NCT00068237

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Head and Neck Cancer
• Radiation Toxicity
• Xerostomia

Interventions

Type	Name	Description
PROCEDURE	salivary gland transfer	Seikaly and Jha method of submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes on Day 1
RADIATION	Post-operative radiation therapy	Dose ranging from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction. Starts within 4-6 weeks of surgery.

Timeline

• Start date: 2003-08-01
• Primary completion: 2008-01-01
• Completion: 2016-12-01
• First posted: 2003-09-11
• Last updated: 2019-02-05
• Results posted: 2014-01-31

Locations

12 sites across 2 countries: United States, Canada