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Article

Phase I Study of Carbon Ion Radiotherapy and Image-Guided Brachytherapy for Locally Advanced Cervical Cancer

1
Gunma University Heavy Ion Medical Center, Gunma University, 3-39-22 Showa, Maebashi, Gunma 371-8511, Japan
2
Department of Radiation Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama 350-1298, Japan
3
Department of Obstetrics and Gynecology, Gunma University Graduate School of Medicine, 3-39-22 Showa, Maebashi, Gunma 371-8511, Japan
4
Division of Gynecology, Gunma Prefectural Cancer Center, 617-1 Takahayashi-nishi, Ota, Gunma 373-0828, Japan
*
Author to whom correspondence should be addressed.
Current address: Department of Radiation Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama 350-1298, Japan.
Current address: National Institute of Radiological Sciences Hospital, National Institute for Quantum and Radiological Science and Technology, 491 Anagawa, Inage, Chiba 263-8555, Japan.
§
Current address: Division of Radiation Oncology, Gunma Prefectural Cancer Center, 617-1 Takahayashi-nishi, Ota, Gunma 373-0828, Japan.
Current address: Department of Radiation Oncology, Fukushima Medical University, 1 Hikarigaoka, Fukushima 960-1247, Japan
Current address: Executive Director of Research, Gunma University, 4-2 Aramaki, Maebashi, Gunma 371-8510, Japan.
Cancers 2018, 10(9), 338; https://doi.org/10.3390/cancers10090338
Received: 17 August 2018 / Revised: 12 September 2018 / Accepted: 13 September 2018 / Published: 18 September 2018
(This article belongs to the Special Issue New Developments in Radiotherapy)
A phase I study was performed to determine the recommended dose of carbon ion radiotherapy and 3D image-guided brachytherapy for histologically confirmed stage II (≥4 cm), III, or IVA cervical cancer. Dose-limiting toxicities (treatment-related toxicities occurring within three months from the start of carbon ion radiotherapy) included Grade 3 non-hematological toxicity, Grade 4 hematological toxicity, or interruption of treatment for more than two weeks due to treatment-related toxicities. Carbon ion radiotherapy consisted of whole-pelvic irradiation with 36.0 Gy (relative biological effectiveness) in 12 fractions and local boost with 19.2 Gy in four fractions for the primary site, and for positive lymph nodes. Three sessions of three-dimensional (3D) image-guided brachytherapy were administered after completion of carbon ion radiotherapy. Weekly cisplatin at a dose of 40 mg/m2 was given concurrently. At a dose level of one, a total rectosigmoid D2cc dose between 67.2 Gy and 71.3 Gy at a biological equivalent dose of 2 Gy per fraction from carbon ion radiotherapy and 3D image-guided brachytherapy was prescribed. Six patients were enrolled into this dose level. No patients developed the pre-defined dose-limiting toxicities. For late toxicities, however, one patient developed Grade 3 rectal hemorrhage requiring transfusion at 10 months after treatment. The median survival time was 50.0 months for the five surviving patients. No further dose escalation was performed, and we determined the dose of level one as the recommended rectosigmoid dose. Although our results are preliminary, the study regimen encourages further investigation (registration: UMIN000013340). View Full-Text
Keywords: cervical cancer; carbon ion radiotherapy; image-guided brachytherapy; concurrent chemoradiotherapy; phase I study cervical cancer; carbon ion radiotherapy; image-guided brachytherapy; concurrent chemoradiotherapy; phase I study
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MDPI and ACS Style

Ohno, T.; Noda, S.-e.; Murata, K.; Yoshimoto, Y.; Okonogi, N.; Ando, K.; Tamaki, T.; Kato, S.; Hirakawa, T.; Kanuma, T.; Minegishi, T.; Nakano, T.; On behalf of the Working Group for Gynecologic Cancer. Phase I Study of Carbon Ion Radiotherapy and Image-Guided Brachytherapy for Locally Advanced Cervical Cancer. Cancers 2018, 10, 338. https://doi.org/10.3390/cancers10090338

AMA Style

Ohno T, Noda S-e, Murata K, Yoshimoto Y, Okonogi N, Ando K, Tamaki T, Kato S, Hirakawa T, Kanuma T, Minegishi T, Nakano T, On behalf of the Working Group for Gynecologic Cancer. Phase I Study of Carbon Ion Radiotherapy and Image-Guided Brachytherapy for Locally Advanced Cervical Cancer. Cancers. 2018; 10(9):338. https://doi.org/10.3390/cancers10090338

Chicago/Turabian Style

Ohno, Tatsuya, Shin-ei Noda, Kazutoshi Murata, Yuya Yoshimoto, Noriyuki Okonogi, Ken Ando, Tomoaki Tamaki, Shingo Kato, Takashi Hirakawa, Tatsuya Kanuma, Takashi Minegishi, Takashi Nakano, and On behalf of the Working Group for Gynecologic Cancer. 2018. "Phase I Study of Carbon Ion Radiotherapy and Image-Guided Brachytherapy for Locally Advanced Cervical Cancer" Cancers 10, no. 9: 338. https://doi.org/10.3390/cancers10090338

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