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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00905047

Acronym

COLOCROSS

Enrollment

Registered

2009-05-20

Start date

2005-11-14

Completion date

2011-09-01

Last updated

2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

colo-rectal cancer, advanced, metastatic, locally advanced or metastatic colo-rectal cancer

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.

Interventions

DRUGXELODA

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

DRUGTEGAFUR URACIL - FOLINIC ACID

Tegafur 300 mg/m2/tid with folinic acid 75 mg/tid during 28 days. Duration of treatment cycle : 35 days.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
patients preference after randomization and cross-over	after 2 cycles of treatment

Secondary

Measure	Time frame
safety of each treatment	at day 56 (after two cycles of treatment)

Countries

France

Contacts

PRINCIPAL_INVESTIGATORADENIS Antoine, MD,PhD

Centre Oscar Lambret

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026