Study Evaluating Isovorin in Colon Cancer
Phase 3
Completed
- Conditions
- Colon Cancer
- Registration Number
- NCT00195585
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief Summary
The purpose of the study is to verify superiority of 1-LV/5FU therapy to UFT Therapy of relapse-free survival time in patients with Dukes C and Cure A colon cancer. Secondary endpoints include disease-free survival time, survival time, and safety.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 650
Inclusion Criteria
- Dukes C, Cure A colon cancer diagnosed histologically or cytologically
- Normal organ function of bone marrow, heart, liver and kidney
- Age 20-75
Other inclusion applies
Exclusion Criteria
- Serious bone marrow suppression, infection, heart disease or complication
- Familial adenomatous polyposis or hereditary nonpolyposis
- Pregnant or breastfeeding women
Other exclusion applies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Relapse-free survival time
- Secondary Outcome Measures
Name Time Method Disease-free survival time, survival time, safety