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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 is a Phase 2 study that has completed, run by Beth Israel Medical Center. The registered enrollment target is 27 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00831181
The ClinicalTrials.gov registry entry for NCT00831181 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Medical Center, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Oxaliplatin is the first listed.
NCT00831181 reports 0 study locations.
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.
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