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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT00112632
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed gastrointestinal stromal tumor
* Locally advanced disease
* Potentially resectable disease\*
* No tumor that can be completely resected (R0) with sufficient margins NOTE: \*Multivisceral resection may be necessary
* Tumor must stain positive for c-Kit (CD117) or platelet-derived growth factor receptor-alpha (PDGFRA) by immunohistochemistry
* At least 1 site of measurable disease
* No known brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-3
Life expectancy
* Not specified
Hematopoietic
* Platelet count \> 100,000/mm\^3
* Absolute neutrophil count \> 1,500/mm\^3
Hepatic
* AST and ALT \< 2.5 times upper limits of normal (ULN) (5 times ULN if hepatic metastases are present)
* Bilirubin \< 1.5 times ULN
* No chronic active hepatitis
* No cirrhosis
* No other chronic liver disease
Renal
* Creatinine \< 1.5 times ULN
* No chronic renal disease
Cardiovascular
* No New York Heart Association class III-IV cardiac disease
* No congestive heart failure
* No myocardial infarction within the past 6 months
Immunology
* No active uncontrolled infection
* No known HIV positivity
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
* Must be medically fit to undergo surgery
* No other primary malignancy within the past 5 years except basal cell skin cancer, carcinoma in situ of the cervix, or a primary malignancy that is not currently clinically significant and does not require active intervention
* No gastrointestinal obstruction or major bleeding episode requiring immediate surgical intervention
* No uncontrolled diabetes
* No other severe or uncontrolled medical disease
* No significant history of noncompliance to medical regimens
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent anticancer biologic agents
Chemotherapy
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) unless disease is rapidly progressing
* No concurrent anticancer chemotherapy
Endocrine therapy
* No concurrent systemic corticosteroid therapy unless approved by the study sponsor
Radiotherapy
* More than 4 weeks since prior radiotherapy
* No prior radiotherapy to ≥ 25% of bone marrow
Surgery
* More than 2 weeks since prior major surgery except tumor biopsy
Other
* More than 4 weeks since prior investigational drugs unless disease is rapidly progressing
* No other concurrent anticancer therapy
* No other concurrent investigational agents
* No concurrent warfarin for therapeutic anticoagulation
* Concurrent low molecular weight heparin (e.g., enoxaparin sodium) or heparin for therapeutic anticoagulation allowed
* Concurrent mini-dose warfarin (e.g.,1 mg/day) for prophylaxis of central venous catheter thrombosis allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00112632
Study Brief:
Protocol Section:
NCT00112632