0 Evaluaciones
ID

18400

Descripción

Trial of Docetaxel Versus Vinorelbine as 1st Line Treatment in Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00441922

Link

https://clinicaltrials.gov/show/NCT00441922

Palabras clave

Versiones (1)
  1. 3/11/16 3/11/16 -
Subido en

3 de noviembre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility Non Small Cell Lung Cancer NCT00441922

    Inglés

    Eligibility Non Small Cell Lung Cancer NCT00441922

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    histologically- or cytologically- confirmed non-small-cell lung cancer
    Descripción

    Non-Small Cell Lung Carcinoma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0007131
    stage iiib/iv
    Descripción

    TNM clinical staging

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C3258246
    no prior chemotherapy
    Descripción

    Prior Chemotherapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1514457
    existence of two-dimensional measurable disease. the measurable disease should not have been irradiated
    Descripción

    Measurable Disease 2-Dimensional | Therapeutic radiology procedure Measurable Disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C1705052
    UMLS CUI [2,1]
    C1522449
    UMLS CUI [2,2]
    C1513041
    life expectancy of more than 3 months
    Descripción

    Life Expectancy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    age ≥ 65 years
    Descripción

    Age

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    performance status (who) ≤ 3
    Descripción

    WHO performance status scale

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1298650
    adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3)
    Descripción

    Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0005953
    UMLS CUI [1,2]
    C0031843
    UMLS CUI [2]
    C0948762
    UMLS CUI [3]
    C0032181
    UMLS CUI [4]
    C0019046
    adequate liver (bilirubin < 1.5 times upper limit of normal and sgot/sgpt < 2 times upper limit of normal), and renal function (creatinine < 2 mg/dl)
    Descripción

    Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C1278039
    UMLS CUI [3]
    C0201899
    UMLS CUI [4]
    C0201836
    UMLS CUI [5]
    C0232804
    UMLS CUI [6]
    C0201976
    informed consent
    Descripción

    Informed Consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    psychiatric illness or social situation that would preclude study compliance.
    Descripción

    Mental disorder Excludes Protocol Compliance | social situation Excludes Protocol Compliance

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0004936
    UMLS CUI [1,2]
    C0332196
    UMLS CUI [1,3]
    C0525058
    UMLS CUI [2,1]
    C0748872
    UMLS CUI [2,2]
    C0332196
    UMLS CUI [2,3]
    C0525058
    other concurrent uncontrolled illness
    Descripción

    Comorbidity Uncontrolled

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0205318
    other invasive malignancy within the past 5 years except nonmelanoma skin cancer
    Descripción

    invasive cancer | Skin carcinoma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0677898
    UMLS CUI [2]
    C0699893
    no absence or irradiated and stable central nervous system metastatic disease.
    Descripción

    CNS metastases Presence | Therapeutic radiology procedure CNS metastases | CNS metastases Stable

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0686377
    UMLS CUI [1,2]
    C0150312
    UMLS CUI [2,1]
    C1522449
    UMLS CUI [2,2]
    C0686377
    UMLS CUI [3,1]
    C0686377
    UMLS CUI [3,2]
    C0205360
    no presence of a reliable care giver
    Descripción

    Caregiver Absence

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0085537
    UMLS CUI [1,2]
    C0332197
    other concurrent investigational agents
    Descripción

    Investigational New Drugs

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    Volver a la parte superior de la página

    Similar models

    Eligibility Non Small Cell Lung Cancer NCT00441922

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Non-Small Cell Lung Carcinoma
    Item
    histologically- or cytologically- confirmed non-small-cell lung cancer
    boolean
    C0007131 (UMLS CUI [1])
    TNM clinical staging
    Item
    stage iiib/iv
    boolean
    C3258246 (UMLS CUI [1])
    Prior Chemotherapy
    Item
    no prior chemotherapy
    boolean
    C1514457 (UMLS CUI [1])
    Measurable Disease 2-Dimensional | Therapeutic radiology procedure Measurable Disease
    Item
    existence of two-dimensional measurable disease. the measurable disease should not have been irradiated
    boolean
    C1513041 (UMLS CUI [1,1])
    C1705052 (UMLS CUI [1,2])
    C1522449 (UMLS CUI [2,1])
    C1513041 (UMLS CUI [2,2])
    Life Expectancy
    Item
    life expectancy of more than 3 months
    boolean
    C0023671 (UMLS CUI [1])
    Age
    Item
    age ≥ 65 years
    boolean
    C0001779 (UMLS CUI [1])
    WHO performance status scale
    Item
    performance status (who) ≤ 3
    boolean
    C1298650 (UMLS CUI [1])
    Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin
    Item
    adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3)
    boolean
    C0005953 (UMLS CUI [1,1])
    C0031843 (UMLS CUI [1,2])
    C0948762 (UMLS CUI [2])
    C0032181 (UMLS CUI [3])
    C0019046 (UMLS CUI [4])
    Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
    Item
    adequate liver (bilirubin < 1.5 times upper limit of normal and sgot/sgpt < 2 times upper limit of normal), and renal function (creatinine < 2 mg/dl)
    boolean
    C0232741 (UMLS CUI [1])
    C1278039 (UMLS CUI [2])
    C0201899 (UMLS CUI [3])
    C0201836 (UMLS CUI [4])
    C0232804 (UMLS CUI [5])
    C0201976 (UMLS CUI [6])
    Informed Consent
    Item
    informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Mental disorder Excludes Protocol Compliance | social situation Excludes Protocol Compliance
    Item
    psychiatric illness or social situation that would preclude study compliance.
    boolean
    C0004936 (UMLS CUI [1,1])
    C0332196 (UMLS CUI [1,2])
    C0525058 (UMLS CUI [1,3])
    C0748872 (UMLS CUI [2,1])
    C0332196 (UMLS CUI [2,2])
    C0525058 (UMLS CUI [2,3])
    Comorbidity Uncontrolled
    Item
    other concurrent uncontrolled illness
    boolean
    C0009488 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    invasive cancer | Skin carcinoma
    Item
    other invasive malignancy within the past 5 years except nonmelanoma skin cancer
    boolean
    C0677898 (UMLS CUI [1])
    C0699893 (UMLS CUI [2])
    CNS metastases Presence | Therapeutic radiology procedure CNS metastases | CNS metastases Stable
    Item
    no absence or irradiated and stable central nervous system metastatic disease.
    boolean
    C0686377 (UMLS CUI [1,1])
    C0150312 (UMLS CUI [1,2])
    C1522449 (UMLS CUI [2,1])
    C0686377 (UMLS CUI [2,2])
    C0686377 (UMLS CUI [3,1])
    C0205360 (UMLS CUI [3,2])
    Caregiver Absence
    Item
    no presence of a reliable care giver
    boolean
    C0085537 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    Investigational New Drugs
    Item
    other concurrent investigational agents
    boolean
    C0013230 (UMLS CUI [1])
    Volver a la parte superior de la página 

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