"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A study looking at surgery to remove cancer that has spread to the lungs in people who have cancer that started in the bowel (PulMICC)
This study is looking to see if removing cancer that has spread to the lungs improves survival. It is for people who have cancer that started in the bowel. This trial is supported by Cancer Research UK.
More about this trial
If bowel cancer spreads to the lungs, you may be able to have surgery to remove it. But you can only have this type of surgery if you are fit enough.
When some of the lung is removed, breathing can be more difficult afterwards. But we don’t have the research evidence to really know how this affects
Researchers want to learn more about the pros and cons of having surgery to remove bowel cancer that has spread to the lungs.
Who can enter
You can enter this study if you
- Have had surgery to remove bowel cancer with the aim of curing it, but the cancer has now come back in your lungs
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
You cannot enter this trial if you
- Have cancer that is known to have spread anywhere else in your body at this time (apart from your lungs)
- Have had any other type of cancer, or have another medical condition that could affect you taking part in this study – the study team can advise you about this
This is a phase 3 international study. The researchers need 300 people to take part in the UK and elsewhere.
The study is in 2 parts called ‘stage 1’ and ‘stage 2’. If you agree to take part in stage 1, your doctor will do a number of tests to see if you could have surgery to remove the cancer in your lung and whether you need to have other treatment such as chemotherapy.
It can take up to a month to have these tests and this will give you and your doctor time to decide what would be best for you. If it is clear that you should have surgery, or clear that you should have another treatment, this will take place and you will not continue in the study. The researchers will ask your permission to contact your doctor in a year’s time to see how you are.
If, after looking at all your test results, your doctor is unsure which treatment would be best for you, they will ask you to take part in stage 2 of the study.
Stage 2 is randomised. This means 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 group A have surgery to remove the cancer in their lungs. There are 2 ways of doing this. You may be able to have a type of keyhole surgery using a camera. This is called video assisted thoracic surgery (VATS). Or you may have an operation which involves opening your chest. This is called a
People in group B will not have surgery, but the study team will monitor them closely. This is called active monitoring and means having regular blood tests and CT scans. If you stay well and the scan results don’t change, you don’t need to have any treatment. If you start to feel less well, or the scan results do change, you may have more tests and scans to help decide which treatment would be best for you.
The study team will closely follow the progress of people in both groups for at least 5 years. You will be asked to fill out questionnaires at the beginning of stage 2 and then after 3, 6, 12 and 24 months. The questionnaires will ask about how you have been feeling. This is called a quality of life study.
You will see the doctors and have some tests at the beginning of the study. The tests include
- Physical examination
- Blood tests
- Tests to measure your breathing (spirometry)
- PET-CT scan
Your doctor may also take a
If you are in group A, you will spend some time in hospital to have surgery. Your surgeon will be able to tell you more about what to expect.
People in both groups will have follow up appointments for at least 5 years. You have a CT scan after 3 months, 1 year, 2 years and 3 years. You will see the doctors and have blood tests and breathing tests
- Every 3 months for a year
- Every 6 months in the next year
- Every year for the following 3 years
Any surgery carries some risk. The risks of surgery to the lung include
- Blood clots
Rarely, surgery can lead to kidney problems, a heart attack or stroke. Your surgeon will be able to tell you how much they expect your breathing to be affected by the surgery in your case.
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.
Professor Tom Treasure
Cancer Research UK
NIHR Clinical Research Network: Cancer
Surgical and Interventional Trials Unit, University College London
University of Sussex
This is Cancer Research UK trial number CRUK/09/022.