A trial looking at having a stent with or without photodynamic therapy for symptoms of advanced biliary tract cancer (PHOTOSTENT - 02)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Bile duct cancer

Biliary tree cancers

Status:

Closed

Phase:

Phase 3

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 bile duct Open a glossary item 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.

Who can enter

You can enter this trial if you

Have been diagnosed with cancer of the biliary tract
Cannot have surgery to remove your cancer
Have satisfactory blood test results
Are well enough to take part in the trial (performance status 0,1,2 or 3)
Are at least 18 years old
Are prepared to use reliable contraception during the trial and for one month afterwards if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

Have biliary cancer that has spread to your brain
Have had treatment aiming to cure your cancer in the last 3 months
Have not recovered from earlier surgery
Have had radiotherapy or chemotherapy in the last 28 days
Have had any other cancers in the past that might affect your treatment - this does not include non melanoma skin cancer or carcinoma in situ of the cervix that have been successfully treated
Have a condition called porphyria which can make you very sensitive to light
Have an infection that is not responding to antibiotics
Have any other serious medical condition that could affect you taking part in the trial
Are pregnant or breastfeeding

Trial design

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

Through a tube that passes down your throat and through your stomach (endoscopically)
Through the skin (percutaneously)

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.

Hospital visits

You will go to the hospital to see the doctors and have some tests before you take part in the trial. These include

Physical examination
CT scan or MRI scan
Chest X-ray
Blood tests

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.

Side effects

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

Sickness
Abdominal pain
Fever

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.