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

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ClinicalTrials.gov Identifier: NCT00805012
Recruitment Status : Terminated (slow accrual rate)
First Posted : December 9, 2008
Last Update Posted : July 26, 2011
Sponsor:
Collaborator:
Clinical Research Center for Solid Tumor, Korea
Information provided by:
Seoul National University Hospital

Brief Summary:
To assess response rate of docetaxel and S-1 combination in metastatic or recurrent head and neck squamous cell carcinoma

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : December 2008
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
docetaxel+CDDP
Drug: docetaxel+CDDP
docetaxel+CDDP
Experimental: 2
docetaxel+S-1
Drug: docetaxel+S-1
docetaxel+S-1



Primary Outcome Measures :
  1. Response rate

Secondary Outcome Measures :
  1. progression-free survival
  2. duration of response
  3. overall survival
  4. safety


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805012


Locations
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

Responsible Party: Dae-Seog Heo, Professor, Clinical Research Center for Solid Tumor, Korea
ClinicalTrials.gov Identifier: NCT00805012     History of Changes
Other Study ID Numbers: CRCST-L-0004
First Posted: December 9, 2008    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: July 2011

Keywords provided by Seoul National University Hospital:
S-1
docetaxel
head and neck cancer
Recurrent or metastatic head and neck squamous cell carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action