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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
Up to 1 year
No
John Hines
Principal Investigator
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
NCI-2012-02300
NCT00003873
April 1999
Name | Location |
---|---|
Eastern Cooperative Oncology Group | Boston, Massachusetts 02215 |