Clinical Trials (PDQ®)
|Phase III Randomized Study of Adjuvant Chemotherapy With L-leucovorin and Fluorouracil Versus Observation in Patients With Resected Colorectal Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.
First Published: 5/1/2000  Last Modified: 5/13/2008
Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.
A total of 2,500 patients (1,250 per arm) will be accrued for this study.
Death from colorectal cancer
This is a randomized, open-label, multicenter study. Patients are randomized to receive adjuvant chemotherapy (arm I) or undergo observation only (arm II).
Patients are followed annually.Published Results
Quasar Collaborative Group, Gray R, Barnwell J, et al.: Adjuvant chemotherapy versus observation in patients with colorectal cancer: a randomised study. Lancet 370 (9604): 2020-9, 2007.[PUBMED Abstract]
Trial Lead Organizations
National Cancer Research Institute
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.