Prospective clinical trial of 12-fraction carbon-ion radiotherapy for primary renal cell carcinoma
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Goro Kasuya1, Hiroshi Tsuji1, Takuma Nomiya2, Hirokazu Makishima1, Yasuo Haruyama3, Gen Kobashi3, Kazuhiko Hayashi4, Daniel K. Ebner1,5, Tokuhiko Omatsu1, Riwa Kishimoto1, Shigeo Yasuda6, Tatsuo Igarashi7,8, Mototsugu Oya9, Koichiro Akakura10, Hiroyoshi Suzuki11, Tomohiko Ichikawa12, Jun Shimazaki12, Tadashi Kamada1 and the Working Group for Genitourinary Tumors
1Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan
2Department of Radiology, Joban Hospital, Iwaki, Japan
3Department of Public Health, Dokkyo Medical University, Tochigi, Japan
4Osaka Heavy Ion Therapy Center, Osaka, Japan
5Harvard TH Chan School of Public Health, Boston, MA, USA
6Department of Radiation Oncology, Chiba Rosai Hospital, Chiba, Japan
7Department of Urology, Seirei Sakura Citizen Hospital, Chiba, Japan
8Center for Frontier Medical Engineering, Chiba University, Chiba, Japan
9Department of Urology, Keio University School of Medicine, Tokyo, Japan
10Department of Urology, Japan Community Health Care Organization Tokyo, Shinjuku Medical Center, Tokyo, Japan
11Department of Urology, Toho University Sakura Medical Center, Chiba, Japan
12Department of Urology, Graduate School of Medicine, Chiba University, Chiba, Japan
Goro Kasuya, email: firstname.lastname@example.org
Keywords: carbon-ion radiotherapy; renal cell carcinoma; prospective study; radiation therapy; renal function
Received: November 07, 2018 Accepted: December 20, 2018 Published: January 01, 2019
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.
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