Launched by the Assistance Publique Hôpitaux de Paris, France, in December 2011, SARAH (Sorafenib versus radioembolization in advanced hepatocellular carcinoma), a French national collaborative randomised controlled trial of radioembolization with yttrium-90 resin microspheres vs. sorafenib in advanced hepatocellular carcinoma has announced it is seeking to enrol 400 patients. To date, according to a press release, more than 150 patients have taken part in this study.
In patients with advanced hepatocellular carcinoma, sorafenib (Nexavar; Bayer Healthcare) with which radioembolization is being compared, is now the standard treatment. Its use, according to the press release, is associated with an increased median overall survival (from eight to 11 months in the SHARP trial). However, 80% of patients also experienced treatment-related adverse events. According to the release, the SARAH trial is testing the hypothesis that radioembolization using yttrium-90 resin microspheres (SIR-Spheres microspheres; Sirtex Medical) can increase the median overall survival with fewer side effects and/or a better quality of life in comparison with sorafenib.
Co-ordinated at a national level by Professor Valérie Vilgrain (Department of Radiology, Beaujon Hospital, Assistance Publique Hôpitaux de Paris, France), who is principal investigator of the large study, 19 specialist cancer centres throughout France (Angers, Bondy, Bordeaux, Caen, Clichy, Créteil, Dijon, Grenoble, Marseille, Montpellier, Nancy, Nantes, Nice, Paris, Poitiers, Saint Etienne, Strasbourg, Villejuif) are reported to be currently accruing patients. The aim is to recruit 400 patients in France with the following inclusion criteria:
- Patients with advanced hepatocellular carcinoma with or without portal vein thrombosis or whose disease has progressed after chemoembolization or recurrence of heptatocellular carcinoma
- No extrahepatic spread
- Ineligible for surgical resection, liver transplantation or radiofrequency ablation.
SIR-Spheres microspheres are approved for use in Australia, the European Union (CE mark), New Zealand, Switzerland, Turkey and several other countries including in Asia (India, Korean, Singapore and Hong Kong) for the treatment of unresectable liver tumours. SIR-Spheres microspheres are indicated in the USA for the treatment of unresectable metastatic liver tumors from primary colorectal cancer together with adjuvant intra-hepatic artery chemotherapy of FUDR (Floxuridine).