Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
- Study ID
- NCT00004885
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- FOLFIRI regimen — DRUG
- fluorouracil — DRUG
- irinotecan hydrochloride — DRUG
- leucovorin calcium — DRUG
Study Details
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether fluorouracil and leucovorin plus irinotecan is more effective than fluorouracil and leucovorin alone for colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and leucovorin with or without irinotecan in treating patients who have metastatic colorectal cancer.
Key Dates
- Start date
- Jul 31, 1999
- Status verified
- Sep 2012
- Primary completion
- Jul 31, 2001
Study Design
- Enrollment
- 430 participants (actual)
- Allocation
- RANDOMIZED
- Primary purpose
- TREATMENT
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