A trial looking at having imatinib with or without surgery for gastrointestinal stromal tumours (EORTC 62063)

Please note this trial is no longer recruiting patients.

This trial is looking at having surgery with imatinib for gastrointestinal stromal tumours. The trial is for gastrointestinal stromal tumours (GIST) that have spread locally or to the liver.

Doctors often treat GIST that has spread with imatinib, and it stops the cancer coming back for a while. Doctors are always looking for ways to increase the amount of time before the GIST starts to come back. They think that having surgery, as well as imatinib may help. But they are not sure.

The aim of this trial is to see if adding surgery to imatinib can increase the amount of time before GIST starts to come back.

Recruitment

Start 01/08/2009

End 18/03/2011

Phase

Phase 3

Who can enter

You can enter this trial if you

Have a gastrointestinal stromal tumour (GIST) that has spread locally or to your liver
Can have surgery to remove your tumour
Have had imatinib treatment for 6-12 months and it has helped to control or shrink your cancer
Are well enough to take part in this trial
Have satisfactory blood test results
Are prepared to use reliable contraception if there is a chance that you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if

You have GIST that has spread outside the area between your chest and hips (abdomen)
You have had drugs that block cancer growth (tyrosine kinase inhibitors) before, except for having imatinib before surgery to remove your tumour
Your tumour has continued to grow while having imatinib
You have had a heart attack, or heart disease that cannot be controlled with medication, in the last 6 months
You have high blood pressure that is not controlled with medication
You have had blood clots in the last 12 months
You have had bleeding problems in the last 6 months
You have had a drug called warfarin, or a similar drug, to treat blood clots in the 7 days before taking part in this trial
You have had major surgery in the last month
You are taking medication that affects the CYP3A enzymes
You have had another cancer unless it was successfully treated and there has been no sign of it for at least 3 years (complete remission) (you can still enter the trial if you have had non melanoma skin cancer, carcinoma in situ of the cervix, or in situ (stage 0) melanoma
You have another serious medical condition that could affect you taking part in this trial

Trial design

This is a phase 3 trial. It will recruit about 350 people in Europe. It is a randomised trial. The people taking part are put into one of two treatment groups. Neither you nor your doctor can choose which group you are in.

Half of the people taking part in this trial will have surgery. And the other half will not have surgery.

Everyone taking part will have imatinib. The people who have surgery will stop their imatinib before surgery and start taking it again after surgery. Your doctor will tell you when you are able to start taking the imatinib again.

The people not having surgery will continue to take their imatinib as normal.

You can continue taking imatinib if you are well enough, or until the cancer starts to grow again.

You will be asked to fill in a questionnaire about any symptoms you have and how you are feeling. You fill it in before you start treatment and at 5, 11 and 23 months after being told if you are to have surgery or not. For people who have surgery, they will fill in an extra questionnaire when they leave hospital after their operation.

The researchers may ask you to take part in 2 extra studies. You can choose if you want to take part in one, both or neither. Your choice will not affect you taking part in the main trial.

In the first, the researchers want to know if having surgery changes the amount of imatinib in the body. Everyone taking part in this study will have a blood sample taken at the start of the trial. Those having surgery will give another blood sample 1 month after their operation. Those not having surgery will give another blood sample 2 months after the start of the trial.

In the second study, the researchers want to learn more about GIST. Everyone taking part in this study will give a blood sample at the start of the trial. The researchers will also ask your permission for a sample of tissue from your tumour from when you had your biopsy. For people having surgery they will ask permission for more samples of tissue to be taken from your tumour after it is removed.