A phase I/II clinical trial of preoperative short-course carbon-ion radiotherapy for patients with squamous cell carcinoma of the esophagus.
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.
Investigators of the Working Group for Gastrointestinal Tumors, Chiba, Japan. yakutsu@faculty.chiba-u.jp
Yasunori
Y
Akutsu
Shigeo
S
Yasuda
Matsuo
M
Nagata
Yosuke
Y
Izumi
Shinichi
S
Okazumi
Hideaki
H
Shimada
Yukio
Y
Nakatani
Hirohiko
H
Tsujii
Tadashi
T
Kamada
Shigeru
S
Yamada
Hisahiro
H
Matsubara
D000368:Aged; D002250:Carbon Radioisotopes / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000473:pathology* / Q000532:radiotherapy*; D004938:Esophageal Neoplasms / Q000401:mortality / Q000473:pathology* / Q000532:radiotherapy*; D005260:Female; D006801:Humans; D008297:Male; D020360:Neoadjuvant Therapy; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D011300:Preoperative Care; D011379:Prognosis; D012074:Remission Induction; D015996:Survival Rate
D002250:Carbon Radioisotopes