measured by FSFI, and PROMIS screener and external sexual function items and cancer distress as measured by the IES. Pearson correlation coefficients will be used for correlating the FACT total score with the FSFI overall score and IES total distress score. Spearman correlation coefficients will be used to assess the correlation between FACT total score and the MSCL symptoms, FSFI, and PROMIS items.
TRIAL NUMBER: NRG-CC010

Title: A Phase III Trial of the Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Endometrial Cancer

Purpose:

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).
- IRB - Ochsner - Central IRB
- 1 Trials Available
- CONTACT US
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.
- LA067 - CHRISTUS Saint Frances Cabrini Hospital
- Rapides Parish
- 4 Trials Available
- CONTACT US
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: 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: 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).
- IRB - University of California, San Francisco - Local IRB
- 1 Trials Available
- CONTACT US
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
- LA138 - Ochsner LSU Health Saint Mary's Medical Center
- 1 Trials Available
- CONTACT US
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.
- LA139 - Our Lady of the Lake - Medical Oncology
- 3 Trials Available
- CONTACT US
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: NRG-GY026

Title: A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined With Either Trastuzumab and Hyaluronidase-Oysk (HERCEPTIN HYLECTA) or Pertuzumab, Trastuzumab, and Hyaluronidase-Zzxf (PHESGO) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma

Purpose: This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab or pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer, so that these medications will have a greater effect. Hyaluronidase also allows trastuzumab and trastuzumab/pertuzumab to be given by injection under the skin and shortens their administration time compared to trastuzumab or pertuzumab alone. Paclitaxel is a taxane and in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving Herceptin Hylecta or Phesgo in combination with paclitaxel and carboplatin may shrink the tumor and prevent the cancer from coming back in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma.

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.
- LA041 - LSU Health - Baton Rouge, North Clinic
- East Feliciana Parish
- 7 Trials Available
- CONTACT US
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: 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: NRG-GY026

Title: A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined With Either Trastuzumab and Hyaluronidase-Oysk (HERCEPTIN HYLECTA) or Pertuzumab, Trastuzumab, and Hyaluronidase-Zzxf (PHESGO) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma

Purpose: This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab or pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer, so that these medications will have a greater effect. Hyaluronidase also allows trastuzumab and trastuzumab/pertuzumab to be given by injection under the skin and shortens their administration time compared to trastuzumab or pertuzumab alone. Paclitaxel is a taxane and in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving Herceptin Hylecta or Phesgo in combination with paclitaxel and carboplatin may shrink the tumor and prevent the cancer from coming back in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma.
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: EAA181

Title: Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation

Purpose:
Primary Outcome Measures :
1. Consolidation overall survival [ Time Frame: Time from Step 2 randomization at the start of consolidation to death or to the 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 treatment hazard ratio (bortezomib, daratumumab and hyaluronidase-fihj (daratumumab), lenalidomide and dexamethasone [Btz-DRd] then daratumumab, lenalidomide and dexamethasone [DRd] then daratumumab and lenalidomide [DR]).
Secondary Outcome Measures :
1. Consolidation progression-free survival [ Time Frame: Time from Step 2 randomization at the start of consolidation until the earlier of progression or death due to any cause, assessed up to 15 years ]
  Patients alive without disease progression will be censored at date of last disease evaluation. Only deaths that occur within 3 months of the last disease evaluation are considered events.
2. Incidence of adverse events [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
3. Incidence of grade 3 or higher non-hematologic adverse events [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
4. Incidence of grade 3 or higher adverse events [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
5. Best response [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
6. FACT-Ntx TOI recovery rate (Patient reported outcome [PRO]) [ Time Frame: From end of induction through consolidation up to 1 year of maintenance, up to 21 weeks ]
  Defined as the proportion of patients with the FACT-Ntx TOI score returning to baseline level reached at consolidation randomization after experiencing a MID decrease while on up to 1 year of maintenance.
Other Outcome Measures:
1. Change in Functional Assessment of Cancer Therapy - Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) score (Patient reported outcome) [ Time Frame: From end of induction to after completion of 9 cycles of consolidation, a period of approximately 36 weeks (9 months) ]
  Calculated as the difference after completion of 9 cycles of consolidation therapy from end of induction. Scores can range from a minimum of 0 and a maximum of 44. A higher score on this assessment means a worse outcome.
2. Levels and changes of FACT-General (G) (physical well-being [PWB] + functional well-being [FWB]) score (PRO) [ Time Frame: From the end of induction through 1 year of maintenance, 21 weeks ]
  The FACT-G is a single outcome measure made up of the PWB and FWB components. Scores range from a minimum of 0 and a maximum of 56. For this assessment, a higher score means a better outcome.
3. Presence, frequency, interference, amount and/or severity of select PRO- Common Terminology Criteria for Adverse Events (CTCAEs) (PRO) [ Time Frame: Up to 15 years ]
  Presence, frequency, interference, amount and/or severity of select PRO-CTCAEs tabulated at each measurement.
4. Comparison of selected PRO-CTCAEs with provider obtained assessment of same CTCAE items (PRO) [ Time Frame: Up to 15 years ]
5. 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).
6. 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: 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: A021806

