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

Colorectal Cancer Clinical Trial

— COLOCROSS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00905047
• Other study ID #: COLOCROSS
• Status: Completed
• Phase: Phase 3
• First received: May 18, 2009
• Last updated: July 20, 2012
• Start date: September 2005
• Est. completion date: September 2011

Study information

• Verified date: July 2012
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Description:

Further study details as provided by Centre Oscar Lambret.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: September 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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
• TEGAFUR URACIL - FOLINIC ACID
Tegafur 300 mg/m2/tid with folinic acid 75 mg/tid during 28 days. Duration of treatment cycle : 35 days.

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers
France	Centre Hospitalier	Armentieres
France	Centre Hospitalier de Béthune	Beuvry
France	Centre Hospitalier de CHOLET	Cholet
France	Centre Leonard de Vinci	Dechy
France	Centre Hospitalier Regional	Lille
France	Centre Oscar Lambret	Lille
France	Hopital Saint Vincent de Paul	Lille
France	Polyclinique du Bois	Lille
France	Centre Hospitalier	Roubaix
France	Centre Joliot-Curie	Saint Martin les Boulogne
France	Centre Hospitalier	Valenciennes
France	Clinique des Dentellieres	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patients preference after randomization and cross-over		after 2 cycles of treatment	No
Secondary	safety of each treatment		at day 56 (after two cycles of treatment)	Yes