Clinical trial NCT00116935 (phase 3, status: completed)
Conditions: sarcoma
ICD codes: C96.A, C46.9, C96.22, C46.0, C46.2, C92.31, C92.32
Drugs: imatinib mesylate, imatinib, imatinib
SMILES: CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1, CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1, CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1
Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older

          -  Histologically documented diagnosis of GIST

          -  Resectable GIST

          -  GIST removed at open surgery

          -  Immunohistochemical documentation of GIST (immunostaining for KIT/CD117)

          -  High risk of tumor recurrence as defined as one of the following: 1) the largest tumor
             diameter greater than 10.0 cm (measured by a pathologist, with any mitotic count); 2)
             mitotic count over 10 mitoses per 50 high power fields (HPFs) (with any tumor size);
             the largest tumor diameter larger than 5.0 cm and the mitotic count is over 5/50 HPFs;
             4) tumor spillage into the abdominal cavity at surgery (or tumor rupture). No residual
             tumors must be present at laparotomy, or in postoperative CT or MRI examinations.
             Patients who have microscopically infiltrated margins (or suspected microscopical
             infiltration, R1) are also allowed to enter study.

          -  Performance status 0, 1, or 2 (ECOG)

          -  Adequate organ function, defined as follows: total bilirubin <1.5 x ULN (upper limit
             of normal), serum AST (SGOT) and ALT (SGPT) <2.5 x ULN, creatinine <1.5 x ULN, ANC
             (neutrophil count) >1.5 x 10^9/L, platelets >100 x 10^9/L.

          -  Negative pregnancy test (females with childbearing potential)

          -  Written, voluntary informed consent

        Exclusion Criteria:

          -  Inoperable or metastatic GIST

          -  Less than 1 week or more than 12 weeks has elapsed from surgery

          -  Recurrent GIST

          -  Patient has received any investigational agents within 28 days as calculated from the
             first day of the study drug dosing

          -  Patient is less than 5 years free from another primary malignancy

          -  Patient with grade III/IV cardiac problems as defined by the New York Heart
             Association Criteria

          -  Female patients who are pregnant or breast-feeding

          -  Patient has severe or uncontrolled medical disease (i.e. uncontrolled diabetes, severe
             chronic renal disease, or active uncontrolled infection). Concurrent use of warfarin
             or acetaminophen are not allowed with imatinib.

          -  Chronic liver disease

          -  Known diagnosis of human immunodeficiency virus (HIV) infection

          -  Patient has received chemotherapy for GIST

          -  Patient has received neoadjuvant imatinib therapy prior to randomization

          -  Radiotherapy to 25% or more of the bone marrow

          -  Patient with any significant history of non-compliance to medical regimens or with
             inability to grant reliable informed consent