Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial comparing chemotherapy and bevacizumab with chemotherapy alone for cancer of the stomach, oesophagus or the junction of the stomach and oesophagus, and a feasibility study looking at lapatinib for HER2 positive cancer (ST03)
This trial is for stomach cancer, oesophageal cancer, or cancer where the stomach joins the
Please note – the main parts of this trial are now closed. The sub study looking at PET-CT scans is still open.
More about this trial
At the hospitals that are involved in the feasibility study, the researchers may ask if they can test some of the tissue removed when you had a
The researchers expect the majority of people not to have large amounts of HER2. But if the tests show your cancer is HER2 positive, they will ask you to join the feasibility study looking at a drug called lapatinib. Lapatinib is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cell use to divide and grow.
In the feasibility study, some people will have lapatinib alongside chemotherapy.
In the main part of the trial (which is now closed to recruitment), chemotherapy alone is being compared with chemotherapy and a drug called bevacizumab.
Bevacizumab (Avastin) is a type of biological therapy called a monoclonal antibody. It targets a protein on the cells called vascular endothelial growth factor (VEGF). This protein helps cancers to grow blood vessels, so they can get food and oxygen from the blood. All cancers need a blood supply to be able to survive and grow. Bevacizumab blocks this protein and stops the cancer from growing blood vessels, so it is starved and won’t be able to grow.
Researchers think that giving bevacizumab as well as chemotherapy may be better than chemotherapy alone. But they are not sure yet. All treatments have side effects, and it is important that people don’t have treatment they don’t need.
The aims of the main trial are to
- Find out if adding bevacizumab to chemotherapy works better than chemotherapy alone for stomach and oesophageal cancer
- Learn more about the side effects
The aims of the feasibility study are to
- Find out how common HER2 positive stomach or oesophageal cancer is
- See if lapatinib alongside chemotherapy helps people with HER2 positive cancer
Who can enter
You can enter this trial if
- You have been diagnosed with stomach cancer, oesophageal cancer, or cancer at the junction of the stomach and oesophagus
- You have not had any treatment for your cancer yet
- Your doctors plan to treat your cancer with both surgery and chemotherapy
- You are well enough to take part in the trial
- You have satisfactory blood test results
- You have satisfactory heart and lung test results
- You are at least 18 years old
- You are prepared to use reliable contraception while you are taking part in the trial if there is any chance that you or your partner could become pregnant
You cannot enter this trial if you
- Have cancer that has spread to another part of your body
- Have had any other cancer that the trial doctors think could affect you taking part in this trial
- Have had surgery in the last 28 days
- Are having any other treatment that is not allowed in this trial (the trial doctor will advise you about this)
- Have previously had treatment with one of a group of drugs called
- Have had a stroke or heart attack in the last year
- Have a serious heart condition or high blood pressure that cannot be controlled with medicine
- Have a peptic ulcer or an inflammatory disease of the bowel
- Have any condition that makes it difficult for you to take or absorb tablets
- Have severe damage to the nerves in your hands or feet (peripheral neuropathy)
- Have a wound that won’t heal or a broken bone that won’t mend
- Have problems with your blood clotting properly
- Have lung disease
- Have severe ringing in your ears (
- Are known to be HIV, hepatitis B or hepatitis C positive
- Are allergic to any of the drugs in this trial or any of their ingredients
- Are pregnant
This trial will recruit 1,103 people altogether but is currently only recruiting 40 people into a feasibility study if tests show their cancer is
When the main part of the trial was open
- People in group A had ECX chemotherapy
- People in group B had a combination of ECX chemotherapy and bevacizumab
At the hospitals which are recruiting to the lapatinib feasibility study, people are put into 1 of 2 other treatment groups. You will only be put into these groups (C or D) if you agreed to have a test looking for the HER2 protein in your cancer cells, and the test showed you have HER2 positive cancer.
