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Japanese Journal of Clinical Oncology Advance Access published online on April 3, 2008
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyn025
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© The Author (2008). Published by Oxford University Press. All rights reserved

Accelerated Fractionation versus Conventional Fractionation Radiation Therapy for Glottic Cancer of T1-2N0M0 Phase III Study: Japan Clinical Oncology Group Study (JCOG 0701)

Kenichi Nakamura1, Takeshi Kodaira2, Naoto Shikama3, Yoshikazu Kagami4, Satoshi Ishikura1, Taro Shibata1 and Masahiro Hiraoka5

1 Clinical Trials and Practice Support Division, Center for Cancer Control and Information Services, National Cancer Center, Tokyo
2 Department of Radiation Oncology, Aichi Cancer Center Hospital, Nagoya
3 Department of Radiology, Shinshu University School of Medicine, Nagano
4 Radiation Oncology Division, National Cancer Center Hospital, Tokyo
5 Department of Radiation Oncology and Image-applied Therapy, Kyoto University Hospital, Kyoto, Japan

For reprints and all correspondence: Takeshi Kodaira, Department of Radiation Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan. E-mail: 109103{at}aichi-cc.jp

Received December 11, 2007; accepted March 1, 2008

A randomized Phase III study was started in Japan to demonstrate the non-inferiority of survival of accelerated fractionation radiation therapy (2.4 Gy/fr) with conventional fractionation radiation therapy (2 Gy/fr) in patients with T1-2N0M0 glottic cancer. This study began in September 2007, and a total of 360 patients will be accrued from 22 institutions within 4 years. The primary endpoint is 3-year progression-free survival (PFS). The secondary endpoints are overall survival, local progression-free survival, disease-free survival, survival with preserved voice function, complete response rate, proportion of treatment completion and adverse events.

Key Words: laryngeal neoplasms • radiotherapy • dose fractionation • clinical trials • phase III


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