Xeloda or UFT (Tegafur-uracil) With Folinic Acid in Advanced or Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The scope of the trial is to determine the preference of patients, after randomization and cross-over, for one of the two treatments.

Another objective of the trial is to assess and compare the safety of each treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Oscar Lambret
• Treatments: Capecitabine; Folic Acid; Leucovorin; Levoleucovorin; Tegafur

Criteria

Inclusion Criteria:

• Locally advanced or metastatic colo-rectal cancer

• Age > or = 18 years old

• PS-WHO < or = 2

• Polynuclear neutrophil leukocytes > or = 1500/mm3, platelets > or = 100000/mm3

• Total bilirubin < or = 3 ULN, ASAT-ALAT < or = 2.5 ULN

• Effective contraception

• Written informed consent signed

Exclusion Criteria:

• Concomitant radiotherapy

• Contraindication to fluoropyrimidines

• Treatment with sorivudine and its chemical analogs such as brivudine

• Severe hepatic insufficiency

• Severe renal insufficiency

• Pregnant or lactating woman

• Hypersensitivity to capecitabine, 5FU, tegafur or one of its excipients