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

Sponsor

Centre Oscar Lambret (Other)

Overall Status

Completed

CT.gov ID

NCT00905047

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

6.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 safety of each treatment.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: XELODA Drug: TEGAFUR URACIL - FOLINIC ACID	Phase 3

Detailed Description

Further study details as provided by Centre Oscar Lambret.

Study Design

Study Type:

Interventional

Actual Enrollment :

89 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (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

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: 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
Other: 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.

Arm

Intervention/Treatment

Other: 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

Other: 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.

Outcome Measures

Primary Outcome Measures

patients preference after randomization and cross-over [after 2 cycles of treatment]

Secondary Outcome Measures

safety of each treatment [at day 56 (after two cycles of treatment)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Centre Paul Papin	Angers	France	49033
2	Centre Hospitalier	Armentieres	France	59280
3	Centre Hospitalier de Béthune	Beuvry	France	62660
4	Centre Hospitalier de CHOLET	Cholet	France	49300
5	Centre Leonard de Vinci	Dechy	France	59187
6	Polyclinique du Bois	Lille	France	59000
7	Centre Oscar Lambret	Lille	France	59020
8	Hopital Saint Vincent de Paul	Lille	France	59020
9	Centre Hospitalier Regional	Lille	France	59035
10	Centre Hospitalier	Roubaix	France	59100
11	Centre Joliot-Curie	Saint Martin les Boulogne	France	62280
12	Centre Hospitalier	Valenciennes	France	59300
13	Clinique des Dentellieres	Valenciennes	France	59300