A phase II, multicenter, study for newly diagnosed glioblastomas using boron neutron capture therapy, additional X-ray treatment and chemotherapy

A phase II, multicenter, study for newly diagnosed glioblastomas using boron neutron capture therapy, additional X-ray treatment and chemotherapy - BNCT, XRT plus chemotherapy for newly diagnosed GBM

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002385

Enrollment

Registered

2009-09-01

Start date

2009-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly-diagnosed glioblastoma

Interventions

Protocol treatments consist of BNCT, additional 24 Gy XRT and chemotherapy with TMZ. Prescription dose by BNCT is regulated as not to be more than 13 Gy-Eq for normal brain. Additional XRT is given

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with definitive newly diagnosed GB by histopathology. 2) The tumor locates at a supra-tentorial hemisphere. 3) The deepest part of the tumor should be less than 6 cm from the scalp. Even if the bottom of the tumor is more than 6 cm from the scalp, the patients may be included in the study, if the air instillation into tumor-removed cavity is possible. 4) KPS is 60% or more. 5) Life expectancy is more than 3 months. 6) Patients who demonstrate appropriate bone marrow, hepatic and renal functions in laboratory tests within four weeks before the registration. a) Leukocyte count is more than 3,000/microlitter b) Hemoglobin level is more than 8.0 g/deciliter c) Platelet count is more than 100000 / microlitter d) Serum creatine level is more than 1.5 mg/ deciliter e) ALT levels is more than 100 IU/litter f) AST levels is more than 100 IU/litter 7) Patients who agreed to participate in this clinical study in writing after receiving sufficient explanation.

Exclusion criteria

Exclusion criteria: 1) Patients who have been treated with chemotherapy or radiotherapy. 2) Female patients in definitive or possible pregnancy or in breast-feeding. 3) Patients with phenylketonuria. 4) Patients with grade III or IV in NYHA classification. 5) Patients with cerebrospinal fluid dissemination. 6) Other patients whose participation in the present study is considered inappropriate by a Principal Investigator or Clinical Investigator.

Design outcomes

Primary

Measure	Time frame
Overall survival (OS)	—

Secondary

Measure	Time frame
Tumor response Objective Response Rate (ORR) Disease Control Rate (DCR) Adverse event	—

Countries

Japan

Contacts

Public ContactShin-Ichi Miyatake

Osaka Medical College Department of Neurosurgery

neu070@poh.osaka-med.ac.jp072-683-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026