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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT00905047
First received: May 18, 2009
Last updated: July 20, 2012
Last verified: July 2012
History of Changes

May 18, 2009
July 20, 2012
September 2005
June 2010   (final data collection date for primary outcome measure)
patients preference after randomization and cross-over [ Time Frame: after 2 cycles of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00905047 on ClinicalTrials.gov Archive Site
safety of each treatment [ Time Frame: at day 56 (after two cycles of treatment) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: XELODA

    XELODA, 2500 mg/m²/bid, with approximatively an interval of 12 hours, 30 minutes after breakfast and dinner - during 14 days.

    Cycle treatment duration : 21 days

  • Drug: TEGAFUR URACIL - FOLINIC ACID

    Tegafur 300 mg/m2/tid with folinic acid 75 mg/tid during 28 days.

    Duration of treatment cycle : 35 days.
  • XELODA
    Intervention: Drug: XELODA
  • UFT
    Intervention: Drug: TEGAFUR URACIL - FOLINIC ACID
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
September 2011
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00905047
COLOCROSS
No
Centre Oscar Lambret
Centre Oscar Lambret
Not Provided
Principal Investigator: ADENIS Antoine, MD,PhD Centre Oscar Lambret
Centre Oscar Lambret
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP