Multicenter prospective study of stereotactic body radiotherapy for untreated solitary primary hepatocellular carcinoma

2018 Fiscal Year Final Research Report

• Project/Area Number: 16K10401
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Radiation science
• Research Institution: Nagoya City University (2017-2018); Juntendo University (2016)
• Principal Investigator: Ishikura Satoshi 名古屋市立大学, 大学院医学研究科, 准教授 (40407242)
• Co-Investigator(Kenkyū-buntansha): 木村 智樹 広島大学, 病院(医), 講師 (90379876)
• Project Period (FY): 2016-04-01 – 2019-03-31
• Keywords: 定位放射線治療 / 肝細胞癌

Outline of Final Research Achievements

The primary endpoint of this study was the 3-year overall survival with a follow-up period of 3 years. We finished the accrual with 36 patients in July, 2018. The early results will be presented at the annual meeting of the American Society for Radiation Oncology in 2019, and the final results will be published in a few years.
With a median follow-up period of 21 months, the 3-year overall survival was 78% (95% confidence interval, 53% - 91%), which exceeded the expected value of 70%. Grade 5 toxicity was not observed. Stereotactic body radiotherapy for untreated solitary primary hepatocellular carcinoma seems to be promising.

Free Research Field

放射線治療

Academic Significance and Societal Importance of the Research Achievements

初発孤立性肝細胞癌に対する定位放射線治療は手術、ラジオ波焼灼療法に比肩しうる高い有効性が強く示唆されているものの、多施設共同臨床試験による科学的な評価が十分でなく標準治療にはなっていない。本研究は定位放射線治療が標準治療となりうるか多施設共同臨床試験により検証することを目的とした貴重なものである。本研究により定位放射線治療の有効性が検証されれば、侵襲の高い治療が困難である多数の高齢がん患者に多大な恩恵となるものと考えられる。