A trial looking at having imatinib for 3 or 5 years for gastrointestinal stromal tumour (SSG XXII)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Sarcoma

Soft tissue sarcoma

Status:

Closed

Phase:

Phase 3

This trial is for people with gastrointestinal stromal tumour (GIST) who have had surgery and taken imatinib for 3 years.

Cancer Research UK supports this trial.

More about this trial

Gastrointestinal stromal tumour (GIST) is a rare type of sarcoma. It usually starts in the wall of the stomach or the small bowel Open a glossary item .

The most common treatment for GIST is surgery and then a targeted therapy (biological therapy). This is to try to stop the cancer from coming back.

A type of biological therapy often used is imatinib (Glivec). It works by blocking a protein called tyrosine kinase that tells cells to divide and grow. Blocking this protein might stop cancer cells from coming back.

You usually take imatinib for 3 years after surgery and then have regular follow ups. But doctors want to find out if taking imatinib for 5 years is better at stopping GIST from coming back.

In this trial you have 1 of the following:

imatinib for 3 years and regular follow up (standard treatment )
imatinib for 5 years and regular follow up (extended treatment)

The main aims of this trial are to:

find out if having imatinib for 5 years is better than 3 years
learn about the side effects of having imatinib for 5 years
learn more about the quality of life

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 may be able to join this trial if all of the following apply.

You have a gastrointestinal stromal tumour (GIST)
You have had an operation to remove the GIST and you have taken imatinib for 3 years
You have a sample of cancer (a tumour tissue sample) available. The trial team will check this
You have had a test to check for certain changes (mutations) in genes . Your doctor will check this
Your doctor thinks there is a high risk of your GIST coming back (recurrence). Your doctor can tell you more about this
You have satisfactory blood tests results
You are able to swallow tablets
You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
You are at least 18 years old
You are willing to use reliable contraception during the trial and for 3 months afterwards if there is any chance you or your partner could become pregnant

You cannot join this trial if any of these apply.

Cancer related

Your GIST has come back or spread to another part of the body (metastatic)
Your GIST has a certain change (mutation) in a gene called PDGFRA. Your doctor will check this
Your doctor thinks you need to have imatinib for more than 3 years (life long imatinib)
You have stopped taking imatinib for more than 4 weeks
You have taken imatinib before surgery (neoadjuvant) for more than 12 months
You have taken imatinib for less than 35 or more than 38 months
You take less than 200 mg or more than 800 mg of imatinib every day
You are having, or have had in the past 3 years, an experimental cancer treatment
You have had another cancer in the past 5 years apart from basal cell skin cancer, an early cancer (carcinoma in situ ) of the cervix that has been successfully treated, a small (less than 2 cm) breast cancer that hasn't spread to the lymph nodes (T1N0M0), or a prostate cancer that has a low Gleason score (less than 8)

Medical conditions

You have HIV
You have active hepatitis B, or hepatitis B that keeps coming back (chronic)
You have heart problems such as congestive heart failure that is causing symptoms or you have had a heart attack in the past 6 months
You have an infection that isn’t controlled
You have diabetes, kidney problems or any other serious medical condition that isn’t controlled

Other

You are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. Researchers hope that around 300 people from Europe and about 20 people from the UK will take part.

This trial is randomised. The people taking part are put into 1 of the following treatment groups by computer:

imatinib for 3 years and regular follow up (standard treatment)
imatinib for 5 years and regular follow up (extended treatment)

Neither you nor your doctor are able to decide which group you are in.

study diagram

Standard treatment
Imatinib are tablets that you take every day, once a day. You take them for 3 years (36 months). Then you have regular follow up.

Extended treatment
You take imatinib tablets for an extra 2 years (5 years in total). Then you have regular follow up.

You start taking 400 mg of imatinib. Then the dose might change. It depends on any side effects you have.

Quality of life
You complete a quality of life questionnaire every 3 months. It takes about 10 minutes to complete each time.

The questionnaire asks about how you have been feeling and what side affects you have had.

Blood tests
You have extra blood tests as part of this trial. The researchers want to look for certain substances (such as proteins) and cells in your bloodstream.

You have the extra blood tests before the start of the trial and at set times during the treatment or regular follow up. If possible, you have the extra blood samples at the same time you have routine blood tests.

Sample of tissue
Researchers will ask to use a tissue sample of your cancer taken during surgery. They want to learn more about how GIST develops and how the treatment works.

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:

a physical examination
blood tests
urine test
a CT scan or MRI scan

During the trial, you see the doctor for blood tests and a physical examination every 3 months for 4 years. Then:

every 6 months for 1 year
once a year for 5 years

You have a CT scan every 6 months. This continues for 5 years. You then have a CT scan every year, for 5 years.

Side effects

The trial team monitor you during the time you have treatment and you have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.

The most common side effects of imatinib are:

a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
tiredness
feeling or being sick
diarrhoea or constipation
loss of appetite and weight changes
liver problems
skin changes such as skin rashes, dry skin, redness and sensitivity to sunlight
increased sweating at night
tingling or pricking sensation, reduced sense of touch or numbness
eye problems such as watery or dry eyes, blurred vision and redness
difficulty sleeping
hair loss (alopecia)
pain in your muscles, joints, bones and tummy (abdominal)
headaches and dizziness
flu like symptoms (including fever, chills and rigors)
indigestion (heartburn), bloating and passing wind
bleeding
dry mouth or taste changes
shortness of breath, cough
swollen face and joints