Recruiting

Study on the Effectiveness of Imatinib for Patients with Intermediate-Risk Gastrointestinal Stromal Tumor and High Genomic Grade Index

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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 effectiveness of a treatment for a type of cancer known as gastrointestinal stromal tumor (GIST). The treatment being tested is a medication called Imatinib, which is taken orally. Imatinib is a type of drug known as a protein-tyrosine kinase inhibitor, which works by blocking certain proteins that can promote the growth of cancer cells.

The purpose of this study is to evaluate how well Imatinib works in preventing the return of cancer in patients who have an intermediate-risk GIST with a high-risk Genomic Grade Index. Participants in the study will be randomly assigned to receive either Imatinib or a placebo. The study will monitor the participants over a period of time to see if the cancer returns and to assess their overall health and quality of life.

Throughout the study, participants will undergo regular check-ups, including imaging tests like CT scans, to track their health status. The study aims to determine the rate of cancer recurrence over two years and to gather information on the overall survival and well-being of the participants. This research will help in understanding the potential benefits of using Imatinib as an additional treatment for patients with this specific type of cancer.

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 such as age, previous treatments, and the status of the gastrointestinal stromal tumor.
The tumor must be of intermediate risk with a high Genomic Grade Index and surgery must have been performed between 2 weeks to 3 months prior to starting the medication.
Step 2
Medication administration
The medication Imatinib is administered orally. The dosage and frequency are determined by the study protocol and are tailored to the patient's specific needs.
The treatment aims to assess the efficacy of Imatinib in preventing metastatic relapse over a period of 2 years.
Step 3
Monitoring and assessments
Regular monitoring through thoraco-abdominal and pelvic CT scans is conducted to evaluate the presence of metastases.
Assessments include 1-year, 2-year, and 3-year metastasis-free survival, overall survival, and clinical and biological tolerance.
Step 4
Quality of life evaluation
Quality of life is assessed using questionnaires, including the French version of the SF36 and the EORTC QLQ-C30.
These evaluations help understand the impact of the treatment on daily life and overall well-being.
Step 5
Completion of the study
The study is estimated to conclude by May 2026, with final assessments and data collection occurring at this time.
The primary endpoint is the rate of metastatic relapse at 2 years, with secondary endpoints including long-term survival and quality of life.

Who can join the trial?

8 criteria

Must be a man or woman who is 18 years old or older.
Must have a **Performance Status** of 0-2, which means the person is fully active or has some limitations but can still take care of themselves.
Must not have had any radiation therapy, chemotherapy, or special treatments targeting specific molecules or biological therapy in the past 3 years.
Must have a **gastrointestinal stromal tumor**, which is a type of tumor found in the digestive system, and it should be classified as intermediate risk according to a specific classification system.
Must have a **Genomic Grade Index** higher than 10, which is a measure of certain genetic features of the tumor, determined by a special test called CGH array.
Must have had surgery to remove the primary tumor between 2 weeks and 3 months before starting the study medication, **Imatinib mesylate**.
Must have no visible remaining disease after surgery, although small microscopic traces at the edges of the removed tissue are allowed.
Must not have any distant metastases, meaning the cancer has not spread to other parts of the body.

Who cannot join the trial?

5 criteria

Patients who have a different type of cancer than a gastrointestinal stromal tumor. This is a type of cancer that occurs in the digestive tract.
Patients who are not within the specified age range for the study.
Patients who are not considered to be at an intermediate risk level for their condition.
Patients who do not have a high Genomic Grade Index. This is a measure of certain genetic characteristics of the tumor.
Patients who are part of a vulnerable population, which means they 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
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Besançon, France
Centr Georges Francois Leclerc
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Dijon, France
Centre De Lutte Contre Le Cancer Eugene Marquis
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Rennes, France

Trial locations

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Investigated drugs

Imatinib is a medication used in this clinical trial to evaluate its effectiveness in preventing the return of cancer in patients with a specific type of tumor called gastrointestinal stromal tumor (GIST). The study focuses on patients who have an intermediate risk of their cancer coming back and a high Genomic Grade Index, which is a measure of how aggressive the cancer might be. Imatinib works by blocking certain proteins that cancer cells need to grow, and the trial aims to see if it can reduce the chance of the cancer spreading within two years.

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 and is used in the treatment of certain types of cancer, including gastrointestinal stromal tumors (GIST). The main therapeutic indication for Imatinib is to prevent the recurrence of cancer in patients with intermediate-risk GIST. At the molecular level, Imatinib works by inhibiting specific proteins that promote cancer cell growth, effectively blocking the signals that lead to tumor development. It is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

Gastrointestinal Stromal Tumor – A gastrointestinal stromal tumor (GIST) is a type of tumor that occurs in the digestive tract, most commonly in the stomach or small intestine. It originates from special cells in the wall of the gastrointestinal tract known as interstitial cells of Cajal. These tumors can vary in size and may grow slowly or more rapidly, depending on their genetic characteristics. GISTs are often discovered incidentally during imaging or surgery for other conditions. As they progress, they may cause symptoms such as abdominal pain, bleeding, or obstruction, depending on their size and location. The risk of metastasis or spread to other parts of the body can vary based on the tumor's size, location, and genetic mutations.