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NCT00069121 · ClinicalTrials.gov registry record · Phase 3
A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,886
- Enrollment target
NCT00069121: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00069121 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,886 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (144% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00069121, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,886 participants
- Enrollment target
Study Summary
This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.
Primary Outcome
Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor a
Interventions
- DRUG Capecitabine
- DRUG 5-Fluorouracil (5-FU)
- DRUG Oxaliplatin
- DRUG Leucovorin (LV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,886 participants |
| Start Date | 2003-04-18 |
| Est. Completion | 2011-04-21 |
| Phase | Phase 3 |
What the finished NCT00069121 record still lists
NCT00069121 is an interventional study that assigns participants to a tested intervention. Its 1,886 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 (144% higher).
The record links to 0 conditions, and to 4 interventions - of which Capecitabine is the first listed.
NCT00069121 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00069121 about?
NCT00069121 is a clinical study titled "A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer". This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either 1) XELOX (Xeloda 1000mg/m2 ...
What is the current status of trial NCT00069121?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,886 participants. The study started on 2003-04-18. Estimated completion is 2011-04-21.
What interventions are being tested in trial NCT00069121?
The interventions under investigation include: Capecitabine (DRUG), 5-Fluorouracil (5-FU) (DRUG), Oxaliplatin (DRUG), Leucovorin (LV) (DRUG).
Who is sponsoring clinical trial NCT00069121?
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 NCT00069121's enrollment target sits among peer trials
1,886 113th of 2000 higher than 1,888 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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