Intensified Chemotherapy in CRC After Resection of Liver Metastases

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Collaborators: Chugai Pharmaceutical; Pfizer; Sanofi
• Treatments: Fluorouracil; Folfirinox; Leucovorin; Oxaliplatin

Criteria

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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