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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.
The purpose of the study is to compare time to progression and overall survival after treatment with Taxotere plus cisplatin versus cisplatin plus 5-FU (PF treatment group) in the first line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
sanofi-aventis US
Bridgewater, New Jersey, United States
Sanofi-Aventis
Buenos Aires, Argentina
sanofi-aventis, Australia
Macquarie Park, New South Wales, Australia
Sanofi-Aventis
Vienna, Austria
sanofi-aventis, Belgium
Diegem, Belgium
Sanofi-Aventis
Rio de Janeiro, Brazil
sanofi-aventis Canada
Laval, Quebec, Canada
sanofi-aventis, France
Paris, France
sanofi-aventis Germany
Berlin, Germany
sanofi-aventis Greece
Athens, Greece
Start Date
January 1, 1998
Primary Completion Date
June 1, 2003
Completion Date
June 1, 2003
Last Updated
January 20, 2011
568
ACTUAL participants
docetaxel (XRP6976)
DRUG
cisplatin
DRUG
5-fluorouracil (5-FU)
DRUG
Lead Sponsor
Sanofi
NCT07213804
NCT07046923
Data Source & Attribution
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