Randomized clinical trial for patients with liver cancer between proton and carbon ion radiotherapy

肝癌患者质子与碳离子放射治疗的随机临床试验

• 批准号: 22390234
• 负责人: MURAKAMI Masao
• 金额: $ 8.07万
• 依托单位: Dokkyo Medical University (2012-2013)Kobe University (2010-2011)
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for Scientific Research (B)
• 财政年份: 2010
• 资助国家: 日本
• 起止时间: 2010-04-01 至 2013-03-31
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-22390234/
• 关键词: 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

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.

比较质子组（PG）与碳离子组（CG）治疗新发孤立性肝癌的临床效果。这是世界上第一个临床前瞻性随机试验。主要终点是总生存率（OS），次要终点是局部控制和副作用。根据年龄、性别、肝损害和肿瘤大小动态分配的倾向匹配，随机选择质子或碳离子放疗，剂量为66 GyE/10 fr。2011 - 2014年共入组44例，退出3例。分析41例患者（PG 21例，CG 20例）。随访中位10.3个月，PG复发3例，CG复发5例。3例患者（1例PG， 2例CG）死于疾病。没有局部复发，也没有3级毒性。1 ~ 2年生存率PG组为100%，87.5%，CG组为100%，66.7% （p < 0.05）。从中期评估中，我们无法发现两梁之间的差异。

项目成果

Current State of Particle Radiotherapy and Innovations in Clinical Oncology

粒子放射治疗的现状和临床肿瘤学的创新

• 发表时间: 2011
• 作者: Murakami Y;Nagata Y;Kimura T;Kenjo M;Kaneyasu Y;et.al.;M.Murakami
• 通讯作者: M.Murakami

5年間にわたり7個の原発性肝癌に対し陽子線または炭素イオン線治療を行い、著効を示した一例

历时5年对7例原发性肝癌进行质子束或碳离子束治疗，疗效显着。

• 发表时间: 2010
• 期刊: 医用原子力だより
• 作者: 丹羽康江;美馬正幸;出水祐介;寺嶋千貴;藤井収;村上昌雄
• 通讯作者: 村上昌雄

粒子線治療の現状と将来展望

粒子束治疗的现状及未来展望

• 发表时间: 2011
• 作者: Hashimoto R;Ohi K;Yasuda Y;Fukumoto M;Yamamori H;Takahashi H;Iwase M;Okochi T;Kazui H;Saitoh O;Tatsumi M;Iwata N;OzakiN;Kamijima K;Kunugi H;Takeda M;WATANABE HIROHISA;松本英樹;村上昌雄
• 通讯作者: 村上昌雄

Risk factors for survival and local recurrence after particle radiotherapy for single small hepatocellular carcinoma

• DOI: 10.1002/bjs.7397
• 发表时间: 2011-04-01
• 期刊: BRITISH JOURNAL OF SURGERY
• 影响因子: 9.6
• 作者: Komatsu, S.;Murakami, M.;Ku, Y.
• 通讯作者: Ku, Y.

A parameter study of pencil beam proton dose distributions for the treatment of ocular melanoma utilizing spot scanning

利用点扫描治疗眼部黑色素瘤的笔形束质子剂量分布参数研究

• 发表时间: 2010
• 期刊: Radiol.Phys.Technol. 3
• 作者: K.Sutherland;S.Miyajima;H.Date;H.Shirato;M.Ishikawa;M.Murakami;M.Yamagiwa;P.Bolton;T.Tajima
• 通讯作者: T.Tajima