Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer
Head and Neck Cancer, Oral Complications of Radiation Therapy, Radiation Toxicity
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring oral complications of radiation therapy, radiation toxicity, stage I squamous cell carcinoma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage I-IVB squamous cell carcinoma of the nasopharynx WHO I-III No stage IVC disease No evidence of distant metastasis Measurable or evaluable disease Must have been treated with primary radiotherapy PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic White blood cell count (WBC) at least 4,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic Not specified Renal Creatinine no greater than 1.6 mg/dL Creatinine clearance at least 60 mL/min Other Not pregnant (If stage T2b or greater or node-positive disease) Negative pregnancy test (If stage T2b or greater or node-positive disease) No other prior head and neck cancer No other malignancy within the past 5 years except nonmelanoma skin cancer No active untreated infection No other major medical or psychiatric illness that would preclude study entry Nutritional and general physical condition compatible with radiotherapy NOTE: *If stage T2b or greater or node-positive disease PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy More than 6 months since prior chemotherapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics More than 6 months since prior radiotherapy for head and neck cancer Surgery No prior head and neck surgery to the primary tumor or lymph nodes except incisional or excisional biopsies Other No other concurrent experimental therapy for cancer No amifostine or pilocarpine during or for 3 months after radiotherapy
Sites / Locations
- Comprehensive Cancer Center at University of Alabama at Birmingham
- University of California Davis Cancer Center
- Radiological Associates of Sacramento Medical Group, Incorporated
- UCSF Comprehensive Cancer Center
- Northeast Georgia Medical Center
- Mayo Clinic Cancer Center
- Siteman Cancer Center at Barnes-Jewish Hospital
- Monmouth Medical Center
- Albuquerque Regional Medical Center at Lovelace Sandia Health System
- Akron City Hospital
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Fox Chase-Temple Cancer Center
- CCOP - MainLine Health
- M.D. Anderson Cancer Center at University of Texas
- Wilford Hall Medical Center
- McKay-Dee Hospital Center
- Medical College of Wisconsin Cancer Center
Arms of the Study
Arm 1
Experimental
IMRT +/- chemotherapy
Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+