Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
UNICANCER
With
OBJECTIVES: * Compare the effect of leucovorin calcium and fluorouracil with or without irinotecan on the 3 year survival rate and overall survival of patients with resected node positive colon cancer at high risk of recurrence. * Compare toxicities of these regimens in these patients. * Compare quality of life of these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, disease type (occlusion vs perforation vs N2 only), delay between surgery and chemotherapy (28 days or less vs over 28 days), and age (under 65 vs 65 and over). Patients are randomized to one of two treatment arms. * Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2. * Arm II: Patients receive irinotecan IV over 90 minutes on day 1 followed by leucovorin calcium and fluorouracil as in arm I. Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before treatment, after 6 and 12 courses, and then at 1 year. Patients are followed every 3 months for 2 years, then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study within 3 years.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted