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

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.

Trial Description

Primary Outcome:

• Regional failure in the pN0 hemi-neck (s)

Secondary Outcome:

• Swallowing Quality of life
• Swallowing Quality of life
• Swallowing Quality of life
• Health Status Quality of life
• Overall survival
• Disease free survival
• Local recurrence
• Regional recurrence
• Locoregional recurrence
• Rate of salvage treatment (surgery +/- radiation therapy) in the pN0 neck and freedom from unsalvageable neck recurrence
• Rate of feeding tub insertion and rate of feeding tube use at 1-year post randomization
• Swallowing function
• Swallowing function
• Swallowing function
• Rate of toxicity
• Rate of failure in the clinically node negative neck

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 tumour location and surrounding area) and Arm 2 (targeted radiation therapy to tumour location). Patients will be followed for a total of 5 years.

View this trial on ClinicalTrials.gov