@article{oai:repo.qst.go.jp:00049516,
 author = {Kasuya, Goro and Tsuji, Hiroshi and Nomiya, Takuma and Makishima, Hirokazu and Haruyama, Yasuo and Kobashi, Gen and Hayashi, Kazuhiko and Ebner, Daniel and Omatsu, Tokuhiko and Kishimoto, Riwa and Yasuda, Shigeo and Igarashi, Tatsuo and Oya, Mototsugu and Akakura, Koichiro and Suzuki, Hiroyoshi and Ichikawa, Tomohiko and Shimazaki, Jun and Kamada, Tadashi and Group for Genitourinary Tumors, Working and Kasuya, Goro and Tsuji, Hiroshi and Nomiya, Takuma and Makishima, Hirokazu and Ebner, Daniel and Omatsu, Tokuhiko and Kishimoto, Riwa and Yasuda, Shigeo and Kamada, Tadashi},
 issue = {1},
 journal = {Oncotarget},
 month = {Jan},
 note = {The aims of this study were to clarify the safety and efficacy of 12-fraction carbon-ion radiotherapy (CIRT) for primary renal cell carcinoma (RCC) and to confirm the recommended dose in a prospective clinical trial.
This clinical trial was planned as a non-randomized, open-label, single-center phase I/II study of CIRT monotherapy. The incidence of acute adverse events was the primary endpoint. Dose-limiting toxicities (DLTs) were defined as grade ≥3 skin, gastrointestinal tract, or urologic adverse events.
Based on the eligibility criteria, 8 patients with primary RCC, including 3 medically inoperable patients and 5 patients with tumors >4 cm, were enrolled. Of the 8 patients, 5 were treated with 66 Gy (relative biological effectiveness [RBE]), and subsequently, the dose was escalated to 72 Gy (RBE) for the remaining 3 patients. The median follow-up time was 43.1 months. No DLTs were observed at any dose level though the end of follow-up. Although 1 patient died of pneumonia 3 months after CIRT, which was determined to be unrelated to CIRT, no grade 3 or higher adverse events were observed, and both local control and cancer-specific survival rates were 100%.
In conclusion, the safety and efficacy of CIRT hypofractionation using 12-fractions for the treatment of eligible RCC patients, including those with inoperable or tumor size >4 cm, were confirmed in this prospective trial, and a recommended dose of 72 Gy (RBE) was established.},
 pages = {76--81},
 title = {Prospective clinical trial of 12-fraction carbon-ion radiotherapy for primary renal cell carcinoma},
 volume = {10},
 year = {2019}
}