CompletedPhase 3

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

France89 participantsStarted 2005-11-14

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

patients preference after randomization and cross-over

Timeframe: after 2 cycles of treatment

Trial details

NCT IDNCT00905047

SponsorCentre Oscar Lambret

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-06

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