A trial looking at a different way to give chemotherapy called PIPAC for cancer that has spread to the peritoneum (PICCOS)
Cancer type:
Status:
Phase:
This trial is looking at pressurised intraperitoneal aerosolised chemotherapy (PIPAC) for cancer that has spread to the peritoneum or primary peritoneal cancer.
It is open to people who have one of the following that has spread to the
:
- bowel (colorectal) cancer
- ovarian cancer including fallopian tube cancer
- stomach (gastric) cancer
It is also open to people with primary peritoneal cancer that has come back after, or got worse while having .
More about this trial
The peritoneum is the sheet of body tissue that lines the tummy (abdominal) cavity and the organs inside it. Cancer that starts in the peritoneum is called primary peritoneal cancer. Doctors can treat primary peritoneal cancer with a . But sometimes this doesn’t work and the cancer might get worse or come back.
Cancer that has spread from another part of the body to the peritoneum is called a secondary cancer. Some cancers that can spread to the peritoneum include:
The for cancer spread to the peritoneum is chemotherapy. The standard way of giving the chemotherapy is as a drip into a vein, taking tablets or a combination of both. Unfortunately, chemotherapy given this way might not work very well. This is because not much of the chemotherapy reaches the peritoneum.
In this trial, researchers are looking at a different way of giving the chemotherapy. It is called pressurised intraperitoneal aerosolised chemotherapy (PIPAC). PIPAC delivers the chemotherapy directly to the peritoneum. They think that PIPAC will work better than the standard way. To find this out they need to compare the 2 ways.
There are 3 different groups in this trial. For those who have bowel cancer or stomach, half the people in these groups will have standard treatment. The other half will have the standard treatment and PIPAC. For those who have ovarian cancer half the people will have the standard care and half will have PIPAC,
The aims of the trial are to find out:
- how well PIPAC works
- more about the side effects
- how PIPAC 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.
There are 3 different groups in this trial depending on your type of cancer. Each group has certain entry conditions which your doctor will know about. The entry conditions below apply to everyone who might be able to join the trial. |
You may be able to join the trial if you have one of the following cancers:
- bowel (colorectal) cancer that is an adenocarcinoma and has spread to the peritoneum
- epithelial ovarian cancer including fallopian tube cancer that has spread to the peritoneum
- stomach (gastric) cancer that is an adenocarcinoma and has spread to the peritoneum. This includes type 3 gastro oesophageal junction cancer.
- primary peritoneal cancer that has come back after, or got worse while having
platinum chemotherapy
And all of the following apply. You:
- have cancer in the peritoneum that the doctor can see on a
CT scan - have satisfactory blood test results
- can look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
- are able to have the full dose of treatment in the first
treatment cycle for your cancer. Your doctor will know about this.
- are at least 16 years old
Who can’t take part
There are 3 different groups in this trial, depending on your type of cancer. Each group has certain entry conditions which your doctor will know about. The entry conditions below apply to everyone who might not be able to join the trial. |
- have had another cancer apart from successfully treated
non melanoma skin cancer - have cancer that has spread to the brain or spinal cord that has not been treated
- have problems with how the blood clots
- have problems with bleeding
- have a blockage of the bowel
- are having liquid food through a drip into a vein or are having food through a tube
- are taking part in another clinical trial
- are not able to have surgery
- are allergic or sensitive to any of the treatments, or their ingredients, used in the trial
- are pregnant or breastfeeding
Trial design
Pressurised intraperitoneal aerosolised chemotherapy (PIPAC) is a way of giving chemotherapy directly to the peritoneum. The peritoneum is a sheet of tissue that covers the inside of the abdomen, pelvis and the organs inside them.
You have to have PIPAC. You have a
. You will be in a deep sleep and have no feeling during the surgery. The surgeon puts 2 or 3 small cuts into the skin on your abdomen.
Through one of the cuts, they put a thin, flexible tube with a camera on the end. They use this to see inside of the abdomen and the peritoneum. Through the tube the surgeon fills the abdomen with carbon dioxide gas. This is to make sure that the chemotherapy reaches all the surfaces of the peritoneum.
To give the chemotherapy, the surgeon puts another tube into another cut. The tube is a nebuliser. The chemotherapy is a liquid. The nebuliser turns the liquid into a fine spray (aerosol). The aerosol comes into contact with the cancer spread in the peritoneum.
The surgeon then removes the chemotherapy and carbon dioxide gas from the abdomen, takes the tubes out and stitches the cuts to close them. The procedure takes about 30 minutes.
You may need to stay in hospital overnight after having PIPAC.
On the day of having PIPAC
You must not drink or eat anything for a few hours before your surgery. Your doctor will tell you how many hours this is. Before surgery you see the surgeon and the . They will tell you about the surgery and what to expect. They will answer any questions you have before you agree to have the surgery.
We have more information about having cancer surgery.
This is a phase 2 trial. This is a randomised trial. A computer puts you into a treatment group. Neither you nor your doctor chooses which treatment group you are in.
