Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
Start Date
9/6/2019
Completion Date
9/1/2026
Summary
The goal of this randomized treatment study is to formally compare quality of life in patients with at least one pN0 hemi-neck after resection of a squamous cell carcinoma of the oral cavity treated with a primary radiation therapy versus a secondary targeted radiation therapy approach, to provide a high level of evidence to guide the selection of treatment options.
Detailed Description
The goal of this randomized treatment study is to formally compare quality of life in patients with at least one pN0 hemi-neck after resection of a squamous cell carcinoma of the oral cavity treated with a primary radiation therapy versus a secondary targeted radiation therapy approach, to provide a high level of evidence to guide the selection of treatment options. The study will require a sample size of 90 patients randomized in a 2:3 between the two arms. Arm 1 (standard radiation therapy to tumor location and surrounding area) and Arm 2 (targeted radiation therapy to tumor location). Patients will be followed for a total of 5 years.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Radiotherapy to all dissected areas
Omit radiation to pN0 neck
Conditions
Locations
Miami Cancer Institute
Miami, Florida 33143
United States
London Regional Cancer Program
London, Ontario N6A 5W9
Canada
CHUM
Montreal, Quebec H2X 0A9
Canada
Cork University Hospital
Wilton, County Cork
Ireland
University Hospital Galway, Newcastle Road
Galway, County Galway H91 T861
Ireland
St. Luke's Radiation Oncology Network
Rathgar, Dublin
Ireland
Beaumont St. Luke's Centre
Dublin, Leinster D09FT51
Ireland
Beatson West of Scotland Cancer Centre
Glasgow, G12 OYN
United Kingdom