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NCT00009737 · ClinicalTrials.gov registry record · Phase 3
A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,987
- Enrollment target
NCT00009737 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,987 participants.
The verdict
NCT00009737, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,987 participants
- Enrollment target
Study Summary
This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer. Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21 days, or leucovorin 20mg/m2 iv + 5-fluorouracil 425mg/m2 iv daily from day 1 to day 5 every 28 days. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Interventions
- DRUG Leucovorin
- DRUG 5-Fluorouracil
- DRUG Capecitabine [Xeloda]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,987 participants |
| Start Date | 1998-11 |
| Est. Completion | 2004-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00009737
The ClinicalTrials.gov registry entry for NCT00009737 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,987 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Leucovorin is the first listed.
NCT00009737 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00009737 about?
NCT00009737 is a clinical study titled "A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer". This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer. Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21 days, or leucovorin 20mg/m2 iv ...
What is the current status of trial NCT00009737?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,987 participants. The study started on 1998-11. Estimated completion is 2004-04.
What interventions are being tested in trial NCT00009737?
The interventions under investigation include: Leucovorin (DRUG), 5-Fluorouracil (DRUG), Capecitabine [Xeloda] (DRUG).
Who is sponsoring clinical trial NCT00009737?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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