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.
A study of stereotactic ablative radiotherapy for lung cancer (SABRTOOTH)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is comparing stereotactic ablative radiotherapy (SABR) with surgery to treat lung cancer. It is open to people with a type of lung cancer called non small cell lung cancer (NSCLC) that is at an early cancer stage (stage 1) and can be treated with either surgery or SABR with the aim to cure.
More about this trial
If fit enough, surgery is the
Stereotactic ablative radiotherapy (SABR) is a type of targeted radiotherapy that aims many radiotherapy beams at the cancer. Because the beams meet at the centre of the cancer, it gets a very high dose of radiotherapy and the healthy tissue around the cancer receives a low dose. SABR has been shown to control the cancer well because of the high dose it delivers. But SABR doesn’t treat the surrounding tissue or lymph nodes.
Doctors can use either surgery or SABR to treat early stage NSCLC . But it is not certain which treatment is the best for people who are considered at higher risk of surgical complications. So researchers need to do a large phase 3 clinical trial to compare both treatments. Before they can do this they need to find out if people with early stage NSCLC that isn’t in the centre of the chest would be willing to take part. This is called a feasibility study.
In this feasibility study the researchers want to find out
- how many people with NSCLC are willing to take part in a trial comparing surgery with SABR
- the reasons why people may not be willing to take part in such a trial
- if it may be possible to do a large phase 3 trial comparing these 2 treatments
Who can enter
You may be able to join this study if all of the following apply. You
- Have stage 1 NSCLC that isn’t in the centre of the chest
- Are able to have either SABR or surgery but are considered by your medical team to be at high risk of getting complications from surgery
- Are willing to use reliable contraception if you or your partner could become pregnant
- Are at least 18 years old
You cannot join this study if any of these apply
- Your cancer is too near one of the major airways in your lung (your doctor can tell this)
- Your cancer is more than 5cm across
- Your cancer has spread to certain
lymph nodesin your chest (your doctor can tell this)
- Your cancer has spread to another part of your body
- You have already had
radiotherapyto the part of your lung to be treated as part of this study
- You have already had treatment for your lung cancer that reaches your whole body (
systemic treatment), for example chemotherapy
- You have, or had, another cancer that could affect you taking part in this study (your doctor can advise you about this)
- You have certain lung conditions (the study team can advise about this)
- You have another medical or mental health problem that could affect you taking part in this study
- You are pregnant
This is a feasibility study. The study team need 54 people to join.
It is a randomised study. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
- People in one group will have stereotactic ablative radiotherapy (SABR)
- People in the other group will have surgery
Before starting SABR you have a CT scan to plan where to give the radiotherapy. You have 3 to 8 radiotherapy treatments over 1 to 3 weeks. You have treatment every other day. Your doctor will tell you how many treatments you need.
Before having surgery you will see your doctor to talk about the best type of surgery for you. After surgery you will be in hospital for 4 to 5 days. You will have a tube in your chest to drain away fluid. This may be taken out before you go home, if not it will be taken out 1 to 2 weeks afterwards.
The study team will ask you to fill out a questionnaire booklet before you enter the study, at the start of treatment, at 6 weeks, 3 months and then every 3 months for up to 2 years. Some of the questions will ask you if you have seen, or phoned, another health professional, such as your GP. The other questions will ask about side effects and how you’ve been feeling. This part of the questionnaire booklet is called a quality of life study.
The researchers want to interview 15 people who decided not to join the study or who decided not to have the treatment. You can do this over the phone, at your home or another place and a time that is convenient to you. The researchers will ask you why you decided not to take part or not have the treatment. They would also like to know if you have ideas about how to improve the way the study was presented. And what your overall thoughts about the study are. This will take about 30 to 45 minutes. With your permission they will audio tape the interview.
You see the doctor to have some tests before you take part in the study. These tests include
- A physical examination
- Blood tests
- Heart trace (
ECG) Tests to find out how well you lungs work
- Tests to find out how fit you are (this could be done using an exercise bike, a treadmill or seeing how far you can walk without resting)
After your treatment you see the doctor for a physical examination at 6 weeks, 3 months and then every 3 months for up to 2 years. You have blood tests at 6 weeks, 6 months and 12 months. You have a CT scan at around 6 months, 1 year and 2 years.
The most common side effects of SABR include
- Tiredness (fatigue)
- A cough
- Shortness of breath
- Pain in your chest wall
The most common complications of surgery can include
- Wound infection
- Chest infection
- Blood clots
- Fluid collection around the wound
The trial doctor or nurse will talk to you about the possible side effects of SABR and the possible complications of surgery before you agree to take part.
How to join a clinical trial
Dr Kevin Franks
Leeds Teaching Hospitals NHS Trust
NIHR Clinical Research Network: Cancer
National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB)