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The objectives of this study were to determine the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 plus cisplatin (CDDP) and to evaluate safety and efficacy using the defined RD in advanced/recurrent head and neck cancer (HNC).

Phase I/II Study of S-1 plus Cisplatin Combination Chemotherapy in Patients with Advanced/Recurrent Head and Neck Cancer