Saint Paul En Jarez

Researchers are evaluating the effects of continuing versus stopping imatinib treatment in patients who have been on the drug for at least 10 years for locally advanced or metastatic gastrointestinal stromal tumors (GIST). This phase II randomized, open-label, multicenter study aims to determine if lifelong treatment is necessary to control the disease or if stopping treatment after 10 years is safe and whether restarting imatinib upon disease relapse remains effective. GISTs often have mutations in KIT or PDGFRA genes, and imatinib targets these pathways, transforming treatment for advanced cases. Participants will be assigned to one of two groups: one will discontinue imatinib treatment after 10 years, and the other will continue the treatment. The study will assess disease control in both groups by monitoring progression-free survival. If patients in the discontinuation group experience disease relapse, imatinib will be reintroduced to evaluate its continued effectiveness. Treatment dosing is maintained at 300 or 400 mg per day, and interruptions during the 10-year period prior to study entry are limited. During the study, participants will attend scheduled visits for clinical evaluations, laboratory tests, and other procedures to monitor disease status and overall health. The main outcome measured is the progression-free rate at six months after randomization. Safety, adherence, and the ability to manage recurrence with imatinib rechallenge will also be evaluated. Participation requires ongoing compliance with visit schedules and study procedures, with the total study duration depending on individual disease progression and response.