Title: A PHASE III TRIAL OF PERIOPERATIVE VERSUS ADJUVANT CHEMOTHERAPY FOR RESECTABLE PANCREATIC CANCER

Purpose:
Primary Outcome Measures :
1. Overall survival (OS) [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Overall survival is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. The treatment arms will be compared using a stratified Cox regression model, and hazard ratios from each arm will be estimated.
Secondary Outcome Measures :
1. Disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Disease-free survival (DFS) is defined as the time from randomization to the date of progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, whichever occurs first. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
2. Time to locoregional recurrence (TLR) [ Time Frame: Time between randomization and locoregional recurrence after resection, assessed up to 6 years. ]
  Time to locoregional recurrence (TLR) is defined as the time from randomization to the date of locoregional recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
3. Time to distant metastases (TDM) [ Time Frame: Time between randomization and metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection, assessed up to 6 years. ]
  Time to distant metastases (TDM) is defined as the time from randomization to the date of metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
4. R0 resection rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients with negative resection margins after undergoing surgery.
5. Rate of unresectability [ Time Frame: At time of surgery or planned time of surgery. ]
  The rate (percentage) of patients who cannot undergo surgery due to adverse events, progressive disease, death, poor performance, or patient/physician decision, are deemed unresectable before surgery, or resection was not performed during surgery.
6. Pathologic complete response (pCR) rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients who achieve a pathologic complete response (pCR) confirmed by histopathologic review of the surgical specimen.
7. Incidence of adverse events (AEs), assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 (v5.0) [ Time Frame: Up to 2 years. ]
  The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns within treatment arms and during the following three time points: during perioperative chemotherapy, surgical complications during surgery and post-operative period for 30 days, and during adjuvant chemotherapy.
8. Fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (modified [m]FOLFIRINOX) dose intensity delivered [ Time Frame: 8 months ]
  Dose intensity is defined as the percentage of total cumulative dose the patient received divided by the total dose planned per protocol times 100.
9. Fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (modified [m]FOLFIRINOX) number of cycles received [ Time Frame: 8 months ]
  The number of cycles received is defined as the total number of cycles that the participant received at least one dose of any agent in mFOLFIRINOX.
10. Quality of life as assessed by the physical functioning, nausea/vomiting, and diarrhea subscales in the Quality of Life Questionnaire-Core 30 (QLQ-C30) [ Time Frame: 8 weeks ]
  Quality of Life Questionnaire-Core 30 (QLQ-C30) is a 30-item questionnaire to assess the overall quality of life in cancer patients. QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning, greater occurrence of nausea/vomiting, and greater occurrence of diarrhea.
11. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for overall survival (OS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
12. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for disease-free survival (DFS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
13. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on the risk of grade 3+ adverse event associated with chemotherapy [ Time Frame: Up to 2 years. ]
  Multivariate Logistic models will be fit for the binary endpoint of grade 3+ adverse event (patient experiences at least one grade 3 or higher adverse event during treatment)
14. The ability of computed tomography (CT)-based radiomics to distinguish post-neoadjuvant chemotherapy (NAC) fibrosis from viable tumor as measured by comparison to histological evaluation [ Time Frame: At time of surgery. ]
  Comparison between computed tomography (CT)-based radiomics and histological tumor fibrosis proportions will be measured using Spearman's rank correlation coefficient.
15. Computed tomography (CT)-based radiomics as non-invasive predictors of overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards model will be fit for overall survival (OS) endpoint (defined above) with covariates chosen from all available radiomics features using the least absolute shrinkage and selection operator (LASSO) method with 10-fold cross-validation (CV) and additionally adjusted for clinically important confounders. After the final model is selected the area under the receiver operating characteristic curve (AUC) will be reported to indicate the prediction performance of the radiomics model.
- LA074 - Our Lady of the Lake - Physician Group
- East Feliciana Parish
- 9 Trials Available
- CONTACT US
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: 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: NRG-GY026

