Recurrent glioblastoma, IDH-wildtype boron, neutron, recurrent glioblastoma, IDH-wildtype
Conditions
Interventions
[Experimental Group: BNCT]
Intravenous administration of Borofalan (10B), followed by neutron irradiation using an accelerator-based neutron capture therapy system.
[Control Group: BPC (Best Physicia
Sponsors
Kawabata Shinji
Nihei Keiji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (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 =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.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Contacts
Public ContactShinji Kawabata
Osaka Medical and Pharmaceutical University Hospital
Outcome results
None listed