Status:
TERMINATED
Docetaxel and S-1 in Head and Neck Squamous Cell Carcinoma (HNSCC)
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Clinical Research Center for Solid Tumor, Korea
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To assess response rate of docetaxel and S-1 combination in metastatic or recurrent head and neck squamous cell carcinoma
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00805012
Start Date
December 1 2008
End Date
July 1 2011
Last Update
July 26 2011
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea