A trial looking at a new device to treat pancreatic cancer (TRIPP-FFX)
Cancer type:
Status:
Phase:
This trial is looking at treating pancreatic cancer with a device called OncoSil and FOLFIRINOX chemotherapy.
It is for people whose:
- pancreatic cancer has grown into surrounding tissues (locally advanced cancer) and
- who can’t have surgery to remove it
More about this trial
FOLFIRINOX chemotherapy is a usual first treatment for pancreatic cancer that has spread. FOLFIRINOX is a combination of cancer drugs. It is made up of folinic acid and the chemotherapy drugs:
- fluorouracil (also called 5FU)
- irinotecan
- oxaliplatin
Chemotherapy aims to stop the cancer from growing and to shrink it. Sometimes it doesn’t work as well as doctors had hoped. So they are looking for ways to improve treatment. In this trial they are looking at adding OncoSil. This is a device that the doctor puts into the pancreas.
OncoSil is a type of brachytherapy device. It consists of tiny 
particles in a gel like substance. The doctor injects the OncoSil device directly into the cancer in the pancreas in your body. The radiation only goes to the cancer cells and doesn’t affect the surrounding tissue.
In this trial some people have FOLFIRINOX chemotherapy. And some have FOLFIRINOX chemotherapy and the OncoSil device.
Doctors already use OncoSil in combination with gemcitabine chemotherapy to treat pancreatic cancer.
The main aims of the trial are to find out:
- how safe it is to have OncoSil and FOLFIRINOX together
- how well OncoSil works with FOLFIRINOX
- about the side effects
- how treatment affects
quality of life
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 cancer that has spread into surrounding tissues and you can’t have surgery to remove it
- are well enough to have FOLFIRINOX chemotherapy as your first treatment for pancreatic cancer. Your doctor will do some tests to check this.
- can care for yourself but might not be able to carry on with all your normal activities or do active work (Karnofsky performance status 70 or less)
- are having or can have a certain type of medication to reduce the amount of stomach acid. This is before you have the device implanted and for a period after. Your doctor will know what this medication is.
- are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant
- are at least 18 years old
Who can’t take part
You cannot join this trial if any of these apply. You:
- have cancer that has spread to distant parts of the body
- have more than one area of cancer in the pancreas
- can’t have the device inserted
- have had another cancer in the last 5 years. You can join if you had
basal cell cancer of the skin or carcinoma in situ of the cervix. - are pregnant or breastfeeding
- have any other medical condition that could affect you taking part
Trial design
This phase 2 trial is taking place in Europe, Australia and the UK. The team need 80 people to take part.
It is a randomised trial. A computer puts you into a treatment group at random. Neither you nor your doctor can decide which group you are in. There are 2 treatment groups. You have one of the following:
- FOLFIRINOX chemotherapy (standard treatment)
- FOLFIRINOX chemotherapy and the OncoSil device (new treatment)
FOLFIRINOX chemotherapy (standard treatment)
You have chemotherapy as . Each cycle of treatment is 2 weeks. You have up to 12 cycles. This takes about 6 months in total. In each cycle you have:
- oxaliplatin, folinic acid and irinotecan on day 1
- fluorouracil starting on day 1 that continues over 2 days. You have this by a small portable pump.
You have all your treatment as a drip into a vein.
There are 2 different doses of FOLFIRINOX you may have. Your doctor will tell you which dose you have. This depends on your individual situation.
You might have chemotherapy for longer than 6 months. Your doctor will let you know if this applies to you.
FOLFIRINOX chemotherapy and the OncoSil device (new treatment)
You have FOLFIRINOX chemotherapy as described above.
You have 2 cycles of FOLFIRINOX before the OncoSil device is implanted. The trial doctor organises a date and time for you to have this done. You have it put in at the hospital in the endoscopy department. You have a procedure called endoscopic ultrasound to put it in. It takes between 30 and 60 minutes.
Endoscopic ultrasound is a combination of an ultrasound and an endoscopy. The doctor puts a long flexible tube into your mouth down the food pipe (oesophagus) close to the pancreas. The endoscope has a tiny camera and light on the end. It also has an ultrasound probe at its tip. This allows the specialist doctor to view your pancreas. This helps them to inject the tiny particles into the cancer in your pancreas through a fine needle. You have this procedure under . Some people may have a short instead. Your doctor can tell you what this involves.
You stay at the hospital for a short time after the procedure. You can go home the same day if you are well enough and you don’t have pain. Some people might have an overnight stay.
You also have a special scan called a Bremsstrahlung scan. This is to check where the OncoSil particles are in your body. It is done within 4 hours of having the device put in.
You continue to have the rest of your chemotherapy after the OncoSil device is in place. The Oncosil device stays permanently in your body.
Both groups
You stop treatment if your cancer gets worse. Your doctor will talk to you about other treatment options.
Tissue samples for research
The team will ask to have access to any tissue samples () collected:
- when you were first diagnosed
- when the OncoSil device is put in if you have this
- if you have surgery at any point in the future
You can say no to having these samples taken for research. It won’t affect you taking part in the rest of the trial.
Quality of life
The trial team ask you to fill out 3 questionnaires:
- before you start treatment
- at set times during treatment
- at set times after treatment
The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study.
The team will also ask if you have any pain. They will ask you to rate it on a scale from 0 to 10. No pain at all is 0 and 10 means the worst pain you can imagine.
Hospital visits
You see the doctor and have tests before you can take part. These include:
- blood tests
- a
physical examination - CT scan
During treatment you see the doctor regularly. This is for blood tests and to see how you are.
You have a CT scan every 8 weeks during treatment. You stop having the trial scans if your cancer gets worse.
Follow up
When you stop treatment, the team follow you up to see how you are getting on. You see them:
- once a month for the first 16 weeks and then
- every 2 months until your cancer gets worse
The trial team may also check your medical notes to see how you are.
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.
The OncoSil device uses radiation to treat cancer cells. Like any other medical treatment OncoSil may cause side effects.
We know from previous studies that the OncoSil device did have some side effects. The possible side effects of OncoSil include:
- pain, discomfort or both related to injecting the device
- tummy (abdominal) pain and discomfort or both
- feeling or being sick
- tiredness
- high temperature (fever)
- a drop in the number of blood cells causing an increased risk of infection, tiredness and breathlessness or bruising and bleeding
- changes to how the liver works
The radiation particles only travel a short distance inside the area of cancer in the body. Very little radiation leaves the body. There may be a small amount of radiation present in your wee, poo or both. Your doctor will give you information about safety precautions that apply. You can be around other people as you normally would. There is no risk of radiation to other people.
We have information about FOLFORINOX and its side effects.
Your doctor will talk to you about all the possible side effects when you join the trial. You’ll have a chance to ask them any questions you may have.
Location
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.
Chief Investigator
Dr Paul Ross
Supported by
OncoSil Medical Ltd
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