Title: A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined With Either Trastuzumab and Hyaluronidase-Oysk (HERCEPTIN HYLECTA) or Pertuzumab, Trastuzumab, and Hyaluronidase-Zzxf (PHESGO) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma

Purpose: This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab or pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer, so that these medications will have a greater effect. Hyaluronidase also allows trastuzumab and trastuzumab/pertuzumab to be given by injection under the skin and shortens their administration time compared to trastuzumab or pertuzumab alone. Paclitaxel is a taxane and in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving Herceptin Hylecta or Phesgo in combination with paclitaxel and carboplatin may shrink the tumor and prevent the cancer from coming back in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma.
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: 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: EAA181

Title: Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation

Purpose:
Primary Outcome Measures :
1. Consolidation overall survival [ Time Frame: Time from Step 2 randomization at the start of consolidation to death or to the 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 treatment hazard ratio (bortezomib, daratumumab and hyaluronidase-fihj (daratumumab), lenalidomide and dexamethasone [Btz-DRd] then daratumumab, lenalidomide and dexamethasone [DRd] then daratumumab and lenalidomide [DR]).
Secondary Outcome Measures :
1. Consolidation progression-free survival [ Time Frame: Time from Step 2 randomization at the start of consolidation until the earlier of progression or death due to any cause, assessed up to 15 years ]
  Patients alive without disease progression will be censored at date of last disease evaluation. Only deaths that occur within 3 months of the last disease evaluation are considered events.
2. Incidence of adverse events [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
3. Incidence of grade 3 or higher non-hematologic adverse events [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
4. Incidence of grade 3 or higher adverse events [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
5. Best response [ Time Frame: During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance). ]
6. FACT-Ntx TOI recovery rate (Patient reported outcome [PRO]) [ Time Frame: From end of induction through consolidation up to 1 year of maintenance, up to 21 weeks ]
  Defined as the proportion of patients with the FACT-Ntx TOI score returning to baseline level reached at consolidation randomization after experiencing a MID decrease while on up to 1 year of maintenance.
Other Outcome Measures:
1. Change in Functional Assessment of Cancer Therapy - Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) score (Patient reported outcome) [ Time Frame: From end of induction to after completion of 9 cycles of consolidation, a period of approximately 36 weeks (9 months) ]
  Calculated as the difference after completion of 9 cycles of consolidation therapy from end of induction. Scores can range from a minimum of 0 and a maximum of 44. A higher score on this assessment means a worse outcome.
2. Levels and changes of FACT-General (G) (physical well-being [PWB] + functional well-being [FWB]) score (PRO) [ Time Frame: From the end of induction through 1 year of maintenance, 21 weeks ]
  The FACT-G is a single outcome measure made up of the PWB and FWB components. Scores range from a minimum of 0 and a maximum of 56. For this assessment, a higher score means a better outcome.
3. Presence, frequency, interference, amount and/or severity of select PRO- Common Terminology Criteria for Adverse Events (CTCAEs) (PRO) [ Time Frame: Up to 15 years ]
  Presence, frequency, interference, amount and/or severity of select PRO-CTCAEs tabulated at each measurement.
4. Comparison of selected PRO-CTCAEs with provider obtained assessment of same CTCAE items (PRO) [ Time Frame: Up to 15 years ]
5. 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).
6. 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: 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: A021806

