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)
Regional failure in the pN0 hemi-neck (s) — Baseline to 5 years Rate of relapse in the pN0 neck in Arm 2 compared to historical controls
Trial sites (8)
Facility
City
Region
Status
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.
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