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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT00727532
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed newly diagnosed clear cell renal cell carcinoma, meeting 1 of the following criteria:
* Localized disease, as evidenced by intact, bulky, and primary renal lesions (T1 \> 3 cm, any T2, T3, or T4) appropriate for nephrectomy
* Limited metastatic disease, as evidenced by any renal primary (T1 \> 3 cm, any T2, T3, or T4) appropriate for cytoreductive nephrectomy
* Isolated abdominal/pelvic recurrence with limited metastatic burden (minimum size \> 2 cm) appropriate for metastasectomy
* No known brain metastasis
* Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis
PATIENT CHARACTERISTICS:
* Eastern Cooperative Oncology Group performance status 0-1
* Hemoglobin ≥ 9.0 g/dL
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Alanine aminotransferase and Aspartate aminotransferase ≤ 2.5 times ULN (≤ 5 times ULN with liver involvement)
* Creatinine ≤ 1.5 times ULN
* Estimated glomerular filtration rate \> 30 mL/min (for patients receiving Gd-enhanced MRI)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception prior to, during (men and women), and for at least 3 months after (men) completion of study therapy
* Adequate cardiac and pulmonary status for operative therapy
* No active clinically serious infection \> CTCAE grade 2
* No known HIV, hepatitis B, or hepatitis C infections
* No serious non-healing wound, ulcer, or bone fracture
* No significant traumatic injury within the past 4 weeks
* No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within the past 4 weeks
* No other hemorrhage/bleeding event ≥ CTCAE grade 3 within the past 4 weeks
* No history of an uncontrolled bleeding disorder including, but not limited to, any of the following:
* Bleeding diathesis
* Coagulopathy
* No cardiac disease or condition including, but not limited to, any of the following:
* New York Heart Association class II-IV congestive heart failure
* Unstable angina (anginal symptoms at rest)
* New onset angina beginning within the last 3 months
* Myocardial infarction within the past 6 months
* Cardiac ventricular arrhythmias requiring antiarrhythmic therapy
* No uncontrolled hypertension (i.e., systolic blood pressure \[BP\] \> 150 mm Hg or diastolic BP \> 100 mm Hg) despite optimal medical management
* No thrombolic or embolic events within the past 6 months (e.g., cerebrovascular accident including transient ischemic attacks)
* No condition that impairs the ability to swallow whole pills
* No malabsorption problem
* No contraindication to MRI, including, but not limited to, any of the following:
* Ferromagnetic implants
* Dental work
* Pacemakers
* Metallic implants
* Severe claustrophobia which precludes closed MRI testing
* No known or suspected allergy to sorafenib tosylate
* No contraindication or allergy to gadolinium (e.g., end stage renal disease requiring hemodialysis)
* No intercurrent illness or situation which, in the judgment of the investigator, would affect assessments of clinical status and study endpoints significantly
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 4 weeks since prior major surgery or open biopsy
* No prior therapy with tyrosine kinase or vascular endothelial growth factor inhibitors (e.g., sunitinib malate, sorafenib, or bevacizumab)
* No concurrent Hypericum perforatum (St. John's wort) or rifampin
* No concurrent use of illicit drugs or other substances that may, in the opinion of the investigator, have a reasonable chance of contributing to toxicity or interfering with study results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00727532
Study Brief:
Protocol Section:
NCT00727532