A Phase 2 Study of Sequential and Concurrent Chemoradiation for Patients With Advanced Nasopharyngeal Carcinoma (NPC)
PRIMARY OBJECTIVE:
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)
SECONDARY OBJECTIVE:
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.
Interventional
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.
2 years
No
Alexander Colevas
Principal Investigator
Stanford University
United States: Food and Drug Administration
NCI-2009-01162
NCT00896181
January 2009
Name | Location |
---|---|
Stanford University | Stanford, California 94305 |