Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer
Condition: Head and Neck Cancer; Radiation Toxicity; Xerostomia
MeSH terms: Head and Neck Neoplasms; Xerostomia
Intervention: salivary gland transfer; Post-operative radiation therapy
Intervention description: Seikaly and Jha method of submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes on Day 1; Dose ranging from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction. Starts within 4-6 weeks of surgery.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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

Summary:

      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.
    

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