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
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 patients: Radiation Therapy for 7-8 weeks
and 3 cycles of cisplatin 100 mg/m2 every 21 days.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete Response (CR)
CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the induction treatment and prior to the radiation treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.
after the completion of the induction treatment (up to 9 weeks)
Clinical Sciences & Operations
United States: Food and Drug Administration