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

Principal Investigator:

Meghna S Trivedi, MD

Contact Number:

212-342-5162

NCT Number:

NCT05812807

Population:

Adult

Phase:

III

This study is being done to answer the following question: Among patients with early-stage triple-negative breast cancer (TNBC) who achieve a pathologic complete response (pCR) after preoperative chemotherapy in combination with pembrolizumab, will observation after surgery be as effective as completing 6 more months of pembrolizumab after surgery at preventing cancer from coming back? This study aims to find out if observation is as good as the usual approach for early-stage TNBC. The usual approach for patients with early-stage TNBC who receive preoperative chemotherapy plus pembrolizumab...
Phase III Trial of Stereotactic Radiosurgery (SRS) versus Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for 10 or fewer Brain Metastases from Small Cell Lung Cancer

Principal Investigator:

Lawrence D. Koutcher, MD

Contact Number:

212-342-5162

NCT Number:

NCT04804644

Population:

Adult

Phase:

III

This study is being done to answer the following question: Will high dose radiation therapy delivered only to the small areas of brain cancer and avoiding the surrounding normal brain tissue, called stereotactic radiosurgery (SRS), decrease side effects related to memory and thinking compared to radiation to the entire brain that avoids the hippocampus (the memory zone of the brain) but treats all of the brain tissue, called whole-brain radiation therapy (WBRT), given along with a drug called memantine? For patients with brain metastases from small-cell lung cancer, the usual treatment is...
Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification And Intensification Clinical Trial Evaluation (GUIDANCE)

Principal Investigator:

Israel Deutsch, MD

Contact Number:

212-342-5162

NCT Number:

NCT05050084

Population:

Adult

Phase:

III

This study is being done to answer the following questions: If a patient has unfavorable intermediate risk prostate cancer, a low gene risk score and plans to receive radiation therapy with hormone therapy, is radiation therapy alone as effective at controlling the cancer compared to the usual combination of radiation and hormone therapy? If a patient has unfavorable intermediate risk prostate cancer, a higher gene risk score and plans to receive radiation therapy with hormone therapy, does adding another new hormone therapy drug to the usual combination of radiation and hormone therapy...
Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III

Principal Investigator:

Katherine D Crew, MD

Contact Number:

212-342-5162

NCT Number:

NCT03418961

Population:

Adult

Phase:

III

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. Are you Eligible? (Inclusion Criteria) Patients must have metastatic breast cancer. There is no limit for number of doses of HER-2 targeted therapy prior to registration. Patients must be at increased risk for cardiotoxicity. Patients must not have taken within 21 days prior to Step 1 Registration, be currently taking at the time of Step 1 Registration,...
Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain Metastases

Principal Investigator:

Tony J. Wang, MD, FASTRO

Contact Number:

212-342-5162

NCT Number:

NCT06500455

Population:

Adult

Phase:

III

This study is being done to answer the following question: Can a type of stereotactic radiosurgery (SRS) radiation treatment called fractionated SRS (or FSRS) completed over 3 treatments to the areas of cancer in your brain delay the time until the cancer worsens or returns compared to the usual SRS given in 1 treatment? We are doing this study because we want to find out if this approach is the same or better than the usual approach for your brain metastasis. The usual approach for patients with cancer that has spread to the brain who are not in a study is treatment with SRS that delivers a...
RANDOMIZED TRIAL OF LIMB CRYOCOMPRESSION VERSUS CONTINUOUS COMPRESSION VERSUS LOW CYCLIC COMPRESSION FOR THE PREVENTION OF TAXANE-INDUCED PERIPHERAL NEUROPATHY

Principal Investigator:

Melissa Accordino, MD

Contact Number:

212-342-5162

NCT Number:

NCT05642611

Population:

Adult

Phase:

III

The purpose of this study is to learn which of the following 3 study approaches is the most helpful to prevent peripheral neuropathy caused by taxane chemotherapy. These approaches will use a study device, called the Paxman Limb Cryocompression System, made of wraps that cool and/or compress your arms and legs. The study will test which of the following combinations of cooling and/or compression to your arms and legs is better at preventing peripheral neuropathy: • Cryocompression (cooling plus moderate and low pressure to your arms and legs) • Continuous compression (moderate,...
Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab Versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL

Principal Investigator:

Nicole Lamanna, MD

Contact Number:

212-342-5162

NCT Number:

NCT04269902

Population:

Adult

Phase:

III

This study is being done to answer the following question about treatment with venetoclax and obinutuzumab (called V-O) in patients with high-risk chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL): Can starting treatment early (before symptoms begin) help patients live longer than the usual approach of waiting to start treatment once symptoms appear? This study will help to find out if this approach is better or worse than the usual approach for patients with high-risk CLL or SLL. The usual approach is the care most people get. For high-risk CLL or SLL, the usual approach...
RANDOMIZED PHASE III TRIAL OF MFOLFIRINOX +/- NIVOLUMAB VS. FOLFOX +/-NIVOLUMAB FOR FIRST-LINE TREATMENT OF METASTATIC HER2-NEGATIVE GASTROESOPHAGEAL ADENOCARCINOMA

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05677490

Population:

Adult

Phase:

III

This study is being done to answer the following question: Can we extend your life after the diagnosis of your cancer in the stomach, esophagus, or gastroesophageal junction by adding a third chemotherapy drug to the usual combination of two chemotherapy drugs? We are doing this study because we want to find out if this approach is better or worse than the usual approach for treatment of your cancer in the stomach, esophagus, or gastroesophageal junction. The usual approach for patients who are not in a study is treatment with two chemotherapy drugs, 5-fluorouracil (5-FU) and oxaliplatin,...
RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of RMC-6236 versus Investigator’s Choice of Standard of Care Therapy in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT06625320

Population:

Adult

Phase:

III

The purpose of this study is to test an experimental drug called RMC-6236. RMC-6236 is an experimental drug, which means that it is not approved by the United States (US) Food and Drug Administration (FDA). RMC-6236 is currently being investigated in other ongoing studies, and this is the first study investigating RMC-6236 in only pancreatic cancer. You will be randomly assigned to receive either RMC-6236 or a chemotherapy regimen chosen by the study doctor (in the form of combinations of approved drugs 5-fluorouracil, leucovorin, oxaliplatin, irinotecan, and liposomal irinotecan or...
Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer (CCTG MA.39)

Principal Investigator:

Eileen Patricia Connolly, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT03488693

Population:

Adult

Phase:

III

The purpose of this study is to compare any good and bad effects of not giving regional radiotherapy to using regional radiotherapy. This study will help researchers learn if not giving regional radiotherapy is just as good as using regional radiotherapy. To be better, the approach of not giving regional radiotherapy should keep your breast cancer from coming back as good as giving regional radiotherapy. There will be about 2140 people taking part in this study. Are you Eligible? (Inclusion Criteria) To be eligible for this study, subjects must: 1. be ≥ 40 years of age. 2. have been...

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