ID

33587

Beschreibung

Assessment of Tumor Vascular Effects of Axitinib With Dynamic Ultrasonography in Patients With Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01486251

Link

https://clinicaltrials.gov/show/NCT01486251

Stichworte

Versionen (1)
  1. 13.12.18 13.12.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

13. Dezember 2018

DOI

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Creative Commons BY 4.0
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Eligibility Colorectal Carcinoma NCT01486251

Englisch

Eligibility Colorectal Carcinoma NCT01486251

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically confirmed diagnosis of crc
Beschreibung

Colorectal Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0009402
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
Beschreibung

Secondary malignant neoplasm of liver Measurable | Disease Progression | Lesion Size Quantity | Lesion Appropriate Dynamic Contrast-Enhanced Ultrasound Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0494165
UMLS CUI [1,2]
C1513040
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0456389
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C1548787
UMLS CUI [4,3]
C3897003
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.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0123931
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C2698651
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0069717
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C2698651
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C0596581
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C2698651
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0027627
UMLS CUI [5]
C0013203
UMLS CUI [6,1]
C0332157
UMLS CUI [6,2]
C0796392
UMLS CUI [7,1]
C0332157
UMLS CUI [7,2]
C4522190
age ≥18 years; performance status (ps) 0-2 and life expectancy > 3 months.
Beschreibung

Age | Performance status | Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1518965
UMLS CUI [3]
C0023671
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.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C3714634
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
UMLS CUI [5]
C2711451
UMLS CUI [6]
C1278039
UMLS CUI [7]
C0201899
UMLS CUI [8]
C0201836
signed written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
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.
Beschreibung

Childbearing Potential Contraceptive methods | Gender Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
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Ähnliche Modelle

Eligibility Colorectal Carcinoma NCT01486251

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
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