Status:
COMPLETED
Xeloda or UFT (Tegafur-uracil) With Folinic Acid in Advanced or Metastatic Colorectal Cancer
Lead Sponsor:
Centre Oscar Lambret
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 safet...
Detailed Description
Further study details as provided by Centre Oscar Lambret.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00905047
Start Date
September 1 2005
End Date
September 1 2011
Last Update
July 23 2012
Active Locations (13)
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1
Centre Paul Papin
Angers, France, 49033
2
Centre Hospitalier
Armentières, France, 59280
3
Centre Hospitalier de Béthune
Beuvry, France, 62660
4
Centre Hospitalier de CHOLET
Cholet, France, 49300