A study of giving radiotherapy in a fewer number of treatments for pancreatic cancer (EMERALD)

Cancer type:

Pancreatic cancer

Status:

Open

Phase:

Other

This study is to find out whether it is possible to treat pancreatic cancer with high dose radiotherapy or in fewer number of treatments.

It is open to people with localised pancreatic cancer Open a glossary item who can’t have surgery to remove it or don’t want surgery. It is also open to people whose cancer has come back in the same area.

More about this trial

Doctors can treat pancreatic cancer with radiotherapy. You have 5 treatments (fractions Open a glossary item ) of radiotherapy daily or on alternate days over 1 to 2 weeks. This is the standard treatment .

Giving a higher dose of radiotherapy or in fewer fractions would mean fewer visits to the hospital and may improve tumour control.

Before using these treatments researchers need to find out whether they might cause more or worse side effects.

There are 3 groups in this study a:

high dose given in 5 treatments on alternate days over 2 weeks
high dose radiotherapy dose given over 3 treatments
high dose radiotherapy dose given in 1 treatment

The aims of the study are to find out whether they can:

safely increase the dose of radiotherapy
give a high dose in fewer treatments

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

You may be able to join this study if all of the following apply. You:

have pancreatic cancer that has spread to the nearby lymph nodes or to the surrounding tissue (locally advanced). You can also join if your cancer has come back in the same area of the pancreas.
can’t have surgery to remove the cancer or you don’t want surgery
have ductal adenocarcinoma pancreatic cancer
can look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
have satisfactory blood test results
are willing to use contraception during treatment and for a time after if there is any chance you or your partner could become pregnant
are at least 16 years old

Who can’t take part

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

have cancer spread to another part of the body or if all of the cancer in the pancreas cannot fit into the radiotherapy field
have had radiotherapy to the tummy (abdomen)
are not able to have an MRI scan . This could be because you have metal in your body such as metal pins or shrapnel, you can’t be in confined spaces or you might not be able to lie still for 90 minutes.

Trial design

The study team need up to 60 people to take part.

There are 3 groups of treatments. Which group you go into depends on when you join the study.

Group 1
You have 5 treatments of high dose radiotherapy. You have treatment on alternate days over 2 weeks or daily over a week.

Group 2
You have 3 treatments of high dose radiotherapy on alternate days.

Group 3
You have 1 treatment of high dose radiotherapy.

The first to open is group 1. To start with only a few people have the treatment. This is to find out if there are any safety concerns such as bad side effects. If there aren’t any safety concerns then up to 20 people can join this group.

Group 2 opens when the team know that the dose in group 1 doesn’t cause any safety concerns. The same happens as in group 1. If there are no safety concerns for the first few people then up to 20 people can join this group.

Group 3 opens as long as there are no safety concerns in group 2. This follows the same as pattern as group 1 and group 2. If there are no safety concerns then up to 20 people can join this group.

You have a planning appointment before you have your radiotherapy. This is similar to how you will have your radiotherapy. The doctor and radiographer use this planning appointment to make sure that the treatment goes exactly where it should.

Hospital visits

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

a physical examination
blood tests

You see the doctor when you have your radiotherapy. This is to see how you are and if you have any side effects.

You see the doctor a week after finishing radiotherapy and then at:

3 weeks
6 weeks
3 months
6 months
12 months
18 months

You can choose to have a face to face visit at 3 weeks and 3 months or if you prefer the team can call you. The other visits may be over the telephone.

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.

One of the aims of the study is to find out if the side effects are worse with this treatment. The most common side effects of standard radiotherapy treatment are: