A Feasibility Study Of Primary Chemotherapy Followed By Concomitant Chemoradiation With And Without Amifostine In Patients With Locally Advanced Undifferentiated Nasopharyngeal Cancer (UNPC)
- Compare the overall incidence of grade 3 or 4 mucositis in patients with locally
advanced undifferentiated nasopharyngeal cancer treated with paclitaxel and carboplatin
followed by cisplatin and radiotherapy with or without amifostine.
- Compare the feasibility and activity of these regimens in these patients.
- Determine the toxicity of paclitaxel and carboplatin in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to WHO
performance status (0 vs 1 vs 2), response to induction chemotherapy (complete vs partial vs
stable disease vs not evaluable), and participating center.
Patients receive induction chemotherapy comprising paclitaxel IV over 3 hours and
carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses
in the absence of disease progression or unacceptable toxicity.
Patients with a complete or partial response after 2 courses of induction chemotherapy
receive 2 additional courses before randomization. Patients with stable disease after 2
courses of induction chemotherapy or who cannot be evaluated after 1 course proceed directly
to randomization. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cisplatin IV on days 1, 22, and 43. Patients also undergo
radiotherapy daily 5 days a week for 6.5 weeks.
- Arm II:Patients receive amifostine subcutaneously daily. Patients receive chemotherapy
and radiotherapy as in arm I.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then
PROJECTED ACCRUAL: A total of 41-93 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Lisa Licitra, MD
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
United States: Federal Government