drugset / Trial / NCT00091312

Fluorouracil and Irinotecan With or Without Leucovorin Compared With Observation in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer

NCT00091312 ↗

Phase 3 Unknown 1976 enrolled Federation Francophone de Cancerologie Digestive
RandomizedTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work in 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 any remaining tumor cells. It is not yet known whether combination chemotherapy is more effective than observation alone in treating patients who have undergone surgery for colon cancer. PURPOSE: This randomized phase III trial is studying irinotecan and fluorouracil with or without leucovorin to see how well they work compared to observation alone in treating patients who have undergone surgery for stage II colon cancer.

Timeline

Start
2004-06
Primary completion
—
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule — Intravenous
Subject Leucovorin Small molecule — Intravenous
Subject fluorouracil Small molecule — Intravenous

Indications