Nakamura Kenichi, Tahara Makoto, Kiyota Naomi, Hayashi Ryuichi, Akimoto Tetsuo, Fukuda Haruhiko, Fujii Masato, Boku Narikazu
Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.
Jpn J Clin Oncol. 2009 Jul;39(7):460-3. doi: 10.1093/jjco/hyp040. Epub 2009 May 8.
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.
在日本开展了一项II期研究，以评估S-1联合顺铂同步放化疗对不可切除的局部晚期头颈部鳞状细胞癌患者的疗效和安全性。该研究于2008年7月开始，将在2年内从13家机构招募总共45例患者。主要终点是临床完全缓解率。次要终点包括局部无进展生存期、总生存期、无进展生存期、治疗失败时间、实现无需营养支持生存期的患者比例以及不良事件。
