Surgery and Reducing Ionizing Radiation of the Unknown Primary

Summary

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.

Conditions

• Head and Neck Squamous Cell Carcinoma
• HPV Positive Oropharyngeal Squamous Cell Carcinoma

Interventions

RADIATION

Intensity Modulated Radiotherapy (IMRT) to Mucosa at Risk

Patients in Arm 1, after the surgical procedure, will receive radiotherapy to the at-risk mucosa.

PROCEDURE

Surgical Intervention

These patients will undergo Neck dissection, TORS tonsillectomy (unilateral vs bilateral tonsillectomy at the discretion of the treating physician) + ipsilateral tongue base mucosectomy.

RADIATION

Intensity Modulated Radiotherapy (IMRT) to Ipsilateral Neck

For Arm1, after the surgical procedure, the patients will receive radiotherapy to the ipsilateral neck. For Arm2, the patients will only receive IMRT to neck, if multiple ipsilateral nodes or single ipsilateral node \>3 cm is observed

Sponsors & Collaborators

• Dr. Jake Jervis-Bardy

  collaborator UNKNOWN

• Dr. David Palma

  collaborator UNKNOWN

• Dr. Adam Mutsaers

  collaborator UNKNOWN

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

  lead OTHER

Principal Investigators

• Adrian I Mendez, MD · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

• Jake Jervis-Bardy, MD · Royal Adelaide Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-01

Primary Completion

2026-12-31

Completion

2027-05-30

Countries

• Australia
• Canada

Study Locations