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Spots Global Cancer Trial Database for Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial

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Trial Identification

Brief Title: Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial

Official Title: Preservation of Swallowing in Resected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects: A Randomized Trial

Study ID: NCT03997643

Study Description

Brief 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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Miami Cancer Institute, Miami, Florida, United States

London Regional Cancer Program, London, Ontario, Canada

CHUM, Montréal, Quebec, Canada

Cork University Hospital, Wilton, County Cork, Ireland

University Hospital Galway, Newcastle Road, Galway, County Galway, Ireland

St. Luke's Radiation Oncology Network, Rathgar, Dublin, Ireland

Beaumont St. Luke's Centre, Dublin, Leinster, Ireland

Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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