Clinical trial · Interventional
Boron Neutron Capture Therapy, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
A Phase II, Multicenter, Study for Newly Diagnosed Glioblastomas Using Boron Neutron Capture Therapy, Additional X-ray Treatment and Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Boron neutron capture therapy and radiation therapy use high-energy x-rays and other types of radiation to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving boron neutron capture therapy followed by radiation therapy and temozolomide may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving boron neutron capture therapy together with radiation therapy and temozolomide in treating patients with newly diagnosed glioblastoma multiforme.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BNCT(boron neutron capture therapy) | Radiation | — | UNRESOLVED |
| TMZ(temozolomide) | Drug | Temozolomide | ALIAS |
| XRT(X-ray radiation treatment) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- BNCT(boron neutron capture therapy), XRT(X-ray radiation treatment) and TMZ(temozolomide) treatment
- interventionNames
- Radiation: BNCT(boron neutron capture therapy)
- Radiation: XRT(X-ray radiation treatment)
- Drug: TMZ(temozolomide)
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- Time to death from BSH injection（up to 6 years）
Secondary outcomes (4)
- measure
- Tumor response（RECIST）
- timeFrame
- From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma multiforme * Newly diagnosed disease * Tumor located at a supratentorial hemisphere * Deepest part of tumor \< 6 cm from the scalp * Bottom of the tumor \> 6 cm from the scalp allowed provided air instillation into tumor-removed cavity is possible * No cerebrospinal fluid dissemination PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Life expectancy \> 3 months * Leukocyte count ≥ 3,000/μL * Platelet count ≥ 10.0 × 10\^4/μL * Hemoglobin ≥ 8.0 g/dL * Serum creatinine ≤ 1.5 mg/dL * ALT and AST ≤ 100 IU/L * No phenylketonuria * Not pregnant or nursing * No NYHA class III-IV heart failure * No patient whose participation in the present study is considered inappropriate by a Principal Investigator or Clinical Investigator PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy
References
Publications (1)
- RESULTKawabata S, Miyatake S, Hiramatsu R, Hirota Y, Miyata S, Takekita Y, Kuroiwa T, Kirihata M, Sakurai Y, Maruhashi A, Ono K. Phase II clinical study of boron neutron capture therapy combined with X-ray radiotherapy/temozolomide in patients with newly diagnosed glioblastoma multiforme--study design and current status report. Appl Radiat Isot. 2011 Dec;69(12):1796-9. doi: 10.1016/j.apradiso.2011.03.014. Epub 2011 Mar 21. PMID 21459588