Phase III Randomized Study of Adjuvant Chemotherapy With L-leucovorin and Fluorouracil Versus Observation in Patients With Resected Colorectal Cancer
Alternate Title Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
Objectives
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Patient Characteristics: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
Expected Enrollment 2500A total of 2,500 patients (1,250 per arm) will be accrued for this study. Outcomes Primary Outcome(s)All-cause mortality Death from colorectal cancer Outline 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 ResultsQuasar 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. |
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