Results of a phase II trial of the GliaSite Radiation Therapy System for the treatment of newly diagnosed, resected single brain metastases

Object The aim of this study was to evaluate the effectiveness of brachytherapy using the GliaSite Radiation Therapy System in patients with a newly diagnosed resected single brain metastasis. The primary end point of the study was local tumor control. The secondary end points included patient survival, distant brain recurrence, quality of life, and treatment toxicity. Methods The authors conducted a prospective multiinstitutional phase II study of GliaSite brachytherapy prescribed at a 60-Gy dose administered to a 1-cm depth after resection of a single brain metastasis. No whole-brain radiation therapy was given. Patients were assessed at 1 and 3 months after brachytherapy and every 3 months thereafter for up to 2 years. Seventy-one patients were enrolled at 13 centers. A GliaSite balloon catheter was implanted in 62 patients. Fifty-four patients received brachytherapy. The median patient age was 60 years. The most common tumor (54%) was non–small cell lung cancer. Fifty-seven percent of patients had bra...