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Brief Title: Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer
Official Title: Multicenter Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FU/FA Infusional Regimen To The Same 5-FU/FA Infusional Regimen Alone As Adjuvant Treatment Of Stage III Colon Cancer
Study ID: NCT00026273
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and leucovorin with or without irinotecan in treating patients who have undergone surgery for stage III colorectal cancer.
Detailed Description: OBJECTIVES: * Compare the disease-free survival at 3 years of patients with resected stage III colorectal cancer treated with adjuvant fluorouracil and leucovorin calcium with or without irinotecan. * Compare the disease-free and overall survival at 5 years of patients treated with these regimens. * Compare the safety profiles of these treatment regimens in these patients. * Compare the quality-adjusted survival of patients treated with these regimens. * Correlate the expression of putative prognostic markers (thymidylate synthase, telomerase, topoisomerase) with disease-free and overall survival of patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. Arm I * Patients receive irinotecan IV over 30-90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV over 24 hours weekly for 6 weeks. Courses repeat every 7 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. * As an alternative schedule, patients may receive irinotecan IV over 30-90 minutes and day 1 and leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2 every 2 weeks for 6 weeks. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Arm II * Patients receive leucovorin calcium and fluorouracil as in arm I. Quality of life may be assessed at baseline; prior to courses 2, 3, and 4; and at 1, 3, and 6 months. Patients are followed every 3 months for 3 years and then every 6 months for 2 years. PROJECTED ACCRUAL: Approximately 1800 patients (900 per arm) will be accrued for this study within 24 months.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Allgemeines Krankenhaus der Stadt Wien, Vienna (Wien), , Austria
U.Z. Gasthuisberg, Leuven, , Belgium
National Cancer Institute of Egypt, Cairo, , Egypt
CHU Pitie-Salpetriere, Paris, , France
Hopital Tenon, Paris, , France
Universitats-Krankenhaus Eppendorf, Hamburg, , Germany
Ospedali Riuniti di Bergamo, Bergamo, , Italy
Universita Degli Studi di Firenze - Policlin. di Careggi, Firenze (Florence), , Italy
Ospedale San Carlo Borromeo, Milano (Milan), , Italy
Azienda Ospedaliera S. Maria, Terni, , Italy
Universita Degli Studi di Udine, Udine, , Italy
Instituto Portugues de Oncologia do Porto, Porto, , Portugal
Hospital Universarito "Reina Sofia", Cordoba, , Spain
Hopital Cantonal Universitaire de Geneva, Geneva, , Switzerland
Royal Marsden Hospital, Sutton, England, United Kingdom
Name: Eric Van Cutsem, MD, PhD
Affiliation: University Hospital, Gasthuisberg
Role: STUDY_CHAIR