A trial looking at stereotactic body radiotherapy and chemotherapy for people with locally advanced bile duct cancer (ABC-07)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at a type of radiotherapy called stereotactic body radiotherapy alongside 2 chemotherapy drugs called cisplatin and gemcitabine. It is for people with bile duct cancer that has grown into surrounding tissues (is locally advanced).
Cancer Research UK supports this trial.
More about this trial
Doctors usually treat bile duct cancer that has grown into surrounding tissues with 2 chemotherapy drugs called cisplatin and gemcitabine. This is known as GC. But sometimes the cancer comes back. So doctors are looking at ways to improve treatment for this group of patients.
In this trial, researchers are looking at having stereotactic body radiotherapy (SBRT) following chemotherapy. SBRT directs radiotherapy beams at the cancer from different positions around the body. It delivers a high dose of treatment to the cancer while the surrounding tissue only receives a low dose. Doctors think it may control the cancer for longer. But they want to find out more.
The aims of the trial are to
- Find out if having chemotherapy and stereotactic body radiotherapy together is a useful treatment for people with locally advanced bile duct cancer
- Learn more about the side effects
Who can enter
The following bullet points list the entry conditions for this trial. If you are unsure about any of these speak with your doctor or the trial team. They will be able to advise you.
You may be able to join this trial if all of the following apply.
- You have cancer of the bile duct that has spread into surrounding tissues and can’t be removed with an operation
- Your cancer can be seen on a scan
- Your tumour doesn't measure more than 12cm across - if it isn't possible to measure because of where it is in the body, you might be able to take part if it is visible for radiotherapy with another type of test such as an
ERCP 
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 or 1)
- You have satisfactory blood test results
- You are willing to use at least 1 form of reliable contraception during the trial and for at least 6 months after the last dose of chemotherapy if there is any chance you or your partner could become pregnant. If you have SBRT, you should continue to use the contraception for at least 12 months after you finish treatment
- You are at least 16 years old
You cannot join this trial if any of these apply.
- You have cancer of the gallbladder
- You have cancer that has spread to another part the body
- Your cancer has grown into your stomach or part of your digestive system called the small and large bowel
- You have had radiotherapy to your tummy (abdomen) or a type of internal radiotherapy called SIRT such as Yttrium treatment into the main artery near the liver (hepatic artery)
- You have had a reaction to substances called platinum salts in the past
- You are having any other type of cancer treatment apart from
steroids - You have had another cancer in the last 2 years apart from successfully treated
early cancers or any other cancer that has been treated with the aim to cure - You have any severe health problem such as heart, lung, kidney or liver problems
- You have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial
- You are pregnant or breastfeeding
Trial design
This started as a feasibility study to check it was possible to find enough people to join. They found it was possible so the trial is continuing as a phase 2 trial. They aim to have a total of 81 people taking part.
Everyone has GC as a drip into a vein once a week for 2 weeks followed by a week without treatment. This makes up a 3 week cycle of treatment. Treatment takes about 2 hours each time.
After 4 cycles of treatment, you have a CT scan. If the scan shows treatment isn’t controlling the cancer, you stop taking part in this trial. Your doctor will discuss further treatment options with you.
If the scan shows the cancer has shrunk, and the side effects aren’t too bad, you have 2 further cycles of GC chemotherapy.
After cycle 6 of treatment, the next part of the trial is randomised. You are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
- One group have 2 further cycles of GC chemotherapy
- The other group have stereotactic body radiotherapy (SBRT)
For every 2 people having SBRT, 1 will have GC chemotherapy.
If you have more GC, you have it the same way as you had the first 6 cycles.
The stereotactic radiotherapy group begin treatment 6 weeks after the 6th cycle of treatment. Depending on the size of the tumour you have 5 or 15 of SBRT.
5 treatments of SBRT
You have 5 treatments of SBRT if your tumuor is smaller. You usually have treatment every 2 days. But this can vary if you need time to recover from side effects. Treatment usually takes between 5 and 15 days.
15 treatments of SBRT
You have 15 treatments of SBRT if your tumour is bigger. You have treatment once a day, Monday to Friday, for 15 days. But this can vary if you need time to recover from side effects. Treatment usually takes between 19 and 21 days.
All treatment takes about 5 to 6 months in total.
Research samples
If you agree to take part in this trial, the researchers will ask for extra blood samples. They want to look at how to improve treatment for bile duct cancer. Where possible, you have these at the same time as your routine blood tests. The samples will be stored safely and used only for research purposes.
The trial team will also ask to look at a sample of tissue that was removed when you had your bile duct cancer surgery or a .
Hospital visits
You see the doctor to have some tests before taking part in the trial. These include
- Blood tests
- A test to see how well your kidneys are working
- A hearing test if you have any hearing problems
- CT scan or MRI scan
You have chemotherapy and SBRT treatment at the hospital. You may have SBRT at the same hospital as your chemotherapy or you may need to go to a different hospital. This is because SBRT is given from a specialised machine and not all hospitals have these machines.
Treatment needs to be planned before having SBRT. This involves coming in to hospital for 1 or 2 planning sessions. Planning is a normal part of SBRT treatment and the doctors will give you more information if you are having this treatment.
You see the doctor and have some scans 1 month after you finish treatment. If the scans show your cancer hasn’t got worse, you see the doctor for a check up and scan every 3 months for up to 2 years.
If the scans show your cancer has got worse, you stop seeing the trial team and go back to the care of your usual doctor. But the trial team will continue to check how you are getting on at routine hospital appointments or they may check your medical notes.
Side effects
You will not feel anything during stereotactic body radiotherapy (SBRT), it is a bit like having an X-ray or a scan. The most common side effects of SBRT are
- Tiredness
- Sore skin in the treatment area
- Liver changes
- Feeling or being sick
We have information on the side effects of GC.
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.
Chief Investigator
Professor Maria Hawkins
Supported by
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University College London (UCL)
Other information
This is Cancer Research UK trial number CRUK/14/029.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
