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TerminatedNCT00805012Updated Jul 26, 2011

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

A Phase 2 interventional study of docetaxel+CDDP and docetaxel+S-1 in Head and Neck Squamous Cell Carcinoma, sponsored by Seoul National University Hospital. Terminated at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-26.

Sponsored by Seoul National University Hospital · Phase 2, Interventional, and Treatment

Why this study was terminated
slow accrual rate
Phase
Phase 2
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Head and Neck Squamous Cell Carcinoma

Keywords

  • S-1
  • docetaxel
  • head and neck cancer
  • Recurrent or metastatic head and neck squamous cell carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 96 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
96 participants (estimated)

Study arms

  • Active comparator
    1

    docetaxel+CDDP

    Drug: docetaxel+CDDP

  • Experimental
    2

    docetaxel+S-1

    Drug: docetaxel+S-1

Interventions

  • Drugdocetaxel+CDDP

    docetaxel+CDDP

  • Drugdocetaxel+S-1

    docetaxel+S-1

06

What researchers measure

Primary outcomes

  1. Response rate

Secondary outcomes

  1. progression-free survival

  2. duration of response

  3. overall survival

  4. safety

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00805012
Lead sponsor
Seoul National University Hospital
Collaborators
Clinical Research Center for Solid Tumor, Korea
First posted
Dec 9, 2008
Start date
Dec 2008
Primary completion
Jul 2011 (estimated)
Completion
Jul 2011 (estimated)
Last update
Jul 26, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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