Docetaxel and S-1 in Head and Neck Squamous Cell Carcinoma (HNSCC)
Overview
To assess response rate of docetaxel and S-1 combination in metastatic or recurrent head and neck squamous cell carcinoma
Full Title of Study: “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)”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: July 2011
Interventions
- Drug: docetaxel+CDDP
- docetaxel+CDDP
- Drug: docetaxel+S-1
- docetaxel+S-1
Arms, Groups and Cohorts
- Active Comparator: 1
- docetaxel+CDDP
- Experimental: 2
- docetaxel+S-1
Clinical Trial Outcome Measures
Primary Measures
- Response rate
Secondary Measures
- progression-free survival
- duration of response
- overall survival
- safety
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Seoul National University Hospital
- Collaborator
- Clinical Research Center for Solid Tumor, Korea
- Provider of Information About this Clinical Study
- Dae-Seog Heo, Professor, Clinical Research Center for Solid Tumor, Korea
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