@misc{oai:repo.qst.go.jp:00064003, author = {Yamamoto, Naoyoshi and Baba, Masayuki and Nakajima, Mio and Horino, Takeshi and Yoshikawa, Kyosan and Imai, Reiko and Matsufuji, Naruhiro and Minohara, Shinichi and Miyamoto, Tadaaki and Tsuji, Hiroshi and Kamada, Tadashi and Tsujii, Hirohiko and 山本 直敬 and 馬場 雅行 and 中嶋 美緒 and 堀野 武 and 吉川 京燦 and 今井 礼子 and 松藤 成弘 and 蓑原 伸一 and 宮本 忠昭 and 辻 比呂志 and 鎌田 正 and 辻井 博彦}, month = {Sep}, note = {From 1994 to 1999, we conducted a phase I/II clinical trial for stage I non-small cell lung cancer (NSCLC) by using carbon ion beams alone, demonstrating optimal doses of 90.0GyE in 18 fractions over 6 weeks (Protocol #9303) and 72.0GyE in 9 fractions over 3 weeks (Protocol #9701) for achieving more than 95% local control with minimal pulmonary damage. In the present study, the total dose was fixed at 72.0GyE in 9 fractions over 3 weeks (Protocol #9802), and at 52.8GyE for stage IA and 60.0GyE for stage 1B in 4 fractions in 1 week (Protocol #0001). Following this schedule, we conducted a phase II clinical trial for stage I NSCLC from 1999 to 2003. We also conducted a phase I/II single fractionation clinical trial (Protocol #0201), a dose escalation study. The total dose was initially 28.0GyE in 2003, and it was raised to 46.0GyE in 2008. This article describes the intermediate steps. Most targets were irradiated from four oblique directions. A respiratory-gated irradiation system was used for all sessions. Local control and survival were assessed by Kaplan-Meier method. For statistical testing, the Log-rank test was used. The local control rate for all patients (#9802 and #0001) was 91.5%, and those for T1 and T2 tumors were 96.3% and 84.7%, respectively. While there was a significant difference (p=0.0156) in tumor control rate between T1 and T2, there was no significant difference (P=0.1516) between squamous cell carcinomas and non-squamous cell carcinomas. The 5-year cause-specific survival rate was 67.0% (IA: 84.4, IB: 43.7), and overall survival was 45.3% (IA: 53.9, 1B: 34.2). No adverse effects greater than grade 2 occurred in the lung. In a single fractionation trial, the 3-year local control rate for 117 patients was 81.9%, and the control rates for T1 and T2 tumors were 84.7% and 78.0%, respectively. No adverse effects greater than grade 2 occurred in the lung. Carbon beam radiotherapy, an excellent new modality in terms of high QOL and ADL, was proven to be a valid alternative to surgery for stage I cancer, especially for elderly and inoperable patients., KI-NIRS Joint Symposium on Carbon Ion Therapy}, title = {Carbon Ion Radiotherapy in Hypofraction Regimen for Stage I Non-Small Cell Lung Cancer}, year = {2010} }