All studies
CompletedInterventional

A trial looking at whether stereotactic radiotherapy together with chemotherapy is a useful treatment for people with locally advanced bile duct cancer (ABC-07)

Bile duct cancer can be difficult to treat, particularly when it has grown into nearby tissues and cannot be removed with surgery. In these cases, chemotherapy is normally the main treatment. This clinical trial, known as ABC-07, is investigating whether adding a focused radiation treatment called stereotactic body radiotherapy (SBRT) makes chemotherapy more effective. SBRT uses modern scanning to deliver high doses of radiation directly to the tumour from many different angles. This aims to treat the cancer while protecting nearby healthy organs like the stomach and bowel. Doctors want to find out whether combining chemotherapy with this precise radiotherapy can shrink tumours, delay the cancer from growing, and help people live longer. The study is open to adults across the UK whose cancer is confined to the bile duct area and cannot be operated on.

At a glance

Status
Completed
Sponsor
University College London
Enrolment target
83
Start
01 Nov 2015
Estimated completion
03 Aug 2022

What is this study about?

Bile duct cancer (also called biliary tract cancer) starts in the small tubes that carry digestive fluid from the liver to the gut. Often, by the time the cancer is found, it has grown into nearby blood vessels or tissues. When this happens, specialist surgeons cannot safely cut the cancer away. Standard treatment is usually chemotherapy, which travels through the bloodstream to slow down cancer growth, but researchers are searching for ways to make treatment work better.

This trial is studying a specialised type of radiation treatment called stereotactic body radiotherapy, or SBRT. Unlike standard radiotherapy, SBRT delivers very precise, powerful beams of radiation directly to the tumour. Because the beams are so carefully targeted, doctors can give a higher dose of radiation while doing less damage to healthy parts of the liver, stomach, and bowel.

Researchers want to see if giving SBRT alongside regular chemotherapy helps shrink or control the tumour for longer than chemotherapy by itself. They also want to understand how the combination affects daily life and wellbeing.

Finding new ways to control bile duct cancer is vital. If this combined approach proves helpful, it could offer a valuable new treatment option for people facing this type of cancer in the future.

Key takeaways

  • Tests whether adding targeted radiotherapy to chemotherapy improves treatment for bile duct cancer.
  • Aimed at people whose cancer cannot be removed with surgery.
  • Uses advanced radiation techniques to protect nearby healthy organs.
  • Participants receive regular monitoring and support from a specialist cancer team.
  • Taking part is completely voluntary and you can change your mind at any time.

Who may be eligible?

This trial is for people aged 16 and over who have been diagnosed with locally advanced bile duct cancer or ampullary cancer (cancer where the bile duct joins the small bowel). A team of hospital specialists must have confirmed that the cancer cannot be removed with surgery. The tumour must be clearly visible on hospital scans and measure 12 centimetres or less across.

To take part, you should be reasonably active and able to look after yourself, such as managing light household activities. You also need to have good enough liver and kidney function, satisfactory blood counts, and working bile drainage, which your hospital team will check using routine tests.

People whose cancer has spread to distant organs, or whose tumour is too large to safely receive targeted radiation, will not be able to join. Your hospital doctor will review your scans and general health to see if the trial is a safe option for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I have been diagnosed with locally advanced bile duct or ampullary cancer.
  2. My specialist team has confirmed surgery is not a suitable option for me.
  3. I am aged 16 or over.
  4. I am generally up and about and able to look after myself.
  5. My tumour is visible on scans and measures 12 centimetres or less.
Answer every question to see your result.

What does participation involve?

If you take part, you will receive standard chemotherapy, usually given in cycles over several months. Some patients will also receive stereotactic radiotherapy sessions, which are planned using detailed body scans and given over a set number of visits to the radiotherapy department. Throughout the trial, you will have regular hospital appointments for blood tests, physical check-ups, and scans to monitor your health and see how the cancer is responding. Your medical team will also ask you questions about how you are feeling and any side effects you might have. After your treatment ends, you will continue to have regular follow-up visits so doctors can keep track of your progress over the long term.

Potential risks and benefits

Taking part may help slow down or shrink your cancer, and you will be closely monitored by a specialist team throughout. The information gathered may also help future patients. However, treatments can cause side effects. Chemotherapy often causes tiredness, sickness, and an increased risk of infections. Radiotherapy can cause temporary fatigue, sore skin, or tummy upset. Your care team will give you medicines to help prevent and manage these symptoms. Joining the study is completely up to you, and you can leave at any point without it affecting your usual NHS care.

Locations (20)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Churchill Hospital
    Unverified
    Oxford, England
  • University College Hospital
    Unverified
    London, England
  • The Royal Marsden Hospital (Surrey)
    Unverified
    Sutton, England
  • The Royal Marsden Hospital
    Unverified
    London, England
  • Mount Vernon Cancer Centre
    Unverified
    Northwood, England
  • Lister Hospital
    Unverified
    London, England
  • Royal Free Hospital
    Unverified
    London, England
  • Velindre Cancer Centre
    Unverified
    Cardiff, Wales
  • St Bart’s Hospital
    Unverified
    London, England
  • Hammersmith Hospital
    Unverified
    London, England
  • Southampton General Hospital
    Unverified
    Southampton, England
  • Addenbrooke’s Hospital
    Unverified
    Cambridge, England

Common questions

What is stereotactic radiotherapy (SBRT)?

It is an advanced form of radiotherapy that targets tumours with pinpoint accuracy from many angles, delivering high doses while sparing surrounding healthy tissue.

Will taking part cost me anything?

No. The trial treatments and tests are provided free of charge through the NHS, though you should check with the hospital team regarding travel expense support.

Will I have to stay overnight in the hospital?

Most chemotherapy and radiotherapy appointments are given as outpatient visits, meaning you can usually go home the same day.

Can I carry on taking my normal medicines?

In most cases yes, but you must tell the trial team about all tablets, supplements, or herbal remedies you take so they can make sure they are safe.

What happens if I decide to stop taking part?

You are free to leave the trial at any time. Your doctors will continue to care for you and will discuss the best alternative standard treatments available.

How to find out more

Shumona Shelly

Always speak to your GP or specialist before deciding to take part in a study.

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