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
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.
- Histological diagnosis of nasopharyngeal carcinoma World Health Organization (WHO)
type II or III
- Children and adolescents newly diagnosed with Stage IIB-IV NPC with measurable
disease, who are >1 month to ≤21 years of age at the time of diagnosis. In France,
patients must be ≥1 year to ≤21 years of age at the time of diagnosis
- Patients with short life expectancy
- Prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of
- Inadequate renal function evidenced by unacceptable laboratory results
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.