Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
|ClinicalTrials.gov Identifier: NCT00005586|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
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 may kill more tumor cells. It is not yet known whether chemotherapy is more effective than observation in patients who have had surgery to remove colorectal cancer.
PURPOSE: This randomized phase III trial is studying leucovorin and fluorouracil to see how well they work compared to observation in treating patients with colorectal cancer that has been surgically removed.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: L-leucovorin Drug: fluorouracil Procedure: adjuvant therapy||Phase 3|
- Compare all-cause mortality in patients with resected colorectal cancer treated with adjuvant chemotherapy with L-leucovorin and fluorouracil vs observation.
- Compare the recurrence rates in patients treated with this regimen vs observation.
- Compare the effectiveness of a monthly 5-day schedule vs a once weekly schedule of L-leucovorin and fluorouracil in this patient population.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to receive adjuvant chemotherapy (arm I) or undergo observation only (arm II).
- Arm I: Within 12 weeks of surgery, patients receive L-leucovorin IV followed by fluorouracil IV on days 1-5 every 4 weeks for 6 courses. Alternatively, patients may receive L-leucovorin IV followed by fluorouracil IV on day 1 weekly for 30 weeks.
- Arm II: Patients undergo observation. Patients are followed annually.
PROJECTED ACCRUAL: A total of 2,500 patients (1,250 per arm) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2500 participants|
|Masking:||None (Open Label)|
|Official Title:||A UKCCCR Study of Adjuvant Chemotherapy for Colorectal Cancer|
|Study Start Date :||October 1997|
- All-cause mortality
- Death from colorectal cancer
- Disease recurrence
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005586
|Royal London Hospital|
|London, England, United Kingdom, E1 1BB|
|Study Chair:||Norman Williams, MD||Royal London Hospital|