Spots Global Cancer Trial Database for Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents
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Trial Identification
Brief Title: Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents
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
Study ID: NCT00565448
Study Description
Brief Summary: 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: * the safety of TCF in comparison to CF after induction treatment of NPC, * the pharmacokinetics of docetaxel when added to CF, * the Overall Response rate of TCF and CF on completion of induction and consolidation (chemo-radiotherapy) treatment of NPC, and to compare overall survival between TCF and CF.
Detailed Description: Planned treatment duration: * induction period: 9 weeks of induction treatment * consolidation period: 9 weeks of chemoradiation treatment. The consolidation treatment was the same for all participants: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks.
Keywords
Eligibility
Minimum Age: 1 Month
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigational Site Number 012001, Alger, , Algeria
Investigational Site Number 076002, Rio De Janeiro, , Brazil
Investigational Site Number 076001, Sao Paulo, , Brazil
Investigational Site Number 156005, Fuzhou, , China
Investigational Site Number 250001, Villejuif Cedex, , France
Investigational Site Number 356003, Ahmedabad, , India
Investigational Site Number 356004, Kolkata, , India
Investigational Site Number 356002, Thiruvananthapuram, , India
Investigational Site Number 356001, Vellore, , India
Investigational Site Number 360001, Jakarta, , Indonesia
Investigational Site Number 380001, Milano, , Italy
Investigational Site Number 410001, Seoul, , Korea, Republic of
Investigational Site Number 410003, Seoul, , Korea, Republic of
Investigational Site Number 410002, Seoul, , Korea, Republic of
Investigational Site Number 484001, Villahermosa, , Mexico
Investigational Site Number 504001, Casablanca, , Morocco
Investigational Site Number 504002, Rabat, , Morocco
Investigational Site Number 504003, Rabat, , Morocco
Investigational Site Number 608002, Quezon City, , Philippines
Investigational Site Number 764001, Bangkok, , Thailand
Investigational Site Number 764002, Chiang Mai, , Thailand
Investigational Site Number 788002, Sousse, , Tunisia
Investigational Site Number 788003, Tunis, , Tunisia
Investigational Site Number 792003, Abacioglu, , Turkey
Investigational Site Number 792001, Ankara, , Turkey
Investigational Site Number 792002, Istanbul, , Turkey
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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