Spots Global Cancer Trial Database for FOLFOXIRI With or Without Cetuximab as First-line Treatment of Patients With Non-resectable Liver - Only Metastatic Colorectal Cancer

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Trial Identification

Brief Title: FOLFOXIRI With or Without Cetuximab as First-line Treatment of Patients With Non-resectable Liver - Only Metastatic Colorectal Cancer

Official Title: A Phase II Study to Evaluate the Surgical Conversion Rate in Patients Receiving FOLFOXIRI +/- Cetuximab for Unresectable Wild-Type KRAS/NRAS Colorectal Cancer With Metastases Confined to the Liver

Study ID: NCT02063529

Conditions

Metastatic Colorectal Cancer

Interventions

FOLFOXIRI + Cetuximab

FOLFOXIRI

Study Description

Brief Summary: PURPOSE: A primary aim of phase II FOCULM study is to explore whether cetuximab in combination with FOLFOXIRI as first treatment could improve surgical conversion in patients with KRAS/NRAS wild-type, unresectable liver - only metastases of colorectal cancer. The first secondary aim is to evaluate the safety and tolerability of the chemotherapy of FOLFOXIRI plus Cetuximab targeted therapy regimen in this patient population. Secondary aims include determination of objective response rate, progression free survival, quality of life and time to recurrence for patients undergoing complete resection and/or ablation of liver.

Detailed Description: Patients will be randomized to two therapy groups: Experimental arm A: Chemotherapy with FOLFOXIRI + Cetuximab Standard arm B: Chemotherapy with FOLFOXIRI