Xeloda or UFT (Tegafur-uracil) With Folinic Acid in Advanced or Metastatic Colorectal Cancer (COLOCROSS)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
XELODA
TEGAFUR URACIL - FOLINIC ACID
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring colo-rectal cancer, advanced, metastatic, locally advanced or metastatic colo-rectal cancer
Eligibility 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
Sites / Locations
- Centre Paul Papin
- Centre Hospitalier
- Centre Hospitalier de Béthune
- Centre Hospitalier de CHOLET
- Centre Leonard de Vinci
- Polyclinique du Bois
- Centre Oscar Lambret
- Hopital Saint Vincent de Paul
- Centre Hospitalier Regional
- Centre Hospitalier
- Centre Joliot-Curie
- Centre Hospitalier
- Clinique des Dentellieres
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
XELODA
UFT
Arm Description
Outcomes
Primary Outcome Measures
patients preference after randomization and cross-over
Secondary Outcome Measures
safety of each treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00905047
Brief Title
Xeloda or UFT (Tegafur-uracil) With Folinic Acid in Advanced or Metastatic Colorectal Cancer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
4. Oversight
Data Monitoring Committee
No
5. 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.
Detailed Description
Further study details as provided by Centre Oscar Lambret.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colo-rectal cancer, advanced, metastatic, locally advanced or metastatic colo-rectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XELODA
Arm Type
Other
Arm Title
UFT
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
XELODA
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
TEGAFUR URACIL - FOLINIC ACID
Intervention Description
Tegafur 300 mg/m2/tid with folinic acid 75 mg/tid during 28 days.
Duration of treatment cycle : 35 days.
Primary Outcome Measure Information:
Title
patients preference after randomization and cross-over
Time Frame
after 2 cycles of treatment
Secondary Outcome Measure Information:
Title
safety of each treatment
Time Frame
at day 56 (after two cycles of treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ADENIS Antoine, MD,PhD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Centre Hospitalier
City
Armentieres
ZIP/Postal Code
59280
Country
France
Facility Name
Centre Hospitalier de Béthune
City
Beuvry
ZIP/Postal Code
62660
Country
France
Facility Name
Centre Hospitalier de CHOLET
City
Cholet
ZIP/Postal Code
49300
Country
France
Facility Name
Centre Leonard de Vinci
City
Dechy
ZIP/Postal Code
59187
Country
France
Facility Name
Polyclinique du Bois
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Hopital Saint Vincent de Paul
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Hospitalier Regional
City
Lille
ZIP/Postal Code
59035
Country
France
Facility Name
Centre Hospitalier
City
Roubaix
ZIP/Postal Code
59100
Country
France
Facility Name
Centre Joliot-Curie
City
Saint Martin les Boulogne
ZIP/Postal Code
62280
Country
France
Facility Name
Centre Hospitalier
City
Valenciennes
ZIP/Postal Code
59300
Country
France
Facility Name
Clinique des Dentellieres
City
Valenciennes
ZIP/Postal Code
59300
Country
France
12. IPD Sharing Statement
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Xeloda or UFT (Tegafur-uracil) With Folinic Acid in Advanced or Metastatic Colorectal Cancer
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