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

IF 1.8 3区工程技术 Q3 CHEMISTRY, INORGANIC & NUCLEAR

Applied Radiation and Isotopes Pub Date : 2025-09-03 DOI:10.1016/j.apradiso.2025.112152

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

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引用次数: 0

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

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.

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筑波大学新开发的加速器对新诊断的胶质母细胞瘤进行硼中子俘获疗法（BNCT） I期临床试验

胶质母细胞瘤是不可切除的，难以通过手术和放化疗治愈。需要新的治疗策略，我们的TB-GB-01研究旨在评估BNCT、外束放疗和替莫唑胺联合治疗新诊断的胶质母细胞瘤患者是否安全。方法：这是一项介入性、开放标签、非随机、单中心、单臂、I期临床试验，由筑波大学设计和实施。诊断为胶质母细胞瘤并根据纳入和排除标准选择的符合条件的患者将接受BNCT、外束放疗和替莫唑胺的联合治疗。治疗包括BNCT、外束放射（总剂量40 Gy， 4周20个周期）和化疗（替莫唑胺联合x线治疗期，75 mg/m2/天）。前3例患者将接受7 Gy / D2cc （mL）的BNCT正常脑最大剂量，在安全监测委员会确认不良事件并确保安全性后转入下一剂量。主要终点是剂量限制性毒性（DLT）的发生率，次要终点包括不良事件发生率、治疗完成率、缓解率、无进展生存期和总生存期。目标样本量为12-18例。TB-GB-01研究是首个评估BNCT、外束x射线和替莫唑胺在加速器中子源下联合治疗新诊断的胶质母细胞瘤安全性的试验。伦理与传播本方案经IBARAKI临床试验与研究网络机构审查委员会批准。研究结果将在国际会议上发表，并发表在同行评议的期刊上。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Applied Radiation and Isotopes 工程技术-核科学技术

CiteScore

3.00

自引率

12.50%

发文量

406

审稿时长

13.5 months

期刊介绍： Applied Radiation and Isotopes provides a high quality medium for the publication of substantial, original and scientific and technological papers on the development and peaceful application of nuclear, radiation and radionuclide techniques in chemistry, physics, biochemistry, biology, medicine, security, engineering and in the earth, planetary and environmental sciences, all including dosimetry. Nuclear techniques are defined in the broadest sense and both experimental and theoretical papers are welcome. They include the development and use of α- and β-particles, X-rays and γ-rays, neutrons and other nuclear particles and radiations from all sources, including radionuclides, synchrotron sources, cyclotrons and reactors and from the natural environment. The journal aims to publish papers with significance to an international audience, containing substantial novelty and scientific impact. The Editors reserve the rights to reject, with or without external review, papers that do not meet these criteria. Papers dealing with radiation processing, i.e., where radiation is used to bring about a biological, chemical or physical change in a material, should be directed to our sister journal Radiation Physics and Chemistry.