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NCT00832299 · ClinicalTrials.gov registry record · Phase 2
Neo-Adjuvant FOLFOX for Rectal Carcinoma
A Phase 2 study, sponsored by Beth Israel Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT00832299 is a Phase 2 study that was terminated before completion, run by Beth Israel Medical Center. The registered enrollment target is 2 participants.
The verdict
NCT00832299, a Phase 2 study, was terminated before completion, sponsored by Beth Israel Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
A Phase II open- labeled, prospective study to determine the efficacy of pre-operative chemotherapy with six cycles of modified FOLFOX 6 followed by total mesorectal excision (TME) followed by an additional six cycles of FOLFOX 6. The objectives of this study are the following: 1. The primary endpoint of this trial is pathologic complete response (response rate). 2. Secondary endpoints will include observation of overall pathologic response rate, correlation of pathologic staging with pre-operative ultrasound and pelvic MRI staging, as well as observation of toxic side effects, patterns of disease relapse, disease-free survival outcomes and overall survival outcomes.
Interventions
- DRUG FOLFOX
- PROCEDURE total mesorectal excision (TME)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2009-01 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00832299
The ClinicalTrials.gov registry entry for NCT00832299 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 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 2 interventions - of which FOLFOX is the first listed.
NCT00832299 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00832299 about?
NCT00832299 is a clinical study titled "Neo-Adjuvant FOLFOX for Rectal Carcinoma". A Phase II open- labeled, prospective study to determine the efficacy of pre-operative chemotherapy with six cycles of modified FOLFOX 6 followed by total mesorectal excision (TME) followed by an additional six cycles of FOLFOX 6. The objectives of this study are the following: 1. The primary endp...
What is the current status of trial NCT00832299?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2009-01. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00832299?
The interventions under investigation include: FOLFOX (DRUG), total mesorectal excision (TME) (PROCEDURE).
Who is sponsoring clinical trial NCT00832299?
This trial is sponsored by Beth Israel Medical Center, which has 44 total clinical trials registered on ClinicalTrials.gov.
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