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.
Patients will be randomized to two therapy groups: Experimental arm A: Chemotherapy with FOLFOXIRI + Cetuximab Standard arm B: Chemotherapy with FOLFOXIRI
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Cetuximab 500mg/m² + irinotecan\* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle until PD or resectability or to max. 12 cycles
Irinotecan\* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle until PD or resectability or to max. 12 cycles
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
the percentage of patients who had a curative liver treatment following protocol treatment, i.e., liver metastases that can be completely resected and/or ablated with no evidence of residual malignant disease.
Time frame: 8 months
Reported adverse events.
Number of patients with adverse events and severity according to NCI CTC 4.0
Time frame: 8 months
Response rate
CR + PR rate according to RECIST
Time frame: 8 months
Progression free survival
Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
Time frame: 2 years
Time to recurrence
Time from date of complete resection and/or ablation of liver until first recurrence
Time frame: 2 years
Quality of life (QLQ C30)
scores according to EORTC QLQ-C30 scoring manual
Time frame: Every 2 weeks after the first treatment until 6 months
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