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SARAH Study completes enrollment for HCC trial, results expected in 2016
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The SARAH Study, a large French study of patients with advanced, inoperable hepatocellular carcinoma, has completed enrollment with more than 400 patients and expects results to be available in 2016, according to a press release.
The SARAH study includes more than 25 cancer centers in France collaborating to compare the efficacy of selective internal radiation therapy (SIRT) using SIR-Spheres Y-90 resin microspheres (yttrium-90 resin microspheres, Sirtex Medical Limited) and Nexavar (sorafenib, Bayer HealthCare Pharmaceuticals), for advanced HCC, according to the release. The goal is to determine if there is an increased survival benefit in SIRT using the Y-90 resin microspheres compared with sorafenib.
“SARAH is the largest randomized study ever to compare selective internal radiation therapy or any liver-directed therapy against the standard-of-care systemic therapy in the treatment of primary liver cancer,” Valérie Vilgrain MD, PhD, professor in the department of radiology, Beaujon Hospital, Assistance Publique - Hôpitaux de Paris and Université Paris Diderot, Sorbonne Paris Cité, France, said in the press release. “The SARAH study team is delighted that enrollment is now complete, with results expected in late 2016.”
The study includes patients in France with advanced HCC, with or without portal vein thrombosis, no extrahepatic spread, whose disease has progressed or recurred after previous therapies and who are ineligible for surgical resection, ablation or liver transplantation, according to the release.
SIR-Spheres Y-90 resin microspheres are approved for treating inoperable liver tumors in Australia, the European Union, Argentina, Brazil and several countries in Asia, such as India and Singapore, according to the release. The microspheres have pre-market approval by the FDA and are used in the United States for the treatment of non-resectable metastatic liver tumors from primary colorectal cancer in combination with intra-hepatic artery chemotherapy using floxuridine.