A trial looking at stereotactic body radiotherapy for breast, prostate and non small cell lung cancer (CORE)

Cancer type:

Breast cancer
Lung cancer
Non small cell lung cancer
Prostate cancer

Status:

Open

Phase:

Phase 2/3

This trial is for people with breast, prostate and 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

Cancers can sometimes spread from where it started to other parts of the body. This is advanced (or metastatic) cancer. If the cancer spreads to no more than 3 areas in the body, it is called oligometastatic disease.

Different treatments can be used in this situation. You might have:

The type of treatment you have depends on your cancer. And what your doctor thinks is best for you. This is the standard care.

But doctors are looking for ways to help people with advanced cancer. In this trial, they are looking at stereotactic body radiotherapy (SBRT).

SBRT gives radiotherapy to the cancer from different positions around the body. So the cancer receives a high dose of radiation and the tissues around it only receive a low dose.

In this trial people have 1 of the following:

  • standard care
  • SBRT and standard care

The main aims of this trial are to:

  • find out how well SBRT works as a treatment
  • learn more about the side effects of SBRT
  • find out how well people cope with treatment and 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.

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

  • You have breast, prostate or NSCLC
  • You have 3 areas or less of cancer spread. But your cancer can’t have spread to more than 2 organs. So for example, you can take part if you have 2 areas of cancer in your liver and 1 area of cancer in your lung but not if you have cancer in your liver, lung and bones
  • You have finished treatment for your original cancer and it is stable. You must have finished treatment more than 6 months ago if you have breast or prostate cancer (you may be allowed to take part if you are still taking hormone therapy) or 4 months if you have NSCLC
  • Your doctor thinks the areas of cancer that have spread can be treated with SBRT and they can be seen on a scan
  • You have satisfactory blood tests
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)  
  • You are at least 18 years old

You cannot join this trial if any of these apply.

Cancer related

  • You have had treatment after your cancer spread (including treatments that reached your whole body) unless it was surgery, radiofrequency ablation (RFA) or SBRT, and the cancer in these treated areas is controlled
  • Your cancer has spread to the brain
  • You have areas of cancer (metastases Open a glossary item) that measure more than 6 cm (5 cm if they are lungs metastases)
  • Your cancer has come back near the area where it first started (local regional recurrence)
  • Your cancer is pressing on the spinal cord (spinal cord compression Open a glossary item)
  • You have fluid in the space between the lungs and the chest wall (the pleura) and the layer of tissue that covers the tummy (peritoneum)
  • You have had the drugs abiraterone, enzalutamide, docetaxel or drugs to stop you from making the male hormone androgen Open a glossary item, if you have prostate cancer

Medical condition

  • You can’t have SBRT for any reason. For example you have certain lung conditions such as interstitial lung disease and you are going to have SBRT to the lungs or you have colitis and are going to have SBRT to the area between your hip bones (pelvis)
  • You have any other serious medical condition or mental health problem that the trial team think could affect you taking part

Other

  • You are pregnant
  • You can’t have scans (such as CT, MRI, bone scan or a PET) for any reason.

Trial design

This is a phase 2/3 trial. The researchers need about 206 people from the UK to take part.

This trial is randomised. The people taking part are put into 1 of the following groups by a computer:

  • standard care
  • SBRT and standard care

Neither you nor your doctor will be able to decide which group you are in. 

Diagram-showing-CORE-randomisation

Standard care
You might have:

  • chemotherapy
  • biological therapy
  • hormone therapy
  • radiotherapy to help with your symptoms (palliative radiotherapy)
  • monitoring of the cancer

Your doctor can tell you what treatment you may need. It depends on where your cancer is.

SBRT and standard care
You have SBRT on alternate days. The number of treatments you have depend on where your cancer is. It can be up to 8 treatments (over 19 days). And it can take between 20 to 60 minutes each time. This depends on the type of radiotherapy machine used. 

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 radiotherapy to it. Your doctor can tell you more about this.

After you finish SBRT you have standard care. Your doctor can tell you what treatments you may need.

Quality of life
As part of this trial you may be asked to complete a quality of life questionnaire before starting treatment and after:

  • 7 days
  • 3 months
  • 6 months
  • then every 6 months for 2 years

It will ask about how you have been feeling and what side affects you have had. It takes about 10 minutes to complete each time.

You do not need to agree to complete the questionnaires if you don’t want to. You can still take part in this trial.  

Hospital visits

You see a doctor and have some tests before taking part. The tests might include:

  • a CT scan
  • bone scan (if you have prostate cancer)
  • a PET scan
  • an MRI scan
  • a physical examination
  • lung tests (such as spirometry, if you have NSCLC) 
  • blood tests
  • urine test

You might also have a type of scan called DMSA scan. This is to check how your kidneys are working. Your doctor can tell you if you need to have this.

You see a doctor regularly at the time you have treatment. This is to check how you are and what side effects you have.

When you finish treatment, you see the doctor after 1 week and then:

  • every 3 months for 2 years
  • every 6 months after

You also have CT scans after you finish treatment. How often you have them depend on your cancer. Your doctor can tell you more about this.

You continue to see the doctor and have CT scans for up to 5 years.

Side effects

The hospital trial team monitor you during the time you have treatment and you have 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. Your doctor can tell you more about this.

The most common side effects of radiotherapy are:

  • tiredness (fatigue)
  • feeling or being sick
  • difficulty swallowing
  • hair loss in the treatment area
  • diarrhoea
  • skin changes in the treatment area

We have more information about radiotherapy

Location

London
Middlesbrough
Newcastle upon Tyne
Northwood
Nottingham
Oxford

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 Vincent Khoo

Supported by

Cancer Research UK
ICR Clinical Trials and Statistics Unit (ICR-CTSU)
Institute of Cancer Research 
The Royal Marsden NHS Foundation Trust 

Other information

This is Cancer Research UK trial number CRUK/14/038.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12763

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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