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OpenTrials
Completed

NCT Number: NCT00905047

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

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Paul Papin, Angers, France

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About this study

Further study details as provided by Centre Oscar Lambret.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xeloda

Drug

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

Drug

Tegafur 300 mg/m2/tid with folinic acid 75 mg/tid during 28 days.

Duration of treatment cycle : 35 days.

Primary outcomes

  1. patients preference after randomization and cross-over

    Time frame: after 2 cycles of treatment

Secondary outcomes

  1. safety of each treatment

    Time frame: at day 56 (after two cycles of treatment)

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study 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

Acronym: COLOCROSS

Important dates

Study start
2005
Primary completion
2010
Study completion
2011
First posted
May 20, 2009
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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