Back to Search Results

Phase III randomized trial comparing systemic versus intra-arterial oxaliplatin, combined with LV5FU2 +/- irinotecan and a targeted therapy, in the first-line treatment of metastatic colorectal cancer restricted to the liver (OSCAR): PRODIGE 49.

Department of Medical Oncology, Institut Bergonié, Bordeaux, France. Electronic address: Simon.pernot@gmail.com. Department of Interventional Radiology, Hopital Européen Georges-Pompidou, Université de Paris, SIRIC CARPEM, France. Department of Medical Oncology, Institut Sainte Catherine, Avignon, France. Federation Francophone de Cancérologie Digestive (FFCD), EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France. Department of Gastroenterology and GI Oncology, CHU Haut-Leveque, Université de Bordeaux, Pessac, France. Department of Interventional Radiology, CHU Haut-Leveque, Université de Bordeaux, Pessac, France. Department of Gastroenterology and GI Oncology, Hopital Européen Georges-Pompidou, Université de Paris, SIRIC CARPEM, France. Department of Gastroenterology and GI Oncology, CH Saint-Jean, Perpignan, France. Department of Interventional Radiology, Gustave Roussy, BIOTHERIS, Université Paris-Saclay, Villejuif, France. Université de Poitiers, Department of Gastroenterology and Hepatology, CHU La Milétrie, Poitiers, France. Department of Medical Oncology, Hôpital Privé d'Antony, Antony, France. Department of Gastroenterology and GI Oncology, CH de la Côte-Basque, Bayonne, France. Department of Gastroenterology and GI Oncology, CH Pau, Pau, France. Department of Gastroenterology and GI Oncology, Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France. Department of Medical Oncology, CH Corbeille Essonne, France. Federation Francophone de Cancérologie Digestive (FFCD), EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France; Department of Gastroenterology and GI Oncology, CHU Haut-Leveque, Université de Bordeaux, Pessac, France; Department of Interventional Radiology, CHU Haut-Leveque, Université de Bordeaux, Pessac, France; Department of Gastroenterology and GI Oncology, Hopital Européen Georges-Pompidou, Université de Paris, SIRIC CARPEM, France; Department of Gastroenterology and GI Oncology, CH Saint-Jean, Perpignan, France; Department of Interventional Radiology, Gustave Roussy, BIOTHERIS, Université Paris-Saclay, Villejuif, France; Université de Poitiers, Department of Gastroenterology and Hepatology, CHU La Milétrie, Poitiers, France; Department of Medical Oncology, Hôpital Privé d'Antony, Antony, France; Department of Gastroenterology and GI Oncology, CH de la Côte-Basque, Bayonne, France; Department of Gastroenterology and GI Oncology, CH Pau, Pau, France; Department of Gastroenterology and GI Oncology, Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France; Department of Medical Oncology, CH Corbeille Essonne, France; Department of Gastroenterology and GI oncology, CHU Le Bocage, University of Burgundy and Franche Comté, Dijon, France. Department of Medical Oncology, Gustave Roussy, Inserm U1279, Université Paris-Saclay, Villejuif, France.

Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver. 2022;(3):324-330
Full text from:

Other resources

Abstract

INTRODUCTION In patients with unresectable liver metastases from colorectal cancer (CRCLM), systemic doublet or triplet chemotherapy and targeted therapy is considered a standard first-line treatment. Hepatic arterial infusion of oxaliplatin (HAI-ox) generates a high response rate, but this still needs to be confirmed in a randomized trial. We incorporated HAI-ox in doublet or triplet + targeted therapy to validate its efficacy. AIM: The OSCAR study is an ongoing randomized phase III trial comparing FOLFOX + targeted therapy according to RAS status, or FOLFOXIRI + bevacizumab in patients eligible for triplet therapy, with the same regimen but with HAI-ox instead of IV-ox as the first-line treatment for CRCLM. MATERIALS AND METHODS Main eligibility criteria are colorectal cancer, unresectable liver metastasis, no extra-hepatic metastases except pulmonary nodules if ≤3 and <10 mm, ECOG performance status 0 or 1. ENDPOINT The primary endpoint is progression-free survival (PFS). A difference of 4 months for the median PFS in favor of HAI-ox is expected (HR = 0.73). Secondary endpoints include overall survival, overall response rate, secondary liver resection, safety, and quality of life. CONCLUSION This study is planned to include 348 patients to demonstrate the superiority of HAI-ox over systemic oxaliplatin in first-line CRCLM treatment (NCT02885753).

Methodological quality

Metadata