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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2011-09-30

Brief Summary

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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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Detailed Description

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Further study details as provided by Centre Oscar Lambret.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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XELODA

Group Type OTHER

XELODA

Intervention Type 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

UFT

Group Type OTHER

TEGAFUR URACIL - FOLINIC ACID

Intervention Type DRUG

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

Duration of treatment cycle : 35 days.

Interventions

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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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No