search
Back to results

Xeloda Vs Monitoring in Advanced Colorectal Cancer Responsive to Chemotherapy

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Monitoring
Xeloda
Sponsored by
Association Européenne de Recherche en Oncologie
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AERORecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
September 12, 2005
Sponsor
Association Européenne de Recherche en Oncologie
Collaborators
Roche Pharma AG
search

1. Study Identification

Unique Protocol Identification Number
NCT00189683
Brief Title
Xeloda Vs Monitoring in Advanced Colorectal Cancer Responsive to Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Association Européenne de Recherche en Oncologie
Collaborators
Roche Pharma AG

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Monitoring
Intervention Type
Procedure
Intervention Name(s)
Xeloda

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annie Jouhaud
Phone
+ 33 1 43 77 72 10
Email
annie.jouhaud@aero-eu.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Fabre-Guillevin, MD
Organizational Affiliation
AERO
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Van Cutsem, MD
Organizational Affiliation
BGDO
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc Polus, MD
Organizational Affiliation
BGDO
Official's Role
Principal Investigator
Facility Information:
Facility Name
AERO
City
Creteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Fabre-Guillevin, MD
Phone
+ 33 1 43 77 72 10
Email
elizabeth.fabre-guillevin@egp.aphp.fr

12. IPD Sharing Statement

Learn more about this trial

Xeloda Vs Monitoring in Advanced Colorectal Cancer Responsive to Chemotherapy

We'll reach out to this number within 24 hrs