Clinical trial NCT00103168 (phase 3, status: completed)
Conditions: gastrointestinal stromal tumor
ICD codes: C49.A0, C49.A1, C49.A2, C49.A5, C49.A3, C49.A4, C49.A9
Drugs: imatinib mesylate
SMILES: CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed gastrointestinal stromal tumor

               -  Localized disease

          -  Meets 1 of the following criteria:

               -  At high-risk of relapse, defined by 1 of the following criteria:

                    -  Tumor size > 10 cm

                    -  Mitotic rate > 10/50 high-power field (HPF)

                    -  Tumor size > 5 cm AND mitotic rate > 5/50 HPF

               -  At intermediate-risk of relapse, defined by 1 of the following criteria:

                    -  Tumor size < 5 cm AND mitotic rate 6-10/50 HPF

                    -  Tumor size 5-10 cm AND mitotic rate < 5/50 HPF

          -  Tumor must stain positive for Kit (CD117) by polyclonal DAKO antibody staining

          -  Must have undergone complete resection of the primary tumor at least 2 weeks, but no
             more than 3 months, before study entry

               -  Meets criteria for 1 of the following resection levels:

                    -  R0 (clear margins)

                    -  R1, defined by 1 of the following criteria:

                         -  Margins of resection are contaminated by tumor, but no macroscopic
                            tumor is left behind

                         -  Intraoperative tumor rupture

                         -  Shelling-out procedure

                         -  Endoscopic maneuver

               -  No residual macroscopic disease after surgery

                    -  Regional positive lymph nodes allowed provided they have been
                       macroscopically excised

          -  No distant metastases*, including any of the following:

               -  Peritoneal lesion not contiguous to the primary tumor

               -  Liver metastases

               -  Hemoperitoneal metastases NOTE: *Even if a complete resection (R0) was performed

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  WHO 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9 g/dL (transfusions allowed)

        Hepatic

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST or ALT ≤ 2.5 times ULN

          -  No uncontrolled liver disease

          -  No chronic viral hepatitis at risk of reactivation

        Renal

          -  Creatinine < 1.5 times ULN

          -  No uncontrolled chronic renal disease

        Cardiovascular

          -  No New York Heart Association class III-IV cardiac disease

          -  No congestive heart failure

          -  No myocardial infarction within the past 2 months

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for up to 3 months after
             study participation

          -  No uncontrolled diabetes

          -  No uncontrolled active infection

          -  No HIV infection

          -  No psychological, familial, sociological, or geographical condition that would
             preclude study compliance or participation

          -  No other severe and/or uncontrolled medical disease

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No other prior molecular targeted or biologic therapy

          -  No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) to support blood counts

          -  No concurrent anticancer biologic agents

        Chemotherapy

          -  No prior chemotherapy for gastrointestinal stromal tumors

          -  No concurrent anticancer chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior radiotherapy

          -  No concurrent anticancer radiotherapy

        Surgery

          -  See Disease Characteristics

          -  Prior non-curative surgery allowed (e.g., surgery with main diagnostic intent or
             emergency surgery with symptomatic intent)

        Other

          -  No prior imatinib mesylate

          -  No prior randomization to this study

          -  No concurrent therapeutic anticoagulation with coumarin derivatives

               -  Concurrent therapeutic low-molecular weight heparin or mini-dose coumarin
                  derivatives (equivalent to oral warfarin 1 mg/day) allowed for prophylaxis of
                  central venous catheter thrombosis

          -  No other concurrent antitumoral therapy

          -  No other concurrent anticancer agents

          -  No other concurrent investigational drugs