Clear cell renal cell carcinoma | Papillary Renal Cell Carcinoma Percentage | Chromophobe Renal Cell Carcinoma Percentage | Renal Cell Carcinoma Oncocytic Percentage | Primary Lesion | Metastatic Lesion
Item
patients will be required to have clear cell renal cell carcinoma with less than 50% of any other histology (papillary or chromophobe or oncocytic). there must be histologic confirmation by the treating center of either the primary or a metastatic lesion
boolean
C0279702 (UMLS CUI [1])
C1306837 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C1266042 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0007134 (UMLS CUI [4,1])
C1378050 (UMLS CUI [4,2])
C0439165 (UMLS CUI [4,3])
C1402294 (UMLS CUI [5])
C1513183 (UMLS CUI [6])
Disease Progression | sorafenib | sunitinib
Item
patients must have experienced disease progression by recist criteria while on sorafenib or sunitinib
boolean
C0242656 (UMLS CUI [1])
C1516119 (UMLS CUI [2])
C1176020 (UMLS CUI [3])
Sorafenib Discontinued | Sunitinib Discontinued | perifosine
Item
patients must be off of sorafenib or sunitinib for >= 2 weeks prior to initiation of perifosine and <= 3 months prior to enrollment
boolean
C1516119 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1176020 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0754570 (UMLS CUI [3])
Sorafenib Adjuvant therapy | Sunitinib Adjuvant therapy | Disease recurrence
Item
patients may have had sorafenib or sunitinib in the adjuvant setting as long as they have experienced disease recurrence while on therapy
boolean
C1516119 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C1176020 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C0679254 (UMLS CUI [3])
Measurable Disease | Therapeutic radiology procedure Unsuccessful | Operative Surgical Procedures Unsuccessful
Item
patients must have measurable disease that is not curable by standard radiation therapy or surgery
boolean
C1513041 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C1272705 (UMLS CUI [3,2])
Age
Item
age >= 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
- patients must have the ability to understand and willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
CNS disorder | Brain Tumor, Primary | Seizures Uncontrolled | Metastatic malignant neoplasm to brain | Cerebrovascular accident
Item
history or clinical evidence of cns disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastasis, or history of stroke
boolean
C0007682 (UMLS CUI [1])
C0750974 (UMLS CUI [2])
C0036572 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0220650 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
Prior Immunotherapy Disease TNM clinical staging allowed | Exception Sorafenib | Exception Sunitinib
Item
other than sorafenib or sunitinib, patients may have only had prior immunotherapy for stage iv disease
boolean
C1514461 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0683607 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C1516119 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1176020 (UMLS CUI [3,2])
Sorafenib Previous allowed | Sunitinib Previous allowed | Tyrosine kinase inhibitor Both
Item
patients may have had prior sorafenib or sunitinib and cannot have been treated with both tkis
boolean
C1516119 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
C1176020 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C1268567 (UMLS CUI [3,1])
C1706086 (UMLS CUI [3,2])
Sorafenib Discontinued Due to Toxicity | Sunitinib Discontinued Due to Toxicity | Disease Progression
Item
patients who have stopped sorafenib or sunitinib due to toxicity but have only progressed off therapy will not be allowed
boolean
C1516119 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0600688 (UMLS CUI [1,4])
C1176020 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0600688 (UMLS CUI [2,4])
C0242656 (UMLS CUI [3])
Angiogenesis Inhibitors allowed | Bevacizumab allowed | Relationship Combination Sorafenib | Relationship Combination Sunitinib
Item
patients may have had prior anti-angiogenic such as bevacizumab only if given in combination with either sorafenib or sunitinib
boolean
C0596087 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C0796392 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0439849 (UMLS CUI [3,1])
C0205195 (UMLS CUI [3,2])
C1516119 (UMLS CUI [3,3])
C0439849 (UMLS CUI [4,1])
C0205195 (UMLS CUI [4,2])
C1176020 (UMLS CUI [4,3])
Thalidomide allowed Adjuvant therapy | Interferon-alpha allowed Adjuvant therapy | Thalidomide allowed Disease TNM clinical staging | Interferon-alpha allowed Disease TNM clinical staging
Item
prior thalidomide or ifnα are allowed for adjuvant therapy or stage iv disease
boolean
C0039736 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C0677850 (UMLS CUI [1,3])
C0002199 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0677850 (UMLS CUI [2,3])
C0039736 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0012634 (UMLS CUI [3,3])
C3258246 (UMLS CUI [3,4])
C0002199 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C0012634 (UMLS CUI [4,3])
C3258246 (UMLS CUI [4,4])
mTOR Inhibitors | CCI 779 | RAD 001
Item
patients may not have had prior mtor inhibitors (cci-779, rad001)
boolean
C1515672 (UMLS CUI [1])
C0796512 (UMLS CUI [2])
C0962969 (UMLS CUI [3])