Xeloda or UFT (Tegafur-uracil) With Folinic Acid in Advanced or Metastatic Colorectal Cancer
COLOCROSS
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
1 other identifier
interventional
89
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 colorectal-cancer
Started Nov 2005
Typical duration for phase_3 colorectal-cancer
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 14, 2005
CompletedFirst Submitted
Initial submission to the registry
May 18, 2009
CompletedFirst Posted
Study publicly available on registry
May 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedMarch 13, 2026
March 1, 2026
4.5 years
May 18, 2009
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
patients preference after randomization and cross-over
after 2 cycles of treatment
Secondary Outcomes (1)
safety of each treatment
at day 56 (after two cycles of treatment)
Study Arms (2)
XELODA
OTHERUFT
OTHERInterventions
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 300 mg/m2/tid with folinic acid 75 mg/tid during 28 days. Duration of treatment cycle : 35 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Centre Paul Papin
Angers, 49033, France
Centre Hospitalier
Armentières, 59280, France
Centre Hospitalier de Béthune
Beuvry, 62660, France
Centre Hospitalier de CHOLET
Cholet, 49300, France
Centre Leonard de Vinci
Dechy, 59187, France
Polyclinique du Bois
Lille, 59000, France
Centre Oscar Lambret
Lille, 59020, France
Hopital Saint Vincent de Paul
Lille, 59020, France
Centre Hospitalier Regional
Lille, 59035, France
Centre Hospitalier
Roubaix, 59100, France
Centre Joliot-Curie
Saint Martin Les Boulogne, 62280, France
Centre Hospitalier
Valenciennes, 59300, France
Clinique des Dentellieres
Valenciennes, 59300, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ADENIS Antoine, MD,PhD
Centre Oscar Lambret
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2009
First Posted
May 20, 2009
Study Start
November 14, 2005
Primary Completion
June 1, 2010
Study Completion
September 1, 2011
Last Updated
March 13, 2026
Record last verified: 2026-03