
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
This trial is for people with advanced non small cell lung cancer that can’t be treated with the aim to cure. And who:
Cancer Research UK supports 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 5 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:
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:
Who can’t take part
You cannot join this trial if any of these apply.
You:
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:
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:
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.
You’ll see a doctor and have some tests before you can take part in the trial.
These include:
You might also have:
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:
The possible long term side effects of SBRT include:
We have more information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Fiona McDonald
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)
This is Cancer Research UK trial number CRUK/16/020.
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.