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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Squamous Cell Carcinoma

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Trial Information

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)


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate

Safety Issue:

No

Authority:

Korea: Food and Drug Administration

Study ID:

CRCST-L-0004

NCT ID:

NCT00805012

Start Date:

December 2008

Completion Date:

July 2011

Related Keywords:

  • Head and Neck Squamous Cell Carcinoma
  • S-1
  • docetaxel
  • head and neck cancer
  • Recurrent or metastatic head and neck squamous cell carcinoma
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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