NCT00565448

Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 1 Month – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nasopharyngeal Neoplasms
• Carcinoma

Interventions

Type	Name	Description
DRUG	docetaxel	Pharmaceutical form:solution for infusion Route of administration:intravenous
DRUG	cisplatin	Pharmaceutical form:solution for infusion Route of administration:intravenous
DRUG	5-fluorouracil	Pharmaceutical form:solution for infusion Route of administration:intravenous

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-03-01
• Completion: 2012-01-01
• First posted: 2007-11-30
• Last updated: 2015-07-30
• Results posted: 2010-03-25

Locations

26 sites across 14 countries: Algeria, Brazil, China, France, India, Indonesia, Italy, Mexico, Morocco, Philippines, South Korea, Thailand, Tunisia, Turkey (Türkiye)