Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer

OBJECTIVES:

- Determine the reproducibility of the surgical technique of submandibular salivary gland
transfer in patients with head and neck cancer.

- Determine the rate and severity of radiation-induced xerostomia after this surgery in
these patients.

- Determine the pattern of recurrence, disease-free survival, and overall survival of
patients treated with this surgery followed by radiotherapy.

- Determine the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo surgical transfer of the submandibular salivary gland to the submental
space.

Within 4-6 weeks after surgery, patients undergo radiotherapy once daily, 5 days a week for 5
½ to 7 weeks in the absence of disease progression or unacceptable toxicity.

Salivary scans are performed before surgery, at 2-3 weeks after surgery, and then at 6 months
from the start of radiotherapy.

Quality of life is assessed at baseline and at 3, 6, and 12 months from the start of
radiotherapy.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years and then
annually.

PROJECTED ACCRUAL: A total of 11-48 patients will be accrued for this study within 1.6 years.

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