NCT01442935

Chemotherapies Associated With Targeted Therapies on the Resection Rate of Hepatic Metastases

Phase II Multicentric Randomized Trial, Evaluating the Best Protocol of Chemotherapy, Associated With Targeted Therapy According to the Tumor KRAS Status, in Metastatic Colorectal Cancer (CCRM) Patients With Initially Non-resectable Hepatic Metastases

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective is to compare resection rates (R0 or R1) for hepatic metastases in the experimental arm (tri chemotherapy plus targeted therapy) versus the control arm (bi chemotherapy plus targeted therapy); in both arms the targeted therapy is selected according to K-Ras status of the patient's tumor. The secondary objectives are to evaluate the objective response rate (CR and PR) after 4 cycles of treatment, according the RECIST V1.1 evaluation scale. * the rate of complete remission (CR) at 6 months after the last study treatment (hepatic surgery or last chemotherapy cycle). * the specific rates of resection R0, R1, R2. * the complete pathological response Rate, * the relapse-free survival rate in (R0 or R1) resected patients, * the response duration in non-resected patients, * the toxicity according to CTC AE V4 scale except for the neurotoxicity that will be evaluated with the Levi scale, * the post operative complications using the DINDO classification, * the progression-free survival (PFS) and overall survival (OS). The objectives of the biological study are: * to evaluate tumor-related predictive factors such as somatic mutations (KRAS, BRAF, TP53) and genetic amplification related factors (EGFR), * to evaluate patient-related predictive factors in connection with genetic polymorphisms (Fc gamma and VEGF receptors), * to evaluate ADCC activity via immunohistochemistry in order to analyze the lympho free and progression-free survival, * to study circulating of tumor cells as prognostic factor for metastatic colorectal cancer, non- resectable at presentation.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Oxaliplatin	85mg/m² over 120 mn every 2 weeks up to progression or toxicity
DRUG	Folinic Acid	400mg/m² over 120 mn every 2 weeks up to progression or toxicity
DRUG	5-FU	400mg/m² in bolus, then 2400mg/m² over 46 h every 2 weeks up to progression or toxicity
DRUG	Irinotecan	180mg/m² over 90 mn every 2 weeks up to progression or toxicity
DRUG	Irinotecan	150mg/m² over 30-90 mn every 2 weeks up to progression or toxicity
DRUG	Bevacizumab	5mg/kg over 90 mn every 2 weeks up to progression or toxicity
DRUG	Cetuximab	500mg/m² over 90 mn every 2 weeks up to progression or toxicity

Timeline

• Start date: 2011-02-01
• Primary completion: 2015-12-01
• Completion: 2021-01-01
• First posted: 2011-09-29
• Last updated: 2021-06-18

Locations

1 site across 1 country: France