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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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

Where this trial is running

• 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