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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00273546 |
Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: XRP6976 (Docetaxel/Taxotere) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase III Multicenter Trial of Neoadjuvant Docetaxel (Taxotere®) Plus Cisplatin and 5-Fluorouracil (TPF) Versus Neoadjuvant Cisplatin Plus 5-Fluorouracil Followed by Concomitant Chemoradiotherapy to Improve the Overall Survival and Progression Free Survival in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck |
| Enrollment: | 500 |
| Study Start Date: | May 1999 |
| Study Completion Date: | February 2006 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New Jersey | |
| Sanofi-Aventis Administrative Office | |
| Bridgewater, New Jersey, United States, 08807 | |
| Argentina | |
| Sanofi-Aventis Administrative Office | |
| Buenos Aires, Argentina | |
| Canada | |
| Sanofi-Aventis Administrative Office | |
| Laval, Canada | |
| France | |
| Sanofi-Aventis Administrative Office | |
| Paris, France | |
| Portugal | |
| Sanofi-Aventis Administrative Office | |
| Porto Salvo, Portugal | |
| Russian Federation | |
| Sanofi-Aventis Administrative Office | |
| Moscow, Russian Federation | |
| Study Chair: | Marshall Posner, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00273546 History of Changes |
| Obsolete Identifiers: | NCT00004214 |
| Other Study ID Numbers: | EFC6043, RP-56976-V-324 |
| Study First Received: | January 6, 2006 |
| Last Updated: | April 28, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Head and Neck Cancer Induction Chemotherapy Chemoradiotherapy |
|
Carcinoma, Squamous Cell Head and Neck Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site Docetaxel Cisplatin Fluorouracil |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |