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)
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