Title: A PHASE III TRIAL OF PERIOPERATIVE VERSUS ADJUVANT CHEMOTHERAPY FOR RESECTABLE PANCREATIC CANCER

Purpose:
Primary Outcome Measures :
1. Overall survival (OS) [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Overall survival is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. The treatment arms will be compared using a stratified Cox regression model, and hazard ratios from each arm will be estimated.
Secondary Outcome Measures :
1. Disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Disease-free survival (DFS) is defined as the time from randomization to the date of progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, whichever occurs first. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
2. Time to locoregional recurrence (TLR) [ Time Frame: Time between randomization and locoregional recurrence after resection, assessed up to 6 years. ]
  Time to locoregional recurrence (TLR) is defined as the time from randomization to the date of locoregional recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
3. Time to distant metastases (TDM) [ Time Frame: Time between randomization and metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection, assessed up to 6 years. ]
  Time to distant metastases (TDM) is defined as the time from randomization to the date of metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
4. R0 resection rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients with negative resection margins after undergoing surgery.
5. Rate of unresectability [ Time Frame: At time of surgery or planned time of surgery. ]
  The rate (percentage) of patients who cannot undergo surgery due to adverse events, progressive disease, death, poor performance, or patient/physician decision, are deemed unresectable before surgery, or resection was not performed during surgery.
6. Pathologic complete response (pCR) rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients who achieve a pathologic complete response (pCR) confirmed by histopathologic review of the surgical specimen.
7. Incidence of adverse events (AEs), assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 (v5.0) [ Time Frame: Up to 2 years. ]
  The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns within treatment arms and during the following three time points: during perioperative chemotherapy, surgical complications during surgery and post-operative period for 30 days, and during adjuvant chemotherapy.
8. Fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (modified [m]FOLFIRINOX) dose intensity delivered [ Time Frame: 8 months ]
  Dose intensity is defined as the percentage of total cumulative dose the patient received divided by the total dose planned per protocol times 100.
9. Fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (modified [m]FOLFIRINOX) number of cycles received [ Time Frame: 8 months ]
  The number of cycles received is defined as the total number of cycles that the participant received at least one dose of any agent in mFOLFIRINOX.
10. Quality of life as assessed by the physical functioning, nausea/vomiting, and diarrhea subscales in the Quality of Life Questionnaire-Core 30 (QLQ-C30) [ Time Frame: 8 weeks ]
  Quality of Life Questionnaire-Core 30 (QLQ-C30) is a 30-item questionnaire to assess the overall quality of life in cancer patients. QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning, greater occurrence of nausea/vomiting, and greater occurrence of diarrhea.
11. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for overall survival (OS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
12. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for disease-free survival (DFS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
13. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on the risk of grade 3+ adverse event associated with chemotherapy [ Time Frame: Up to 2 years. ]
  Multivariate Logistic models will be fit for the binary endpoint of grade 3+ adverse event (patient experiences at least one grade 3 or higher adverse event during treatment)
14. The ability of computed tomography (CT)-based radiomics to distinguish post-neoadjuvant chemotherapy (NAC) fibrosis from viable tumor as measured by comparison to histological evaluation [ Time Frame: At time of surgery. ]
  Comparison between computed tomography (CT)-based radiomics and histological tumor fibrosis proportions will be measured using Spearman's rank correlation coefficient.
15. Computed tomography (CT)-based radiomics as non-invasive predictors of overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards model will be fit for overall survival (OS) endpoint (defined above) with covariates chosen from all available radiomics features using the least absolute shrinkage and selection operator (LASSO) method with 10-fold cross-validation (CV) and additionally adjusted for clinically important confounders. After the final model is selected the area under the receiver operating characteristic curve (AUC) will be reported to indicate the prediction performance of the radiomics model.
- LA008 - Veteran's Administration Medical Center - New Orleans
- Orleans Parish
- 1 Trials Available
- CONTACT US
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.
- LA117 - MBP Cancer Center - Covington
- Saint Tammany
- 4 Trials Available
- CONTACT US
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: 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: NRG-LU002

Title: MAINTENANCE SYSTEMIC THERAPY VERSUS CONSOLIDATIVE STEREOTACTIC BODY RADIATION THERAPY (SBRT) PLUS MAINTENANCE SYSTEMIC THERAPY FOR LIMITED METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC): A RANDOMIZED PHASE II/III TRIAL

Purpose: (Arm 1): Maintenance systemic therapy should begin within 2 weeks of randomization. (Arm 2): Radiation should begin within 2 weeks of randomization, and maintenance systemic therapy should begin within 2 weeks of the completion of radiation.
TRIAL NUMBER: A021806

