Head and Neck Cancer Clinical Trial
Official title:
A Feasibility Study Of Primary Chemotherapy Followed By Concomitant Chemoradiation With And Without Amifostine In Patients With Locally Advanced Undifferentiated Nasopharyngeal Cancer (UNPC)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor
cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Giving
chemoprotective drugs such as amifostine may protect normal cells from the side effects of
chemotherapy and radiation therapy.
PURPOSE: Randomized phase II trial to compare the effectiveness of paclitaxel and
carboplatin followed by cisplatin plus radiation therapy with or without amifostine in
treating patients who have locally advanced cancer of the nasopharynx.
OBJECTIVES:
- 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
annually thereafter.
PROJECTED ACCRUAL: A total of 41-93 patients will be accrued for this study.
;
Allocation: Randomized, Primary Purpose: Treatment
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