A trial looking at stereotactic ablative radiotherapy for non small cell lung cancer (SARON)

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Open

Phase:

Phase 3

This trial is for people with non small cell lung cancer (NSCLC) that has spread (advanced cancer). The cancer must not have spread to more than 3 areas in the body. 

Cancer Research UK supports this trial.

More about this trial

Non small cell lung cancer can sometimes spread to other parts of the body. This is called advanced non small cell lung cancer. 

Doctors can treat advanced NSCLC with a combination of 2 chemotherapy drugs. You have either:

and 1 other chemotherapy drug. Drugs commonly used include:

Doctors are looking for ways to improve treatment for people with advanced NSCLC.

In this trial, they are looking at radiotherapy and chemotherapy. They think it can help kill the cancer and reduce the risk of it coming back. 

Doctors can give radiotherapy in 3 different ways

SABR and SRS gives radiotherapy to the cancer from different positions around the body or head. Doctors can direct a high dose of treatment to the cancer. And small doses to the healthy tissues and organs that surround the cancer. This is the standard of care treatment.

Sometimes you can’t have SABR. This might be because of the size or location of the cancer in your lungs. In this situation the doctors will use conventional radiotherapy to treat the cancer in your lungs.

In this trial you have:

  • SABR or conventional radiotherapy to the primary cancer in your lungs 
  • SABR to treat the areas in your body where the cancer has spread 
  • SRS  to treat any cancer spread to the brain (metastases)

People have 1 of the following:

  • chemotherapy
  • chemotherapy and radiotherapy 

The main aims of this trial are to:

  • find out how well chemotherapy and radiotherapy works as a treatment
  • learn more about the side effects

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 of the following apply:

  • You have non small cell lung cancer (NSCLC)
  • Your cancer does not have receptors to a protein called epidermal growth factor Open a glossary item (EGFR negative) following EGFR testing
  • Your cancer has a change to a protein called anaplastic lymphoma kinase (ALK negative) – the doctor will check for this if this is something done routinely in your hospital
  • Your cancer has spread to no more than 3 areas in your body
  • Your cancer can be treated with radiotherapy
  • You have between 1 to 3 areas of cancer outside your lungs that can be seen and measured on a scan (stage 4 lung cancer)
  • You have had a recent PET CT scan Open a glossary item
  • You are well enough to have treatment with platinum based chemotherapy (cisplatin or carboplatin) and radiotherapy
  • Your lungs are working well enough to have treatment
  • You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You are at least 18 years old 
  • You are willing to use reliable contraception during treatment and for 6 months after the final dose of chemotherapy if there is any possibility you or your partner could become pregnant. If you have chemotherapy and radiotherapy, you must use reliable contraception for 12 months after you finish treatment 

You have a scan after 2 chemotherapy treatments. Continuing in the trial will depend on these results. You will be able to continue in the trial as long as you still meet all the above and:

  • Your cancer stayed the same or got better after 2 chemotherapy treatments
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2) 

Who can’t take part

You cannot join this trial if any of these apply:

  • You have previously had treatment for NSCLC
  • You have had radiotherapy to help with symptoms, or you are due to have it after starting in this trial
  • You have certain lung conditions such as thickening of the lung tissue (fibrosis) or a connective tissue disease (such as Lupus)
  • You have had surgery or radio frequency ablation (RFA) to 1 or more areas of your cancer that has spread
  • Your cancer has only spread to one lesion in your brain or you have more than 2 areas of cancer in your brain
  • Your cancer has spread to the area where the brain meets the spinal cord (the brain stem) or the membranes surrounding the brain (leptomeningeal disease)
  • Your cancer has spread, or is at high risk of spreading, into large veins or arteries
  • Your cancer has spread to both glands on top of the kidneys (adrenal glands Open a glossary item)
  • You have had another cancer, apart from cancers that have been successfully treated more than 3 years ago, non melanoma skin cancer or an early cervical cancer
  • You have fluid between the sheets of tissue that cover the outside of the lung (pleural effusion) or the heart (pericardial effusion)
  • You are pregnant or breastfeeding

Trial design

This is a phase 3 trial. The researchers need about 340 people from the UK to take part.

The first day of treatment is called day 1. You have a platinum chemotherapy (cisplatin or carboplatin) and 1 other chemotherapy drug. Your doctor will explain which drug will be best for you.

