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RECRUITING
NCT03997643
PHASE2

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

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2019-09-06

Completion Date

2026-09

Last Updated

2023-08-03

Healthy Volunteers

No

Interventions

RADIATION

Radiotherapy to all dissected areas

Post operative radiation therapy +/- chemotherapy based on historic treatment volumes (including the primary site, dissected areas +/- elective areas

RADIATION

Omit radiation to pN0 neck

post operation radiation therapy +/- chemotherapy that avoids targeting the dissected pN0 neck

Locations (8)

Miami Cancer Institute

Miami, Florida, United States

London Regional Cancer Program

London, Ontario, Canada

CHUM

Montreal, 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