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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.

japanese journal of clinical oncology

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)