Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
Condition(s) studied
Investigational drug(s) / intervention(s)
Radiotherapy to all dissected areas: Post operative radiation therapy +/- chemotherapy based on historic treatment volumes (including the primary site, dissected areas +/- elective areas
Omit radiation to pN0 neck: post operation radiation therapy +/- chemotherapy that avoids targeting the dissected pN0 neck
Study 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
Primary outcome measure(s)
- Regional failure in the pN0 hemi-neck (s) — Baseline to 5 years
Rate of relapse in the pN0 neck in Arm 2 compared to historical controls
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| Miami Cancer Institute | Miami | Florida | |
| London Regional Cancer Program | London | Ontario | |
| CHUM | Montreal | Quebec | |
| Cork University Hospital | Wilton | County Cork | |
| University Hospital Galway, Newcastle Road | Galway | County Galway | |
| St. Luke's Radiation Oncology Network | Rathgar | Dublin | |
| Beaumont St. Luke's Centre | Dublin | Leinster | |
| Beatson West of Scotland Cancer Centre | Glasgow | United Kingdom |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03997643 on ClinicalTrials.gov ↗ ← All trials in Ireland