A Phase 2 Study of Sequential and Concurrent Chemoradiation for Patients With Advanced Nasopharyngeal Carcinoma (NPC)
I. To establish the progression free survival rate at 2 years, using RECIST criteria, to
induction treatment with docetaxel, cisplatin, and fluorouracil (TPF) followed by
chemoradiotherapy of locoregionally advanced nasopharyngeal carcinoma (NPC)
I. To evaluate complete response rates, safety and feasibility of TPF followed by
chemoradiation in patients with NPC
OUTLINE: This is a single site study.
INDUCTION THERAPY: Patients receive docetaxel IV over 60 minutes on day 1; cisplatin IV over
1-3 hours (or carboplatin IV over 30 minutes) on day 1; and fluorouracil IV continuously
over 24 hours on days 1-5. Treatment repeats every 21 days for up to 3 courses in the
absence of disease progression or unacceptable toxicity.
CONCURRENT CHEMORADIOTHERAPY: Beginning within 3-6 weeks after initiating the last course of
induction chemotherapy, patients undergo 3-dimensional conformal or intensity-modulated
radiotherapy once daily for 6.5-7 weeks. Patients also receive cisplatin IV over 1 hour (or
carboplatin IV over 30 minutes) once weekly in weeks 1-6 in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 2 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival rate, using RECIST criteria
Estimated according to the methods of Kaplan and Meier.
United States: Food and Drug Administration
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