RecruitingPHASE2INTERVENTIONAL

Efficiency of Imatinib Treatment After 10 Years of Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) (Gist-Ten)

This study is for people with a type of cancer called Gastrointestinal Stromal Tumour (GIST) who have been taking imatinib medicine for at least 10 years. Currently, it's not clear if people need to take imatinib forever. This study aims to find out if it's safe to stop the treatment after such a long time, or if continuing it is better for keeping the cancer under control. Patients taking part will be divided into two groups: one group will stop taking imatinib, and the other will continue. Researchers will then check how well the cancer is controlled in both groups. They will also see if imatinib still works effectively if restarted in those who stopped and whose cancer started to grow again. The goal is to understand the best treatment plan for long-term GIST patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Centre Leon Berard

Enrolment target

Start

03 Jan 2022

Estimated completion

01 Jan 2027

Metastatic Gastrointestinal Stromal Tumor (GIST)C-KIT Mutation Advanced Gastrointestinal Stromal Tumor (GIST)

What is this study about?

This study is looking at a type of cancer called Gastrointestinal Stromal Tumour, or GIST for short. GIST often starts in the digestive system and is treated with a medicine called imatinib. This medicine has been a huge step forward for people with GIST.

Doctors know that imatinib works well to control GIST because it targets specific changes within the cancer cells. However, what they don't know for sure is whether people need to take this medicine for their entire lives, especially after many years of successful treatment. Past research has shown that stopping imatinib too early can cause the cancer to grow back quickly, but it's not clear what happens after a very long time, like 10 years.

This study aims to answer the important question of whether patients who have been on imatinib for at least 10 years can safely stop taking it. Some patients will continue with their imatinib, while others will stop. By comparing these two groups, the researchers hope to understand if stopping the medicine is a safe option for some people, or if continuing it is always the best way to keep the cancer under control. They will also collect information on whether the medicine works just as well if it's restarted after a break.

Key takeaways

This study is for people with advanced GIST who have been on imatinib for at least 10 years.
It aims to see if stopping imatinib after a long period is safe or if continuing it is better.
Participants will either continue imatinib or stop it, with close monitoring.
If you stop and your cancer progresses, imatinib will be restarted to see if it still works.
The study helps doctors understand the best long-term treatment plans for GIST.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of advanced GIST. This means your GIST has spread to other parts of your body or is locally advanced. Your cancer must have specific genetic changes (called c-kit mutations).

You must have been taking imatinib at a steady dose (either 300mg or 400mg per day) for 10 years or more, with only very short breaks if any. Importantly, your GIST must be well-controlled and not have grown worse while you've been on imatinib. You should also be generally well enough to take part in the study activities.

There are also reasons why you might not be able to join. For example, if you are currently taking other cancer medications, have specific types of GIST mutations (like D842V in PDGFRA), or have certain serious health problems affecting your heart, liver, or kidneys. You also can't take part if you have HIV or have had major surgery recently.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have advanced GIST with a c-kit change in your cancer cells?
Have you been taking imatinib for at least 10 years with your GIST under control?
Are you generally well and able to attend regular clinic visits?
Do you not have other serious long-term health conditions that might affect the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of two groups. One group will continue taking your imatinib as usual, and the other group will stop taking it. Your treatment plan will depend on which group you are in.

You will have regular visits to the clinic for check-ups, which will include blood tests and other assessments. These appointments are designed to monitor your health and how your cancer is responding to treatment. The doctors will monitor for any signs of the cancer returning in those who stopped treatment, and if it does, imatinib will be restarted. The study will continue for a period of time to gather enough information, and you will be informed about the specific duration of your involvement.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study could be finding that some patients can safely stop imatinib after 10 years, which might mean fewer side effects from the medication and less daily treatmentburden. However, if you are in the group that stops imatinib, there is a risk that your GIST could start to grow again. The study is set up to restart imatinib quickly if this happens. Continuing imatinib also has the benefit of potentially maintaining disease control, though it means continuing medication. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

CHU Besançon
Verified postcode
Besançon, France· Recruiting
Institut Bergonié
Verified postcode
Bordeaux, France· Recruiting
CHU Dupuytren
Verified postcode
Limoges, France· Recruiting
Centre Léon Bérard
Verified postcode
Lyon, France· Recruiting
Institut Paoli Calmettes
Verified postcode
Marseille, France· Not yet recruiting
Institut Curie
Verified postcode
Paris, France· Not yet recruiting
CHU de Reims
Verified postcode
Reims, France· Recruiting
Centre Eugène Marquis
Verified postcode
Rennes, France· Not yet recruiting
Institut de Cancérologie de l'Ouest - Site Réné Gauducheau
Verified postcode
Saint-Herblain, France· Not yet recruiting
Institut de Cancérologie Lucien NEUWIRTH
Verified postcode
Saint-Paul-en-Jarez, France· Not yet recruiting
Institut Claudius Regaud
Verified postcode
Toulouse, France· Not yet recruiting
Institut de Cancérologie de Lorraine
Verified postcode
Vandœuvre-lès-Nancy, France· Not yet recruiting

Common questions

What is GIST?

GIST stands for Gastrointestinal Stromal Tumour. It's a type of cancer that usually starts in the digestive system.

What is imatinib?

Imatinib is a medicine that targets specific changes in GIST cancer cells to help control the disease. It's also known by its brand name, Glivec.

Why is this study happening?

This study wants to find out if people who have been taking imatinib for 10 years or more for GIST can safely stop the medicine, or if they need to continue taking it for longer.

Will I have to stop my medicine if I join?

Not necessarily. Patients in this study will be split into two groups – one group will stop taking imatinib, and the other will continue. You won't know which group you're in until after you join.

What if my cancer grows back if I stop the medicine?

The study design includes restarting imatinib if your cancer shows signs of coming back. The researchers want to see if the medicine is still effective at controlling the disease when restarted.

How to find out more

Jean-Yves BLAY, Pr

jean-yves.blay@lyon.unicancer.fr +33 4 78 78 27 57 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.