臨床研究等提出・公開システム

Phase 3 Randomized, Open-label, Comparative Study of Boron Neutron Capture Therapy (BNCT) in Patients with Recurrent IDH-wildtype Glioblastoma Previously Treated with Radiotherapy and Temozolomide (BNCT Validation Evidence in Recurrent Glioblastoma Evaluation (BNCT-VERGE))

Phase 3 Study of Boron Neutron Capture Therapy (BNCT) for Recurrent Glioblastoma (BNCT-VERGE)

Kawabata Shinji

Osaka Medical and Pharmaceutical University Hospital

2-7, Daigaku-machi, Takatsuki, Osaka, JAPAN

bnct.dr@ompu.ac.jp

Kawabata Shinji

Osaka Medical and Pharmaceutical University Hospital

2-7, Daigaku-machi, Takatsuki, Osaka, JAPAN

+81-72-683-1221

bnct.dr@ompu.ac.jp

Recruiting

May. 08, 2026

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

(1) Japanese patients who provided written informed consent, aged 18 to 84 years at the time of consent.
(2) Patients with a KPS of 70% or higher and at least one supratentorial target lesion.
(3) Patients for whom curative surgical resection is difficult, with all lesions within the maximum collimator diameter.
(4) Patients histologically confirmed with IDH-wildtype glioblastoma at initial presentation or recurrence.
(5) Patients with recurrent or residual tumor after standard therapy (Radiotherapy <=70 Gy, TMZ >=3 cycles).
(6) Patients with >=90 days since previous radiotherapy, currently receiving drug therapy (TMZ or angiogenesis inhibitors).
(7) Patients with adequate bone marrow, liver, and kidney function, and no clinically significant abnormalities on ECG or chest X-ray.

(1) Patients with active double cancer (within a 2-year disease-free interval, excluding carcinoma in situ).
(2) Patients with extracranial metastasis, leptomeningeal dissemination, or lesions outside the maximum collimator diameter.
(3) Patients with active infectious diseases requiring systemic therapy (including HBV, HCV, and HIV).
(4) Patients with severe comorbidities (Grade 3 or higher per CTCAE), including cardiac, pulmonary, renal, diabetes, or hypertension.
(5) Patients with myocardial infarction, unstable angina, or uncontrolled arrhythmia/epilepsy within the past 6 months.
(6) Patients with phenylketonuria, hereditary fructose intolerance, or severe hypersensitivity to drugs or contrast agents.
(7) Patients with surgical resection within 30 days or treatment with unapproved drugs within 4 weeks.
(8) Patients with contraindications to MRI, or those who are pregnant/lactating or do not agree to adequate contraception.
(9) Patients with a history of previous BNCT treatment.
(10) Other patients judged ineligible by the investigator or sub-investigator.

Both

Recurrent glioblastoma, IDH-wildtype

[Experimental Group: BNCT]
Intravenous administration of Borofalan (10B), followed by neutron irradiation using an accelerator-based neutron capture therapy system.
[Control Group: BPC (Best Physician's Choice)]
Existing drug therapy (e.g., Bevacizumab) selected by the investigator, administered according to standard dosage and administration at each institution.

boron, neutron, recurrent glioblastoma, IDH-wildtype

Boron Neutron Capture Therapy, BNCT

D005909

D001890, D001889

Overall Survival (OS)

Progression-Free Survival (PFS) and 6-month PFS rate based on RANO criteria.
Best Local Control Rate (LCR) based on RANO criteria.
Disease Control Rate (DCR) and Duration of Disease Control (DCD) based on RANO criteria.
Timepoint-specific survival rate (e.g., 1-year survival rate).
Incidence and severity of adverse events and adverse drug reactions (based on CTCAE).

+81-72-683-1221

Jan. 07, 2026

No

none