Title: A PHASE III TRIAL OF PERIOPERATIVE VERSUS ADJUVANT CHEMOTHERAPY FOR RESECTABLE PANCREATIC CANCER

Purpose:
Primary Outcome Measures :
1. Overall survival (OS) [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Overall survival is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. The treatment arms will be compared using a stratified Cox regression model, and hazard ratios from each arm will be estimated.
Secondary Outcome Measures :
1. Disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Disease-free survival (DFS) is defined as the time from randomization to the date of progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, whichever occurs first. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
2. Time to locoregional recurrence (TLR) [ Time Frame: Time between randomization and locoregional recurrence after resection, assessed up to 6 years. ]
  Time to locoregional recurrence (TLR) is defined as the time from randomization to the date of locoregional recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
3. Time to distant metastases (TDM) [ Time Frame: Time between randomization and metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection, assessed up to 6 years. ]
  Time to distant metastases (TDM) is defined as the time from randomization to the date of metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
4. R0 resection rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients with negative resection margins after undergoing surgery.
5. Rate of unresectability [ Time Frame: At time of surgery or planned time of surgery. ]
  The rate (percentage) of patients who cannot undergo surgery due to adverse events, progressive disease, death, poor performance, or patient/physician decision, are deemed unresectable before surgery, or resection was not performed during surgery.
6. Pathologic complete response (pCR) rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients who achieve a pathologic complete response (pCR) confirmed by histopathologic review of the surgical specimen.
7. Incidence of adverse events (AEs), assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 (v5.0) [ Time Frame: Up to 2 years. ]
  The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns within treatment arms and during the following three time points: during perioperative chemotherapy, surgical complications during surgery and post-operative period for 30 days, and during adjuvant chemotherapy.
8. Fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (modified [m]FOLFIRINOX) dose intensity delivered [ Time Frame: 8 months ]
  Dose intensity is defined as the percentage of total cumulative dose the patient received divided by the total dose planned per protocol times 100.
9. Fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (modified [m]FOLFIRINOX) number of cycles received [ Time Frame: 8 months ]
  The number of cycles received is defined as the total number of cycles that the participant received at least one dose of any agent in mFOLFIRINOX.
10. Quality of life as assessed by the physical functioning, nausea/vomiting, and diarrhea subscales in the Quality of Life Questionnaire-Core 30 (QLQ-C30) [ Time Frame: 8 weeks ]
  Quality of Life Questionnaire-Core 30 (QLQ-C30) is a 30-item questionnaire to assess the overall quality of life in cancer patients. QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning, greater occurrence of nausea/vomiting, and greater occurrence of diarrhea.
11. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for overall survival (OS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
12. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for disease-free survival (DFS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
13. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on the risk of grade 3+ adverse event associated with chemotherapy [ Time Frame: Up to 2 years. ]
  Multivariate Logistic models will be fit for the binary endpoint of grade 3+ adverse event (patient experiences at least one grade 3 or higher adverse event during treatment)
14. The ability of computed tomography (CT)-based radiomics to distinguish post-neoadjuvant chemotherapy (NAC) fibrosis from viable tumor as measured by comparison to histological evaluation [ Time Frame: At time of surgery. ]
  Comparison between computed tomography (CT)-based radiomics and histological tumor fibrosis proportions will be measured using Spearman's rank correlation coefficient.
15. Computed tomography (CT)-based radiomics as non-invasive predictors of overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards model will be fit for overall survival (OS) endpoint (defined above) with covariates chosen from all available radiomics features using the least absolute shrinkage and selection operator (LASSO) method with 10-fold cross-validation (CV) and additionally adjusted for clinically important confounders. After the final model is selected the area under the receiver operating characteristic curve (AUC) will be reported to indicate the prediction performance of the radiomics model.
- LA123 - Women's Cancer Care
- Saint Tammany
- 2 Trials Available
- CONTACT US
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: NRG-GY003

Title: Phase II Randomized Trial of Nivolumab With or Without Ipilimumab in Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Purpose: This phase II trial studies how well nivolumab works with or without ipilimumab in treating patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer that has not responded after prior treatment (persistent) or has come back (recurrent). Monoclonal antibodies, such as nivolumab and ipilimumab, may block tumor growth in different ways by targeting certain cells.
- LA028 - MBP Cancer Center - Houma
- Terrebonne Parish
- 3 Trials Available
- CONTACT US
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: 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: NRG-LU002

Title: MAINTENANCE SYSTEMIC THERAPY VERSUS CONSOLIDATIVE STEREOTACTIC BODY RADIATION THERAPY (SBRT) PLUS MAINTENANCE SYSTEMIC THERAPY FOR LIMITED METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC): A RANDOMIZED PHASE II/III TRIAL

Purpose: (Arm 1): Maintenance systemic therapy should begin within 2 weeks of randomization. (Arm 2): Radiation should begin within 2 weeks of randomization, and maintenance systemic therapy should begin within 2 weeks of the completion of radiation.
- AL073 - Lewis & Faye Manderson Cancer Center
- Tuscaloosa County
- 3 Trials Available
- CONTACT US
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-19178

