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

September 15, 2026 updated by: Centre Oscar Lambret

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Further study details as provided by Centre Oscar Lambret.

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49033
        • Centre Paul Papin
      • Armentières, France, 59280
        • Centre Hospitalier
      • Beuvry, France, 62660
        • Centre Hospitalier de Béthune
      • Cholet, France, 49300
        • Centre Hospitalier de CHOLET
      • Dechy, France, 59187
        • Centre Leonard de Vinci
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lille, France, 59020
        • Hopital Saint Vincent de Paul
      • Lille, France, 59000
        • Polyclinique du Bois
      • Lille, France, 59035
        • Centre Hospitalier Regional
      • Roubaix, France, 59100
        • Centre Hospitalier
      • Saint Martin Les Boulogne, France, 62280
        • Centre Joliot-Curie
      • Valenciennes, France, 59300
        • Centre Hospitalier
      • Valenciennes, France, 59300
        • Clinique des Dentellieres

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
patients preference after randomization and cross-over
Time Frame: after 2 cycles of treatment
after 2 cycles of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
safety of each treatment
Time Frame: at day 56 (after two cycles of treatment)
at day 56 (after two cycles of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Investigators

  • Principal Investigator: ADENIS Antoine, MD,PhD, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2005

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

May 18, 2009

First Submitted That Met QC Criteria

May 19, 2009

First Posted (Estimated)

May 20, 2009

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COLOCROSS-0501
  • 2005 (U.S. NIH Grant/Contract)
  • 2005-002443-11 (Other Identifier: AFSSAPS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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