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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France

Other Sites

Site Name City Country Status
Hopital Beaujon Clichy France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Ccjqrb Lwor Bvnkbd Lyon France
Cjkpvv Hukpljtmaww Uztmkxfrodjkw Rmksz Reims France
Cdmnak Hyjuendqbpe Ev Ucvuccdgtpbdi Ds Lahgsuo Limoges France
Bmaveuze Utwnthjxmg Hbyrujft Cbdnlm Besançon France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
22.12.2021

Trial locations

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.

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.

Trial ID:
2024-512631-77-00
Protocol code:
ET21-084
NCT ID:
NCT05009927
Trial Phase:
Therapeutic exploratory (Phase II)

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