Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
Recruiting
Phase 2
Interventional Study
Head and Neck Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 90 (estimated)
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 (≤…
Contacts
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