Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT00103168
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00103168
Study Brief:
Protocol Section:
NCT00103168