Xeloda Vs Monitoring in Advanced Colorectal Cancer Responsive to Chemotherapy

September 12, 2005 updated by: Association Européenne de Recherche en Oncologie
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Européenne de Recherche en Oncologie

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Elizabeth Fabre-Guillevin, MD, AERO
  • Principal Investigator: Eric Van Cutsem, MD, BGDO
  • Principal Investigator: Marc Polus, MD, BGDO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

September 19, 2005

Last Update Submitted That Met QC Criteria

September 12, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AERO-MC04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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