A trial looking at treatment before and after surgery for stomach or gastro oesophageal junction cancer (the INNOVATION Trial) (EORTC 1203)

Cancer type:

Oesophageal cancer
Stomach cancer

Status:

Open

Phase:

Phase 2

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 HER2 Open a glossary item.

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 monoclonal antibodies Open a glossary item. They seek out cancer cells by looking for a particular protein. Pertuzumab works in a slightly different way to trastuzumab. 

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
  • 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 adenocarcinoma Open a glossary item of 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 Open a glossary item) 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 had any other cancer in the last 5 years apart from carcinoma in situ of the cervix (CIS), non melanoma skin cancer Open a glossary item or 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

Trial design

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.

The Innovation trial diagram

You have the same treatment before and after surgery.

Standard treatment before surgery
You have

and either

  • 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.

Research samples
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.

Hospital visits

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 Open a glossary item)
  • Echocardiogram Open a glossary item or MUGA Open a glossary item

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.

Follow up
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

Side effects

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 (neutropenia Open a glossary item)
  • itchy, dry skin

The most common side effects of pertuzumab are

We have information about

Location

Belfast
London
Sutton

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr John Bridgewater

Supported by

European Organisation for Research and Treatment of Cancer (EORTC)
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13571

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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