We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00805012
Recruitment Status : Terminated (slow accrual rate)
First Posted : December 9, 2008
Last Update Posted : July 26, 2011
Information provided by:

Study Description
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 Design

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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Response rate

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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
Contacts and Locations

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

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
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:
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