Recurrent Rectal Cancer Clinical Trial
Official title:
Phase III Trial Comparing a 28 Day Schedule of Daily Oral 5-FU Plus Eniluracil to Protracted Intravenous Infusion in Previously Untreated Patients With Advanced Colorectal Cancer
Randomized phase III trial to compare the effectiveness of fluorouracil given by infusion with that of fluorouracil plus eniluracil given by mouth in treating patients who have metastatic, recurrent, or residual advanced colorectal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if fluorouracil is more effective with or without eniluracil for advanced colorectal cancer
OBJECTIVES:
I. Compare the response rate, response duration, and survival of patients with advanced
colorectal cancer treated with oral fluorouracil (5-FU) and eniluracil or with protracted
infusion 5-FU.
II. Compare the toxicity of these treatment regimens in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to performance status
(0 vs 1-2) and measurable disease (yes vs no). Patients are randomized to one of two
treatment arms.
ARM I: Patients receive fluorouracil IV as a continuous infusion for 28 days.
ARM II: Patients receive eniluracil/fluorouracil orally twice a day for 28 days.
Treatment continues every 35 days in the absence of disease progression or unacceptable
toxicity.
Patients are followed at least every 10 weeks for 1 year.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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