Status:
COMPLETED
Intensified Chemotherapy in CRC After Resection of Liver Metastases
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Collaborating Sponsors:
Pfizer
Sanofi
Conditions:
Colorectal Cancer
Liver Metastases
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.
Eligibility Criteria
Inclusion
- Histologically proven adenocarcinoma of the colon or rectum without previous resection, or clinically asymptomatic (with or without stent)
- Hepatic unresectable metastases R0: due to close vascular contact, or due to liver remaining mass less than 25 to 30 % of functional liver.
- Not optimally resectable metastases
- Extra-hepatic disease will be accepted in case of: asymptomatic primary tumour or tumor requiring no urgent surgery (in less than 3 months); three of less than three lung metastases (thoracic scan diameter less than 2 cm) and potentially respectable.
- Synchronous and metachronous hepatic metastases
- WHO performance status 0-1
- Adjuvant chemotherapy allowed, except oxaliplatin and irinotecan based combination.
- No prior treatment of the liver metastases, whatever.
- Life expectancy equal or more than 3 months
Exclusion
- \-
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00208260
Start Date
April 1 2004
End Date
August 1 2007
Last Update
June 16 2010
Active Locations (1)
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1
CRLC Val d'Aurelle
Montpellier, France, 34298