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Japanese Journal of Clinical Oncology Advance Access published online on May 8, 2009
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyp040
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© The Author (2009). Published by Oxford University Press. All rights reserved

Phase II Trial of Concurrent Chemoradiotherapy with S-1 Plus Cisplatin in Patients with Unresectable Locally Advanced Squamous Cell Carcinoma of the Head and Neck: Japan Clinical Oncology Group Study (JCOG0706)

Kenichi Nakamura1, Makoto Tahara2, Naomi Kiyota3, Ryuichi Hayashi4, Tetsuo Akimoto5, Haruhiko Fukuda1, Masato Fujii6 and Narikazu Boku7

1 Clinical Trials and Practice Support Division, Center for Cancer Control and Information Services, National Cancer Center, Tokyo
2 Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Chiba
3 Department of Medical Oncology, Kobe University Hospital, Kobe
4 Department of Head and Neck Surgery, National Cancer Center Hospital East, Kashiwa, Chiba
5 Department of Radiology, Tokyo Women's Medical University Hospital, Tokyo
6 Department of Otolaryngology, National Hospital Organization Tokyo Medical Center
7 Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan

For reprints and all correspondence: Makoto Tahara, Department of Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan. E-mail: matahara{at}east.ncc.go.jp

Received March 19, 2009; accepted April 1, 2009

A Phase II study was started in Japan to evaluate the efficacy and safety of concurrent chemoradiotherapy with S-1 plus cisplatin in patients with unresectable locally advanced squamous cell carcinoma of the head and neck. This study began in July 2008, and a total of 45 patients will be accrued from 13 institutions within 2 years. The primary endpoint is the clinical complete remission rate. The secondary endpoints are local progression-free survival, overall survival, progression-free survival, time to treatment failure, proportion of patients who achieve nutritional support-free survival and adverse events.

Key Words: head and neck neoplasms • chemoradiotherapy • clinical trials • Phase II


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