RANDOMIZED PHASE II STUDY OF URACIL / FTORAFUR ORAL (UFT) PLUS LEUCOVORINE 5-FLUOROURACIL PARENTERAL AND LEUCOVARIN IN PATIENTS WITH METASTASIC COLORECTAL CANCER

Interventions: Group name:UFT + Leucovorin Type of group;1 N° of participants:50 Intervention(s) description:The total dose of UFT should be determined and rounded to the nearest 100 mg. The total total daily dose of UFT will have to be divided into three doses, which will be administered with an interval of 8 hours between them. The hours suggested for the administration are 7:00, 15:00 and 23:00 hrs. If the total number of tablets could not be divided evenly, the highest dose will be given in the morning and the lowest doses in the afternoon and evening.
Each dose of UFT should be taken with 30 mg of leucovorin.
The treatment will be provided daily for 28 days, followed by 7 days without receiving it. The dosage will be resumed on the 36th.
Group name:5-Fluoracil + Leucovorin Type of group;1 N° of participants:50 Intervention(s) description:The leucovorin will be given in bolus IV in a dose of 20 mg / m2 / day, immediately followed by 5-FU in a dose of 425 mg / m2 / day, administered in the course of 5 minutes as a rapid IV injection. Both medications will be administered daily for 5 days with repeated courses at 4 weeks, at 8 weeks and every 5 weeks thereafter.
Primary outcome(s): Outcome name:Measurable disease: disappearance or decrease of clinical evidence of the tumor in at least 4 weeks.
Response time: measurement until the decrease or disappearance of clinical signs and symptoms.
Measure:Response to treatment
Timepoints:Week 4
Study Design: This study is an open, randomized, multicenter open-label trial designed to evaluate the efficacy and safety of UFT plus leucovorin in the treatment of patients with colorectal adenocarcinoma. Patients are stratified by country, performance status and previous adjuvant chemotherapy.