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The next clinical trial of 2-fraction/2-day carbon ion radiotherapy is going on within a phase I/II study from April 2003. Patients and Methods: Twenty-five patients with histologically proven HCC were treated with 2-fraction/2-day carbon ion radiotherapy of 32.0GyE in 6, 33.6GyE in 7, 35.2GyE in 6, and 37.0GyE in 6 in a step-wise dose-escalation study from April 2003 to August 2004. Common Toxicity Criteria, RTOG/EORTC criteria were used for evaluation of toxicity. Serial changes in Child-Pugh score were investigated after the start of therapy to evaluate its invasiveness to the liver. Anti-tumor effect was evaluated by the tumor response and directly- calculated local control rate. Results: During a median follow-up of 12.1 (3.9-19.5) months, no severe adverse effects and no treatment-related deaths occurred. In the early phase, no change in the Child-Pugh score was observed in 79% (19/24), only a 1-point increase in 17% (4/24), and 2-point increase in 4% (1/24) of the patients. 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Two-fraction Carbon Ion Radiotherapy for Hepatocellular Carcinoma: Preliminary Results of a Phase I/II Clinical Trial
https://repo.qst.go.jp/records/68055
https://repo.qst.go.jp/records/68055359bb883-f367-4538-b86f-e370ae7af1b4
Item type | 会議発表用資料 / Presentation(1) | |||||
---|---|---|---|---|---|---|
公開日 | 2005-05-10 | |||||
タイトル | ||||||
タイトル | Two-fraction Carbon Ion Radiotherapy for Hepatocellular Carcinoma: Preliminary Results of a Phase I/II Clinical Trial | |||||
言語 | ||||||
言語 | eng | |||||
資源タイプ | ||||||
資源タイプ識別子 | http://purl.org/coar/resource_type/c_c94f | |||||
資源タイプ | conference object | |||||
アクセス権 | ||||||
アクセス権 | metadata only access | |||||
アクセス権URI | http://purl.org/coar/access_right/c_14cb | |||||
著者 |
Katou, Hirotoshi
× Katou, Hirotoshi× Yamada, Shigeru× Yasuda, Shigeo× Yamaguchi, Kazuya× Kitabayashi, Hiroyuki× Kamada, Tadashi× Mizoe, Junetsu× Ootou, Masao× Tsujii, Hirohiko× 加藤 博敏× 山田 滋× 安田 茂雄× 山口 和也× 北林 宏之× 鎌田 正× 溝江 純悦× 大藤 正雄× 辻井 博彦 |
|||||
抄録 | ||||||
内容記述タイプ | Abstract | |||||
内容記述 | Background: We reported that the 4-fraction/1-week carbon ion radiotherapy, that had been conducted from April 2001 to February 2003 within a phase II clinical study, appeared to be safe and to have a promising potential as a new, radical, and minimally invasive therapeutic option for hepatocellular carcinoma (HCC) at the last ASCO annual meeting. The next clinical trial of 2-fraction/2-day carbon ion radiotherapy is going on within a phase I/II study from April 2003. Patients and Methods: Twenty-five patients with histologically proven HCC were treated with 2-fraction/2-day carbon ion radiotherapy of 32.0GyE in 6, 33.6GyE in 7, 35.2GyE in 6, and 37.0GyE in 6 in a step-wise dose-escalation study from April 2003 to August 2004. Common Toxicity Criteria, RTOG/EORTC criteria were used for evaluation of toxicity. Serial changes in Child-Pugh score were investigated after the start of therapy to evaluate its invasiveness to the liver. Anti-tumor effect was evaluated by the tumor response and directly- calculated local control rate. Results: During a median follow-up of 12.1 (3.9-19.5) months, no severe adverse effects and no treatment-related deaths occurred. In the early phase, no change in the Child-Pugh score was observed in 79% (19/24), only a 1-point increase in 17% (4/24), and 2-point increase in 4% (1/24) of the patients. In the late phase, similar observations were made in 75% (12/16), 6% (1/16), and 19% (3/16), respectively. The overall tumor response rate was 96% (24/25) at 6 months after the therapy. Local control rates were 96% (24/25) and 93% (13/14) at 6 and 12 months, respectively. Overall survival rates were 100% at 6 and 12 months, respectively. There were preliminarily no differences between the results in the current study and those in the 4-fraction carbon ion radiotherapy. Conclusion: Two-fraction carbon ion radiotherapy for HCC appears preliminarily to be safe and effective. However, further observation is needed to confirm its clinical usefulness. | |||||
会議概要(会議名, 開催地, 会期, 主催者等) | ||||||
内容記述タイプ | Other | |||||
内容記述 | American Society of Clinical Oncology Annual Meeting 2005 | |||||
発表年月日 | ||||||
日付 | 2005-05-17 | |||||
日付タイプ | Issued |