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RECRUITING Phase 2

Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial

NCT03997643 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 90 participants
Start Date 2019-09-06
Est. Completion 2026-09
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03997643

The ClinicalTrials.gov registry entry for NCT03997643 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03997643 reports 8 study locations spanning 8 distinct geographic areas — top geographies include Florida, Ontario, Quebec. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

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. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial