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Clinical Trials in Ireland / NCT03997643
Recruiting Phase 2

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

NCT03997643 · tracked via the Priya Life Science Ireland tracker
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Phase
Phase 2
Started
2019-09-06
Last updated
2023-08-03

Condition(s) studied

Head and Neck Cancer

Investigational drug(s) / intervention(s)

Radiotherapy to all dissected areasOmit radiation to pN0 neck

Radiotherapy to all dissected areas: Post operative radiation therapy +/- chemotherapy based on historic treatment volumes (including the primary site, dissected areas +/- elective areas

Omit radiation to pN0 neck: post operation radiation therapy +/- chemotherapy that avoids targeting the dissected pN0 neck

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Miami Cancer Institute Miami Florida Recruiting
London Regional Cancer Program London Ontario Recruiting
CHUM Montreal Quebec Recruiting
Cork University Hospital Wilton County Cork Recruiting
University Hospital Galway, Newcastle Road Galway County Galway Recruiting
St. Luke's Radiation Oncology Network Rathgar Dublin Recruiting
Beaumont St. Luke's Centre Dublin Leinster Recruiting
Beatson West of Scotland Cancer Centre Glasgow United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03997643 on ClinicalTrials.gov ↗ ← All trials in Ireland