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Xeloda Vs Monitoring in Advanced Colorectal Cancer Responsive to Chemotherapy

NCT ID: NCT00189683

Last Updated: 2005-09-19

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

UNKNOWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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To compare maintenance chemotherapy with Xeloda to control after best response with first line chemotherapy in advanced colorectal cancer. Main endpoint is progression free survival. A total of 300 patients will be included.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Monitoring

Intervention Type PROCEDURE

Xeloda

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with metastatic colorectal cancer (confirmed histologically) with objective response or stabilization after at least 6 cycles of first line chemotherapy (treatment of choice is selected freely by the investigator according to the recommendations and consensus in force),
* The interval between completion of first line chemotherapy and randomization should not exceed 4 weeks
* Age\>18 years
* ECOG status 0 to 2
* Biological criteria prior to any chemotherapy:

Neutrophils\>1.5 109 g/l, platelets\>100 109/l, haemoglobin\>10 g/dl, Creatininaemia\<150 mol/l, bilirubinaemia\<2x normal level

* Signed informed consent
* Life expectancy \> 3 months

Exclusion Criteria

* Metastatic colorectal cancer treated with more than one modality of first line chemotherapy (including oral fluoropyrimidines)
* Tumour progression after first line chemotherapy or before randomization
* Other tumour pathology
* Symptomatic cerebral metastases
* Any severe uncontrolled disease in addition to colorectal cancer (in particular decompensated cardiac failure (LVEF\<50%) or coronary insufficiency)
* Lack of integrity of the upper GI tract: malabsorption syndrome or major surgery of the stomach or the small intestine
* Severe renal impairment (creatinine clearance \< 30 ml/min)
* Severe psychiatric disorder (other than controlled depressive syndrome)
* Patient participating in another experiment
* Pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

Association Européenne de Recherche en Oncologie

OTHER

Sponsor Role lead

Principal Investigators

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Elizabeth Fabre-Guillevin, MD

Role: PRINCIPAL_INVESTIGATOR

AERO

Eric Van Cutsem, MD

Role: PRINCIPAL_INVESTIGATOR

BGDO

Marc Polus, MD

Role: PRINCIPAL_INVESTIGATOR

BGDO

Locations

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AERO

Créteil, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Annie Jouhaud

Role: CONTACT

Phone: + 33 1 43 77 72 10

Email: [email protected]

Facility Contacts

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Elizabeth Fabre-Guillevin, MD

Role: primary

Other Identifiers

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AERO-MC04

Identifier Type: -

Identifier Source: org_study_id