Head and Neck Cancer Clinical Trial
Official title:
A Phase II Study Of Alternating Chemoradiotherapy For Nasopharyngeal Cancer Using Cisplatin And 5-Fluorouracil
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in 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 fluorouracil and cisplatin with
radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving fluorouracil and cisplatin together
with radiation therapy works in treating patients with stage II, stage III, or stage IV
nasopharyngeal cancer.
OBJECTIVES:
Primary
- Determine progression-free survival of patients with previously untreated stage IIB-IVB
nasopharyngeal cancer treated with fluorouracil, cisplatin, and radiotherapy.
Secondary
- Determine overall survival and response rate in patients treated with this regimen.
- Determine compliance to this regimen in these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive chemotherapy comprising fluorouracil IV continuously on days 1-5 and
cisplatin IV continuously on days 6-7. Beginning 2-3 days after the completion of
chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 4 weeks. With 2-3
days between each course, patients receive a second course of chemotherapy, undergo a second
course of radiotherapy, and then receive a third course of chemotherapy. Treatment continues
in the absence of unacceptable toxicity or disease progression.
Patients are followed for 3 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 2 years.
;
Masking: Open Label, Primary Purpose: Treatment
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