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NCT03997643 · ClinicalTrials.gov registry record · Phase 2
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
A Phase 2 study of Head and Neck Cancer, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 8
- Study locations
NCT03997643: Recruiting Phase 2 study of Head and Neck Cancer, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
NCT03997643 is a Phase 2 study of Head and Neck Cancer that is actively recruiting participants, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The registered enrollment target is 90 participants, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (65% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03997643, a Phase 2 study of Head and Neck Cancer, is actively recruiting participants, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 8
- Study locations
Study Summary
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.
Primary Outcome
Rate of relapse in the pN0 neck in Arm 2 compared to historical controls
Conditions Studied
Interventions
- RADIATION Radiotherapy to all dissected areas
- RADIATION Omit radiation to pN0 neck
Study Locations (8)
Florida
- Miami Cancer Institute - Miami
Ontario
- London Regional Cancer Program - London
Quebec
- CHUM - Montreal
County Cork
- Cork University Hospital - Wilton
County Galway
- University Hospital Galway, Newcastle Road - Galway
Dublin
- St. Luke's Radiation Oncology Network - Rathgar
Leinster
- Beaumont St. Luke's Centre - Dublin
Other
- Beatson West of Scotland Cancer Centre - Glasgow
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2019-09-06 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
What NCT03997643 shows while recruiting
NCT03997643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 2 interventions - of which Radiotherapy to all dissected areas is the first listed.
NCT03997643 lists 8 locations in 8 states (Florida, Ontario, Quebec).
Frequently Asked Questions
What is clinical trial NCT03997643 about?
NCT03997643 is a clinical study titled "Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized 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...
What is the current status of trial NCT03997643?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2019-09-06. Estimated completion is 2026-09.
What conditions does trial NCT03997643 study?
This clinical trial studies the following conditions: Head and Neck Cancer.
What interventions are being tested in trial NCT03997643?
The interventions under investigation include: Radiotherapy to all dissected areas (RADIATION), Omit radiation to pN0 neck (RADIATION).
Who is sponsoring clinical trial NCT03997643?
This trial is sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03997643 being conducted?
This trial has 8 study locations across Florida, Ontario, Quebec, County Cork, County Galway. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03997643's enrollment target sits among peer trials
90 92nd of 250 higher than 158 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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