Post-Approved Phase III Study of 1-LV/5FU Therapy
Phase 3
20 Years
75 Years
20 Years
75 Years
Not Enrolling
Both
Colon Cancer
Both
Colon Cancer
Trial Information
Post-Approved Phase III Study of 1-LV/5FU Therapy
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Relapse-free survival time
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Wyeth is now a wholly owned subsidiary of Pfizer
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
ISO/5FU-11
NCT ID:
NCT00195585
Start Date:
October 2002
Completion Date:
February 2006
Related Keywords:
- Colon Cancer
- Colon Cancer
- Colonic Neoplasms
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