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Tracking Information | |
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First Received Date † | November 17, 2006 |
Last Updated Date | March 24, 2009 |
Start Date † | January 1998 |
Current Primary Outcome Measures † |
Primary efficacy data: time to progression |
Original Primary Outcome Measures † | Same as current |
Change History | Complete list of historical versions of study NCT00401323 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † |
Secondary efficacy data: overall survival, overall response rate (complete response + partial response), duration of response, and time to treatment failure |
Original Secondary Outcome Measures † | Same as current |
Descriptive Information | |
Brief Title † | Taxotere (Docetaxel) in 1st Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma |
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. |
Brief Summary | 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. |
Detailed Description | |
Study Phase | Phase II, Phase III |
Study Type † | Interventional |
Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Condition † |
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Intervention † | Drug: docetaxel (XRP6976) |
Study Arms / Comparison Groups | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Completed |
Enrollment † | 642 |
Completion Date | |
Primary Completion Date | |
Eligibility Criteria † | 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. |
Gender | Both |
Ages | 18 Years to 75 Years |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Greece, Guadeloupe, Hungary, Israel, Italy, Russian Federation, Réunion, South Africa, Spain, Switzerland, Uruguay |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00401323 |
Responsible Party | |
Secondary IDs †† | XRP6976G-322 |
Study Sponsor † | Sanofi-Aventis |
Collaborators †† | |
Investigators † | |
Information Provided By | Sanofi-Aventis |
Verification Date | March 2009 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |