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

Radiation Therapy Oncology Group49 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer Radiation Toxicity Xerostomia

Interventions

salivary gland transferPROCEDURE

Seikaly and Jha method of submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes on Day 1

Post-operative radiation therapyRADIATION

Dose ranging from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction. Starts within 4-6 weeks of surgery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

University of Florida Shands Cancer Center

Gainesville, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol"

Surgery will be scored as "per protocol prescription" if scored as such by both central reviewers- the Study Chair and the Radiation Therapy Oncology Group Head and Neck Committee Surgical Chair. If 21 or more of 43 subjects are scored as having surgery "per protocol prescription", then the technique will be considered reproducible with 80% power and 5% type I error using Simon's two stage design with unacceptable/acceptable rates set at 60%/80%.

Time frame: At the time of the submandibular salivary gland transfer

Secondary Outcomes

Percentage of Patients With Acute Xerostomia

The proportion of patients who experience grade 2 or higher xerostomia or start amifostine and/or pilocarpine within 90 days of the start of radiation therapy. A proportion less than or equal to 51% would be considered acceptable based on the results of the U.S. Bioscience phase III amifostine trial (this trial preceded FDAAA requirements).

Time frame: From start of treatment to 90 days

Percentage of Patients With Normal Functioning Transferred Submandibular Gland

Salivary gland functioning classified as "Non-functioning", "Minimal function", "Well-functioning but some impairment", "Normal functioning", or "Other" is determined by central review of scintigraphy scans using sodium pertechnetate (Na-99mTcO4-) with a sialagogue (lemon juice) administered halfway through the study to determine if secretory function is maintained.

Time frame: Pre-surgery, post-surgery (4-6 weeks), post radiation therapy (10-13 weeks)

Change From Baseline to One Year in Total Score on the Modified University of Washington Head and Neck Symptom Questionnaire

The University of Washington Head and Neck Symptom Questionnaire, also referred to as the University of Washington Health Related Quality of Life tool (UW-QOL) was modified for use by the Radiation Therapy Oncology Group (RTOG). The resulting UW-QOL-RTOG modification is a valid tool that can be used to assess symptom burden of head and neck cancer patients receiving radiation therapy or those who have recently completed radiation. The UW-QOL-RTOG modification consists of 15 items with response options ranging from 10-50, in multiples of 10. That is, the lowest symptom burden is rated as 10, while the highest symptom burden is rated as 50. The individual item scores are averaged to obtain the final score which also ranges from 10 to 50. This scoring results in a lower score indicating greater HR-QOL; and conversely, higher scores indicating lower health-related quality of life (HR-QOL). Change = baseline score - one year score, such that a positive change score indicates improvement.

Data from ClinicalTrials.gov

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