Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
S-1, docetaxel, head and neck cancer, Recurrent or metastatic head and neck squamous cell carcinoma
Brief summary
To assess response rate of docetaxel and S-1 combination in metastatic or recurrent head and neck squamous cell carcinoma
Interventions
DRUGdocetaxel+CDDP
docetaxel+CDDP
DRUGdocetaxel+S-1
docetaxel+S-1
Sponsors
Clinical Research Center for Solid Tumor, Korea
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival | — |
| duration of response | — |
| overall survival | — |
| safety | — |
Countries
South Korea
Outcome results
None listed