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

RATIONALE: Moving a salivary gland out of the area that will undergo radiation therapy may protect the gland from side effects of radiation therapy and may prevent xerostomia (dry mouth).

PURPOSE: Phase II trial to study the effectiveness of salivary gland surgery in preventing xerostomia in patients who are undergoing radiation therapy for 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.

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