Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents
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.
Timeline
- Start
- 2007-11
- Primary completion
- 2009-03
- Completion
- 2012-01
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Docetaxel /Cisplatin/5-FU vs Cisplatin/5-FU; p = 1.0000; Fisher Exact; NCT00565448 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 80 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 100 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 750 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 1000 mg/m2 | Intravenous |