Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
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.
The study will require a sample size of 90 patients randomized in a 2:3 between the two arms. Arm 1 (standard radiation therapy to tumor location and surrounding area) and Arm 2 (targeted radiation therapy to tumor location).
Patients will be followed for a total of 5 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
