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 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
NCT ID:
NCT00831857
Eligibility Criteria:
Inclusion criteria:
* locally advanced irresectable or metastatic renal cell cancer
* no untreated brain metastases (CT or MRI not necessary in the absence of symptoms)
* no uncontrolled hypertension
* no clinically significant cardiovascular events or disease during the last 12 months
* no surgery in the last 4 weeks
* no treatment with bevacizumab or another monoclonal antibody with anti-angiogenic properties in the last 4 months
* no treatment with a tyrosine kinase inhibitor during the last 4 weeks
* measurable disease with x-ray or CT scan, at least one site of disease must be unidimensionally measurable as follows: X-ray \> 20 mm, Spiral CT scan \> 10 mm, non-spiral CT scan \> 20 mm
* clear cell histology component
* not pregnant or nursing
* women of childbearing potential must use effective contraception
* absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
* before patient randomization, written informed consent must be given according to GCP, and local regulations
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00831857
Study Brief:
Protocol Section:
NCT00831857