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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00565448 |
The primary objective is to estimate the Complete Response rate of docetaxel to the combination of cisplatin-5-fluorouracil (TCF) compared to cisplatin-5-fluorouracil (CF) in the Induction treatment of Nasopharyngeal Carcinoma (NPC).
The secondary objectives are to determine:
Condition | Intervention | Phase |
---|---|---|
Nasopharyngeal Neoplasms Carcinoma |
Drug: docetaxel (XRP6976) Drug: cisplatinum Drug: fluorouracil |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | International Randomized Study to Evaluate the Addition of Docetaxel to the Combination of Cisplatin-5-Fluorouracil (TCF) vs. Cisplatin-5-Fluorouracil (CF) in the Induction Treatment of Nasopharyngeal Carcinoma (NPC) in Children and Adolescents |
Estimated Enrollment: | 72 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | September 2012 |
Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
TCF: Experimental |
Drug: docetaxel (XRP6976)
IV route
Drug: cisplatinum
IV route
Drug: fluorouracil
IV route
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CF: Active Comparator |
Drug: cisplatinum
IV route
Drug: fluorouracil
IV route
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Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
United States, New Jersey | |
Sanofi-Aventis Aministrative Office | |
Bridgewater, New Jersey, United States, 08807 | |
Algeria | |
Sanofi-Aventis Administrative Office | |
Alger, Algeria | |
Brazil | |
Sanofi-Aventis Aministrative Office | |
Sao Paulo, Brazil | |
China | |
Sanofi-Aventis Administrative Office | |
Beijing, China | |
France | |
Sanofi-Aventis Administrative Office | |
Paris, France | |
India | |
Sanofi-Aventis Aministrative Office | |
Mumbai, India | |
Indonesia | |
Sanofi-Aventis Administrative Office | |
Jakarta, Indonesia | |
Italy | |
Sanofi-Aventis Aministrative Office | |
Milano, Italy | |
Korea, Republic of | |
Sanofi-Aventis Aministrative Office | |
Seoul, Korea, Republic of | |
Mexico | |
Sanofi-Aventis Administrative Office | |
Mexico, Mexico | |
Morocco | |
Sanofi-Aventis Administrative Office | |
Casablanca, Morocco | |
Philippines | |
Sanofi-Aventis Administrative Office | |
Makati City, Philippines | |
Thailand | |
Sanofi-Aventis Aministrative Office | |
Bangkok, Thailand | |
Tunisia | |
Sanofi-Aventis Administrative Office | |
Megrine, Tunisia | |
Turkey | |
Sanofi-Aventis Aministrative Office | |
Istanbul, Turkey |
Study Director: | ICD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC10339 |
Study First Received: | November 29, 2007 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00565448 |
Health Authority: | United States: Food and Drug Administration; Hong Kong: Ethics Committee; India: Ministry of Health; Turkey: Ministry of Health |
Nasopharyngeal carcinoma |
Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Pharyngeal Neoplasms Pharyngeal Diseases Nasopharyngeal Neoplasms Carcinoma Docetaxel |
Nasopharyngeal carcinoma Cisplatin Head and Neck Neoplasms Fluorouracil Stomatognathic Diseases Neoplasms, Glandular and Epithelial |
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Nasopharyngeal Diseases |