A trial looking at stereotactic radiotherapy and chemotherapy for people with locally advanced bile duct cancer (ABC 07)

Cancer type:

Bile duct cancer
Biliary tree cancers

Status:

Open

Phase:

Other

This trial is looking at a type of radiotherapy called stereotactic 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 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 it is possible to get enough people to take part 
  • Find out if having chemotherapy and stereotactic 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. Or you have cancer where the pancreatic duct Open a glossary item meets the bile duct Open a glossary item. This is called ampullary cancer.
  • Your cancer can be seen on a scan
  • Your tumour measures less than 6 cm across
  • 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 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
  • You are at least 16 years old

You cannot join this trial if any of these apply. 

  • 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 Open a glossary item
  • You have had another cancer in the last 5 years apart from successfully treated early cancers Open a glossary item or any other cancer that has been treated with the aim to cure and there hasn’t been any sign of it for at least 5 years
  • 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 is a feasibility study. To begin with, the researchers hope to find between 12 and 18 people to take part. If it takes too long to find this number of people, they will stop the trial. If it is easy to recruit people, they will continue it as a phase 2 trial. They aim to have a total of 83 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 radiotherapy (SBRT)

For every 2 people having SBRT, 1 will have GC chemotherapy.

Diagram for ABC 07

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. You have 5 treatments of SBRT. 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.

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 biopsy Open a glossary item.

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

We have information on the side effects of GC.

Location

Birmingham
Cambridge
Cardiff
London
Manchester
Northwood
Nottingham
Oxford
Southampton
Stevenage
Sutton

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

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.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12653

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

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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