Boron neutron capture therapy (BNCT) phase I clinical trial for newly diagnosed glioblastoma by newly developed accelerator at University of Tsukuba
Kei Nakai, Hiroaki Kumada, Yoshitaka Matsumoto, Keiichiro Baba, Motohiro Murakami, Toshiki Ishida, Takashi Saito, Masatoshi Nakamura, Haruko Numajiri, Masashi Mizumoto, Narushi Sugii, Shunichiro Miki, Eiichi Ishikawa, Kazushi Maruo, Masae Takemura, Koichi Hashimoto, Tomomi Takahashi, Toshimitsu Hayashi, Hideyuki Sakurai
Abstract
BACKGROUND: Glioblastoma is unresectable and difficult to cure using surgery and chemoradiotherapy. New treatment strategies are needed, and our TB-GB-01 study aims to evaluate whether the combination of BNCT, external beam radiation, and temozolomide is a safe treatment for patients with newly diagnosed glioblastoma. METHODS: /day). The first 3 patients will receive a BNCT normal brain maximum dose of 7 Gy at D2cc (mL) and will be moved to the next dose after adverse events are verified by the Safety monitoring committee and safety is ensured. The primary endpoint is the incidence of dose-limiting toxicities (DLT), and secondary endpoints include adverse event rates, treatment completion rate, response rate, progression-free survival, and overall survival. The target sample size is 12-18 patients. DISCUSSION: Study TB-GB-01 is the first trial to evaluate the safety of the combination of BNCT, external beam X-rays, and temozolomide for newly diagnosed glioblastoma at an accelerator neutron source. ETHICS AND DISSEMINATION: This protocol was approved by the Institutional Review Board of Clinical Trials & Research Network, IBARAKI. Results will be presented at international meetings and published in peer-reviewed journals.