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NCT00250835 · ClinicalTrials.gov registry record · Phase 2
Combination of Oxaliplatin, Capecitabine, and Celecoxib With Concurrent Radiation for Rectal Cancer
A Phase 2 study, sponsored by New Mexico Cancer Research Alliance.
- Terminated
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
NCT00250835: Clinical Trial Phase 2 study, sponsored by New Mexico Cancer Research Alliance.
NCT00250835 is a Phase 2 study that was terminated before completion, run by New Mexico Cancer Research Alliance. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00250835, a Phase 2 study, was terminated before completion, sponsored by New Mexico Cancer Research Alliance.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
Study Summary
A combination of chemotherapy and radiation is often used to treat rectal cancer patients before surgery in an effort to shrink the tumor and make it easier to remove as well as to help increase the chances of sphincter-sparing surgery. Many previous clinical studies have suggested that rectal cancer patients may survive longer if the surgery results in a pathological complete response - that is, the absence of any tumor cells in the surgical specimen. However, there is still controversy over this. This study attempts to start to answer this question by treating rectal cancer patients with a combination of chemotherapy drugs (oxaliplatin and capecitabine), a cyclooxygenase-2 (COX-2) enzyme inhibitor and radiation before surgery. The rates of pathologic complete response, sphincter-sparing surgery, and disease-free survival are some of the therapeutic endpoints that will be studied.
Primary Outcome
The pathologic complete response (PCR) rate will be calculated as the proportion of patients who achieve complete response out of all evaluable patients. PCR is defined as the total absence of residual tumor cells by microscopic examination of the resected surgical specimen, including all of the sampled lymph nodes.
Interventions
- OTHER Chemotherapy, Celecoxib, and Radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2005-04 |
| Est. Completion | 2015-05 |
| Phase | Phase 2 |
Why NCT00250835 stopped before completion
NCT00250835 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 1 intervention - of which Chemotherapy, Celecoxib, and Radiation is the first listed.
NCT00250835 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00250835 about?
NCT00250835 is a clinical study titled "Combination of Oxaliplatin, Capecitabine, and Celecoxib With Concurrent Radiation for Rectal Cancer". A combination of chemotherapy and radiation is often used to treat rectal cancer patients before surgery in an effort to shrink the tumor and make it easier to remove as well as to help increase the chances of sphincter-sparing surgery. Many previous clinical studies have suggested that rectal cance...
What is the current status of trial NCT00250835?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2005-04. Estimated completion is 2015-05.
What interventions are being tested in trial NCT00250835?
The interventions under investigation include: Chemotherapy, Celecoxib, and Radiation (OTHER).
Who is sponsoring clinical trial NCT00250835?
This trial is sponsored by New Mexico Cancer Research Alliance, which has 66 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00250835's enrollment target sits among peer trials
38 1467th of 2000 higher than 517 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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