| Project/Area Number |
18K07772
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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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| Review Section |
Basic Section 52040:Radiological sciences-related
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| Research Institution | Tokyo Women's Medical University |
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Principal Investigator |
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| Co-Investigator(Kenkyū-buntansha) |
小此木 範之 国立研究開発法人量子科学技術研究開発機構, 放射線医学総合研究所 重粒子線治療研究部, 医長(定常) (00750572)
平野 明 東京女子医科大学, 医学部, 准教授 (10349665)
神尾 孝子 東京女子医科大学, 医学部, 准教授 (20177570)
川井 佐和 (河野佐和 / 河野 佐和) 東京女子医科大学, 医学部, 助教 (80645820)
尾松 徳彦 国立研究開発法人量子科学技術研究開発機構, 放射線医学総合研究所 分子イメージング診断治療研究部, 医長(定常) (90374280)
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| Project Period (FY) |
2018-04-01 – 2022-03-31
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| Project Status |
Completed (Fiscal Year 2021)
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| Budget Amount *help |
¥3,120,000 (Direct Cost: ¥2,400,000、Indirect Cost: ¥720,000)
Fiscal Year 2020: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2019: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2018: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
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| Keywords | 乳癌 / 炭素イオン線治療 / 標準的補助薬物療法 / 加速乳房部分照射 / 全乳房照射 / 早期乳癌 / 放射線療法 / 非切除 |
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| Outline of Final Research Achievements |
We conducted clinical trial of curative partial breast irradiation using carbon ion radiotherapy to patients with stage 0 and I breast cancer. The candidate of this study was patients with Tis-1N0M0 breast cancer aged 20 years and older. In this study, carbon ion partial breast irradiations were combined with standard systemic therapy and x-ray whole-breast irradiation. Phase I was a dose-escalation study and phase II was treated with the recommended dose determined in Phase I. The starting dose is 52.8 Gy (RBE). By April 2022, a total of 5 eligible cases were enrolled in phase I, and 10 eligible cases in phase II with a recommended dose of 60.0 Gy (RBE). As acute adverse effects more than grade 2, acute grade 2 radiation dermatitis was observed in 1 case. As late adverse effects, grade 3 pneumonia of unknown causality were observed in 1 case. The cosmetic results of breast were excellent in all cases. No local recurrences or metastases have been observed.
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| Academic Significance and Societal Importance of the Research Achievements |
乳がんは日本人女性で最も多いがんであり、根治のみならず切らずに治す低侵襲治療の要望も多い。今までの早期乳癌に対する炭素イオン線治療の研究では、対象を高齢者の低リスク患者に限定していたが、本研究により、20歳以上の全てのサブタイプの早期乳癌に対して、標準的補助療法との組み合わせで、非切除の根治乳癌治療が可能となるとしたら、併存症や高齢で手術切除に適さない患者、あるいは精神的理由などで手術が行えない患者、手術を希望しない患者にとっての恩恵となる。
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