Study Comparing 12 Months Versus 36 Months of Imatinib in the Treatment of Gastrointestinal Stromal Tumor (GIST)
Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
Participant gender:
Summary
In this study, patients who have been diagnosed with gastrointestinal stromal tumor (GIST)
will be randomly allocated in a 1:1 ratio to receive imatinib (Gleevec) either for 12 or for
36 months following surgery. The study participants are required to have a histologically
verified GIST with a high risk of GIST recurrence despite complete removal of all macroscopic
GIST tissue at surgery. The high/very high risk of recurrence is defined as one of the
following: 1) the largest tumor diameter is over 10 cm; 2) the mitosis count is high (over 10
mitoses per 50 high power microscope fields, HPFs); 3) the largest tumor diameter over 5 cm
and the mitosis count is over 5/50 HPFs; 4) tumor spillage has taken place into the abdominal
cavity at the time of surgery or following spontaneous tumor rupture. All study participants
will receive imatinib 400 mg/day orally, but the duration of imatinib administration will be
determined randomly (either for 12 or for 36 months). The study participants will be followed
up using blood tests and computed tomography (or MRI) of the abdomen. The computed tomography
examinations will be performed at 6 month intervals for a median of 5 years. A total of 280
patients will be entered into the study. The study hypothesis is that adjuvant imatinib may
prevent some of the GIST recurrences, and that there may be a difference in the rate of GIST
recurrence between the two groups.