Recruiting

Study on Continuing or Stopping Imatinib in Patients with Advanced or Metastatic Gastrointestinal Stromal Tumors After 10 Years of Treatment

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Gastrointestinal Stromal Tumors (GISTs), which are a type of tumor that occurs in the digestive tract. The study involves the use of a medication called imatinib, also known by its brand name Glivec. Imatinib is a drug that has been used to treat patients with GISTs for many years. The purpose of this study is to evaluate whether continuing or stopping imatinib treatment after at least 10 years is more beneficial for patients whose disease has been controlled with the medication.

Participants in the study will be randomly assigned to one of two groups. One group will continue taking imatinib, while the other group will stop taking the medication. The study will monitor the health of participants over a period of time to see if there is any difference in the progression of the disease between the two groups. This will help researchers understand the best approach to managing long-term treatment for patients with advanced or metastatic GISTs.

The study will last for several years, and participants will have regular follow-up visits to check on their health and the status of their disease. The main goal is to determine if stopping the medication after a long period of use is safe and effective, or if continuing the treatment provides better outcomes for patients. This information will be valuable in guiding future treatment decisions for individuals with GISTs.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis, and treatment history.
The patient must have been on imatinib treatment for at least 10 years with controlled disease and no significant interruptions.
Step 2
Randomization
The patient is randomly assigned to one of two groups: one group continues imatinib treatment, and the other group stops the treatment.
The purpose is to compare the effects of continuing versus stopping the medication.
Step 3
Treatment phase
For those continuing treatment, imatinib is administered orally at a dose of 300 or 400 mg per day.
The treatment phase lasts for a period of 6 months, during which the patient's health and disease progression are monitored.
Step 4
Monitoring and assessment
Regular follow-up visits are scheduled to assess the patient's health status and any changes in the disease.
The primary focus is on the progression-free rate at 6 months, which measures the percentage of patients without disease progression.
Step 5
End of study evaluation
At the end of the 6-month period, a comprehensive evaluation is conducted to determine the outcomes of the treatment strategy.
Secondary assessments include overall survival, safety, and quality of life, using standardized questionnaires and grading scales.

Who can join the trial?

9 criteria

Patients must be **18 years of age or older**.
Must have a confirmed diagnosis of **advanced or metastatic Gastrointestinal Stromal Tumors (GIST)**. This means the cancer has spread or is in a stage that is difficult to treat.
Must have a test showing **c-kit (CD117) expression**. This is a specific marker found in the tumor or areas where the cancer has spread.
Must have an **ECOG Performance status** of 0, 1, or 2. This is a scale that measures how well a patient can perform daily activities. A lower number means the patient is more active.
Must be taking **imatinib** (a type of medication) at a dose of 300 or 400 mg per day for at least 10 years. There should be no more than 12 months total or 3 consecutive months of breaks in treatment during this time.
The disease must be **controlled**, meaning there has been no worsening of the condition while on imatinib.
Must be able to **understand** and be willing to attend follow-up visits.
Must have **medical insurance** coverage.
Must have signed a document called **informed consent**, which shows they understand the trial and agree to participate.

Who cannot join the trial?

3 criteria

Patients who have not been treated with **imatinib** for 10 years. Imatinib is a medication used to treat certain types of cancer.
Patients whose **Gastrointestinal Stromal Tumors (GIST)** are not controlled. Gastrointestinal Stromal Tumors are a type of tumor found in the digestive system.
Patients who are part of a vulnerable population. This means people who might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Besancon University Hospital Center
Verified
Besançon, France
Centre De Lutte Contre Le Cancer Eugene Marquis
Verified
Rennes, France
Centre Hospitalier Et Universitaire De Limoges
Verified
Limoges, France

Trial locations

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Investigated drugs

Imatinib (Glivec) is a medication used in this clinical trial to treat patients with locally advanced or metastatic Gastrointestinal Stromal Tumors (GISTs). The trial is investigating whether continuing or stopping the treatment after at least 10 years affects the progression of the disease. Imatinib works by blocking certain proteins that promote the growth of cancer cells, helping to control the tumor.

Imatinib Mesilate

What is already known about the treatment

Imatinib – Imatinib is administered orally in tablet form. It is currently well-established in medical literature as a treatment for certain types of cancer, particularly for locally advanced or metastatic Gastrointestinal Stromal Tumors (GISTs). The main therapeutic indication for imatinib is to manage and control GISTs. At the molecular level, imatinib works by inhibiting specific proteins called tyrosine kinases, which are involved in the growth and spread of cancer cells. It is classified pharmacologically as a tyrosine kinase inhibitor.

Investigated diseases

Gastrointestinal Stromal Tumors (GIST) – These are tumors that occur in the digestive tract, most commonly in the stomach or small intestine. They originate from special cells in the wall of the gastrointestinal tract known as interstitial cells of Cajal. GISTs can be either benign or malignant, with the potential to grow and spread to other parts of the body. The progression of the disease can vary, with some tumors growing slowly over time, while others may grow more rapidly. Symptoms may include abdominal pain, bleeding, or a feeling of fullness. The disease is often discovered incidentally during imaging or surgery for other conditions.