A trial of stereotactic body radiotherapy with targeted drug treatment in advanced non small lung cancer (HALT)

Cancer type:

Lung cancer

Non small cell lung cancer

Secondary cancers

Status:

Open

Phase:

Phase 2/3

This trial is for people with advanced non small cell lung cancer that can’t be treated with the aim to cure. And who:

have certain changes (mutations) in their lung cancer cells
are having a targeted cancer drug
have 3 or less areas of cancer that have now stopped responding to targeted cancer treatment

Cancer Research UK supports this trial.

More about this trial

Non small cell lung cancer is the most common type of lung cancer. It can sometimes spread to other areas of the body. This is called metastatic cancer or advanced cancer. You might have chemotherapy, immunotherapy or a targeted cancer drug to treat this.

Some people with non small lung cancer have changes (mutations) in their lung cancer cells. For example, they might have changes to 1 of 2 genes called EGFR or ALK. Chemotherapy and immunotherapy don’t work very well if you have these gene changes. So, you usually have a targeted cancer drug called a tyrosine kinase inhibitor (TKI). It is a type of cancer growth blocker. These block signals that cancer cells use to divide and grow.

This can work well and keep the cancer under control. But after a while, it might stop working in a few areas of the body and the cancer might get bigger in these areas. It is called oligo progressive disease if the cancer starts to grow in 3 sites or less in the body while the cancer remains under control in other parts of the body. Researchers are trying to increase the length of time the TKI works. They think that a type of radiotherapy called stereotactic body radiotherapy (SBRT) might help.

SBRT allows radiation to be delivered to the cancer from different angles around the body. So, the cancer receives a high dose of radiation and the normal tissues around it only receive a low dose. Researchers hope that giving radiotherapy to the few areas where the cancer has stopped responding can help increase the time patients benefit from TKI treatment.

In this trial, some people will have SBRT and some people will not. But everyone will continue to take their current TKI.

The aims of this trial are to:

find out if targeting the areas of cancer growth with SBRT helps TKIs work for longer
find out more about quality of life after having SBRT and TKI
learn more about the side effects of SBRT and TKI when used together

Who can enter

The following bullet points list 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 the following apply:

you have non small cell lung cancer that can’t be removed with surgery
you have a gene change in your lung cancer cells such as ALK or EGFR
you are having a type of targeted drug called a tyrosine kinase inhibitor such as ceritinib or erlotinib and treatment isn’t working anymore
you have 3 or fewer areas of cancer that have stopped responding to TKI treatment and have grown
you have no areas of cancer in the brain that are growing.
the doctors can see the 3 (or fewer) areas of cancer on a scan and they are all suitable for SBRT
are well enough to be up and about for at least half the day (performance status 0,1 or 2)
are at least 16 years old

Who can’t take part
You cannot join this trial if any of these apply.

You:

have more than 3 areas of cancer growth
have cancer in the brain that can’t be removed with surgery or treated with stereotactic radiosurgery unless the areas in the brain have been stable for more than 6 months
have any problems with your organs such as your liver meaning you can’t safely have SBRT.
have already had radiotherapy near where there are new areas of cancer growth
have any other medical condition that means you can’t have SBRT safely
have any other serious medical condition or mental health problem that the trial team think could affect you taking part
are pregnant

Trial design

This is a phase 2/3 trial. It is taking place in the UK and in some parts of Europe.

The researchers need 110 people to join. It is a randomised trial. You are put into 1 of 2 treatment groups at random by a computer. Neither you nor your doctor will be able to decide which group you are in.

You will have 1 of the following:

stereotactic radiotherapy (SBRT) and a tyrosine kinase inhibitor
a tyrosine kinase inhibitor alone

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2 out of 3 people will be in the group having SBRT. This is so as many people as possible can have SBRT.

Trial treatment
You continue to have the TKI you are currently taking. Your doctor can tell you how often you have it and for how long.

If you are to have SBRT, you will first have a planning scan at the hospital. This takes about 30 minutes. You have SBRT on alternate days. The number of SBRT treatments you have will depend on where the cancer being treated is in your body. On average, you have 3 treatments over 5 days. But you might have up to 8 treatments over 19 days.

The SBRT takes between 20 minutes and an hour each time. This depends on the type of machine the hospital uses to deliver SBRT treatment.

Some people might need to have small markers (fiducial markers) put in the cancer before the start of treatment. This is so doctors can track the cancer and direct the SBRT to the right location. Your doctor can tell you more about this.

Follow up visits
Everyone will go to the clinic for a check up 8 weeks after starting the trial. After this visit, you have a check up every 3 months.

Quality of life
Everyone will be asked to take part in a quality of life study. The trial team will ask you to fill out a questionnaire when you start the trial and at set times during the trial. The questionnaire will ask about side effects and how you’ve been feeling. The questionnaires shouldn’t take longer than 20 minutes to complete.

Samples for research
The trial team will ask you to give some extra blood samples:

the start of the trial
8 weeks later
after your first SBRT treatment (only if you are having SBRT)
at your first and second 3 monthly check up visits
if your cancer starts to grow or spread again

They will also ask to look at a sample of tissue (biopsy) you gave when you were first diagnosed or when you started your TKI treatment. If your cancer starts to grow while you are taking part in the trial you will be asked to give a new sample. But you don’t have to agree to give tissue samples if you don’t want to. You can still take part in the trial.

The samples you give will help researchers to better understand the effect of SBRT. And find out more about non small cell lung cancer. They might use the samples for future research.

Hospital visits

You’ll see a doctor and have some tests before you can take part in the trial.

These include:

a physical examination
blood tests
CT scan or MRI scan of the brain

You might also have:

a scan of your kidneys (DMSA scan)
a test to see how well your lungs are working (lung function tests)
an MRI scan of your spine

Side effects

The possible side effects of SBRT will depend on which part of your body is being treated.

The possible short term side effects of SBRT include:

tiredness
shortness of breath and cough
feeling or being sick
skin changes in the treatment area
hair loss in the treatment area
diarrhoea
problems or pain with swallowing

The possible long term side effects of SBRT include:

skin changes
bone fractures
chest wall pain or rib fractures
difficulty breathing
liver or kidney damage

We have more information about:

radiotherapy side effects

Location

Belfast

Bristol

Cottingham

Glasgow

Guildford

Leicester

Liverpool

London

Manchester

Nottingham

Oxford

Sheffield

Southampton

Sutton

Recruitment start:

27/11/2017

Recruitment end:

27/11/2021

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

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Questions to ask your doctor about clinical trials

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Fiona McDonald

Supported by

Cancer Research UK
European Organisation for Research and Treatment of Cancer (EORTC)
ICR Clinical Trials and Statistics Unit (ICR-CTSU)
NHS England
Radiotherapy trials quality assurance (RTTQA)