None listed
Conditions
Interventions
UFT + Leucovorin Type of group
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 m
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.
Sponsors
BRISTOL MYERS SQUIBB PERÚ S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Patients with histologically confirmed metastatic colorectal adenocarcinoma. • Men or women whose physiological age is 18 years and 75 years old. • Patients who have received adjuvant colorectal treatment at least 6 months before enrolling in the study. • Adjuvant therapy at least 6 months before enrolling in the study. Adjuvant therapy may have been given before and / or after surgery. This includes any modality. • Potentially fertile women may receive treatment, but 72 hours before the start of the study, the results of the pregnancy test performed on serum or urine should have been evaluated. • Performance status score according to the ECOG scale must be 0 - 2. • Patients´ disease must be measurable two-dimensionally, or it must be an evaluable disease, located outside the fields that have been previously irradiated. • The functioning of the bone marrow should be adequate: absolute granulocyte count, neutrophils of segmented nuclei and neutrophils with nuclei in bands greater than or equal to 2000 / mm3, platelet count greater than or equal to 100000 / mm3 • Total bilirubin less than or equal to 1.5 times the upper limit of the normal institutional. • Creatinine less than or equal to 1.5 times the upper limit of the normal institutional. • Informed Consent of the patient must be obtained in accordance with the oaths of the local Ethics Committee. • Patients must be available for follow-up.
Exclusion criteria
Exclusion criteria: • Participants who have undergone any type of previous treatment for metastatic disease, with the exception of radiotherapy applied to locally treat the symptomatic disease. • Patients who have had a serious, uncontrolled concurrent medical disorder. • Patients with a previous neoplasm, except skin cancer of the epithelial cells or localized cervical cancer, appropriately treated. Patients with distant histories of other tumors already cured may enter after discussing it with the sponsor and once their approval has been obtained. • Pregnant or breastfeeding patients, or potentially fertile women who are not applying an adequate method for birth control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:For all patients, survival will be calculated from the day of randomization until the date of death. In the case of patients who have not died, they will be counted until the last day when they were told they were still alive. Measure:Survival Timepoints:From the day of randomization onward. | — |
Outcome results
None listed