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Docetaxel and S-1 in Head and Neck Squamous Cell Carcinoma (HNSCC)

This study has been terminated.
(slow accrual rate)
Clinical Research Center for Solid Tumor, Korea
Information provided by:
Seoul National University Hospital Identifier:
First received: December 6, 2008
Last updated: July 23, 2011
Last verified: July 2011
To assess response rate of docetaxel and S-1 combination in metastatic or recurrent head and neck squamous cell carcinoma

Condition Intervention Phase
Head and Neck Squamous Cell Carcinoma
Drug: docetaxel+CDDP
Drug: docetaxel+S-1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Response rate

Secondary Outcome Measures:
  • progression-free survival
  • duration of response
  • overall survival
  • safety

Estimated Enrollment: 96
Study Start Date: December 2008
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Drug: docetaxel+CDDP
Experimental: 2
Drug: docetaxel+S-1


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT00805012

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Clinical Research Center for Solid Tumor, Korea
  More Information

Responsible Party: Dae-Seog Heo, Professor, Clinical Research Center for Solid Tumor, Korea Identifier: NCT00805012     History of Changes
Other Study ID Numbers: CRCST-L-0004
Study First Received: December 6, 2008
Last Updated: July 23, 2011

Keywords provided by Seoul National University Hospital:
head and neck cancer
Recurrent or metastatic head and neck squamous cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 24, 2017