Randomized, Multicentre, Phase II Study Evaluating Imatinib Treatment Maintenance or Interruption After at Least 10 Years in Patients With Locally Advanced/Metastatic Gastrointestinal Stromal Tumors

What this Trial Is About

Researchers are studying patients with locally advanced or metastatic gastrointestinal stromal tumors (GIST) who have been treated with imatinib for at least 10 years. The study aims to find out if stopping imatinib after this long treatment period affects disease control and whether restarting the drug at relapse remains effective. This phase II trial will compare continued imatinib treatment with treatment interruption to better understand the long-term need for this therapy in advanced GIST patients. Participants are randomly assigned to one of two groups. One group will stop imatinib until disease progression, with imatinib reintroduced at 400 mg daily if relapse occurs, and increased to 800 mg daily if a second relapse happens. The other group will continue imatinib at their current dose (300 or 400 mg daily), with an option to increase the dose to 800 mg daily if the disease progresses. This open-label, multicenter study evaluates the impact of maintaining versus interrupting imatinib after 10 years of use. Participants will be followed for up to 5 years after randomization. Researchers will monitor progression-free survival, overall survival, safety, quality of life, and response to imatinib rechallenge if treatment is interrupted. Assessments include regular clinical visits, laboratory tests, and imaging. The primary outcome is progression-free rate at 6 months, with secondary measures covering longer-term disease control and patient well-being.

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