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NCT00216424 · ClinicalTrials.gov registry record · Phase 4
Capecitabine (Xeloda) and Radiation for Patients With Rectosigmoid Carcinoma
A Phase 4 study, sponsored by James A. Haley Veterans Administration Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT00216424 is a Phase 4 study that was terminated before completion, run by James A. Haley Veterans Administration Hospital. The registered enrollment target is 40 participants.
The verdict
NCT00216424, a Phase 4 study, was terminated before completion, sponsored by James A. Haley Veterans Administration Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
This study is designed primarily to establish efficacy and estimate resource utilization. The short-term hypothesis is that the dose of capecitabine (825 mg/m2 twice/day 5 days per week) during the course of radiation therapy is efficacious in locally advanced, non-metastatic rectosigmoid carcinoma and will improve resectability. The long-term working hypothesis is that if 3-D CRT is combined with the potentiating and additive effect of capecitabine one hopes to see improved and durable tumor response and survival with acceptable toxicity. In addition, it is expected that the simplicity of using an oral agent (capecitabine) will be associated with reduced cost and resource utilization.
Interventions
- DRUG Capecitabine (Xeloda)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2005-02 |
| Est. Completion | 2007-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00216424
The ClinicalTrials.gov registry entry for NCT00216424 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is James A. Haley Veterans Administration Hospital, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Capecitabine (Xeloda) is the first listed.
NCT00216424 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00216424 about?
NCT00216424 is a clinical study titled "Capecitabine (Xeloda) and Radiation for Patients With Rectosigmoid Carcinoma". This study is designed primarily to establish efficacy and estimate resource utilization. The short-term hypothesis is that the dose of capecitabine (825 mg/m2 twice/day 5 days per week) during the course of radiation therapy is efficacious in locally advanced, non-metastatic rectosigmoid carcinoma ...
What is the current status of trial NCT00216424?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2005-02. Estimated completion is 2007-01.
What interventions are being tested in trial NCT00216424?
The interventions under investigation include: Capecitabine (Xeloda) (DRUG).
Who is sponsoring clinical trial NCT00216424?
This trial is sponsored by James A. Haley Veterans Administration Hospital, which has 7 total clinical trials registered on ClinicalTrials.gov.
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