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

Phase 3

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: TEGAFUR URACIL - FOLINIC ACID; Drug: XELODA

• Registration Number: NCT00905047
• Lead Sponsor: Centre Oscar Lambret

Brief 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.

Detailed Description

Further study details as provided by Centre Oscar Lambret.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2009-05-18
• Study First Submitted QC: 2009-05-19
• Study First Posted: 2009-05-20
• Primary Completion: 2010-06
• Study Completion: 2011-09
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-20
• Last Update Posted: 2012-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
UFT	TEGAFUR URACIL - FOLINIC ACID	-
XELODA	XELODA	-

Primary Outcome Measures

Name	Time	Method
patients preference after randomization and cross-over	after 2 cycles of treatment

Secondary Outcome Measures

Name	Time	Method
safety of each treatment	at day 56 (after two cycles of treatment)

Trial Locations

Locations (11)

Centre Hospitalier Regional; 🇫🇷 Lille, France

Centre Hospitalier de CHOLET; 🇫🇷 Cholet, France

Centre Hospitalier; 🇫🇷 Valenciennes, France

Centre Hospitalier de Béthune; 🇫🇷 Beuvry, France

Centre Leonard de Vinci; 🇫🇷 Dechy, France

Polyclinique du Bois; 🇫🇷 Lille, France

Centre Paul Papin; 🇫🇷 Angers, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Hopital Saint Vincent de Paul; 🇫🇷 Lille, France

Centre Joliot-Curie; 🇫🇷 Saint Martin les Boulogne, France

Clinique des Dentellieres; 🇫🇷 Valenciennes, France