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

Open Comparative Study With a Cross-over According to Patients'Preference Receiving Xeloda or UFT With Folinic Acid in Advanced or Metastatic Colo-rectal Cancer

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.

Further study details as provided by Centre Oscar Lambret.

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