Docetaxel and S-1 in Head and Neck Squamous Cell Carcinoma (HNSCC)

A Randomized, Multicenter, Phase II Study of Docetaxel and TS-1 Combination as a First-line Treatment in Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

To assess response rate of docetaxel and S-1 combination in metastatic or recurrent head and neck squamous cell carcinoma

Inclusion Criteria:

• histologically confirmed HNSCC
• adequate primary site: oral cavity, oropharynx, hypopharynx, nasal cavity, paranasal sinus, other head and neck site (except nasopharynx)
• at least one measurable lesion
• no previous palliative chemotherapy (adjuvant/neoadjuvant chemotherapy and/or radiotherapy longer than 6 months ago is permitted)
• 18 years or older
• ECOG 0 or 1
• adequate laboratory result
• written, informed consent

Exclusion Criteria:

• pregnant or lactating women (negative pregnancy test within 7 days is required for women with potential of child-bearing)
• experimental drug clinical trial within 30 days
• other malignancy (exemption: treated basal cell carcinoma of skin, CIS, cured cancer with disease-free interval with more than 5 years)
• patient with organ transplantation
• grade 2 or more peripheral neuropathy
• grade 2 or more hearing loss
• severe, medical condition