Abstract
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.
Publication types
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Clinical Trial, Phase II
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Multicenter Study
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Research Support, Non-U.S. Gov't
MeSH terms
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Adult
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Aged
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Carcinoma, Squamous Cell / drug therapy*
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Carcinoma, Squamous Cell / radiotherapy*
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Carcinoma, Squamous Cell / secondary
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Cisplatin / administration & dosage
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Combined Modality Therapy
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Drug Combinations
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Female
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Follow-Up Studies
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Head and Neck Neoplasms / drug therapy*
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Head and Neck Neoplasms / pathology
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Head and Neck Neoplasms / radiotherapy*
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Humans
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Male
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Middle Aged
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Neoplasm Staging
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Oxonic Acid / administration & dosage
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Prognosis
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Safety
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Survival Rate
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Tegafur / administration & dosage
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Treatment Outcome
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Young Adult
Substances
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Drug Combinations
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S 1 (combination)
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Tegafur
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Oxonic Acid
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Cisplatin