
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 photodynamic therapy combined with a tube called a stent to relieve symptoms of advanced cancer of the bile duct or gallbladder. This trial is supported by Cancer Research UK.
Bile duct cancers and gallbladder cancer are known together as biliary tract cancers. If doctors are not able to remove them with surgery, or they spread to other parts of the body, these cancers can be difficult to treat. Biliary tract cancer can cause the to get blocked. This blockage leads to jaundice.
A stent is a small metal or plastic tube that keeps the bile duct open. The use of stents to relieve symptoms is part of standard treatment for biliary cancer.
Doctors think that a treatment called photodynamic therapy (PDT) is another way to relieve these symptoms. But they are not sure if PDT will help people with this type of cancer.
In this trial, the doctors are trying to find out if having PDT and a stent works better than having a stent alone. The aims of the trial are to see which treatment works best and to find out more about side effects.
You can enter this trial if you
You cannot enter this trial if you
This is a randomised trial. It will recruit 240 people. If you take part, you will be put into one of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
Everybody taking part in the trial will have a stent. You can have a stent put into your bile duct
If you are in group A, you will have a stent put into your bile duct using one of these methods.
If you are in group B, you will have a stent put in as above. Your stent will then be temporarily removed and you have photodynamic therapy (PDT) to the blocked bile duct. After the PDT, a stent will be put back in in endoscopically or percutaneously.
Before either procedure you will have a sedative to make you drowsy and relaxed.
If you have PDT, you will have a drug called porfimer sodium as an injection into a vein. This is a drug that makes cells sensitive to light (a photosensitising agent). The porfimer sodium circulates around your body and is absorbed by the cancer cells.
Two days later, the doctors will pass a tube called an endoscope into your mouth, down your throat, into your stomach and then into your bile duct. Then, through the endoscope, they will shine a laser light at the cancer. The light works with the porfimer sodium to kill the cancer cells. After the laser treatment, they will put a stent into the bile duct.
You will have to stay out of bright light for 3 or 4 days after having the porfimer sodium. And you must avoid direct sunlight for at least 4 weeks. During that time, you have to be very careful and wear gloves, hat and sunglasses as well as long sleeves and trousers. If you expose any skin to sunlight, it may burn. The trial doctors will give you more information about this.
At the beginning of the trial, the doctors will ask everybody taking part to fill in a questionnaire about how they are feeling and any symptoms they have. This is called a quality of life study. If you agree to take part in this study, they will ask you to fill in more questionnaires 3 months and 6 months after your treatment.
You will go to the hospital to see the doctors and have some tests before you take part in the trial. These include
If you are in group A, you will stay in hospital for at least 1 day when you have your treatment. If you are in group B, you will stay in hospital for at least 3 days.
After the treatment, everybody taking part will see the doctors and have a CT scan every 3 months.
PDT is still quite a new treatment and there may be side effects that the doctors don’t know about yet. The main side effect of porfimer sodium is that it makes the skin very sensitive to light. This can last for up to 90 days.
In earlier trials, some people have also had
As with any surgical procedure, there is a risk of bleeding and infection when you have a stent put in. To reduce the risk of infection, you will have antibiotic tablets, starting on the day that you have the stent put in. There is more information about the side effects from having a stent on CancerHelp UK.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Steve Pereira
Cancer Research UK
NIHR Clinical Research Network: Cancer
University College London (UCL)
This is Cancer Research UK trial number CRUK/08/011.
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.