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

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

Gastrointestinal Stromal Tumor

Recruiting

2

Start Date 01/03/2022

Age of Trial (yrs) 2.9

First-line

KIT/PDGFRA inhibitor

Block KIT

Specifically GIST and only GIST

GIST-TEN

Centre Leon Berard

Jean-Yves BLAY, Pr +33 4 78 78 27 57 jean-yves.blay@lyon.unicancer.fr

Randomized

Oral

Official Title:

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

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.