Head and Neck Cancer Clinical Trial
Official title:
A Phase II Study Of Intensity Modulated Radiation Therapy (IMRT) +/- Chemotherapy For Nasopharyngeal Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation
therapy in different ways may cause less damage to normal tissue, prevent or lessen mouth
dryness, and may help patients live more comfortably. Drugs used in chemotherapy use
different ways to stop tumor cells from dividing so they stop growing or die. Combining
chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of specialized radiation therapy
techniques with or without chemotherapy in reducing mouth dryness in patients who have
nasopharyngeal cancer.
OBJECTIVES:
- Determine the transportability of IMRT to a multi-institutional setting.
- Determine the rate of late xerostomia in patients with nasopharyngeal cancer treated
with intensity-modulated radiotherapy (IMRT) with or without chemotherapy.
- Correlate reduction of side effects on salivary flow with compliance in patients
treated with these regimens.
- Determine the rate of local-regional control, distant metastasis, and disease-free and
overall survival of patients treated with these regimens.
- Determine the acute and late toxicity of these regimens in these patients.
- Determine chemotherapy compliance in patients treated with these regimens.
OUTLINE: Patients undergo daily intensity-modulated radiotherapy (IMRT) 5 days a week for
approximately 6.5 weeks (total of 33 fractions) in the absence of disease progression or
unacceptable toxicity.
Patients with stage T2b or greater and/or node-positive disease receive cisplatin IV over
20-30 minutes on days 1, 22, and 43 concurrently with IMRT followed by cisplatin IV over
20-30 minutes and fluorouracil IV over 96 hours starting on days 71, 99, and 127.
Quality of life is assessed through saliva measurement at baseline and then at 3, 6, and 12
months after IMRT.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 64 patients will be accrued for this study within 36-40
months.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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