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
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
patients preference after randomization and cross-over
Outcome Time Frame:
after 2 cycles of treatment
Safety Issue:
No
Principal Investigator
ADENIS Antoine, MD,PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Oscar Lambret
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
COLOCROSS
NCT ID:
NCT00905047
Start Date:
September 2005
Completion Date:
September 2011
Related Keywords:
- Colorectal Cancer
- colo-rectal cancer
- advanced
- metastatic
- locally advanced or metastatic colo-rectal cancer
- Rectal Neoplasms
- Colorectal Neoplasms
Name | Location |
|---|
