New Study of Primary Liver Cancer Seeks to Enroll 400 French Patients
PARIS, February 3, 2012 /PRNewswire/ --
'SARAH' - a French national collaborative randomized controlled trial of radioembolization with yttrium-90 resin microspheres versus sorafenib in advanced hepatocellular carcinoma is now open for recruitment
The start of SARAH, a new randomized controlled trial to directly compare the effectiveness of radioembolization with yttrium-90 resin microspheres (SIR-Spheres® microspheres; Sirtex Medical Limited, Australia) versus sorafenib (Nexavar®, Bayer HealthCare Pharmaceuticals, Germany), a systemic therapy that is the current standard of care for patients with non-surgical advanced hepatocellular carcinoma (HCC), was announced today by the principal investigator, Professor Valérie Vilgrain MD, PhD, Department of Radiology, Beaujon Hospital, Assistance Publique - Hôpitaux de Paris, Clichy and Université Paris Diderot, Sorbonne Paris Cité, France.
SARAH (SorAfenib versus Radioembolization in Advanced Hepatocellular carcinoma)is a Phase III multi-centre prospective randomized open-labelled trial, which aims to recruit 400 patients in France with advanced HCC (Barcelona Clinic Liver Cancer stage C) with or without portal vein thrombosis and no extrahepatic spread, who are ineligible for surgical resection, liver transplantation or radiofrequency ablation; or whose disease has progressed or recurred after previous therapies.
The primary goal of the study will be to assess if radioembolization with yttrium-90 resin microspheres provides an increased survival benefit compared to sorafenib in patients with advanced HCC.
Professor Vilgrain said: "Around 20 specialist cancer centres throughout France will be involved in this trial. SIR-Spheres microspheres were selected for the test arm of this collaborative trial, which is being promoted by the 'Assistance Publique - Hôpitau