Docetaxel and S-1 in Head and Neck Squamous Cell Carcinoma (HNSCC)
Phase 2
Terminated
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Interventions
- Drug: docetaxel+CDDPDrug: docetaxel+S-1
- Registration Number
- NCT00805012
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
To assess response rate of docetaxel and S-1 combination in metastatic or recurrent head and neck squamous cell carcinoma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 96
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 docetaxel+CDDP docetaxel+CDDP 2 docetaxel+S-1 docetaxel+S-1
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method progression-free survival safety duration of response overall survival
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of