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 @ 1:32 PM
Ignite Modification Date:
2025-12-24 @ 1:32 PM
NCT ID:
NCT00764595
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of gastrointestinal stromal tumor (GIST)
* Hepatic metastasis meeting the following criteria:
* No more than 3 hepatic metastases
* Clinically diagnosed as surgically resectable with no macroscopic residual tumor
* Synchronous hepatic metastasis allowed provided primary tumor is also resectable
* No metastatic tumor that requires radiofrequency ablation and/or microwave coagulation therapy to control the disease
* No extrahepatic metastasis
* No history of GIST recurrence
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Leukocyte count ≥ 3,000/μL
* Neutrophil count ≥ 1,500/μL
* Hemoglobin ≥ 8.0 g/dL
* Platelet count ≥ 75,000/μL
* Total bilirubin ≤ 2.0 mg/dL
* ALT and AST \< 120 IU/L
* GTP \< 210 IU/L
* Not pregnant
* No poorly controlled diabetes mellitus
* No NYHA class III-IV cardiac function
* No hepatitis B or hepatitis B carriers
* No other malignancy requiring treatment
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior imatinib mesylate
* No prior interventional radiology for metastatic disease
* No other concurrent treatment, including surgery or radiotherapy, for metastatic lesions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT00764595
Study Brief:
Protocol Section:
NCT00764595