ID

38490

Descripción

Sequential Use of Low-dose Sunitinib With Chemotherapy in Advanced NSCLC After Failure of Conventional Regimen; ODM derived from: https://clinicaltrials.gov/show/NCT01850147

Link

https://clinicaltrials.gov/show/NCT01850147

Palabras clave

Versiones (1)
  1. 22/10/19 22/10/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

22 de octubre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Cancer NCT01850147

Inglés

Eligibility Cancer NCT01850147

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT01850147
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic or cytologic diagnosis of stage iiib/iv nsclc
Descripción

Non-Small Cell Lung Carcinoma TNM clinical staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
ecog ps: 0,1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
unidimensional or bi-dimensional measurable disease
Descripción

Measurable Disease Linear | Measurable Disease 2-Dimensional

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1705052
receive prior treatment including first-line platinum-based chemotherapy, standard second-line chemotherapy and 1 egf/egfr inhibitor
Descripción

First line Chemotherapy Platinum-Based | Second line Chemotherapy | EGFR inhibitor Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C1514162
UMLS CUI [2,1]
C1710038
UMLS CUI [2,2]
C0392920
UMLS CUI [3,1]
C1443775
UMLS CUI [3,2]
C1265611
evidence of disease progression
Descripción

Disease Progression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242656
life expectancy >12 weeks
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
neutrophils > 1.5 109/l, platelets > 100 109/l, hemoglobin > 9g/dl, total bilirubin < 1.5 unl, ast (sgot) and alt (sgpt) < 2.5 unl, alkaline phosphatases < 5 unl, creatinine < 1 unl
Descripción

Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0201850
UMLS CUI [8]
C0201976
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pre-existing hemoptysis of a severity > grade 3 by nci ctcae criteria within 4 weeks prior to study entry
Descripción

Hemoptysis Pre-existing CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019079
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
uncontrolled hypertension
Descripción

Uncontrolled hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1868885
chf, angina or arrhythmias
Descripción

Congestive heart failure | Angina Pectoris | Cardiac Arrhythmia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0003811
lvef < 1 unl
Descripción

Left ventricular ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428772
existing a second malignancy within 5 years
Descripción

Second Primary Cancer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0751623
infected with hiv
Descripción

HIV Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693
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Similar models

Eligibility Cancer NCT01850147

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT01850147
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
histologic or cytologic diagnosis of stage iiib/iv nsclc
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
ECOG performance status
Item
ecog ps: 0,1
boolean
C1520224 (UMLS CUI [1])
Measurable Disease Linear | Measurable Disease 2-Dimensional
Item
unidimensional or bi-dimensional measurable disease
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C1705052 (UMLS CUI [2,2])
First line Chemotherapy Platinum-Based | Second line Chemotherapy | EGFR inhibitor Quantity
Item
receive prior treatment including first-line platinum-based chemotherapy, standard second-line chemotherapy and 1 egf/egfr inhibitor
boolean
C1708063 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1514162 (UMLS CUI [1,3])
C1710038 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C1443775 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Disease Progression
Item
evidence of disease progression
boolean
C0242656 (UMLS CUI [1])
Life Expectancy
Item
life expectancy >12 weeks
boolean
C0023671 (UMLS CUI [1])
Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Creatinine measurement, serum
Item
neutrophils > 1.5 109/l, platelets > 100 109/l, hemoglobin > 9g/dl, total bilirubin < 1.5 unl, ast (sgot) and alt (sgpt) < 2.5 unl, alkaline phosphatases < 5 unl, creatinine < 1 unl
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0201850 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Hemoptysis Pre-existing CTCAE Grades
Item
pre-existing hemoptysis of a severity > grade 3 by nci ctcae criteria within 4 weeks prior to study entry
boolean
C0019079 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Congestive heart failure | Angina Pectoris | Cardiac Arrhythmia
Item
chf, angina or arrhythmias
boolean
C0018802 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
Left ventricular ejection fraction
Item
lvef < 1 unl
boolean
C0428772 (UMLS CUI [1])
Second Primary Cancer
Item
existing a second malignancy within 5 years
boolean
C0751623 (UMLS CUI [1])
HIV Infection
Item
infected with hiv
boolean
C0019693 (UMLS CUI [1])
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