Not yet recruitingPHASE2INTERVENTIONAL

Surgery and Reducing Ionizing Radiation of the Unknown Primary

Around 3% of people with head and neck cancer have it in their neck lymph nodes, but the main cancer spot (primary tumour) can't be found. This is often linked to the HPV virus, and these cancers usually have a good outlook. Doctors are getting better at finding these hidden cancers using new imaging scans and special surgery. This study, called SUPERIOR, wants to see if we can give less radiation or use surgery alone for certain patients with HPV-related cancers. The goal is to make treatments as effective as possible while also reducing common side effects like trouble swallowing or dry mouth, which can greatly improve a patient's quality of life.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

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

Enrolment target

Start

01 Jan 2025

Estimated completion

30 May 2027

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

What is this study about?

This study is for people who have a type of head and neck cancer found in their neck lymph nodes, but doctors can't pinpoint exactly where the cancer started in the head or neck area. This situation has become more common, often linked to the human papillomavirus (HPV). The good news is that HPV-related cancers generally have a very positive outlook for patients.

Traditionally, treatments for this type of cancer could involve surgery, radiation therapy, or both. However, doctors are always looking for ways to make treatments kinder, especially since many patients with HPV-related cancers do so well. They want to find out the best way to treat the cancer effectively while also reducing any lasting side effects that can impact daily life.

This study, called SUPERIOR, is exploring two main ideas. First, it's looking at whether using less radiation on smaller areas might work just as well as treating a larger area, and if it could help reduce problems like difficulty swallowing or having a dry mouth. Second, for certain patients with HPV-related cancers, the study wants to see if surgery alone might be enough, instead of needing radiation afterwards. The aim is to improve patients' quality of life during and after treatment without affecting their successful recovery.

Key takeaways

This study explores kinder treatments for HPV-linked neck cancer where the origin is unknown.
It aims to reduce treatment side effects like swallowing problems and dry mouth.
The study investigates if less radiation or surgery alone can be just as effective.
HPV-related head and neck cancers generally have a very good prognosis.
Participation involves close monitoring and filling out quality of life questionnaires.

Who may be eligible?

To join this study, your head and neck cancer must be located in the lymph nodes of your neck, and doctors must have confirmed that it's linked to the HPV virus. You need to be 18 years or older and generally well enough for treatment, as assessed by your medical team. Your cancer should not have spread to other parts of your body, and your swollen lymph nodes in the neck can't be too large or show signs of having spread outside the node.

Before you can officially join the main part of the study, doctors will need to do a thorough check to make sure the original cancer spot still can't be found, even after special imaging scans and minor surgical checks of your tonsils and the base of your tongue. You also can't have had head and neck cancer in the last two years, or have certain other active cancers.

There are also some reasons why you wouldn't be able to join. For example, if your scans show that your neck nodes are very large or have spread beyond the node, or if your cancer is linked to the Epstein-Barr Virus (EBV). Pregnant or breastfeeding women also cannot participate, and you need to be able to fill out questionnaires about how you're feeling.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your cancer in your neck and linked to HPV?
Are you 18 years or older?
Have doctors confirmed they can't find the original cancer spot?
Is your cancer still only in your neck (not spread widely or with very large nodes)?
Are you able to fill out forms about your well-being?
Do you have no other recent or active serious cancers?

Answer every question to see your result.

What does participation involve?

If you join this study, it actually happens in two main parts. First, there's a registration phase where your doctors will confirm your diagnosis and do all necessary checks to make sure you fit the study criteria, including special scans and a minor surgical procedure to check your tonsils and tongue base for the primary cancer. If no primary cancer is found after this, you may then move to the second phase.

In the second phase, you would be assigned to one of the treatment groups. This might involve radiation therapy to a specific area of your neck, or surgery to remove the affected lymph nodes. The study will carefully monitor your progress and health throughout this period. You'll have regular follow-up appointments with your medical team, which will include examinations and possibly further scans to check how you're doing. You'll also be asked to fill out questionnaires about your quality of life, which helps the researchers understand the impact of the treatments. The total duration of your involvement, including long-term follow-up, will be discussed by your doctor but clinical trials typically follow patients for several years.

Potential risks and benefits

Taking part in this study could offer potential benefits, such as receiving a cutting-edge treatment approach that might reduce side effects while being just as effective. You'll also be closely monitored by a specialist medical team. However, there are also potential risks, as with any medical treatment. The treatments being studied, even reduced ones, can have side effects like discomfort, changes in swallowing, or dry mouth, though the aim is to minimise these. There's also the possibility that the new approaches aren't as effective as standard treatments for everyone. You are free to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (3)

Royal Adelaide Hospital
Verified postcode
Adelaide, Australia
Flinders Medical Centre
Verified postcode
Adelaide, Australia
London Health Sciences Centre
Verified postcode
London, Canada

Common questions

What is HPV and how is it related to this cancer?

HPV is a common virus that can cause certain types of cancer, including some head and neck cancers. It's often linked to a better outlook for patients.

What does 'unknown primary' mean?

It means cancer is found in the lymph nodes in your neck, but doctors can't find where the cancer originally started in your head or neck area.

Will I definitely get less radiation if I join?

The study aims to see if less radiation is effective, and you might be in a group that receives less. However, the study involves different treatment groups, and your doctor will explain which one you might be in.

What kind of side effects are they trying to reduce?

The study is looking to reduce common side effects of treatment like difficulty swallowing, having a dry mouth, and other issues that can affect your daily life.

Can I still get standard treatment if I don't join this study?

Yes, joining a clinical trial is always your choice. You will still receive the best available standard care if you decide not to participate.

How to find out more

Halema Khan, PhD

halema.khan@lhsc.on.ca 5196858500 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.