- People in group C have ECX chemotherapy
- People in group D have chemotherapy in the same way, but will also have lapatinib tablets each day during chemotherapy followed by a further 18 weeks of lapatinib tablets
You have chemotherapy in 3 week cycles of treatment. On the first day of each cycle, you will have cisplatin via a drip into a vein. This will take 4 hours. You will also have a short injection of epirubicin into a vein. You will have capecitabine tablets twice a day for 21 days.
You will have 3 cycles of treatment and then a break of at least 5 weeks before you have surgery. Between 6 and 10 weeks after your surgery, you will start another 3 cycles of chemotherapy. Your treatment will last about 34 weeks in total.
The doctors will ask you to complete some questionnaires at the beginning of the trial, during your treatment and after your treatment finishes. This is to find out about any side effects you have. They are called quality of life studies.
If you take part in this trial, the researchers will ask your permission to take an extra blood sample, and samples of tissue taken when you had a biopsy and when you have surgery. This is because studying these samples may help them to learn more about stomach and oesophageal cancer.
If you do not want to give these extra samples for research, you don't have to. You can still take part in the the trial. The blood and tissue samples will be stored safely and may be used in the future, but only for research purposes.
Please note - this main part of the trial has now closed.
The main trial also includes 2 sub studies looking at different types of scans.
The MRI sub study is looking at whether an MRI scan can improve the information about the precise location of the tumour to help plan surgery to remove it. If you agree to take part in this sub study, you will have 2 MRI scans. You have one before you begin your treatment and one before you have surgery. Please note -you can no longer join this sub study as it has closed to recruitment.
The PET-CT sub study is looking at whether PET-CT scans can give an early indication as to whether chemotherapy is working. If you agree to take part in this sub study, you will have a PET-CT scan before you begin treatment and another one following your first cycle of chemotherapy.
Taking part in either of these sub studies does not affect your treatment in any way.
Before you take part in the trial, you will go to the hospital to see the doctors and have some tests. These include
- Physical examination
ECG Echocardiogramor MUGA scan
- Urine test
- Blood tests
Lung function tests
- CT scan or PET-CT scan
You will go to the hospital once every 3 weeks for your chemotherapy treatment. Before each treatment, you will have a urine test and blood tests. You may have to stay in hospital overnight to have the chemotherapy, or you may be able to have it as an outpatient.
In the first cycle of treatment, you will have an extra blood test after about 10 days. This is to see if the treatment has caused a drop in the number of blood cells. If it has, you will have injections of a growth factor called G-CSF for the next 3 to 5 days. If your blood count was very low, you will have these injections again in the following cycles of treatment.
Your doctor may want you to have more blood tests to check your blood count during the other cycles of treatment.
If you are in group D, you will go to the hospital for 6 extra visits to have a further 6 doses of lapatinib tablets after the chemotherapy finishes. People in both groups (C & D) will have another CT scan and ECG before their surgery.
If you take part in the MRI sub study, you have 2 extra scans around the same time as your routine scans. The trial team will try to ensure these are booked on days when you would be going to hospital anyway. Please note - this sub study has now closed.
If you take part in the PET-CT sub study, you have a PET-CT scan before you start treatment. You then have an extra scan before your 2nd cycle of chemotherapy.
When your chemotherapy has finished, you will see the trial doctors 3 times in the first 6 months, after 1 year, then every 6 months for the next 2 years and once a year after that.
The most common side effects of ECX chemotherapy are
The most common side effects of lapatinib include
- Changes to the way your liver works
- Swelling (inflammation) or scarring of the lungs
- Changes to the way your heart works
People taking part in the lapatinib study have another heart scan 3 months after starting treatment. You must avoid certain other drugs - the trial team can explain more about this. And if you are in group D, you must not eat grapefruit, star fruit, or paw paw (or drink their juices), within 7 days of taking lapatinib tablets.
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.
Professor David Cunningham
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUK/06/025.