NCT03997643Active, not recruitingPhase 2
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
Preservation of Swallowing in Resected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects: A Randomized Trial
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 14 Jun 2019
- Start date
- 6 Sept 2019
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Diseases
- Head and neck cancer
- NCT number
- NCT03997643
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From 6 Sept 2019 to the primary completion date, 30 Sept 2027
- 8 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Serious medical comorbidities or other contraindications to radiotherapy
- Prior history of head and neck cancer within 5 years
- Prior head and neck radiation at any time
- Prior oncologic head and neck surgery in the oral cavity or neck
- 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
Other illness
- Any other active invasive malignancy, except non-melanotic skin cancers
- Metastatic disease
Other
- Unable or unwilling to complete QoL questionnaires
- Pregnant or lactating women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Regional Cancer Program Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| CHUM Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Beatson West of Scotland Cancer Centre Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Beaumont St. Luke's Centre Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| University Hospital Galway, Newcastle Road Coordinator of this site? Confirm its status | Galway | Ireland | Unknown status |
| St. Luke's Radiation Oncology Network Coordinator of this site? Confirm its status | Rathgar | Ireland | Unknown status |
| Cork University Hospital Coordinator of this site? Confirm its status | Wilton | Ireland | Unknown status |
| Miami Cancer Institute Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.