A trial looking at quality of life after radiotherapy for advanced non small cell lung cancer (QUARTZ LUNG)

Cancer type:

Lung cancer

Non small cell lung cancer (NSCLC)

Secondary cancers

Status:

Open

Phase:

Phase 3

This trial is looking at giving early low dose radiotherapy to the chest for non small cell lung cancer (NSCLC).

It is for people who:

are not having chemotherapy, other systemic treatment or both and
don’t have symptoms of lung cancer that need radiotherapy straight away

More about this trial

Advanced lung cancer is also called metastatic lung cancer. This is stage 4 lung cancer. People in this situation have treatment to control symptoms if they have any.

Treatment to control symptoms is also called palliative treatment or supportive care Open a glossary item . Palliative treatment aims to control symptoms and improve quality of life . You might have anti sickness medication or painkillers.

You usually only have radiotherapy Open a glossary item for advanced lung cancer if you have symptoms. These symptoms might include pain or coughing up blood. Radiotherapy can help to reduce symptoms and help you feel better.

Doctors aren’t sure if giving early radiotherapy routinely to people with advanced lung cancer will help them. So the trial team are doing this trial to find out more.

In this trial, some people have symptom based supportive and palliative care only. And some have symptom based supportive and palliative care and low dose radiotherapy.

The main aims of this trial are to find out:

if having radiotherapy early is useful
the best dose of early radiotherapy to give
more about the side effects
how early radiotherapy affects quality of life
what you and healthcare professionals think about having early radiotherapy

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 non small cell lung cancer that is stage T2 and has spread. This may be to lymph nodes , other parts of the lung or the other lung, or to another part of the body (stage 4 lung cancer).
have cancer that is suitable to treat with radiotherapy to the chest
might be fully active and able to look after yourself or you are in bed or a chair for more than half the day and need help (performance status 0, 1, 2 or 3)
are well enough to have low dose palliative radiotherapy
are willing to use reliable contraception during the trial and for a period after if there is any chance you could become pregnant
are at least 16 years old

Who can’t take part

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

are having treatment to the whole body (systemic treatment ) for NSCLC
have already had certain treatments for this advanced non small cell lung cancer. Your doctor will know this.
need to have palliative radiotherapy to the chest before you are put into a group for this trial
have another medical condition that means you can’t have radiotherapy. This includes interstitial lung disease and active inflammation in the connective tissues in the body. Your doctor will know this.
have cancer that has spread to the thin tissue layers that cover the brain and spinal cord
are having an experimental treatment as part of another clinical trial
are pregnant or breastfeeding

Trial design

This phase 3 trial is taking place in the UK. The team need 448 people to take part.

It is a randomised trial. A computer puts you into a treatment group. Neither you nor your doctor will be able to decide which group you are in.

There are 2 groups. You have 1 of the following:

supportive care
supportive care and radiotherapy

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Supportive care
You have supportive care based on your symptoms. This could be anti sickness medication or painkillers.

Supportive care and radiotherapy
You have supportive care as described above. You also have radiotherapy to the chest.

Before starting radiotherapy, you have a planning appointment. This is so the doctor can work out where to give the radiotherapy. It is measured in units called Gray (Gy).

You have one of the following:

2 radiotherapy treatments over 2 weeks. This is a total of 16 to 17 Gy.
5 radiotherapy treatments over 1 week. This is a total of 20 Gy.

Your doctor will decide which schedule of radiotherapy will work best for you.

Radiotherapy takes about 15 to 20 minutes each time. You start radiotherapy as soon as possible. This is no later than 3 weeks after you are put into this group.

Quality of life
The trial team ask everyone to fill out some questionnaires:

when you join the trial
at set times during the trial

The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study.

Interviews
The team might ask if you are interested in taking part in an interview. This is to learn about people’s experiences of taking part in the study. They might also ask you to give the name of the person you get the most support from. This is only if you are happy to do this. The team would like to interview a few of them too. The interviews are done separately.

A member of the team will ask everyone some questions about the trial, including what you think about having radiotherapy.

They take place over the telephone or online. The team will arrange the interview for a time that suits you.

The team also plan to interview some healthcare professionals. This is to find out more about the benefits and drawbacks of having radiotherapy early. And what they think about it.

The team will audio record the interviews.

You can say no to taking part in the interviews if you don’t want to. It won’t affect you taking part in the rest of the trial.

Hospital visits

You see the doctor for a physical examination Open a glossary item and have some tests before you can take part. These include:

blood tests
urine tests
a CT scan. This is only if you haven’t had one recently to confirm you have non small cell lung cancer.

The doctor also asks you some questions about smoking.

You have radiotherapy at the hospital. You shouldn’t need to stay overnight.

You see the doctor for regular checks ups during the trial. Or a member of the trial team will call you to see how you are. This is for up to 6 months. After that a member of trial team may call you to see how you are getting on.

Side effects

The trial team monitor you during the trial. Contact your advice line or tell your doctor or nurse if you have any side effects.

The most common side effects of radiotherapy to the chest are:

tiredness and weakness
difficulty swallowing
a cough
skin problems such as soreness, reddening or darkening of your skin, itching or dry skin. Sometimes the skin may blister and peel.
hair loss
chest discomfort or pain

We have more information about the long term side effects of radiotherapy.