Surgery and Reducing Ionizing Radiation of the Unknown Primary

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

About 3% of people with head and neck cancer have cancer in their lymph nodes, but doctors are unable to find the primary tumour. This situation has become more common due to human papillomavirus (HPV), a virus linked to certain cancers. Generally, patients with HPV-related cancers have a good outlook, with around 90% surviving for at least five years.

Recent advancements in medical technology, such as advanced imaging and specialized surgeries, have significantly improved doctors' ability to find these hidden tumours. These techniques can locate the primary tumour in 70-80% of cases. If the tumour remains undetected, it could be very small or potentially eliminated by the body's immune system.

The best way to treat this type of cancer is still debated. Current treatment options include surgery to remove lymph nodes or radiation therapy. There is no clear agreement on which areas should receive radiation. Often, surgery is performed on one side of the throat to try and locate the tumour's origin.

Researchers are exploring ways to minimize the harmful side effects of treatment. Some studies suggest that surgery alone might be sufficient for patients with small tumours in their neck, but more research is needed. Another important question is whether radiation needs to cover the entire throat area. Recent findings suggest that omitting radiation from some areas might reduce side effects such as difficulty swallowing and dry mouth.

The SUPERIOR trial aims to investigate whether reducing the amount of radiation can still be effective and improve patients' quality of life. The study also examines whether surgery alone is adequate for certain patients with HPV-related cancers.

Eligibility criteria

Qualifiers

p16 positive PUK SCC of the neck

Age 18 years or older

Willing to provide informed consent

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Disqualifiers

Radiological or pathological extra-nodal extension

Epstein-Barr Virus (EBV)-positive

Clinical nodal stage (i.e. before neck dissection) N2-3, AJCC 8th edition (ie. bilateral nodes or node >6cm)

Pathological nodal stage (i.e. after neck dissection) pN3

Trial design

Treatments tested in this trial

  • Intensity Modulated Radiotherapy (IMRT) to Mucosa at Risk
  • Surgical Intervention
  • Intensity Modulated Radiotherapy (IMRT) to Ipsilateral Neck

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead sponsor

Dr. Jake Jervis-Bardy

Collaborator

Dr. David Palma

Collaborator

Dr. Adam Mutsaers

Collaborator