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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: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00009737 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,987 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (157% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participants with disease-free survival were reported. Disease-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participant was known to be disease free (censoring time).
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 |
What the finished NCT00009737 record still lists
NCT00009737 is an interventional study that assigns participants to a tested intervention. Its 1,987 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (157% higher).
The record links to 0 conditions, and to 3 interventions - of which Leucovorin is the first listed.
NCT00009737 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00009737's enrollment target sits among peer trials
1,987 106th of 2000 higher than 1,895 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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