People with bowel cancer
The team need 78 people to join this group. The treatment groups are:
- standard chemotherapy
- standard chemotherapy and pressurised intraperitoneal aerosolised chemotherapy (PIPAC)
You have one or a combination of the following standard chemotherapy treatments:
- FOLFIRI and cetuximab
- FOLFOX and cetuximab
- capecitabine and oxaliplatin (CAPOX)
- panitumumab
Your doctor will tell you which treatment you have. You have all the chemotherapy as a drip into a vein, apart from capecitabine. Capecitabine is a tablet you take at home.
Depending on the chemotherapy, you have treatment every 2 or 3 weeks. Each 2 or 3 weeks is a . If your cycle of treatment is 2 weeks, you have up to 9 cycles. If your cycle of treatment is 3 weeks, you have up to 6 cycles.
Those having PIPAC will have 3 treatments. There is 6 weeks between each PIPAC procedure. The chemotherapy they use for PIPAC will be either oxaliplatin or mitomycin C. Your doctor will tell you more about this. You will have standard chemotherapy treatment between each PIPAC.
People with ovarian cancer
The team need 66 people to join this group. The treatment groups are:
- standard chemotherapy
- pressurised intraperitoneal aerosolised chemotherapy (PIPAC)
You have one of the following standard chemotherapy treatments:
You have these as a drip into a vein.
You have chemotherapy treatment every 4 weeks. Each 4 weeks is a . You have up to 6 cycles.
Those who have PIPAC will have 3 treatments. You have it once every 6 weeks. The chemotherapy they use for PIPAC is a combination of cisplatin and doxorubicin. Your doctor will tell you more about this.
People with stomach cancer
The team need 72 people to join this group. The treatment groups are:
- standard chemotherapy
- standard chemotherapy and pressurised intraperitoneal aerosolised chemotherapy (PIPAC)
You have one of the following standard chemotherapy treatments:
- FOLFOX
- CAPOX
- cisplatin and capecitabine (CX)
- CX and trastuzumab
- CAPOX and trastuzumab
- FOLFOX and trastuzumab
- CAPOX and nivolumab
- FOLFOX and nivolumab
Your doctor will tell you which treatment you are to have. You have all the chemotherapy as a drip into a vein, apart from capecitabine. Capecitabine is a tablet you take at home.
Depending on the chemotherapy, you have treatment every 2 or 3 weeks. Each 2 or 3 weeks is a cycle of treatment. If your cycle of treatment is 2 weeks, you have up to 9 cycles. If your cycle of treatment is 3 weeks, you have up to 6 cycles.
Those who have PIPAC have 3 treatments. There is 6 weeks between each PIPAC. The chemotherapy they use for PIPAC is a combination of doxorubicin and cisplatin. Your doctor will tell you more about this. You will still have standard chemotherapy between your PIPAC treatment.
Samples for research
The team ask everyone for a piece of the sample tissue () taken when you were first diagnosed. If you have surgery to remove the cancer, the team will ask for a piece of the tissue that is taken out.
These may be used to learn more about these cancers. The samples may also be stored in a safe and secure place for future researchers to use.
You don’t have to agree to have these samples taken. You can still take part in the trial.
Quality of life
Everyone fills in questionnaires:
- before starting treatment
- at regular times during treatment
- at regular times after treatment
The questions ask about:
- your general health and wellbeing
- your daily activities
- any side effects or symptoms
These are quality of life questionnaires.
Hospital visits
You see the doctor to have a and tests before taking part. These tests include:
You see the doctor or nurses regularly while having chemotherapy. This is for blood tests and to see how you are.
PIPAC
The nurse will call you the day before each PIPAC. This is to see how you are and answer any questions.
Before your first PIPAC, you see the nurse and in a pre assessment clinic. You have:
- a physical examination
- blood tests
- heart trace (ECG), if needed. Your doctor will tell you if you need this test.
A few days before your other PIPAC treatments you have a blood test at your local hospital. You may have an ECG before your treatment if you had one before.
A nurse calls you about a month after each PIPAC. This is to see how you are and to ask about any side effects.
CT scans
Everyone has 2 CT scans during their treatment. You then have a CT scan after treatment every 2 months for up to a year. And then every 3 months until your cancer starts to grow again or until the end of the trial.
Follow up
When you stop treatment a nurse will call you every 2 months for up to a year. And then every 3 months after this. This is to see how you are and ask about any side effects.
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.
Side effects of having chemotherapy by PIPAC
PIPAC is a new way of treating cancer that has spread to the peritoneum. There may be side effects that we don’t know about. The side effects we do know about include:
- pain in the tummy (abdomen)
- feeling and being sick
- chest infection
- infection where the small cuts are made
- changes to how the kidneys and liver works
You might have an allergic reaction while having PIPAC. If you do have a reaction the doctors in the operating theatre will treat it straight away.
We have information about possible problems after surgery. And the possible side effects of:
- FOLFIRI
- FOLFOX
- capecitabine and oxaliplatin (CAPOX)
- cetuximab
- panitumumab
- gemcitabine
- paclitaxel
- liposomal doxorubicin
- cisplatin and capecitabine (CX)
- trastuzumab
- nivolumab
Your doctor will tell you about the possible side effects of all the treatments you might have and answer any questions you have before you agree to join the trial.
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
Professor Jared Torkington
Mrs Sadie Jones
Supported by
Cardiff and Vale University Health Board
National Institute for Health Research (NIHR)
Cardiff University
UKCRC
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040