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NCT02921256 · ClinicalTrials.gov registry record · Phase 2
Veliparib, Pembrolizumab, and Combination Chemotherapy in Treating Patient With Locally Advanced Rectal Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 363
- Enrollment target
NCT02921256: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT02921256 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 363 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (173% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02921256, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 363 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well veliparib or pembrolizumab work with combination chemotherapy and radiation therapy in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as modified (m)FOLFOX6 regimen, 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 veliparib or pembrolizumab with combination chemotherapy and radiation therapy may kill more tumor cells, make the tumor smaller, and reduce the amount of normal tissue that needs to be removed.
Primary Outcome
A linear regression model that controls for the stratification factors (cT-stage and cN-stage) will be used. Mean NAR scores along with standard errors and confidence intervals will be reported by treatment. The NAR score ranges from zero to 100 with lower values corresponding to better prognosis.
Interventions
- DRUG Capecitabine
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG Oxaliplatin
- RADIATION Intensity-Modulated Radiation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 363 participants |
| Start Date | 2017-01-11 |
| Est. Completion | 2023-09-20 |
| Phase | Phase 2 |
What the finished NCT02921256 record still lists
NCT02921256 is an interventional study that assigns participants to a tested intervention. The registered 363 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (173% higher).
The record links to 0 conditions, and to 5 interventions - of which Capecitabine is the first listed.
NCT02921256 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02921256 about?
NCT02921256 is a clinical study titled "Veliparib, Pembrolizumab, and Combination Chemotherapy in Treating Patient With Locally Advanced Rectal Cancer". This randomized phase II trial studies how well veliparib or pembrolizumab work with combination chemotherapy and radiation therapy in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Veliparib may stop the growth of tumor...
What is the current status of trial NCT02921256?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 363 participants. The study started on 2017-01-11. Estimated completion is 2023-09-20.
What interventions are being tested in trial NCT02921256?
The interventions under investigation include: Capecitabine (DRUG), Fluorouracil (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), Intensity-Modulated Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT02921256?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02921256's enrollment target sits among peer trials
363 122nd of 2000 higher than 1,879 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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