Carcinoma Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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