UFT plus leucovorin vs 5-FU plus leucovorin for metastatic colorectal cancer.

An open-label, randomized phase III trial has been established to compare the efficacy and safety profile of tegafur and uracil (UFT) plus leucovorin with fluorouracil (5-FU) plus leucovorin as first-line chemotherapy for patients with metastatic colorectal adenocarcinoma. The primary end point of this study is time to progression. Secondary end points include tumor response, symptom control, quality of life, and pharmacoeconomics. Patients randomized to the experimental arm will receive UFT 300 mg/m2/day for 28 days followed by 1 week of rest, plus leucovorin 30 mg three times daily for 28 days. Patients in the control arm will receive 5-FU 425 mg/m2/day plus leucovorin 20 mg/m2/day for 5 days every 35 days. All patients eligible to participate in the study have evaluable or measurable disease. Assessments of tumor size and symptoms will be conducted every 5 weeks (every cycle), with scanning investigations repeated every 10 weeks (two cycles). Symptom evaluation includes assessment of pain, analgesic use, weight loss, and performance status. The intention was to recruit 362 patients by April 1996, with accrual planned for completion by July 1997. As of May 1997, 312 patients had been randomized in 15 countries, covering 45 active sites. All patients had good performance status, and the majority had no prior adjuvant chemotherapy. The study is currently ongoing, and no safety data are available at this time.