A trial of GC4711 and SBRT for pancreatic cancer (GRECO-2)

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:

Phase 2

This trial is looking at adding GC4711 to stereotactic body radiotherapy for pancreatic cancer.

It is for people:

who can’t have surgery to remove the cancer or it could be difficult to remove and
whose cancer hasn’t spread to other parts of the body

More about this trial

You might have chemotherapy for pancreatic cancer that hasn’t spread, or isn’t possible to remove with surgery. After chemotherapy you might have stereotactic body radiotherapy (SBRT). Doctors are looking for ways to improve how well radiotherapy works for pancreatic cancer. In this trial they are looking at adding GC4711.

GC4711 is a drug still being studied. Early research shows that it may improve how well radiotherapy works. It might also reduce damage to tissue that radiotherapy can cause.

In this trial some people have SBRT and GC4711. And some have SBRT and a dummy drug (placebo Open a glossary item ).

The main aims of the trial are to find out:

how safe GC4711 is
if adding GC4711 to SBRT improves how well radiotherapy works
more about the side effects
what happens to GC4711 in the body
if treatment can shrink the cancer enough to remove it by surgery

Who can enter

The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial 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 trial if all of the following apply. You:

have adenocarcinoma of the pancreas
have newly diagnosed pancreatic cancer that hasn’t spread to other parts of the body
have cancer that has grown into surrounding tissues and it isn’t possible to remove, it could be difficult to remove or you don’t want to have surgery
have a CT scan to confirm your cancer hasn’t spread elsewhere in the body after your chemotherapy is finished
are suitable to have stereotactic body radiotherapy (SBRT)
have cancer that your doctor can see on a scan
have completed at least 6 weeks of a combination of chemotherapy called FOLFIRINOX, modified FOLFIRINOX or a combination of chemotherapy that included gemcitabine before starting SBRT
have satisfactory blood test results
are up and about more than half the day, you can look after yourself but might not be able to work (performance status 0 to 2)
are willing to use reliable contraception during treatment and for a period of time after if there is any chance you or your partner could become pregnant.
are at least 18 years old

Who can’t take part

Cancer related
You cannot join this trial if any of these apply. You:

have cancer that has spread elsewhere in the body
have had chemotherapy other than FOLFIRINOX, modified FOLFIRINOX or a combination of chemotherapy that included gemcitabine before starting SBRT
have pancreatic cancer that has grown into the bowel or stomach
have already had radiotherapy to the tummy (abdomen) that overlaps where you will have your SBRT
have side effects from past treatments that aren’t better
have another cancer that needs treatment
are having treatment with an experimental drug as part of another clinical trial

Medical conditions
You cannot join this trial if any of these apply. You:

have a significant heart problem or heart condition that isn’t well controlled with medication. Your doctor checks your heart before you join the trial.
have a peptic ulcer that isn’t well controlled with treatment within 30 days of starting trial treatment
have an ongoing infection that would delay your treatment
have a condition called Gilbert’s syndrome
have a low level of potassium in the blood with a change to your heart rhythm
are having treatment with another drug that can cause a drop in your blood pressure. Your doctor will check the medications you are taking.
have any other health condition or mental health problem that the trial team think would affect you taking part

Other
You cannot join this trial if any of these apply. You:

have had an allergic reaction to another drug similar to GC4711 or anything it contains
are pregnant or breastfeeding

Trial design

This phase 2 trial is taking place worldwide. The team need to find 160 people to take part including 38 from the UK.

It is a randomised trial. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. Nor will you know which group you are in. Your doctor can find this out if necessary.

There are 2 treatment groups. You have 1 of the following:

stereotactic body radiotherapy (SBRT) and GC4711
SBRT and a dummy drug (placebo)

Diagram 1

Before you start SBRT you must have completed at least 6 weeks of chemotherapy. This chemotherapy is part of your standard treatment Open a glossary item and isn’t part of the trial treatment.

Trial treatment
You start trial treatment about a week after you finish chemotherapy. You have some scans at the hospital first to plan the stereotactic radiotherapy. The team can tell you when you have these scans and how long you’ll be at the hospital for.

You have 5 doses of SBRT. It takes about 15-60 minutes each time. Before each dose you have one dose of GC4711 or the dummy drug. You have this as a drip into a vein. It takes about 15 minutes each time.

Treatment takes up to about 10 days in total. The team tell you which days you have treatment on. There is likely to be a day or 2 between each treatment.

You also take a proton pump inhibitor (PPI) medication during treatment. This medication works by blocking and reducing the production of stomach acid. This gives any damaged tissue from radiotherapy time to heal.

Further treatment
After you finish SBRT, your doctor and the team will decide whether surgery is possible. If so, you may have surgery to remove the cancer. You may also have additional chemotherapy after radiotherapy or surgery. Your doctor will talk to you about surgery and what this involves.

Blood samples for research
The team ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests. They plan to use the samples to see what happens to GC4711 in the body.

Activities of daily living questionnaire
You fill out a questionnaire at set times during the trial and after finishing treatment. The questionnaire is to find out how you are getting on with your normal activities of daily living. The team can tell you more about this.

Hospital visits

You see a doctor and have some tests before you can take part in the trial.

These include:

a physical examination
blood tests
heart trace (ECG )
CT scan and MRI scan

You might need to have an endoscopy.

You have all your treatment at the hospital.

Follow up visits
The trial team follow you up for 3 years after your last dose of radiotherapy. You see them for a check up and blood tests:

at one month
at 3 months
every 2 to 3 months for the first 2 years and then
every 6 months in the 3rd year

When you finish treatment you have a CT or MRI scan at 1 month. After that you have a CT scan:

every 3 months in the first year and second year and then
every 6 months in the third year

You stop having these trial check ups and scans if your cancer gets worse. Your doctor will talk to you about other treatment options. The team then continue to follow you up regularly. A member of the team may call you or see you at a routine hospital appointment.

Side effects

The trial 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.

About 100 healthy volunteers have had GC4711 so far. The most common side effects of GC4711 we know about so far include: