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
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: XELODA
Drug: TEGAFUR URACIL - FOLINIC ACID
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • patients preference after randomization and cross-over [ Time Frame: after 2 cycles of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety of each treatment [ Time Frame: at day 56 (after two cycles of treatment) ] [ Designated as safety issue: Yes ]

Enrollment: 89
Study Start Date: September 2005
Study Completion Date: September 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
XELODA 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

UFT 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.


Detailed Description:

Further study details as provided by Centre Oscar Lambret.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905047

Locations
France
Centre Paul Papin
Angers, France, 49033
Centre Hospitalier
Armentieres, France, 59280
Centre Hospitalier de Béthune
Beuvry, France, 62660
Centre Hospitalier de CHOLET
Cholet, France, 49300
Centre Leonard de Vinci
Dechy, France, 59187
Hopital Saint Vincent de Paul
Lille, France, 59020
Polyclinique du Bois
Lille, France, 59000
Centre Hospitalier Regional
Lille, France, 59035
Centre Oscar Lambret
Lille, France, 59020
Centre Hospitalier
Roubaix, France, 59100
Centre Joliot-Curie
Saint Martin les Boulogne, France, 62280
Centre Hospitalier
Valenciennes, France, 59300
Clinique des Dentellieres
Valenciennes, France, 59300
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Principal Investigator: ADENIS Antoine, MD,PhD Centre Oscar Lambret
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT00905047     History of Changes
Other Study ID Numbers: COLOCROSS
Study First Received: May 18, 2009
Last Updated: July 20, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Oscar Lambret:
colo-rectal cancer
advanced
metastatic
locally advanced or metastatic colo-rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Levoleucovorin
Folic Acid
Leucovorin
Capecitabine
Tegafur
Antidotes
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014