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
18 Years
75 Years
Not Enrolling
Both
Head and Neck Neoplasms, Neoplasm Recurrence, Local, Neoplasm Metastasis
Both
Head and Neck Neoplasms, Neoplasm Recurrence, Local, Neoplasm Metastasis
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 US | Bridgewater, New Jersey 08807 |
