@misc{oai:repo.qst.go.jp:00068055, author = {Katou, Hirotoshi and Yamada, Shigeru and Yasuda, Shigeo and Yamaguchi, Kazuya and Kitabayashi, Hiroyuki and Kamada, Tadashi and Mizoe, Junetsu and Ootou, Masao and Tsujii, Hirohiko and 加藤 博敏 and 山田 滋 and 安田 茂雄 and 山口 和也 and 北林 宏之 and 鎌田 正 and 溝江 純悦 and 大藤 正雄 and 辻井 博彦}, month = {May}, note = {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., American Society of Clinical Oncology Annual Meeting 2005}, title = {Two-fraction Carbon Ion Radiotherapy for Hepatocellular Carcinoma: Preliminary Results of a Phase I/II Clinical Trial}, year = {2005} }