Taxotere (Docetaxel) in 1st Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	November 17, 2006
Last Updated Date	March 24, 2009
Start Date ^†	January 1998
Current Primary Outcome Measures ^† (submitted: November 17, 2006)	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 ^† (submitted: November 17, 2006)	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 ^†	Head and Neck Neoplasms Neoplasm Recurrence, Local Neoplasm Metastasis
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.

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.