Colorectal Carcinoma
Item
patients with histologically confirmed diagnosis of crc
boolean
C0009402 (UMLS CUI [1])
Secondary malignant neoplasm of liver Measurable | Disease Progression | Lesion Size Quantity | Lesion Appropriate Dynamic Contrast-Enhanced Ultrasound Imaging
Item
measurable metastatic disease to the liver in proven disease progression (according to recist criteria) at baseline (within 4 weeks prior to study entry), with at least one lesion > 2cm considered appropriate for dce-us examination
boolean
C0494165 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
C0221198 (UMLS CUI [3,1])
C0456389 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0221198 (UMLS CUI [4,1])
C1548787 (UMLS CUI [4,2])
C3897003 (UMLS CUI [4,3])
Exposure to Irinotecan Dose Optimum | Exposure to Oxaliplatin Dose Optimum | Exposure to Fluoropyrimidine Dose Optimum | Chemotherapy Regimen Quantity Neoplasm Metastasis | Drug resistance | Exposure to Bevacizumab | Exposure to Anti-EGFR Monoclonal Antibody
Item
previously exposed to at least, irinotecan, oxaliplatin and a fluoropyrimidine, all 3 administered at optimal doses, over one or two chemotherapy (ct) lines for metastatic disease with a clear resistance to these drugs. previous exposure to bevacizumab and/or anti-egfr monoclonal antibody is allowed.
boolean
C0332157 (UMLS CUI [1,1])
C0123931 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C2698651 (UMLS CUI [1,4])
C0332157 (UMLS CUI [2,1])
C0069717 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C2698651 (UMLS CUI [2,4])
C0332157 (UMLS CUI [3,1])
C0596581 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C2698651 (UMLS CUI [3,4])
C0392920 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0027627 (UMLS CUI [4,3])
C0013203 (UMLS CUI [5])
C0332157 (UMLS CUI [6,1])
C0796392 (UMLS CUI [6,2])
C0332157 (UMLS CUI [7,1])
C4522190 (UMLS CUI [7,2])
Age | Performance status | Life Expectancy
Item
age ≥18 years; performance status (ps) 0-2 and life expectancy > 3 months.
boolean
C0001779 (UMLS CUI [1])
C1518965 (UMLS CUI [2])
C0023671 (UMLS CUI [3])
Biological functions | Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Estimation of creatinine clearance by Cockcroft-Gault formula | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
adequate biological functions: neutrophils ≥ 1.5 x 109/l; platelets ≥ 100 x 109/l; hemoglobin > 9 g/dl; creatinine clearance > 30 ml/min (cockcroft & gault formula). serum bilirubin < 1,5 x the upper normal limit (unl) and ast/alt < 5 x unl.
boolean
C3714634 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C2711451 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
female patients with childbearing potential (<2 years after last menstruation) and male must use effective means of contraception during the study treatment and at least 6 months after the last study drug administration.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])