Boron neutron capture therapy (BNCT) phase I clinical trial for newly diagnosed glioblastoma by newly developed accelerator at University of Tsukuba

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

This is an interventional, open-label, non-randomized, single-center, single-arm, phase I physician-initiated trial designed and conducted by the University of Tsukuba. Eligible patients diagnosed with glioblastoma and selected according to inclusion and exclusion criteria will receive a combination of BNCT, external beam radiation, and temozolomide. Treatment includes BNCT, external-beam radiation (total dose 40 Gy, 20 cycles over 4 weeks), and chemotherapy (temozolomide in combination with x-ray therapy period, 75 mg/m²/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.