You have cisplatin or carboplatin as a drip into a vein. It takes between 1 to 4 hours to have cisplatin. And around 1 hour to have carboplatin. 

If you are having either gemcitabine or vinorelbine, you have chemotherapy again on day 8. Then you have a break of 2 weeks. This is called a treatment cycle

After 2 treatment cycles you have a scan. Your doctor looks at the results of the scan. Continuing in the trial depends on these results:

  • if your cancer has grown or spread to new areas, you stop the trial
  • if your cancer has stayed the same or shrunk, you continue on the trial

If you continue, the next part of the trial is randomised. The people taking part are put into 1 of the following treatment groups by computer:

  • chemotherapy
  • chemotherapy and radiotherapy

SARON trial diagram

Neither you nor your doctor can choose which group you are in. 

Chemotherapy
You have another 2 cycles of chemotherapy. You may be able to continue having the same treatment if it is helping you and the side effects aren’t too bad.  

Chemotherapy and radiotherapy 
You have another 2 cycles of chemotherapy. Within 2 to 6 weeks of finishing, you start radiotherapy.  

You have SABR or conventional radiotherapy to the areas of cancer inside your lungs. It can take up to 21 days to have SABR and 6 ½ weeks to have conventional radiotherapy. 

If you have conventional radiotherapy, you have it every day, Monday to Friday, with a break at weekends. Each treatment takes about 15 to 20 minutes.

You might need to travel to another hospital to have your SABR treatment. You have treatment with SABR every day, Monday to Friday. Or on alternate days. You always have a break at weekends.
 
If you have treatment with SABR to the areas of cancer inside your lungs, you might need to have small metal markers (fiducial markers) put in before the start of treatment. This is the size of a grain of rice. Doctors use this to track the cancer and direct the radiotherapy to it.   

You have SABR or SRS to the areas of cancer outside the lungs. This can take between 5 to 21 days depending on the area of your body having radiotherapy. 

Quality of life 
Everybody taking part on this trial will be asked to complete a quality of life questionnaire:

  • before starting chemotherapy
  • at set times after you finish treatment

 It will ask about how you have been feeling and what side affects you have had.

Hospital visits

You see a doctor and have some tests before taking part. These tests may include:

  • a PET CT scan
  • a CT scan if needed 
  • an MRI scan or a CT scan of the brain
  • a physical examination
  • lung tests (such as spirometry)
  • blood tests
  • urine test

You see the doctor for blood tests and a physical examination before each treatment cycle. And then:

  • you have weekly check ups during your course of SABR or SABR and conventional radiotherapy
  • if you are having conventional radiotherapy for your primary lung cancer you have check ups every 2 weeks during the course of your treatment

When you finish your chemotherapy, you see the trial doctor after 1 month and then:

  • every month for the first 3 months
  • every 3 months after 

After 3 years, you see the trial doctor every 6 months. 

If you have SABR to the lungs, you might have 2 extra visits after:

  • 2 weeks
  • 3 months

You have a CT scan 3 months after finishing treatment. Then at set times, until 3 years after the end of your treatment.

Side effects

The hospital trial team monitor you during the time you have treatment and you will be given a phone number to call them if you are worried about anything.  The team will tell you about all the possible side effects before you start the trial.

The side effects you have depend on the area of your body having radiotherapy. You doctor can tell more about this. 

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

  • chest pain
  • difficulty swallowing
  • tiredness (fatigue)
  • loss of appetite
  • drop in the number of red blood cells (anaemia) and white blood cells (causing you to feel tired, breathless and have an increased risk of infections)
  • skin changes (such as redness and itchiness)
  • lung inflammation

We have more information about radiotherapy for lung cancer. 

We also have information about:

Location

Belfast
Birmingham
Bristol
Cambridge
Chelsea
Glasgow
Leeds
Leicester
Liverpool
London
Manchester
Middlesbrough
Newcastle upon Tyne
Northwood
Nottingham
Sheffield
Southampton
Surrey

Recruitment start:

Recruitment end:

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.

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
Experimental Cancer Medicine Centre (ECMC)
National Cancer Research Institute (NCRI)
University College London (UCL)

Other information

This is Cancer Research UK trial number CRUK/14/027.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12658

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

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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