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

This study has been terminated.
(slow accrual rate)
Sponsor:
Collaborator:
Clinical Research Center for Solid Tumor, Korea
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00805012
First received: December 6, 2008
Last updated: July 23, 2011
Last verified: July 2011
  Purpose

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
Endpoint Classification: Efficacy Study
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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression-free survival [ Designated as safety issue: No ]
  • duration of response [ Designated as safety issue: No ]
  • overall survival [ Designated as safety issue: No ]
  • safety [ Designated as safety issue: Yes ]

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
docetaxel+CDDP
Drug: docetaxel+CDDP
docetaxel+CDDP
Experimental: 2
docetaxel+S-1
Drug: docetaxel+S-1
docetaxel+S-1

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: December 6, 2008
Last Updated: July 23, 2011
Health Authority: Korea: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014