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

Launched by CENTRE LEON BERARD · Aug 10, 2021

Keywords

ClinConnect Summary

The Gist-Ten trial is studying how effective a medication called Imatinib is for patients with a type of cancer known as gastrointestinal stromal tumors (GIST) after they have been on the treatment for at least 10 years. The trial has two groups: one group will stop taking Imatinib to see if the drug can still help if they need to start it again later, while the other group will continue taking Imatinib to find out if it still works well for controlling their cancer.

To participate in this trial, you need to be at least 18 years old and have a confirmed diagnosis of advanced GIST that has been stable while on Imatinib for the past 10 years. You also need to be in good health overall and willing to follow the study's requirements, which include regular check-ups and tests. This trial may help determine the best way to manage GIST for long-term patients, and it's currently looking for participants who meet these criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients ≥18 years of age;
• • Histologically documented diagnosis of malignant advanced/metastatic GIST with immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases;
• • Eastern Cooperative Oncology Group (ECOG) - Performance status (PS) 0 to 2 evaluated within 7 days prior to the date of inclusion.
• • Patient must be under imatinib treatment (at 300 or 400mg/day) maintained for 10 years or over with no more than 12 months in total or 3 consecutive months of interruption during the treatment period;
• • Patient with controlled disease (without any progression under imatinib);
• • Willingness and ability to comply with scheduled visits, treatment plans , laboratory tests, and other study procedures;
• • Covered by a medical/health insurance;
• • Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.
• Exclusion Criteria:
• • Patient concurrently using other approved or investigational antineoplastic agents;
• • Patient with GIST harboring the mutation D842V in PDGFRA;
• • Major concurrent disease affecting cardiovascular system, liver, kidneys, haematopoietic system or else considered as clinically important by the investigator and that could be incompatible with patient's participation in this trial or would likely interfere with study procedures or results;
• • Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 3 years;
• • Patient receiving concurrent treatment with warfarin (acceptable alternative: low-molecular weight heparin) or any prohibited concomitant and/or concurrent medications
• • Patient has a known diagnosis of human immunodeficiency virus (HIV) infection;
• • Major surgery within 2 weeks prior to study entry.
• • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
• • Pregnant or breastfeeding woman
• • Patient requiring tutorship or curatorship or patient deprivied of liberty.