Intensified Chemotherapy in CRC After Resection of Liver Metastases

Randomized Phase II Trial Followed by Phase III Trial With Molecular Biology Study, Comparing a Standard Bi-therapy vs 3 Arms of Intensified Chemotherapy in Patients With Unresectable or Not Optimally Resectable Colorectal Cancer Liver Metastases.

Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.

Inclusion Criteria:

• 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 Criteria:

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