Status:
UNKNOWN
Xeloda Vs Monitoring in Advanced Colorectal Cancer Responsive to Chemotherapy
Lead Sponsor:
Association Européenne de Recherche en Oncologie
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00189683
Last Update
September 19 2005
Active Locations (1)
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1
AERO
Créteil, France, 94000