Comparing radiation therapy methods for preserving swallowing in oral cavity cancer patients
Preservation of Swallowing in Resected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects: A Randomized Trial
PHASE2 · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · NCT03997643
This study is testing whether standard or targeted radiation therapy helps oral cavity cancer patients swallow better and have a better quality of life after treatment.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (other) |
| Drugs / interventions | radiation |
| Locations | 8 sites (Miami, Florida and 7 other locations) |
| Trial ID | NCT03997643 on ClinicalTrials.gov |
What this trial studies
This randomized treatment study aims to compare the quality of life in patients with resected oral cavity squamous cell carcinoma who receive either standard radiation therapy or targeted radiation therapy. The study will involve 90 patients, randomized in a 2:3 ratio between the two treatment arms. Patients will be monitored for a total of 5 years to assess the impact of the different radiation approaches on their swallowing function and overall quality of life. The findings are intended to provide high-level evidence to guide treatment decisions for this patient population.
Who should consider this trial
Good fit: Ideal candidates are patients with resected oral cavity squamous cell carcinoma who have at least one pN0 hemi-neck and meet specific pathological criteria.
Not a fit: Patients with serious medical comorbidities, prior head and neck cancer, or those with metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved swallowing function and quality of life for patients with oral cavity squamous cell carcinoma.
How similar studies have performed: Other studies have shown success with similar radiation therapy approaches, indicating potential for meaningful advancements in treatment.
Eligibility criteria
Show full inclusion / exclusion 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 (≤ 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 Exclusion Criteria: * Serious medical comorbidities or other contraindications to radiotherapy * Prior history of head and neck cancer within 5 years * Any other active invasive malignancy, 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 identified following surgical resection but prior to the start of radiotherapy * Inability to attend full course of radio therapy or follow-up visits * Unable or unwilling to complete QoL questionnaires * Pregnant or lactating women
Where this trial is running
Miami, Florida and 7 other locations
- Miami Cancer Institute — Miami, Florida, United States (RECRUITING)
- London Regional Cancer Program — London, Ontario, Canada (RECRUITING)
- CHUM — Montreal, Quebec, Canada (RECRUITING)
- Cork University Hospital — Wilton, County Cork, Ireland (RECRUITING)
- University Hospital Galway, Newcastle Road — Galway, County Galway, Ireland (RECRUITING)
- St. Luke's Radiation Oncology Network — Rathgar, Dublin, Ireland (RECRUITING)
- Beaumont St. Luke's Centre — Dublin, Leinster, Ireland (RECRUITING)
- Beatson West of Scotland Cancer Centre — Glasgow, United Kingdom (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Head and Neck Cancer, Radiation Therapy, Oral Cavity Squamous Cell Carcinoma, Randomized Trial