Neoplasm Metastasis Clinical Trial
Official title:
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.
Verified date | January 2011 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 568 |
Est. completion date | June 2003 |
Est. primary completion date | June 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Sanofi-Aventis | Buenos Aires | |
Australia | sanofi-aventis, Australia | Macquarie Park | New South Wales |
Austria | Sanofi-Aventis | Vienna | |
Belgium | sanofi-aventis, Belgium | Diegem | |
Brazil | Sanofi-Aventis | Rio de Janeiro | |
Canada | sanofi-aventis Canada | Laval | Quebec |
France | sanofi-aventis, France | Paris | |
Germany | sanofi-aventis Germany | Berlin | |
Greece | sanofi-aventis Greece | Athens | |
Guadeloupe | Sanofi-Aventis | Basse-Terre | |
Hungary | Sanofi-Aventis Hungaria | Budapest | |
Israel | sanofi-aventis Israel | Natanya | |
Italy | sanofi-aventis Italy | Milano | |
Réunion | Sanofi-Aventis | Saint-Denis | |
Russian Federation | Sanofi-Aventis | Moscow | |
South Africa | sanofi-aventis South Africa | Midrand | |
Spain | Sanofi-Aventis | Madrid | |
Switzerland | sanofi-aventis Switzerland | Geneva | |
United States | sanofi-aventis US | Bridgewater | New Jersey |
Uruguay | Sanofi-Aventis | Montevideo |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
United States, Uruguay, Argentina, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Greece, Guadeloupe, Hungary, Israel, Italy, Russian Federation, Réunion, South Africa, Spain, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | time to progression | up to 5 years | No | |
Secondary | overall survival, overall response rate (complete response + partial response), duration of response, and time to treatment failure | up to 5 years | No |
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