@misc{oai:repo.qst.go.jp:00064526, author = {Yamamoto, Naoyoshi and Baba, Masayuki and Nakajima, Mio and Yoshikawa, Kyosan and Matsufuji, Naruhiro and Minohara, Shinichi 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 吉川 京燦 and 松藤 成弘 and 蓑原 伸一 and 辻 比呂志 and 鎌田 正 and 辻井 博彦}, month = {Feb}, note = {From 1994 to 1999, we conducted a phase I/II clinical trial for patients with 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), which achieved a more than 95% local control rate 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) as a dose escalation study. The total dose was initially 28.0GyE in 2003, and it was increased to 50.0GyE in 2011. 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 the 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 the tumor control rates between T1 and T2 tumors, 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 the overall survival was 45.3% (IA: 53.9, 1B: 34.2). No adverse effects greater than grade 2 occurred in the lungs. In a single fractionation trial, the 5-year local control rate for 131 patients was 80.5%, and the control rates for T1 and T2 tumors were 82.8% and 78.4%,respectively. No adverse effects greater than grade 2 occurred in the lungs. 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 NSCLC, especially for elderly and inoperable patients., NIRS-KFSHRC Joint Symposium on Carbon Ion Radiotherapy and Radiation Emergency Medicine}, title = {Carbon Ion Radiotherapy in a Hypo-fraction Regimen for Stage I Non-Small Cell Lung Cancer}, year = {2012} }