Three Versus Five Years of Adjuvant Imatinib as Treatment of Patients With Operable GIST
Status:
Recruiting
Trial end date:
2028-05-01
Target enrollment:
Participant gender:
Summary
In this study, patients who have been diagnosed with gastrointestinal stromal tumor (GIST)
and have been treated with adjuvant imatinib for 3 years after surgery will be randomly
allocated in a 1:1 ratio to receive imatinib (Gleevec) for 2 more years (Arm A) or to stop
imatinib (Arm B). The study participants are required to have histologically verified GIST
with a high risk of GIST recurrence despite removal of all macroscopic GIST tissue at surgery
and 3 years of adjuvant imatinib. The high risk of GIST recurrence is defined as one of the
following: gastric GIST with mitotic count >10/50 high power fields (HPFs) of the microscope,
non-gastric GIST with mitotic count >5/50 HPFs, or tumor rupture. Study participants
allocated to Arm A will receive imatinib 400 mg/day for 24 months after the date of
randomization. All study participants will be followed up using blood tests and computerized
tomography (or MRI) of the abdomen. The computerized tomography examinations will be
performed at 6 month intervals. A total of 300 patients will be entered to the study. The
study hypothesis is that adjuvant imatinib given for a total of 5 years may prevent some of
the GISTs to recur as compared to patients who receive adjuvant imatinib for 3 years, and
there may be a difference in the rate of GIST recurrence between the two groups.