Study Evaluating Isovorin in Colon Cancer

Wyeth

Status and phase: Completed; Phase 3

Conditions: Colon Cancer

Treatments: Drug: UFT; Drug: Isovorin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00195585

ISO/5FU-11

Details and patient eligibility

About

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.

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)