A Pilot Study to Evaluate the Feasibility of Combining Submandibular Salivary Gland Tx & IMRT Tomo to Reduce Xerostomia
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A Pilot Study to Evaluate the Feasibility of Combining Submandibular Salivary Gland Transfer Procedure and Intensity Modulated Radiation Therapy (Helical Tomotherapy) to Reduce Dryness of Mouth (Xerostomia) in Head and Neck Cancer Patients After Surgery
Study Start Date
Estimated Primary Completion Date
Estimated Study Completion Date
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
histologically-proven newly-diagnosed squamous cell carcinoma of oropharynx, larynx, hypopharynx and unknown primary of cancer with neck node metastasis after primary surgery
AJCC stage I-IV patients are eligible provided they are MO and NO-2b
18 years of age or older
KPS of 70 or greater
N3/N2C disease or M1 disease
salivary gland disease i.e. Sjogren's syndrome
prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
prior radiotherapy to the head and neck region
lymph node involvement (level I-III) or proximity of disease to submandibular gland on the side chosen for salivary gland transfer on frozen section or permanent pathological evaluation
pre-epiglottic space involvement on pathological examination
involvement of level I nodes on either side of neck