Efficiency of Imatinib Treatment After 10 Years of Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) (Gist-Ten)
Metastatic Gastrointestinal Stromal Tumor (GIST), C-KIT Mutation, Advanced Gastrointestinal Stromal Tumor (GIST)
About this trial
This is an interventional treatment trial for Metastatic Gastrointestinal Stromal Tumor (GIST) focused on measuring Gastrointestinal Stromal Tumors (GIST), Tyrosine kinase inhibitor, Maintenance therapy, Bayesian design, KIT +, Imatinib, Randomisation study
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.
Sites / Locations
- CHU BesançonRecruiting
- Institut BergoniéRecruiting
- CHU DupuytrenRecruiting
- Centre Léon BérardRecruiting
- Institut Paoli Calmettes
- Institut Curie
- CHU de ReimsRecruiting
- Centre Eugène Marquis
- Institut de Cancérologie de l'Ouest - Site Réné Gauducheau
- Institut de Cancérologie Lucien NEUWIRTH
- Institut Claudius Regaud
- Institut de Cancérologie de Lorraine
- Institut Goustave RoussyRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Imatinib interruption
Imatinib maintenancce
Immediate interruption of imatinib until progressive disease. In case of 1st relapse, imatinib will be reintroduced at 400mg/d and further increased at 800mg/d in case of 2nd relapse after re-introduction.
Maintenance of imatinib at the last dose routinely taken by the patient in the 10-year period prior to randomization (either 300 or 400 mg once daily). In case of progressive disease imatinib will be increased up to 800mg/day.