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NCT03997643PHASE2Recruiting

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

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

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

Inclusion Criteria: * Willing to provide informed consent * ECOG performance status 0-2 * Histologically confirmed, resected oral cavity squamous cell carcinoma with at least ipsilateral selective neck disection * Patient has pathological features that are indications for PORT: positive or close (≤ 3 mm) margin, presence of LVI or PNU, pT3 or pT4 disease, positive lymph nodes, and PORT is recommended by treating physician * Pathologically lympth node negative in at least one dissected hemi-neck with at least 10 nodes recovered in each pN0 hemi-neck Exclusion Criteria: * Serious medical comorbidities or other contraindications to radiotherapy * Prior history of head and neck cancer within 5 years * Any other active invasive malignancy, except non-melanotic skin cancers * Prior head and neck radiation at any time * Prior oncologic head and neck surgery in the oral cavity or neck * Metastatic disease * Locoregional disease recurrence identified following surgical resection but prior to the start of radiotherapy * Inability to attend full course of radio therapy or follow-up visits * Unable or unwilling to complete QoL questionnaires * Pregnant or lactating women

Interventions

RADIATION

Radiotherapy to all dissected areas

RADIATION

Omit radiation to pN0 neck

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Conditions

Head and Neck Cancer

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