Metastatic Renal Cell Cancer | Independent of Histology | Independent of Nephrectomy status | Progressive Disease | Sunitinib First line treatment | Sunitinib Course Quantity
Item
histologically confirmed diagnosis of mrcc (regardless of histology or nephrectomy status) with well-documented radiological pd by recist criteria or clinical pd as judged by the investigator while receiving first-line sunitinib therapy. subjects must have at least 1 cycle of sunitinib therapy (minimum of four weeks continuously).
boolean
C0278678 (UMLS CUI [1])
C0332291 (UMLS CUI [2,1])
C4048239 (UMLS CUI [2,2])
C0332291 (UMLS CUI [3,1])
C1404808 (UMLS CUI [3,2])
C1335499 (UMLS CUI [4])
C1176020 (UMLS CUI [5,1])
C1708063 (UMLS CUI [5,2])
C1176020 (UMLS CUI [6,1])
C0750729 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
Sunitinib | Palliative Radiation Therapy | Palliative Surgery
Item
at time of randomization, at least 2 weeks since prior treatment with sunitinib, palliative radiation therapy, and/or surgery.
boolean
C1176020 (UMLS CUI [1])
C3898008 (UMLS CUI [2])
C0282282 (UMLS CUI [3])
Measurable lesion Quantity | Therapeutic radiology procedure Lesion Excluded | Therapeutic Embolization Lesion Excluded
Item
at time of randomization, there must be at least 1 measurable lesion per recist. lesions that have been previously irradiated or embolized cannot be selected as target lesions.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
C0013931 (UMLS CUI [3,1])
C0221198 (UMLS CUI [3,2])
C2828389 (UMLS CUI [3,3])
Criteria Additional
Item
more criteria apply
boolean
C0243161 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
CNS metastases Due to Renal Cell Carcinoma
Item
metastatic cns from rcc.
boolean
C0686377 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0007134 (UMLS CUI [1,3])
Sutent Discontinued | Intolerance to Sutent
Item
subjects who discontinued sutent therapy due specifically to intolerance.
boolean
C1698963 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C1698963 (UMLS CUI [2,2])
Systemic therapy Metastatic Renal Cell Cancer | Exception Sunitinib
Item
prior systemic therapy for mrcc other than sunitinib.
boolean
C1515119 (UMLS CUI [1,1])
C0278678 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1176020 (UMLS CUI [2,2])
Ketonuria | Secondary diabetes mellitus | Diabetes mellitus poor control
Item
active ketonuria, secondary to poorly controlled diabetes mellitus
boolean
C0162275 (UMLS CUI [1])
C0271640 (UMLS CUI [2])
C0860161 (UMLS CUI [3])
Criteria Additional
Item
more criteria apply
boolean
C0243161 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])