Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer
Head and Neck Cancer, Radiation Toxicity, Xerostomia
About this trial
This is an interventional supportive care trial for Head and Neck Cancer focused on measuring xerostomia, radiation toxicity, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, untreated metastatic squamous neck cancer with occult primary, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the oropharynx
Eligibility Criteria
DISEASE CHARACTERISTICS: One of the following diagnoses: Histologically confirmed, previously untreated squamous cell carcinoma of the oropharynx, hypopharynx, or larynx Head and neck cancer of unknown primary with unilateral metastases to the neck nodes No N3 disease No carcinoma of the oral cavity or nasopharynx No bilateral neck node involvement No suspicious neck node on the contralateral neck or the side chosen for salivary gland transfer by CT scan or MRI No pre-epiglottic space involvement No involvement of level 1 nodes on either side of the neck No salivary gland malignancy No recurrent disease PATIENT CHARACTERISTICS: Age At least 18 years old Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Hemoglobin at least 10 g/dL Hepatic Not specified Renal Not specified Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No salivary gland disease (e.g., Sjögren's syndrome) No other malignancy within the past 3 years except basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy More than 3 years since prior chemotherapy No prior or concurrent neoadjuvant chemotherapy Concurrent adjuvant chemoradiotherapy (in addition to study radiotherapy) allowed Endocrine therapy Not specified Radiotherapy See Chemotherapy No prior radiotherapy to the head and neck No concurrent intensity-modulated radiotherapy Surgery Not specified Other No concurrent cholinergic drugs No concurrent anti-cholinergic drugs No concurrent tricyclic drugs No concurrent prophylactic amifostine or pilocarpine during and for at least 3 months after completion of study radiotherapy
Sites / Locations
- University of Florida Shands Cancer Center
- University of Miami Sylvester Comprehensive Cancer Center - Miami
- Cancer Institute at St. John's Hospital
- Josephine Ford Cancer Center at Henry Ford Hospital
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
- Hollings Cancer Center at Medical University of South Carolina
- M. D. Anderson Cancer Center at University of Texas
- Medical College of Wisconsin Cancer Center
- Veterans Affairs Medical Center - Milwaukee
- Cross Cancer Institute at University of Alberta
- Doctor H. Bliss Murphy Cancer Centre
- Centre Hospitalier Universitaire de Quebec
Arms of the Study
Arm 1
Experimental
Surgery + Transfer + Radiation
Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.