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A Randomized Phase II-III Multicenter Trial of Docetaxel Plus Cisplatin and Docetaxel Plus 5-FU Versus Cisplatin Plus 5-FU in 1st Line Treatment of Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck.


Phase 2/Phase 3
18 Years
75 Years
Not Enrolling
Both
Head and Neck Neoplasms, Neoplasm Recurrence, Local, Neoplasm Metastasis

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Trial Information

A Randomized Phase II-III Multicenter Trial of Docetaxel Plus Cisplatin and Docetaxel Plus 5-FU Versus Cisplatin Plus 5-FU in 1st Line Treatment of Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck.


Inclusion Criteria:



Patients with histologically or cytologically documented squamous cell carcinoma of the
head and neck (SCCHN) (eligible primary sites: oral cavity, oropharynx, hypopharyx, or
larynx) presenting with locally recurrent and/or metastatic disease, with at least 1
unidimensionally or bidimensionally measurable lesion.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

time to progression

Outcome Time Frame:

up to 5 years

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC6051

NCT ID:

NCT00401323

Start Date:

January 1998

Completion Date:

June 2003

Related Keywords:

  • Head and Neck Neoplasms
  • Neoplasm Recurrence, Local
  • Neoplasm Metastasis
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Neoplasm Metastasis
  • Neoplasm Recurrence, Local
  • Recurrence

Name

Location

Sanofi-Aventis USBridgewater, New Jersey  08807