Xeloda or UFT (Tegafur-uracil) With Folinic Acid in Advan... | NCT00905047

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

NCT00905047

Sponsor

Centre Oscar Lambret

Status

Completed

Last Update Posted

Mar 13, 2026Actual

Enrollment

89Actual

Phase

Phase 3

Conditions

Colorectal Cancer

Interventions

XELODA
TEGAFUR URACIL - FOLINIC ACID

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 14, 2005Actual

Primary Completion Date

Jun 2010Actual

Completion Date

Sep 2011Actual

First Submitted Date

May 18, 2009

First Submission Date that Met QC Criteria

May 19, 2009

First Posted Date

May 20, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2026

Last Update Posted Date

Mar 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

89Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
XELODA	Other		Drug: XELODA
UFT	Other		Drug: TEGAFUR URACIL - FOLINIC ACID

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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	XELODA

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ADENIS Antoine, MD,PhD	Centre Oscar Lambret	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Paul Papin		Angers		49033	France
Centre Hospitalier

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D003110	Colonic Neoplasms
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069287	Capecitabine

Ancestor Terms

ID	Term
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines

Browse Leaves

Not provided

Browse Branches

Not provided