ORIGINAL RESEARCH article
Front. Oncol.
Sec. Thoracic Oncology
Volume 15 - 2025 | doi: 10.3389/fonc.2025.1573462
This article is part of the Research TopicRecent Advances in Radiation Oncology for the Management of Thoracic MalignanciesView all 11 articles
A phase I study of S-1 and cisplatin with concurrent hypofractionated carbon-ion radiotherapy for patients with stage III non-small cell lung cancer
Provisionally accepted
Yosuke Miura1
Nobuteru Kubo2
Noriaki Sunaga1
Naoko Okano2Hiroaki Tsurumaki1
Hidemasa Kawamura2Reiko Sakurai1Toshitaka Maeno1
Takeshi Hisada3
Tatsuya Ohno2*- 1Graduate School of Medicine, Gunma University, Maebashi, Japan
- 2Gunma University Heavy Ion Medical Center, Maebashi, Gunma, Japan
- 3Gunma University, Maebashi, Gunma, Japan
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We conducted a phase I study to evaluate the recommended dose of S-1 in combination with cisplatin (SP) and concurrent carbon ion radiotherapy (CIRT) in patients with stage III locally advanced non-small cell lung cancer (LA-NSCLC). Materials and Methods: S-1 was administered orally twice daily after a meal for 14 consecutive days, and cisplatin was administered on days 1 and 8. The dose of each drug in this study was planned as follows: level 0, S-1 30 mg/m 2 twice daily and cisplatin 40 mg/m 2 ; level 1, S-1 40 mg/m 2 twice daily and cisplatin 40 mg/m 2 . CIRT was conducted at a total dose of 64 Gy (relative biological effectiveness) in 16 fractions. Results: Six patients were enrolled in this study. At level 1, one patient experienced grade 3 elevated alanine aminotransferase and aspartate aminotransferase levels, which is regarded as a dose-limiting toxicity. This event improved immediately. Five patients developed grade 2 esophagitis. In three of the five patients, symptoms such as pain and dysphagia due to esophagitis recurred several months after resolution of the acute esophagitis that occurred during irradiation. None of the patients experienced adverse events of ≥grade 3. Thus, level 1 was determined to be the recommended dose. Conclusion:Chemotherapy with SP and concurrent CIRT is feasible and well-tolerated in patients with Stage III LA-NSCLC.
Keywords: Carbon-ion radiotherapy, concurrent chemoradiotherapy, Non-small cell lung cancer, Platinum-based chemotherapy, Clinical Trial
Received: 09 Feb 2025; Accepted: 14 Jul 2025.
Copyright: © 2025 Miura, Kubo, Sunaga, Okano, Tsurumaki, Kawamura, Sakurai, Maeno, Hisada and Ohno. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Tatsuya Ohno, Gunma University Heavy Ion Medical Center, Maebashi, 371-0034, Gunma, Japan
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