
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.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at adding other treatments to chemotherapy for bowel cancer that has spread elsewhere in the body. Bowel cancer that has spread is called metastatic or advanced bowel cancer.
The trial is for people who:
Chemotherapy is the usual treatment for advanced bowel cancer. Doctors are looking for ways to improve treatment.
They think having other treatments to get rid of as much cancer as possible might help. This is debulking treatment. These treatments might include:
These debulking treatments are not new. They are usual treatments for cancer that has spread to a few places in the body. But it is not usual to have them for cancer that is more widespread.
In this trial everyone has chemotherapy to start. Then some people have chemotherapy on its own. And some have chemotherapy and a debulking treatment.
The main aims of the 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 you have bowel cancer spread to 2 or more different organs in the body. And at least 1 of the following also apply:
As well as the above the following must also apply:
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
You:
Medical conditions
You:
Other
You:
This is a phase 3 trial. It is taking place in the UK and the Netherlands. The team hope to find 478 people to join including 70 from the UK.
Initial chemotherapy
Everyone has first. This includes 1 of the following combinations of treatment:
You have . You have 3 cycles of XELOX or 4 cycles of FOLFOX.
You then have a scan to check if treatment has worked. If your cancer has stayed the same or got smaller you are put into a treatment group at random by a computer. There are 2 treatment groups. Neither you nor your doctor can decide which group you are in. You have 1 of the following:
You won’t be able to continue with the trial if your cancer gets worse. Your doctor will discuss other treatments with you.
More chemotherapy (Group A)
You continue with XELOX or FOLFOX chemotherapy. You have this for as long as the treatment is working and the side effects aren’t too bad.
Debulking treatment and then continue with chemotherapy (Group B)
For people whose cancer got smaller after initial chemotherapy you have 1 cycle of chemotherapy followed by debulking treatment.
People whose cancer stayed the same after initial chemotherapy have:
If your cancer stays the same or gets smaller you 1 have more cycle of chemotherapy followed by debulking treatment. But you can’t go on to have debulking treatment if your cancer gets worse.
The possible debulking treatments include:
A team of medical specialists decide which debulking treatment you should have. Where possible you have surgery first. Then the debulking treatment to the other areas of cancer spread if possible.
To have TACE your doctor puts a fine tube (catheter) into your groin. You then have a chemotherapy drug through the catheter directly into the area of cancer. The drug is inside tiny spheres. These then block the blood flow to the cancer.
To have ablation treatment you have an . You then have a
or an
. Your surgeon or radiologist use the scan to guide a needle through your skin into the tumour. The needle heats up and kills the cancer cells. Some people might have ablation treatment when they have surgery.
You might need to have a before you start radiotherapy treatment. This is to plan the treatment. The number of radiotherapy sessions you have depends on your treatment plan. The trial doctors can tell you more about this.
Quality of life
You fill in questionnaires before starting treatment, at set times during and after treatment. The questions ask about how you are feeling and about any side effects you have. This is a quality of life study.
You see a doctor and have some tests before you join the trial. These include:
You go to hospital for all your treatment.
The trial team can tell you more about your surgery and how long you stay in hospital for afterwards.
You stay in hospital for a few days if you have TACE or ablation treatment.
When you finish treatment you see the trial team:
You have these check ups until your cancer gets worse.
You have a CT or PET-CT scan:
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
The most common side effects of TACE include:
The most common side effects of ablation include:
These usually gets better within 10 days.
The most common side effects of radiotherapy are:
The possible risks of having surgery 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 Lotte Bakkerus
Radboud University Medical Center
If you have questions about the trial please contact our cancer information nurses
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.