A Clinical Trial Comparing Oral Uracil/Ftorafur (UFT) Plus Leucovorin (LV) With 5-Fluorouracil (5-FU) Plus LV in the Treatment of Patients With Stages II And III Carcinoma of the Colon
OBJECTIVES: I. Compare the relative efficacy of oral uracil/tegafur (UFT) with leucovorin
(CF) vs. fluorouracil (5-FU) with CF in prolonging overall and disease-free survival in
patients with potentially curatively resected stage II/III adenocarcinoma of the colon. II.
Compare the prognostic significance of several biomarkers alone or in combination, including
DNA mismatch repair gene mutations, p53, deleted colon cancer gene, proliferation status,
and thymidylate synthase, in patients treated with UFT/CF vs. 5-FU/CF. III. Evaluate the
relationships of various biomarkers to each other and their association with patient and
tumor characteristics. IV. Compare quality of life in patients treated with UFT/CF vs.
OUTLINE: This is a randomized study. Patients are stratified by number of positive lymph
nodes and participating institution. For the quality-of-life portion of the study, patients
are stratified by age, sex, and ethnicity. Treatment begins within 6 weeks after curative
resection and within 1 week of randomization. Patients are randomly assigned to one of two
groups. The first group receives intravenous leucovorin followed by intravenous fluorouracil
weekly for 6 weeks. Treatment repeats every 8 weeks for a total of 3 courses. The second
group receives oral uracil/tegafur, and oral leucovorin every 8 hours for 28 days. Treatment
repeats every 5 weeks for a total of 5 courses. No concurrent halogenated antiviral agents
(e.g., sorivudine) are permitted. After completing treatment, patients complete
quality-of-life questionnaires at one year.
PROJECTED ACCRUAL: Approximately 1,500 patients will be entered over 3 years to provide
1,452 evaluable patients.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Compare the relative efficacy of UFT + LV with that of 5-FU + LV in prolonging disease-free survival and survival
Michael J. O'Connell, MD
Allegheny Cancer Center at Allegheny General Hospital
United States: Federal Government