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

Cancer type:

Bile duct cancer
Biliary tree cancers
Secondary cancers

Status:

Results

Phase:

Phase 3

This trial looked at having photodynamic therapy Open a glossary item and a tube called a stent to relieve symptoms of advanced cancer of the bile duct Open a glossary item or gallbladder Open a glossary item

The trial was supported by Cancer Research UK. It was open for people to join between 2007 and 2009. The team reported the results in 2018.

More about this trial

Bile duct cancer and gallbladder cancer are known together as biliary tract cancers. 

Sometimes biliary tract cancers can cause a blockage in the bile duct Open a glossary item. This can lead to jaundice Open a glossary item.

A stent is a small metal or plastic tube that keeps the bile duct open. Doctors commonly use stents as part of treatment for biliary tract cancers. They hoped that a treatment called photodynamic therapy (PDT) Open a glossary item may also help.

People in this trial were put into a treatment group at random:

  • half had a stent inserted (standard care)
  • half had a stent and photodynamic therapy

The main aims of this trial were to find out:

  • which treatment is best for biliary tract cancer that has grown or spread
  • more about side effects

Summary of results

The trial team found that photodynamic therapy (PDT) and a stent was not better than a stent alone for advanced biliary tract cancer.

Results
A total of 92 people joined this trial:

  • 46 people had a stent
  • 46 people had a stent and photodynamic therapy (PDT)

The team looked at how long it was until the cancer started to grow. They found it was:

  • 4.3 months for those who had a stent
  • 3.4 months for those who had a stent and PDT

When they looked at how long people lived, they found it was:

  • 9.8 months for those who had a stent
  • 6.2 months for those who had a stent and PDT

More people who had a stent but not PDT went on to have chemotherapy treatment. This could be part of the reason why people in this group did better than those who had PDT. But it’s hard to say for sure.

Side effects
People in both groups had some side effects. But many were mild or didn’t last long.  A few more people who had PDT had a serious side effect. 

Some people taking part had a change in liver function. This affected more people who had PDT. It happened in:

  • 28 people who had a stent
  • 36 people who had a stent and PDT

Conclusion
The research team concluded that having PDT and a stent was not better than having a stent alone. This is for people with biliary tract cancer that has grown or spread. 

They say that having a stent is the best treatment option for this group of patients. And that people should only have PDT as part of a clinical trial.

Sometimes trials show a treatment isn’t useful for a particular type or stage of cancer. But these trials still add to our knowledge and understanding of cancer and how to treat it.

More detailed information
There is more information about this research in the reference below. 

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

PHOTOSTENT-02: porfimer sodium photodynamic therapy plus stenting versus stenting alone in patients with locally advanced or metastatic biliary tract cancer
S Pereira and others
ESMO Open, 2018. Volume 3, issue 5; e000379. 

Where this information comes from    
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.

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 Stephen Pereira

Supported by

Cancer Research UK
NIHR Clinical Research Network: Cancer
University College London (UCL)

Other information

This is Cancer Research UK trial number CRUK/08/011. 

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

502

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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