Conditions: Nasopharyngeal Neoplasms Carcinoma
Keywords: Nasopharyngeal carcinoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 75
Healthy volunteers: no

Brief 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.

Arms:
arm 1: * Docetaxel 75 milligrams per square meter (mg/m²) over 1 hour on Day 1 every 3 weeks
* Cisplatin 75 mg/m² Day 1 over 6 hours every 3 weeks
* 5-Fluorouracil 750 mg/m²/day continuous infusion Days 1 to 4 every 3 weeks as an induction therapy

Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. arm 2: * Cisplatin 80 mg/m² Day 1 over 6 hours every 3 weeks
* 5-Fluorouracil 1000 mg/m²/day continuous infusion Day 1 to 4 every 3 weeks as an induction therapy.

Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks.

Interventions: intervention 1: docetaxel intervention 2: cisplatin intervention 3: 5-fluorouracil
Intervention descriptions: intervention 1: Pharmaceutical form:solution for infusion

Route of administration:intravenous intervention 2: Pharmaceutical form:solution for infusion

Route of administration:intravenous intervention 3: Pharmaceutical form:solution for infusion

Route of administration:intravenous

Protocol document: