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

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
docetaxel+CDDP
docetaxel+S-1
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma focused on measuring S-1, docetaxel, head and neck cancer, Recurrent or metastatic head and neck squamous cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

docetaxel+CDDP

docetaxel+S-1

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

progression-free survival
duration of response
overall survival
safety

Full Information

First Posted
December 6, 2008
Last Updated
July 23, 2011
Sponsor
Seoul National University Hospital
Collaborators
Clinical Research Center for Solid Tumor, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00805012
Brief Title
Docetaxel and S-1 in Head and Neck Squamous Cell Carcinoma (HNSCC)
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 Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Terminated
Why Stopped
slow accrual rate
Study Start Date
December 2008 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital
Collaborators
Clinical Research Center for Solid Tumor, Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma
Keywords
S-1, docetaxel, head and neck cancer, Recurrent or metastatic head and neck squamous cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
docetaxel+CDDP
Arm Title
2
Arm Type
Experimental
Arm Description
docetaxel+S-1
Intervention Type
Drug
Intervention Name(s)
docetaxel+CDDP
Intervention Description
docetaxel+CDDP
Intervention Type
Drug
Intervention Name(s)
docetaxel+S-1
Intervention Description
docetaxel+S-1
Primary Outcome Measure Information:
Title
Response rate
Secondary Outcome Measure Information:
Title
progression-free survival
Title
duration of response
Title
overall survival
Title
safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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