At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed, previously untreated squamous cell carcinoma of the oropharynx, hypopharynx, or larynx
- ✓Head and neck cancer of unknown primary with unilateral metastases to neck nodes
- ✓Age at least 18 years old
- ✓Zubrod performance status 0-1
- ✕N3 disease
- ✕Carcinoma of the oral cavity or nasopharynx
- ✕Bilateral neck node involvement
- ✕Suspicious neck node on the contralateral neck or the side chosen for salivary gland transfer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating salivary gland transfer and Post-operative radiation therapy for Head and Neck Cancer and 2 related conditions. Completed, enrolled 49 participants across 12 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.