Phase 3
N=1,987
A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00009737 ↗Enrolled (actual)
1,987
Serious AEs
18.4%
Results posted
Jun 2016
Primary outcome: Primary: Disease-free Survival — 656; 603 Participants — p=0.053
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 5-Fluorouracil (Drug); Leucovorin (Drug); Capecitabine [Xeloda] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Apr 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease-free Survival |
656; 603 | 0.053 |
| SECONDARY Relapse-Free Survival |
677; 621 | 0.041 sig |
| SECONDARY Overall Survival |
804; 756 | 0.071 |
| SECONDARY Mean Change From Baseline in Global Health Status at Week 25 |
2.1; 2.6 | — |
| SECONDARY Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters |
327; 333; 300; 288; 334; 289 | — |
| SECONDARY Number of Participants With Any Adverse Events and Serious Adverse Events |
910; 885; 181; 182 | — |
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.
Eligibility Criteria
Inclusion Criteria
- adult patients 18-75 years of age;
- histologically confirmed colon cancer with potentially curative resection of the tumor within 8 weeks before study initiation.
Exclusion Criteria
- previous chemotherapy
Data sourced from ClinicalTrials.gov (NCT00009737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.