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

A Phase II Study Of Submandibular Salivary Gland Transfer To The Submental Space Prior To Start Of Radiation Treatment For Prevention Of Radiation-Induced Xerostomia In Head And Neck Cancer Patients

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.

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