| Project/Area Number |
17K10877
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Neurosurgery
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| Research Institution | Osaka Medical College |
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Principal Investigator |
MIYATAKE Shin-Ichi 大阪医科大学, 医学部, 特別職務担当教員(教授) (90209916)
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| Co-Investigator(Kenkyū-buntansha) |
近藤 夏子 京都大学, 複合原子力科学研究所, 助教 (00582131)
川端 信司 大阪医科大学, 医学部, 准教授 (20340549)
道上 宏之 岡山大学, 中性子医療研究センター, 准教授 (20572499)
古瀬 元雅 大阪医科大学, 医学部, 准教授 (70340560)
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| Project Period (FY) |
2017-04-01 – 2020-03-31
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| Project Status |
Completed (Fiscal Year 2019)
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| Budget Amount *help |
¥4,680,000 (Direct Cost: ¥3,600,000、Indirect Cost: ¥1,080,000)
Fiscal Year 2019: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Fiscal Year 2018: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Fiscal Year 2017: ¥2,340,000 (Direct Cost: ¥1,800,000、Indirect Cost: ¥540,000)
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| Keywords | BNCT / bevacizumab / 再発悪性神経膠腫 / 放射線脳壊死 / malignant glioma / RPA |
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| Outline of Final Research Achievements |
We applied a phase 2 clinical trial using reactor-based BNCT and simultaneous administration of bevacizumab for recurrent malignant gliomas with poor prognosis. ２０cases were set at the initial protocol, however only 4 cases were enrolled with this clinical trial. The reasons of shortage of the subjects in this clinical trials might be ascribed to unstable operation of Kyoto University Research Reactor and simultaneously started phase 2 accelerator-based BNCT clinical trial for recurrent malignant gliomas.
3 cases were dead due to tumor progression during the observation period and 1 case is still alive 19 months after BNCT. All cases showed the prolonged survival in comparison with historical control. No case showed brain radiation necrosis. We will not extend the period of case entry because all BNCT will be performed using accelerator very soon.
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| Academic Significance and Societal Importance of the Research Achievements |
予後不良再発悪性グリオーマに対象を絞って、その予後を改善するために、二つの治療、すなわち ホウ素中性子捕捉療法およびベバシズマブ投与のコンビネーションによる臨床試験を行い、その治療効果を明らかにし、ひいては将来の加速器中性子源を用いた再発悪性グリオーマに対する標準治療への布石にすることを目的とした。
標準治療の確立していない再発悪性グリオーマに対する治療のオプションを増やし、近々に予定しているBNCTの再発悪性神経膠腫に対する保険診療に直結するデータが得られ、患者に希望を与えることが予想される。
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