A trial looking at treatment before and after surgery for stomach or gastro oesophageal junction cancer (MATTERHORN)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at adding durvalumab to chemotherapy for people having surgery to remove their cancer.
It is open to people with:
More about this trial
A combination of chemotherapy called FLOT is a usual treatment for stomach cancer and 
cancer.
FLOT includes the drugs:
- F – fluorouracil (5FU)
- L – leucovorin, also known as folinic acid or calcium folinate
- O – oxaliplatin
- T - docetaxel
You usually have FLOT before and after surgery to remove the cancer. Doctors want to improve treatment for people who have these cancers. In this trial they are looking at a drug called durvalumab. It is a type of immunotherapy. It stimulates the body's to fight cancer cells.
Some people have FLOT and durvalumab before and after surgery. And some have FLOT and a dummy drug () before and after surgery.
The main aims of the trial are to:
- find out if adding durvalumab to FLOT is safe
- find out how well durvalumab and FLOT work
- learn more about the side effects of having this combination of treatment
- learn more about 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 stomach cancer or cancer where the food pipe (oesophagus) meets the stomach (the
gastro oesophageal junction or GOJ ) - it is possible to completely remove your cancer with surgery. It may have spread into surrounding
lymph nodes but it hasn’t spread elsewhere in the body. - you are suitable to have FLOT chemotherapy before surgery
- you are fit and active but might not be able to do heavy physical work (performance status 0 or 1)
- you have a tissue sample available for the trial team to do some tests on. You may need to give a new sample if there isn’t a suitable one.
- you have satisfactory blood test results
- you weigh more than 30kg when you join the trial or when you go into a treatment group
- you are willing to use reliable contraception during the trial and for a period after if there is any chance that you or your partner could become pregnant
- you agree not to donate blood while you are taking part in the trial and for a period after
- you 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 had treatment in the past for stomach or gastro oesophageal junction cancer such as chemotherapy,
radiotherapy , or chemoradiation - have had an
immunotherapy drug in the past. This is apart from a vaccine to treat cancer. - have cancer that has spread into the tissue that covers the organs in the abdomen (the
peritoneum ). This includes having cancer cells in any fluid in this area. - have cancer that has spread elsewhere in the body
- have a type of cancer called adenosquamous cell cancer,
squamous cell cancer or you have a gastrointestinal stromal tumour . Your doctor will know this. - took part in another trial looking at durvalumab even if you didn’t have durvalumab
- have had another cancer that has got worse or needed treatment in the past 5 years unless it has a low chance of coming back. You can take part if you had successfully treated
non melanoma skin cancer , very early cancer (carcinoma insitu) or a very early type of melanoma skin cancer called lentigo maligna. - have taken part in another clinical trial using an experimental treatment in the last month
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 lung condition called interstitial lung disease
- have problems with your
digestive system such as Crohn's disease or ulcerative colitis with symptoms in the past 5 years - have a problem with your
immune system and it doesn’t work well - have had major surgery in the last month
- have had treatment that damps down the immune system. This includes steroids within 2 weeks of starting trial treatment unless it was a low dose.
- have HIV, an active hepatitis B or hepatitis C infection, active tuberculosis (TB) or any severe infection that needs treatment
- have another medical condition or mental health problem that your doctor or the trial team think could affect you taking part
Other
You cannot join this trial if any of these apply. You:
- are allergic to any of the drugs in the trial or anything they contain
- have had a
live vaccine within 30 days of the start of treatment. Please note that the COVID-19 vaccine is allowed as it isn’t a live vaccine. - are pregnant or breastfeeding
Trial design
This phase 3 trial is taking place worldwide. The team need to find 900 people to take part including 32 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 or your doctor know which treatment you are having. They can find this out if necessary.
You have 1 of the following:
- FLOT chemotherapy and durvalumab
- FLOT chemotherapy and a dummy drug
You stay in the same treatment group during the trial.
How you have treatment
You have FLOT as a drip into your vein. You have it once every 2 weeks. This takes about 4 to 5 hours each time.
You have durvalumab or the dummy drug as a drip into a vein. You have it once a month. It takes about an hour each time.
Each 4 week period is a .
Treatment before surgery
You have:
- 2 treatments of durvalumab or the dummy drug
- 4 treatments of FLOT chemotherapy
This takes about 2 months in total.
Surgery
The team then check if you are well enough to have your surgery as planned. You have surgery about 4 to 8 weeks after you finish chemotherapy. Your surgeon or doctor can tell you more about the type of surgery and what it involves. You can ask them any questions you may have. You might be in hospital for up to 10 days after surgery while you get better.
Treatment after surgery
After surgery you have more FLOT and durvalumab or the dummy drug. You restart this about 4 to 12 weeks after surgery. Exactly when you start depends on how well you are. Your doctor can tell you more about this.
To begin with you have:
- 2 treatments of durvalumab or the dummy drug
- 4 treatments of FLOT
This takes about 2 months in total.
You then continue to have durvalumab or the dummy drug only. You have this for up to 10 months.
Blood and tissue samples
The researchers ask you to give an extra tissue sample. They also 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 durvalumab in the body
- see if your body develops resistance to durvalumab
- look at
genes to understand more about stomach and GOJ cancer - see how well the treatment is working
- look for substances called
biomarkers to help work out why treatment might work for some people and not for others
The team collect tissue samples during surgery. They would also like to collect an extra tissue sample if your cancer gets worse. You don’t have to agree to give this sample if you don’t want to. You can still take part in the rest of the trial.
Quality of life
The trial team ask you to fill out a questionnaire:
- before you start treatment
- at set times during treatment
The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
Hospital visits
You see the doctor and have tests before you can take part. These include:
- blood tests
- urine tests
- a
physical examination MUGA or heart scan (echocardiogram )- heart trace (
ECG ) - CT scan
- MRI scan
You may also have a bone scan or x-rays.
You see the doctor regularly during treatment to see how you are and for blood tests.
You have a CT scan or an MRI scan:
- before surgery and then
- every 3 months for 2 years and then every
- 6 months until your cancer gets worse
You see the doctor for a check up within a month of stopping treatment. You then see them every 2 months for about 4 years. Or a member of the team may call you to see how you are getting on.
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.
| Durvalumab can affect the immune system. It may cause inflammation in different parts of the body. This can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening. If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy. |
The most common side effects of durvalumab are:
- diarrhoea
- skin rash or dry, itchy skin
- tummy (abdominal) pain
- colds, runny nose, sneezing or a sore throat
- a cough
- high temperatures (fever)
- your
thyroid not making enough hormones. You may feel tired or gain weight.
The trial doctor will talk to you about all the possible side effects of treatment. You have a chance to ask any questions you may have.
We have more information about:
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 Elizabeth Smyth
Supported by
AstraZeneca
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
