"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at treatment before and after surgery for stomach or gastro oesophageal junction cancer (the INNOVATION Trial) (EORTC 1203)
This trial is looking at 2 biological therapy drugs called trastuzumab and pertuzumab and chemotherapy. It is for people
- with stomach cancer or cancer where the foodpipe (oesophagus) meets the stomach (gastro oesophageal junction)
- who have HER2 positive cancer. This means the cancer has large amounts of a protein called
More about this trial
Surgery and chemotherapy are the usual treatments for stomach cancer or gastro oesophageal cancer. But doctors are always looking for ways to improve treatment.
Trastuzumab (Herceptin) and pertuzumab are both types of biological therapy drugs called
We know from research that both drugs have helped people with other types of HER 2 positive cancers. Researchers think these drugs might help people having surgery and chemotherapy for stomach or gastro oesophageal junction.
To be able to take part in the trial you must have HER2 positive cancer. The trial team will test your cancer cells to check for this.
In this trial, people have 1 of the following
- chemotherapy and trastuzumab
- chemotherapy, trastuzumab and pertuzumab
The aims of this trial are to
- compare treatment to see which works best
- find out how safe it is
- learn more about the side effects
Who can enter
The following bullet points list 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.
You might be able to join this trial if all of the following apply.
- You have a type of cancer called
adenocarcinomaof the stomach or place where the stomach and foodpipe join (the gastro oesophageal junction)
- Your cancer is stage 1b to stage 3. This means the cancer
- has grown into the stomach wall or has spread to the lymph nodes OR
- has grown into surrounding tissues or lymph nodes but hasn’t spread to another part of the body.
- The trial team can test a sample of tissue (
biopsy) for the HER2 protein
- You have cancer that is HER2 positive
- It is possible to remove your cancer with an operation
- You have satisfactory blood test results
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 or 1)
- You are willing to use reliable contraception during treatment and for up to 7 months afterwards if there is any chance that you or your partner could become pregnant
- You are at least 18 years old
You cannot join this trial if any of these apply. You
- Have cancer that has spread elsewhere in the body
- Have already had chemotherapy or a monoclonal antibody
- Have problems with your heart, such as a heart attack in the last 6 months, high blood pressure that isn’t well controlled, angina that isn’t well controlled, an abnormal rhythm of your heart, a problem with your heart valves or a problem with how the left side of your heart works
- Have a condition called interstitial lung disease
- Have had any other cancer in the last 5 years apart from carcinoma in situ of the cervix (CIS),
non melanoma skin canceror any other cancer that was successfully treated and won’t affect your treatment
- Have low levels of an enzyme called DPD (dihydropyrimidine dehydrogenase) in your body
- Are taking a drug to thin your blood such as warfarin and isn’t possible to change to injections such as heparin
- Are taking an anti viral drug called sorivudine or brivudine
- Are having high dose steroids as a drip into a vein
- Are known to be allergic to trastuzumab, pertuzumab, cisplatin, 5FU or capecitabine or anything they contain
- Have any other serious medical condition or mental health problem that the trial team think could affect you taking part
- Are pregnant or breastfeeding
This is a phase 2 international trial. Researchers need 255 people to take part including 10 from the UK.
The trial is randomised. You are put into 1 of the following 3 treatment groups by computer.
- Standard treatment (cisplatin and either capecitabine or 5 FU)
- Standard treatment and trastuzumab
- Standard treatment, trastuzumab and pertuzumab
Neither you nor your doctor will be able to decide which group you are in.
You are 2 times more likely to have trastuzumab or pertuzumab than standard treatment.
You have the same treatment before and after surgery.
Standard treatment before surgery
- cisplatin as a drip into a vein once every 3 weeks
- capecitabine tablets twice a day for 2 weeks OR
- 5 FU as a drip into the vein once a day for 5 days every 3 weeks
Each 3 week period is a cycle of treatment. You have 3 cycles of treatment followed by surgery.
Standard treatment and trastuzumab before surgery
You have chemotherapy as described above and trastuzumab as a drip into a vein. You have it once every 3 weeks. You have 3 treatments before surgery.
Standard treatment, trastuzumab and pertuzumab before surgery
You have chemotherapy as described above. You also have trastuzumab and pertuzumab as a drip into a vein once every 3 weeks. You have 3 treatments before surgery.
Surgery and treatment after surgery
The trial team can tell you more about your operation and how long you need to stay in hospital. When you have recovered you have another 3 cycles of chemotherapy.
If you had trastuzumab, pertuzumab or both before surgery, you continue having them once every 3 weeks. You have these drugs for up a year as long as the treatment is helping and the side effects aren’t too bad.
If your cancer gets worse, you stop treatment. Your doctor will talk to you about other treatment options.
The researchers will collect samples of tissue when you have surgery. They will be able to compare these tissue samples with previous ones and check how well treatment has worked.
You’ll see the doctors and have some tests before you start treatment. The tests include
- A physical examination
- Blood tests and urine tests
- CT scan or MRI scan
- Heart trace (
ECG) Echocardiogramor MUGA
You go to hospital to have treatment. You probably won’t need to stay overnight. You see the doctors once every 3 weeks for a check up and blood tests.
You stay in hospital for a little while after surgery. You can talk to your doctor more about this.
When you finish treatment you see the doctors
- every 3 months for 2 years
- every 6 months for a further 3 years
- once a year after that
You have a CT scan
- every 6 months for 2 years
- once a year for a further 3 years
The most common side effects of trastuzumab are
- a reaction while having the drug causing fever and chills, pain, weakness and feeling sick - this often happens with the first treatment but less often with further treatments.
- a drop in white blood cells and fever (
- itchy, dry skin
The most common side effects of pertuzumab are
- feeling or being sick
- sore mouth
- tiredness (fatigue)
- tummy (abdominal pain)
- low levels of white blood cells
We have information about
How to join a clinical trial
Dr John Bridgewater
European Organisation for Research and Treatment of Cancer (EORTC)
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer