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NCT03257163 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab, Capecitabine, and Radiation Therapy in Treating Patients With Mismatch-Repair Deficient and Epstein-Barr Virus Positive Gastric Cancer
A Phase 2 study of Gastric Adenocarcinoma and Stage III Gastric Cancer AJCC v7, sponsored by Rutgers, The State University of New Jersey.
- Active
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 4
- Study locations
NCT03257163: Active Phase 2 study of Gastric Adenocarcinoma and Stage III Gastric Cancer AJCC v7, sponsored by Rutgers, The State University of New Jersey.
NCT03257163 is a Phase 2 study of Gastric Adenocarcinoma and Stage III Gastric Cancer AJCC v7 that is active but no longer recruiting, run by Rutgers, The State University of New Jersey. The registered enrollment target is 40 participants, below the 244-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (84% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03257163, a Phase 2 study of Gastric Adenocarcinoma and Stage III Gastric Cancer AJCC v7, is active but no longer recruiting, sponsored by Rutgers, The State University of New Jersey.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 4
- Study locations
Study Summary
This phase II trial studies how well pembrolizumab works with capecitabine and radiation therapy in treating patients with mismatch repair deficient and Epstein-Barr virus positive gastric cancer. Monoclonal antibodies, such as pembrolizumab may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as capecitabine, 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 to kill tumor cells and shrink tumors. Giving pembrolizumab, capecitabine and radiation therapy may work better at treating gastric cancer.
Primary Outcome
At the time of analysis (after 18 months of accrual and 18 additional months of follow-up), will compute a Kaplan-Meier survival curve and will compare the observed survival rate at three years to the historical level of 0.45.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Capecitabine
- OTHER Laboratory Biomarker Analysis
- RADIATION Radiation Therapy
Study Locations (4)
New Jersey
- RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton - Hamilton
- Rutgers Cancer Institute of New Jersey - New Brunswick
Georgia
- Emory University - Atlanta
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-09-29 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT03257163 still lists
NCT03257163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 244-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (84% lower).
The record links to 10 conditions, with Gastric Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT03257163 reports a single indexed study location in New Jersey, Georgia, New York.
Frequently Asked Questions
What is clinical trial NCT03257163 about?
NCT03257163 is a clinical study titled "Pembrolizumab, Capecitabine, and Radiation Therapy in Treating Patients With Mismatch-Repair Deficient and Epstein-Barr Virus Positive Gastric Cancer". This phase II trial studies how well pembrolizumab works with capecitabine and radiation therapy in treating patients with mismatch repair deficient and Epstein-Barr virus positive gastric cancer. Monoclonal antibodies, such as pembrolizumab may interfere with the ability of tumor cells to grow and ...
What is the current status of trial NCT03257163?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2017-09-29. Estimated completion is 2026-12-31.
What conditions does trial NCT03257163 study?
This clinical trial studies the following conditions: Gastric Adenocarcinoma, Stage III Gastric Cancer AJCC v7, Epstein-Barr Virus Positive, Mismatch Repair Protein Deficiency, Stage IB Gastric Cancer AJCC v7.
What interventions are being tested in trial NCT03257163?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Capecitabine (DRUG), Laboratory Biomarker Analysis (OTHER), Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT03257163?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03257163 being conducted?
This trial has 4 study locations across Georgia, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03257163's enrollment target sits among peer trials
40 31st of 47 higher than 15 of 47 other Gastric Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastric Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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