Title: Optimizing Functional Outcomes of Older Cancer Survivors after Chemotherapy: The GEM-S Study

Purpose: This phase III trial compares the effect of geriatric evaluation and management with survivorship health education (GEMS) to usual care on patient-reported physical function in older survivors of cancer. Survivorship care for older adults of cancer usually consists of getting advice from their doctor. This advice may include how to do their daily activities, so they are less tired or how to manage multiple diseases, or long-term side effects from treatment. GEMS may help improve the physical ability to perform activities of daily living, mental well-being, and memory in older survivors of cancer after chemotherapy. This study may help doctors learn if including GEMS in their practices improves physical, mental and memory functions in their patients. The study may also help to understand how such care affects cancer patients and their caregivers' quality of life.

TRIAL NUMBER: NRG-GU013

Title: The Phase III 'High Five Trial' Five Fraction Radiation for High-Risk Prostate Cancer

Purpose: This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.
- LA142 - MBP Cancer Center - Baton Rouge General
- 1 Trials Available
- CONTACT US
TRIAL NUMBER: WF-1806

Title: MYOPENIA AND MECHANISMS OF CHEMOTHERAPY TOXICITY IN OLDER ADULTS WITH COLORECTAL CANCER: THE M&M STUDY

Purpose:
Primary Outcome Measures :
1. Number of Chemotherapy Toxicities (Grade 3 - 5) [ Time Frame: Up to 6 months (after initiation of chemotherapy) ]
  Chemotoxicity will be measured after initiation of chemotherapy using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Secondary Outcome Measures :
1. Overall Survival [ Time Frame: 1 year ]
  Participants will be followed for the duration of the study with each participant followed for at least one year after diagnosis, to determine vital status. Loss-to-follow-up will be minimized by asking participating sites to provide date of last contact every 3 months.
- MS009 - Hattiesburg Clinic - Hematology/Oncology Clinic
- 2 Trials Available
- CONTACT US
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.
- LA113 - Ochsner Medical Center Kenner
- 4 Trials Available
- CONTACT US
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: 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: A021806

