| Project/Area Number |
22390234
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| Research Category |
Grant-in-Aid for Scientific Research (B)
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| Allocation Type | Single-year Grants |
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| Section | 一般 |
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| Research Field |
Radiation science
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| Research Institution | Dokkyo Medical University (2012-2013)
Kobe University (2010-2011) |
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Principal Investigator |
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| Co-Investigator(Kenkyū-buntansha) |
GU Eisei 神戸大学, 医学(系)研究科(研究院), 教授 (40195615)
DEMIZU Yusuke 神戸大学, 医学(系)研究科(研究院), 准教授 (50452496)
NISHIMURA Kunihiro 独立行政法人国立循環器病研究センター, その他部局等, 室長 (70397834)
菱川 良夫 神戸大学, 医学(系)研究科(研究院), 客員教授 (20122335)
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| Co-Investigator(Renkei-kenkyūsha) |
TERASHIMA Kazuki 兵庫県立粒子線医療センター, 医員
NIWA Yasue 兵庫県立粒子線医療センター, 医員
MIMA Masayuki 兵庫県立粒子線医療センター, 医員
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| Project Period (FY) |
2010-04-01 – 2013-03-31
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| Project Status |
Completed (Fiscal Year 2013)
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| Budget Amount *help |
¥12,610,000 (Direct Cost: ¥9,700,000、Indirect Cost: ¥2,910,000)
Fiscal Year 2012: ¥4,680,000 (Direct Cost: ¥3,600,000、Indirect Cost: ¥1,080,000)
Fiscal Year 2011: ¥3,770,000 (Direct Cost: ¥2,900,000、Indirect Cost: ¥870,000)
Fiscal Year 2010: ¥4,160,000 (Direct Cost: ¥3,200,000、Indirect Cost: ¥960,000)
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| Keywords | 原発性肝癌 / 陽子線治療 / 炭素線治療 / 臨床試験 / 粒子線治療 / 肝細胞癌 / 臨床比較試験 / 炭素イオン線治療 / 非劣性試験 / 無作為比較試験 / 医療経済学的評価 |
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| Research Abstract |
To compare the clinical results for patients with fresh solitary HCC between proton group (PG) and carbon-ion group (CG). This is the world's first clinical prospective randomized trial. Primary endpoint was overall survival rates (OS), secondary was local control and side effects. According to the propensity matching using dynamic allocation of age, sex, liver damage and tumor size, randomly-determined proton or carbon-ion radiotherapy was delivered with the doses of 66 GyE/10 fr.
From 2011 to 2014, 44 patients were enrolled and three were dropped. Forty-one patients (PG in 21 and CG in 20) were analyzed. During follow-up median 10.3 months, there were 3 hepatic relapse in PG and 5 relapse in CG. Three patients (PG in 1 and CG in 2) died of disease. There was neither local recurrence nor grade 3 toxicity. OS at 1, 2 year was 100%, 87.5% in PG and 100%, 66.7% in CG, respectively (p>0.05).
From the interim assessment, we cannot find the difference between two beams.
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