Actively Recruiting
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2023-08-03
90
Participants Needed
8
Research Sites
364 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to provide informed consent
- ECOG performance status 0-2
- Histologically confirmed, resected oral cavity squamous cell carcinoma with at least ipsilateral selective neck dissection
- Pathological features indicating postoperative radiation therapy (positive or close margin ≤ 3 mm, lymphovascular invasion or perineural invasion, pT3 or pT4 disease, positive lymph nodes) recommended by treating physician
- Pathologically lymph node negative in at least one dissected hemi-neck with at least 10 nodes recovered in each pN0 hemi-neck
You will not qualify if you...
- Serious medical comorbidities or contraindications to radiotherapy
- Prior head and neck cancer within 5 years
- Any other active invasive cancer 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 after surgery but before radiotherapy
- Unable to attend full radiation therapy or follow-up visits
- Unable or unwilling to complete quality of life questionnaires
- Pregnant or lactating women
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Miami Cancer Institute
Miami, Florida, United States, 33143
Actively Recruiting
2
London Regional Cancer Program
London, Ontario, Canada, N6A 5W9
Actively Recruiting
3
CHUM
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
4
Cork University Hospital
Wilton, County Cork, Ireland
Actively Recruiting
5
University Hospital Galway, Newcastle Road
Galway, County Galway, Ireland, H91 T861
Actively Recruiting
6
St. Luke's Radiation Oncology Network
Rathgar, Dublin, Ireland
Actively Recruiting
7
Beaumont St. Luke's Centre
Dublin, Leinster, Ireland, D09FT51
Actively Recruiting
8
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 OYN
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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