Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Irinotecan

Cetuximab

Leucovorin

Fluorouracil

Oxaliplatin

Liver Extracts

Iron-Dextran Complex

Levoleucovorin

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Antineoplastic Agents, Immunological

Folinic Acid

Folate

Vitamin B9

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

FOLFOXIRI + Cetuximab

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

FOLFOXIRI

Yanhong Deng, M.D.

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

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

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

Number of patients with adverse events and severity according to NCI CTC 4.0

Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first.

Time from date of complete resection and/or ablation of liver until first recurrence

scores according to EORTC QLQ-C30 scoring manual

Sun Yat-sen University

Associate professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FOLFOXIRI With or Without Cetuximab as First-line Treatment of Patients With Non-resectable Liver - Only Metastatic Colorectal Cancer	NCT02063529	Metastatic Colo...	FOLFOXIRI + Cet... FOLFOXIRI	18 Years - 65 Years	Sun Yat-sen University
FOLFOXIRI With or Without Cetuximab as First-line Treatment of Patients With Non-resectable Liver - Only Metastatic Colorectal Cancer	NCT02063529	Metastatic Colo...	FOLFOXIRI + Cet... FOLFOXIRI	18 Years - 65 Years	Sun Yat-sen University
FOLFOXIRI With or Without Cetuximab as First-line Treatment of Patients With Non-resectable Liver - Only Metastatic Colorectal Cancer	NCT02063529	Metastatic Colo...	FOLFOXIRI + Cet... FOLFOXIRI	18 Years - 65 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for folfoxiri + cetuximab