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NCT00831181 · ClinicalTrials.gov registry record · Phase 2
Neo-adjuvant Chemoradiation With Oxaliplatin/5-FU in Rectal Cancer
A Phase 2 study, sponsored by Beth Israel Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT00831181: Completed Phase 2 study, sponsored by Beth Israel Medical Center.
NCT00831181 is a Phase 2 study that has completed, run by Beth Israel Medical Center. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00831181, a Phase 2 study, has completed, sponsored by Beth Israel Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
RATIONALE: 5FU based neoadjuvant chemoradiation (nCRT) is the standard of care for Stage II/III rectal cancer. Pathologic complete response (pCR) and downstaging have been associated with improved outcomes. The addition of oxaliplatin (OXA) to neoadjuvant therapy may reduce distant disease recurrence. Adjuvant treatment with OXA for rectal cancer has been motivated by benefits demonstrated in stage III colon cancer. Objective: To determine the feasibility, toxicity, and efficacy of preoperative OXA/5FU and RT followed by total mesorectal excision (TME) and adjuvant PURPOSE: This phase II trial is studying the side effects and how well giving neo-adjuvant combination chemotherapy with radiation works in treating patients undergoing surgery for rectal cancer.
Primary Outcome
Pathologic Response and Complete Response to preoperative therapy will be determined at the time of surgical resection. All grossly visible areas of ulceration and/or induration with be measured and submitted for histological evaluation. The unit of measure is the tumor response rate to preoperative chemoradiation. Pathologic complete response (pCR) is defined as no evidence of invasive tumor cells on pathologic examination of the primary rectal cancer. Tumor regression grade (TRG) will be qu
Interventions
- DRUG Oxaliplatin
- DRUG 5-FU
- DRUG leucovorin
- PROCEDURE mesorectal excision
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2004-07 |
| Est. Completion | 2009-11 |
| Phase | Phase 2 |
What the finished NCT00831181 record still lists
NCT00831181 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 4 interventions - of which Oxaliplatin is the first listed.
NCT00831181 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00831181 about?
NCT00831181 is a clinical study titled "Neo-adjuvant Chemoradiation With Oxaliplatin/5-FU in Rectal Cancer". RATIONALE: 5FU based neoadjuvant chemoradiation (nCRT) is the standard of care for Stage II/III rectal cancer. Pathologic complete response (pCR) and downstaging have been associated with improved outcomes. The addition of oxaliplatin (OXA) to neoadjuvant therapy may reduce distant disease recurrenc...
What is the current status of trial NCT00831181?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2004-07. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00831181?
The interventions under investigation include: Oxaliplatin (DRUG), 5-FU (DRUG), leucovorin (DRUG), mesorectal excision (PROCEDURE).
Who is sponsoring clinical trial NCT00831181?
This trial is sponsored by Beth Israel Medical Center, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00831181's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 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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