Clinical Trials Directory

Trials / Completed

CompletedNCT00905047

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
Phase
Phase 3
Study type
Interventional
Enrollment
89 (actual)
Sponsor
Centre Oscar Lambret · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGXELODAXELODA, 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 ACIDTegafur 300 mg/m2/tid with folinic acid 75 mg/tid during 28 days. Duration of treatment cycle : 35 days.

Timeline

Start date
2005-11-14
Primary completion
2010-06-01
Completion
2011-09-01
First posted
2009-05-20
Last updated
2026-03-13

Locations

13 sites across 1 country: France

Source: ClinicalTrials.gov record NCT00905047. Inclusion in this directory is not an endorsement.