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

Head and Neck Squamous Cell Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00805012
• Other study ID #: CRCST-L-0004
• Status: Terminated
• Phase: Phase 2
• First received: December 6, 2008
• Last updated: July 23, 2011
• Start date: December 2008
• Est. completion date: July 2011

Study information

• Verified date: July 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 96
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma

Intervention

Drug:
• docetaxel+CDDP
docetaxel+CDDP
• docetaxel+S-1
docetaxel+S-1

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Clinical Research Center for Solid Tumor, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate			No
Secondary	progression-free survival			No
Secondary	duration of response			No
Secondary	overall survival			No
Secondary	safety			Yes