Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
Recruiting now · Phase 2
Conditions studied: Head and Neck Cancer
In brief
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.
Key facts
- Study ID
- NCT03997643
- Run by
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- People needed
- 90
- Starts
- 2019-09-06
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2023-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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 it is running
- Miami Cancer Institute — Miami, Florida, United States (enrolling)
- London Regional Cancer Program — London, Ontario, Canada (enrolling)
- CHUM — Montreal, Quebec, Canada (enrolling)
- Cork University Hospital — Wilton, County Cork, Ireland (enrolling)
- University Hospital Galway, Newcastle Road — Galway, County Galway, Ireland (enrolling)
- St. Luke's Radiation Oncology Network — Rathgar, Dublin, Ireland (enrolling)
- Beaumont St. Luke's Centre — Dublin, Leinster, Ireland (enrolling)
- Beatson West of Scotland Cancer Centre — Glasgow, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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