Renal Cell Carcinoma Advanced Locally unresectable | Metastatic Renal Cell Cancer
Item
locally advanced irresectable or metastatic renal cell cancer
boolean
C0007134 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C1519810 (UMLS CUI [1,4])
C0278678 (UMLS CUI [2])
Metastatic malignant neoplasm to brain Untreated Absent | Symptoms Absent | CT Redundant | MRI Redundant
Item
no untreated brain metastases (ct or mri not necessary in the absence of symptoms)
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1457887 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0040405 (UMLS CUI [3,1])
C1313915 (UMLS CUI [3,2])
C0024485 (UMLS CUI [4,1])
C1313915 (UMLS CUI [4,2])
Uncontrolled hypertension Absent
Item
no uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Cardiovascular event Absent | Cardiovascular Disease Absent
Item
no clinically significant cardiovascular events or disease during the last 12 months
boolean
C1320716 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Operative Surgical Procedures Absent
Item
no surgery in the last 4 weeks
boolean
C0543467 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Bevacizumab Absent | Monoclonal Antibodies Absent | Angiogenesis Inhibitors Absent
Item
no treatment with bevacizumab or another monoclonal antibody with anti-angiogenic properties in the last 4 months
boolean
C0796392 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0003250 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0596087 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Tyrosine kinase inhibitor Absent
Item
no treatment with a tyrosine kinase inhibitor during the last 4 weeks
boolean
C1268567 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Measurable Disease X-Ray | Measurable Disease CT scan | Site Measurable Linear X-Ray | Site Measurable Linear Spiral CT scan | Site Measurable Linear CT scan
Item
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
boolean
C1513041 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C1515974 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
C0205132 (UMLS CUI [3,3])
C0034571 (UMLS CUI [3,4])
C1515974 (UMLS CUI [4,1])
C1513040 (UMLS CUI [4,2])
C0205132 (UMLS CUI [4,3])
C0860888 (UMLS CUI [4,4])
C1515974 (UMLS CUI [5,1])
C1513040 (UMLS CUI [5,2])
C0205132 (UMLS CUI [5,3])
C0040405 (UMLS CUI [5,4])
Clear cell renal cell carcinoma Component
Item
clear cell histology component
boolean
C0279702 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods
Item
women of childbearing potential must use effective contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Exclusion Criteria | Mental condition Interferes with Protocol Compliance | Condition Familial Interferes with Protocol Compliance | Sociological Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Protocol Compliance
Item
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
boolean
C0680251 (UMLS CUI [1])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0241888 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0525058 (UMLS CUI [3,4])
C3850138 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0017444 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
Informed Consent
Item
before patient randomization, written informed consent must be given according to gcp, and local regulations
boolean
C0021430 (UMLS CUI [1])