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Study on the Effect of Extending Imatinib Treatment from Three to Five Years for Patients with High-Risk Gastrointestinal Stromal Tumor (GIST)

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 a type of cancer known as gastrointestinal stromal tumor (GIST). GIST is a tumor that occurs in the digestive tract, and this study is particularly interested in patients who have a high risk of the tumor coming back after surgery. The treatment being tested is a medication called imatinib, which is taken in the form of film-coated tablets known as Glivec. Imatinib is a chemical substance that helps to prevent the growth of cancer cells.

The purpose of the study is to see if taking imatinib for five years, instead of the usual three years, can help patients stay free from the tumor for a longer time. Patients who have already completed three years of imatinib treatment after surgery will be randomly assigned to either continue taking the medication for an additional two years or to stop the treatment. This will help researchers understand if the extended treatment period offers better protection against the tumor returning.

Throughout the study, participants will have regular check-ups, including scans like CT or MRI, to monitor their health and check for any signs of the tumor coming back. These check-ups will occur every six months for the first five years and then once a year. The study will also look at overall survival, survival specific to GIST, safety, and quality of life for the participants. The trial is expected to continue until the end of 2030.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, the patient must have provided written, voluntary informed consent.

    The patient must be at least 18 years old and have a confirmed diagnosis of gastrointestinal stromal tumor (GIST) through specific tests.

    The patient must have undergone complete surgical removal of the tumor and be at high risk for recurrence.

  2. Step 2

    Initial treatment phase

    The patient will begin taking Glivec 100 mg film-coated tablets, which contain the active substance imatinib.

    The medication is taken orally, and the dosage and frequency will be determined by the study protocol.

    This phase involves taking the medication for a period of three years as an adjuvant treatment to reduce the risk of tumor recurrence.

  3. Step 3

    Randomization and extended treatment

    After completing three years of treatment, the patient will be randomly assigned to either continue taking imatinib for an additional two years or to stop the treatment.

    The purpose of this phase is to evaluate if extending the treatment improves recurrence-free survival.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, the patient's health will be monitored through regular check-ups and imaging tests such as CT or MRI scans every six months for the first five years, and then annually.

    The primary goal is to track recurrence-free survival, which is the time from randomization to the first detection of tumor recurrence or death.

  5. Step 5

    Study completion

    The study is expected to conclude by December 31, 2030.

    Upon completion, the data collected will help determine the effectiveness of the extended treatment in preventing tumor recurrence.

Who can join the trial?

10 criteria

  • Must be **18 years or older**.
  • Must have given **written, voluntary consent** to participate in the study.
  • Must have a confirmed diagnosis of **gastrointestinal stromal tumor (GIST)**, which is a type of tumor in the digestive system. This confirmation is done through specific tests on the tumor tissue.
  • Must have had a **complete surgical removal** of the tumor.
  • Must have had a **mutation analysis** done on specific genes related to the tumor.
  • Must be at **high risk of the tumor coming back** after surgery and treatment with a drug called imatinib for 3 years. This risk is determined by specific criteria related to the tumor's characteristics.
  • Must have an **ECOG performance status of 2 or less**, which is a scale used to assess how well a person can perform daily activities.
  • Must have **adequate organ function**, which means certain blood tests must be within normal limits.
  • **Women who can become pregnant** must have a negative pregnancy test before starting the study and must use effective birth control during the study and for 3 months after. **Men and women** must agree to use birth control during the study.
  • Must be **willing to attend follow-up visits** at the study site, regardless of the study's outcome.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of cancer than a gastrointestinal stromal tumor cannot participate. A gastrointestinal stromal tumor is a type of tumor that occurs in the digestive tract.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
  • Patients who are not part of the specified clinical trial groups cannot participate. The study is looking for specific groups of patients.
  • Patients who are not willing to follow the study procedures or take the study medication as directed cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate. This is to ensure the safety and accuracy of the study results.
  • Patients who are pregnant or breastfeeding cannot participate. This is to protect the health of the mother and child.
  • Patients who have participated in another clinical trial recently may not be eligible. This is to avoid any interference with the study results.
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Investigated drugs

Imatinib is a medication used in this clinical trial to treat patients with operable gastrointestinal stromal tumors (GIST) that have a high risk of coming back after surgery. The trial is comparing the effects of taking this medication for three years versus five years to see which duration is more effective in preventing the cancer from returning.

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 widely used in clinical practice. The main therapeutic indication for Imatinib is the treatment of gastrointestinal stromal tumors (GIST), particularly in patients with a high risk of recurrence after surgery. At the molecular level, Imatinib works by inhibiting specific tyrosine kinases, which are enzymes that promote the growth of cancer cells. It belongs to the pharmacological class of tyrosine kinase inhibitors.

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 specific characteristics. GISTs can cause symptoms such as abdominal pain, bleeding, or a feeling of fullness, but some may not cause noticeable symptoms initially. As they progress, they may lead to complications like obstruction or bleeding in the digestive tract. The behavior of GISTs can differ significantly, with some remaining stable for long periods while others may grow or spread to other parts of the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512243-23-00Estimated enrolment300 patientsSponsorRegion Skane

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