A study of radiotherapy before surgery for pancreatic cancer (PORTICO-SABR)

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

Cancer type:

Pancreatic cancer

Status:

Closed

Phase:

Other

This study is looking at stereotactic radiotherapy Open a glossary item (SABR) for pancreatic cancer before surgery to remove it. 

It is open to people who are going to the Addenbrookes Hospital in Cambridge.

More about this trial

You might have chemotherapy or chemoradiotherapy Open a glossary item to shrink pancreatic cancer before surgery. The type of surgery you might have depends on:

  • where your cancer is in the pancreas
  • how big it is
  • what the cells look like (grade)
  • your general health

Whipple’s procedure Open a glossary item is one type of surgery you might have. 

Stereotactic radiotherapy (SABR) is a type of radiotherapy. It targets the cancer more accurately. This means the surrounding healthy tissue gets a lower dose of radiotherapy. So there are fewer side effects with SABR. 

Research suggests that using SABR before surgery might be just as good as chemotherapy or chemoradiotherapy. To find this out, researchers need to do a large clinical trial comparing SABR with chemotherapy or chemoradiotherapy. But first they need to find out if it is safe to give SABR before surgery to remove pancreatic cancer. 

In this study, everyone has SABR before having their operation. The aim is to find out if it is possible and safe to give SABR before having a Whipple’s procedure to remove cancer of the pancreas. 

Who can enter

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 

Who can take part

There are 2 stages to this study. 

You may be able to join the study if you are:

  • going Addenbrookes Hospital in Cambridge
  • at least 16 years old 

And all of the following apply. 

Stage 1 
You have a scan that shows there is a mass on your pancreas. And your healthcare team (multi disciplinary team) Open a glossary item thinks you have a primary cancer Open a glossary item of the pancreas that they can remove with surgery. 

Stage 2
You:

  • have adenocarcinoma of the pancreas
  • are due to have an operation called a Whipple’s procedure Open a glossary item
  • have satisfactory blood test results that shows your kidneys work well enough
  • are fit but might not be able to do heavy physical work (performance status 0 or 1)
  • are willing to use contraception during treatment if you or your partner could become pregnant

Who can’t take part

You cannot join this study if any of these apply. You:

  • have had radiotherapy to the tummy (abdomen)
  • have any other medical condition or mental health problem that the study team or your doctor thinks could affect you taking part
  • are pregnant

Trial design

The study team need 10 people to join the study. There are 2 stages to this study.

Stage 1
You have a tissue sample and blood samples taken.

You have an endoscopic ultrasound. During the ultrasound they take samples of tissue (biopsy Open a glossary item). A specialist (pathologist Open a glossary item) in the lab checks the sample to see if you have pancreatic cancer. 

The team will ask you to join stage 2 of the study if you have pancreatic cancer and you can have surgery to remove it.  

If you can’t have surgery or you don’t have cancer, the team will refer you back to your healthcare team. 

Stage 2
Before your surgery you have a type of radiotherapy called stereotactic ablative radiotherapy (SABR). 

SABR uses thin beams of radiation to target the cancer more accurately. This means that the healthy tissue surrounding the cancer gets less radiation. The lower radiation to the healthy tissue means there is a lower risk of side effects. 
 
Before having SABR you have a planning appointment. You have this appointment so the radiologist Open a glossary item can work out where to give the radiotherapy.

You have SABR once a day for 5 days. The treatment lasts between 20 and 30 minutes. You have surgery between 3 and 7 days after SABR.

You have a general anaesthetic Open a glossary item for surgery. 

Extra scans for the study
You have an extra scan before SABR and another after. You don’t have to agree to have these scans. You can still take part in the study.

Samples for research
You give blood samples during the study. The team will take their samples at the same time as your routine bloods where possible.

When you have the endoscopic ultrasound, the team will take 2 extra samples if it is possible and safe to do so. 

During surgery, the surgeon will take 2 to 4 tissue samples if it is safe and possible. 

After surgery when the cancer is removed the team will take more tissue samples from it. 

They will also ask for any tissue samples taken in stage 1 or at another time, for example when you were diagnosed. 

Researchers will use these samples to learn more about pancreatic cancer and how to treat it.

Hospital visits

You see the doctor to have tests before taking part. These tests include:

You see the doctor after the start of SABRE at:

  • 60 days
  • 90 days
  • 6 months
  • 1 year

They will check how you are, and you will have blood tests. You have a CT scan at 1 year. 

Your doctor will then tell you how often they want to see you. 

Side effects

The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad, or not getting better. 
 
Side effects of SABR can happen during and after completing treatment. These can include:

  • tiredness (fatigue)
  • feeling or being sick 
  • skin reactions 

We have information about:

Your doctor or a member of the study team will talk to you about the side effects. 

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

Dr Thankamma Ajithkumar

Supported by

AstraZeneca
Cambridge University Hospitals NHS Foundation Trust
Cambridge Clinical Trials Unit - Cancer Theme

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

Freephone 0808 800 4040

Last review date

CRUK internal database number:

17542

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

Last reviewed:

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