Clinical Trial Notes 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 Nakamura 1 , Makoto Tahara 2 , Naomi Kiyota 3 , Ryuichi Hayashi 4 , Tetsuo Akimoto 5 , Haruhiko Fukuda 1 , Masato Fujii 6 and Narikazu Boku 7 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 and 7 Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan Received March 19, 2009; accepted April 1, 2009; published online May 8, 2009 A Phase II study was started in Japan to evaluate the efficacy and safety of concurrent che- moradiotherapy with S-1 plus cisplatin in patients with unresectable locally advanced squa- mous 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 INTRODUCTION More than 60% of squamous cell carcinomas of the head and neck (SCCHN) are revealed to be Stage III or IV at diagnosis, because they are not symptomatic and it is difficult to detect them in their early stages (1). The prognosis of unresectable locally advanced SCCHN is still poor. The standard therapy for locally advanced SCCHN is chemoradiotherapy (CRT) with cisplatin alone or 5-fluorouracil (5-FU) plus cisplatin (2–5). S-1 is a new oral fluoropyrimidine, consisting of tegafur, 5-chloro-2,4- dihydropyrimidine and potassium oxonate, which as monotherapy led to a response rate of 34.1% in patients with progressive or recurrent SCCHN (6). S-1 monother- apy also demonstrated a response rate of 30.4% in patients with pre-treated SCCHN, which was much better than the response rate of 15% seen with 5-FU continuous infusion (6). Thus, higher efficacy may be expected if 5-FU is replaced with S-1 in CRT as well as in che- motherapy alone. A Phase I study of concurrent CRT with S-1 plus CDDP in patients with unresectable locally advanced SCCHN showed quite a high complete response rate (86%) (7). Therefore, we have undertaken a Phase II study to evaluate the efficacy and safety of concurrent CRT with S-1 plus CDDP for patients with unresectable locally advanced SCCHN. The Protocol Review Committee of the Japan Clinical Oncology Group (JCOG) approved the protocol in June 2008 and the study was activated in July 2008. This trial was registered at the UMIN Clinical Trials Registry as UMIN000001272 (http://www.umin.ac.jp/ctr/index.htm). 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@east.ncc.go.jp # The Author (2009). Published by Oxford University Press. All rights reserved. Jpn J Clin Oncol 2009 2009;39(7)460–463 doi:10.1093/jjco/hyp040 Downloaded from https://academic.oup.com/jjco/article/39/7/460/845553 by guest on 13 February 2022