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 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
NCT ID:
NCT00082459
Eligibility Criteria:
Inclusion Criteria:
* Suspected metastatic renal cell carcinoma (AJCC Stage IV) with intact primary tumor
* No previous therapy for metastatic renal cell carcinoma
* Measurable disease (RECIST criteria)
* Primary tumor greater than or equal to 7cm on CT or MRI
* ECOG performance status 0-1
* At least 18 years old
* Life expectancy \> 3 months
* Adequate cardiac function (NYHA I-II)
* Not pregnant
* Provide written informed consent
* Absence of multiple liver metastases, brain or threatening bone metastases (axial skeleton and/or pathological features)
* Planned complete nephrectomy
Exclusion Criteria:
* History of primary or secondary immunodeficiency, or patients using systemic corticosteroids or cyclosporin A
* Other cancer (including renal cell carcinoma) within the last five years (with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin)
* Embolization of the renal artery prior to nephrectomy
* Active, uncontrolled infection or other serious medical illnesses, preventing study completion, in the opinion of the Principal Investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00082459
Study Brief:
Protocol Section:
NCT00082459