Title: A PHASE III TRIAL OF PERIOPERATIVE VERSUS ADJUVANT CHEMOTHERAPY FOR RESECTABLE PANCREATIC CANCER

Purpose:
Primary Outcome Measures :
1. Overall survival (OS) [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Overall survival is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. The treatment arms will be compared using a stratified Cox regression model, and hazard ratios from each arm will be estimated.
Secondary Outcome Measures :
1. Disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Disease-free survival (DFS) is defined as the time from randomization to the date of progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, whichever occurs first. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
2. Time to locoregional recurrence (TLR) [ Time Frame: Time between randomization and locoregional recurrence after resection, assessed up to 6 years. ]
  Time to locoregional recurrence (TLR) is defined as the time from randomization to the date of locoregional recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
3. Time to distant metastases (TDM) [ Time Frame: Time between randomization and metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection, assessed up to 6 years. ]
  Time to distant metastases (TDM) is defined as the time from randomization to the date of metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
4. R0 resection rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients with negative resection margins after undergoing surgery.
5. Rate of unresectability [ Time Frame: At time of surgery or planned time of surgery. ]
  The rate (percentage) of patients who cannot undergo surgery due to adverse events, progressive disease, death, poor performance, or patient/physician decision, are deemed unresectable before surgery, or resection was not performed during surgery.
6. Pathologic complete response (pCR) rate [ Time Frame: At time of surgery. ]
  The rate (percentage) of patients who achieve a pathologic complete response (pCR) confirmed by histopathologic review of the surgical specimen.
7. Incidence of adverse events (AEs), assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 (v5.0) [ Time Frame: Up to 2 years. ]
  The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns within treatment arms and during the following three time points: during perioperative chemotherapy, surgical complications during surgery and post-operative period for 30 days, and during adjuvant chemotherapy.
8. Fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (modified [m]FOLFIRINOX) dose intensity delivered [ Time Frame: 8 months ]
  Dose intensity is defined as the percentage of total cumulative dose the patient received divided by the total dose planned per protocol times 100.
9. Fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (modified [m]FOLFIRINOX) number of cycles received [ Time Frame: 8 months ]
  The number of cycles received is defined as the total number of cycles that the participant received at least one dose of any agent in mFOLFIRINOX.
10. Quality of life as assessed by the physical functioning, nausea/vomiting, and diarrhea subscales in the Quality of Life Questionnaire-Core 30 (QLQ-C30) [ Time Frame: 8 weeks ]
  Quality of Life Questionnaire-Core 30 (QLQ-C30) is a 30-item questionnaire to assess the overall quality of life in cancer patients. QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning, greater occurrence of nausea/vomiting, and greater occurrence of diarrhea.
11. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for overall survival (OS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
12. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on disease-free survival (DFS) [ Time Frame: Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years. ]
  Multivariate Cox proportional hazards models will be fit for disease-free survival (DFS) endpoint (defined above) with covariates corresponding to baseline diet and lifestyle questionnaire responses and hazard ratios and 95% confidence intervals will be reported.
13. Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on the risk of grade 3+ adverse event associated with chemotherapy [ Time Frame: Up to 2 years. ]
  Multivariate Logistic models will be fit for the binary endpoint of grade 3+ adverse event (patient experiences at least one grade 3 or higher adverse event during treatment)
14. The ability of computed tomography (CT)-based radiomics to distinguish post-neoadjuvant chemotherapy (NAC) fibrosis from viable tumor as measured by comparison to histological evaluation [ Time Frame: At time of surgery. ]
  Comparison between computed tomography (CT)-based radiomics and histological tumor fibrosis proportions will be measured using Spearman's rank correlation coefficient.
15. Computed tomography (CT)-based radiomics as non-invasive predictors of overall survival [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]
  Multivariate Cox proportional hazards model will be fit for overall survival (OS) endpoint (defined above) with covariates chosen from all available radiomics features using the least absolute shrinkage and selection operator (LASSO) method with 10-fold cross-validation (CV) and additionally adjusted for clinically important confounders. After the final model is selected the area under the receiver operating characteristic curve (AUC) will be reported to indicate the prediction performance of the radiomics model.
- LA119 - Cancer Center of Acadiana
- Lafayette Parish
- 4 Trials Available
- CONTACT US
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: A211901

Title: Reaching Rural Cancer Survivors Who Smoke Using Text-Based Cessation Interventions

Purpose: This phase III trial compares the effect of text-based cessation intervention to a manual in helping rural cancer patients who smoke, quit. Text-based scheduled gradual reduction may reduce the frequency of cigarette use to zero and may be effective in quitting smoking.

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.
- LA129 - Ochsner Hematology Oncology North Shore - Slidell (East Region)
- 1 Trials Available
- CONTACT US
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.
- LA032 - Ochsner Baptist Medical Center
- Orleans Parish
- 2 Trials Available
- CONTACT US
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).
- LA144 - Mary Bird Perkins Cancer Center - Metairie
- 9 Trials Available
- CONTACT US
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: 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: S2210

Title: A Phase II Study of Neoadjuvant Carboplatin for Localized, High Risk Prostate Cancer With Germline BRCA1/2 Mutations

Purpose: This phase II trial tests how well carboplatin before surgery works in treating patients with high-risk prostate cancer and an inherited BRCA1 or BRCA2 gene mutation. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping, or slowing the growth of tumor cells. Giving carboplatin before surgery may shrink tumors in patients with high-risk prostate cancer with BRCA1 and BRCA2 gene mutations.

TRIAL NUMBER: NRG-GU012

Title: Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)

Purpose: This phase II trial tests whether the addition of radiation to the primary tumor, typically given with stereotactic ablative radiation therapy (SABR), in combination with standard of care immunotherapy improves outcomes in patients with renal cell cancer that is not recommended for surgery and has spread to other places in the body (metastatic). Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses of radiation over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, avelumab, 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. Axitinib, cabozantinib, and lenvatinib are in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving SABR in combination with standard of care immunotherapy may help shrink or stabilize the cancer in patients with renal cell cancer.

TRIAL NUMBER: S2200

Title: A Phase II Randomized Trial of Cabozantinib (NSC #761968) With or Without Atezolizumab (NSC #783608) in Patients With Advanced Papillary Renal Cell Carcinoma (PAPMET2)

Purpose: This phase II trial tests whether cabozantinib with or without atezolizumab works to shrink tumors in patients with papillary kidney cancer that has spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 cabozantinib with atezolizumab may prevent papillary kidney cancer from growing or spreading compared to cabozantinib alone.

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.

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