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


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


  • 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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