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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000650829 | Registry Identifier | PDQ (Physician Data Query) | |
| UMIN000002385 | Registry Identifier | UMIN CTR |
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| Name | Class |
|---|---|
| Department of Nuerosurgery, Osaka Medical College | UNKNOWN |
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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.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients undergo boron neutron capture therapy followed by radiotherapy and concurrent and adjuvant oral temozolomide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | BNCT(boron neutron capture therapy), XRT(X-ray radiation treatment) and TMZ(temozolomide) treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNCT(boron neutron capture therapy) | Radiation | BSH(sodium borocaptate) 100mg/kg iv for one hour starting 13 hours before irradiation, and BPA(p-boronophenylalanine) 500/mg/kg iv at a speed of 200mg/kg/hr for 2 hours starting 2 hours before irradiation. During irradiation, BPA iv continues at a speed of 100mg/kg/hr. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Time to death from BSH injection(up to 6 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response(RECIST) | From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks | |
| Objective Response Rate (ORR) | From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks |
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DISEASE CHARACTERISTICS:
Histologically confirmed glioblastoma multiforme
Tumor located at a supratentorial hemisphere
No cerebrospinal fluid dissemination
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Shin-Ichi Miyatake, MD, PhD | Osaka Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka Medical College | Takatsuki | Osaka | 569-8686 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21459588 | Result | Kawabata 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. |
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| XRT(X-ray radiation treatment) | Radiation | After BNCT, 2Gy irradiation every day for 12 days. |
|
| TMZ(temozolomide) | Drug | 75mg/m2 for day1-12. After XRT, repeat the cycle of 150-200mg/m2 for 5 days and cessation for 23 days. |
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| Disease Control Rate (DCR) | From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks |
| Adverse event | Time to final follow-up survey from the date of enrollment |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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