A trial looking at proton beam radiotherapy for sinus cancer (PROTIS)

Cancer type:

Head and neck cancers

Nasal and paranasal sinus cancer

Status:

Open

Phase:

Phase 3

This trial is comparing proton beam therapy with intensity modulated radiotherapy to treat cancer of the nose and sinuses.

It is open to people with cancer of the nose and sinuses that has:

spread to other parts of the head such as the eye socket, skin, roof of the mouth or other sinus cavities or
spread to the ethmoidal sinus only. These are the small cavities in the spongy ethmoid bone in the upper part of the nose.

More about this trial

The standard treatments for cancer of the nose and sinuses are:

surgery
chemotherapy
radiotherapy

Doctors use radiotherapy either to treat the cancer when it has not been removed by surgery or to treat any cancer that might remain after surgery. The radiotherapy they can use is called intensity modulated radiotherapy (IMRT).

IMRT uses high energy photons (x-rays). The radiotherapy beams are shaped to closely fit the area of cancer. This means that the cancer receives a very high dose of radiotherapy, and the normal healthy cells nearby receive a much lower dose. This means you might have fewer side effects.

Proton beam therapy (PBT) uses protons to treat the cancer. Protons are tiny particles from the centre of atoms. They can only be seen under a special microscope. Protons treat cancer by producing a sudden burst of energy when they stop. So by directing the proton beams at a cancer and making them stop inside the cancer, they destroy it. As a result, it causes little damage to the nearby healthy cells.

Researchers think that PBT might be better to treat cancer of the nose and sinuses than IMRT. To find this out, half the people in this trial will have PBT with their standard care. And the other half will have IMRT with their standard care.

The aims of the trial are to compare PBT with IMRT to find out which treatment:

is better at treating the cancer
has fewer long term side effects
results in a better quality of life

Who can enter

The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this trial if all of the following apply. You:

have cancer of the nose and sinuses that has spread to other parts of the head such as the eye socket, skin, roof of the mouth or other sinus cavities (T3 and T4). Or you have cancer of the nose and sinus that has only spread to the ethmoidal sinus (T2).
have cancer that is either a squamous cell carcinoma or an adenocarcinoma type of nose and sinus cancer
are due to have treatment with the aim to cure. Your doctor will tell you this.
are able to look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
are willing to use reliable contraception during the trial if you or your partner could become pregnant
are at least 25 years old

Who can’t take part

You cannot join this trial if any of these apply. You:

have cancer that has spread to another part of the body
have already had radiotherapy to the head and neck
had another cancer in the past 2 years. This is apart from non melanoma skin cancer and carcinoma in situ (CIS) of the cervix.
have any other medical condition, mental health condition or circumstances that could affect you taking part
are pregnant or breastfeeding

Trial design

Before radiotherapy you might have surgery or chemotherapy. Some people will have chemotherapy at the same time as their radiotherapy. This is standard care. Your doctor will tell you whether you are to have any of these before radiotherapy.

This is a phase 3 trial. The team need 276 people to take part.

It is a randomised trial. A computer puts you into 1 of 2 groups. Neither you nor your doctor can choose which group you go into. The 2 groups are:

intensity modulated radiotherapy (IMRT)
proton beam therapy (PBT)

PROTIS trial randomisation diagram

Before starting radiotherapy, everyone has a planning appointment. This is so the radiotherapy team can work out the dose to give and where to give the radiotherapy.

You might need to have a radiotherapy mask made. This helps to keep your head still during treatment. This is usually a separate appointment to the planning appointment. It takes about 30 minutes.

You have radiotherapy once a day Monday to Friday for 6 to 7 weeks. This is a total of 30 to 35 sessions.

People having IMRT
You have your planning appointment and treatment at your local hospital.

People having PBT
You have your planning appointment and treatment at either the proton beam centre at The Christie Hospital, Manchester or at the proton beam centre at the University College Hospital (UCLH), London. You stay at accommodation provided by the hospital while you have your proton beam therapy. Your partner or carer can stay at the accommodation with you.

After treatment you then go back to your local hospital for follow up.

Samples for research
The team will ask everyone for blood samples. They will take these when you have blood taken as part of your standard care.

The team will ask for a sample of the tissue that was taken when you were first diagnosed.

If you are having surgery as part of your standard care, the team will ask the surgeon to take some samples of tissue (biopsies Open a glossary item ) during the operation.

If your cancer comes back during the trial, the team will ask the surgeon to take some biopsies when they remove the cancer.

They will use these samples to find out more about cancer of the nose and sinuses.

You don’t have to agree to have any of these samples taken. You can still take part in the trial.

Quality of life
You fill in questionnaires:

before starting radiotherapy
at the end of radiotherapy
after radiotherapy

The questions ask about how you are feeling and what you can do. These are quality of life questionnaires.

Hospital visits

You see the doctor before taking part for a physical examination Open a glossary item , blood tests and to discuss whether you will have surgery, chemotherapy or both. This is a part of your standard care.

Before starting radiotherapy, you have:

a test to find out how good your sense of smell is
a hearing test
blood tests
tests to find out how well the brain works by looking at your reading, use of language, memory, concentration and similar things
eye tests
a physical examination

During radiotherapy you see the doctor regularly to see how you are.

At the end of radiotherapy and follow up
At the end of radiotherapy you see the doctor. This is to see how you are. You then see the doctor at:

6 weeks
12 weeks
6 months
12 months
18 months
2 years then every year up to 5 years

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.

The side effects of radiotherapy depend on where in the head and neck area you have it. These side effects can include: