A Randomized, Open-label Study Comparing Adjuvant Chemotherapy With Xeloda, or 5-fluorouracil Plus Leucovorin, on Disease-free and Overall Survival in Patients Who Have Had Surgery for Colon Cancer
Phase 3
18 Years
75 Years
18 Years
75 Years
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
A Randomized, Open-label Study Comparing Adjuvant Chemotherapy With Xeloda, or 5-fluorouracil Plus Leucovorin, on Disease-free and Overall Survival in Patients Who Have Had Surgery for Colon Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Non-inferiority in disease-free survival, overall survival, and relapse-free survival.
Outcome Time Frame:
Event driven
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
M66001
NCT ID:
NCT00009737
Start Date:
November 1998
Completion Date:
March 2008
Related Keywords:
- Colorectal Cancer
- Colonic Neoplasms
- Colorectal Neoplasms
Name | Location |
|---|---|
| New Britain, Connecticut 06052 | |
| Albany, Georgia 31701 | |
| Birmingham, Alabama 35294 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 |
