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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00401323 |
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Date of registration:
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17/11/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Taxotere (Docetaxel) in 1st Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
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Scientific title:
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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. |
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Date of first enrolment:
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January 1998 |
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Target sample size:
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568 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00401323 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belgium
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Brazil
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Canada
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France
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Germany
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Greece
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Guadeloupe
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Hungary
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Israel
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Italy
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Réunion
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Russian Federation
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South Africa
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Spain
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Switzerland
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United States
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Uruguay
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Contacts
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Name:
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Clinical Sciences & Operations |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Head and Neck Neoplasms
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Neoplasm Metastasis
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Neoplasm Recurrence, Local
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Intervention(s)
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Drug: cisplatin
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Drug: docetaxel (XRP6976)
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Drug: 5-fluorouracil (5-FU)
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Primary Outcome(s)
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time to progression
[Time Frame: up to 5 years]
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Secondary Outcome(s)
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overall survival, overall response rate (complete response + partial response), duration of response, and time to treatment failure
[Time Frame: up to 5 years]
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Secondary ID(s)
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EFC6051
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XRP6976G-322
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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