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A phase I/II clinical trial of preoperative short‐course carbon‐ion radiotherapy for patients with squamous cell carcinoma of the esophagus
Author(s) -
Akutsu Yasunori,
Yasuda Shigeo,
Nagata Matsuo,
Izumi Yosuke,
Okazumi Shinichi,
Shimada Hideaki,
Nakatani Yukio,
Tsujii Hirohiko,
Kamada Tadashi,
Yamada Shigeru,
Matsubara Hisahiro
Publication year - 2011
Publication title -
journal of surgical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.201
H-Index - 111
eISSN - 1096-9098
pISSN - 0022-4790
DOI - 10.1002/jso.22127
Subject(s) - medicine , radiation therapy , esophagus , carcinoma , stage (stratigraphy) , adverse effect , pathological , surgery , clinical trial , basal cell , gastroenterology , paleontology , biology
Background Carbon‐ion radiotherapy (CIR) has been under development. We report the results of a phase I/II clinical trial of preoperative CIR for esophageal squamous cell carcinoma (ESCC). Methods Thirty‐one thoracic ESCC patients were enrolled. They were first treated with CIR. The radiation dose was escalated from the initial dose of 28.8 GyE up to 36.8. Four to 8 weeks after CIR followed by clinical evaluation of the therapy, surgery was performed. Thereafter, a pathological evaluation was made. Results Acute toxicity was not seen except in one case (3.2%), and there were no late toxicities. Throughout the study period, there were no cases of withdrawal due to the effects of preoperative CIR. Twelve out of 31 (38.7%) patients achieved a clinical complete response (CR) and 13 patients (41.9%) achieved a partial response. Twelve out of 31 patients (38.7%) achieved a pathological CR. The overall 1‐, 3‐, and 5‐year survival rates in the stage I cases were 91%, 81%, and 61%, and was 100%, 85%, and 77% for the stage II, and 71%, 43%, and 29% for the stage III cases, respectively. Conclusions CIR showed strong local tumor control and is highly effective as a neoadjuvant therapy without severe adverse events. J. Surg. Oncol. 2012; 105:750–755. © 2011 Wiley Periodicals, Inc.