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Intensified Chemotherapy in CRC After Resection of Liver Metastases

NCT00208260

CompletedPhase 2, Phase 3

Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Conditions: Colorectal Cancer, Liver Metastases, Chemotherapy

Interventions: FOLFIRI, FOLFOX-4, FOLFIRI-HD, FOLFOX-7, FOLFIRINOX

Countries: France

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

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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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Locations (1)

Montpellier, France