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About
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.
Full description
OBJECTIVES:
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed stage I-IVB squamous cell carcinoma of the nasopharynx
Measurable or evaluable disease
Must have been treated with primary radiotherapy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Primary purpose
Allocation
Interventional model
Masking
68 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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