RecruitingPhase 2NCT03997643

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

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


Sponsor

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

Enrollment

90 participants

Start Date

Sep 6, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether reducing the area of the neck treated with radiation after surgery for mouth cancer can protect swallowing function while still being safe. Patients are randomly assigned to either standard radiation covering both sides of the neck or a reduced area covering only one side. **You may be eligible if...** - You have been diagnosed with mouth (oral cavity) squamous cell carcinoma that has been surgically removed - You had at least a selective neck dissection (removal of lymph nodes from the neck) on one side - Your pathology report shows features that require radiation after surgery (such as close or positive margins, nerve/vessel invasion, advanced tumor stage, or positive lymph nodes) - At least one side of the neck had no cancer found in lymph nodes, with at least 10 nodes recovered - You are in good enough health to receive radiation **You may NOT be eligible if...** - You have had head and neck cancer in the past 5 years - You have another active cancer - You previously had radiation to the head or neck - You have serious medical conditions that prevent radiation therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiotherapy to all dissected areas

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

RADIATIONOmit 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

View Full Details on ClinicalTrials.gov

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NCT03997643


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