0 Evaluaciones
ID

41558

Descripción

3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01563354 according to the information on clinicaltrials.gov "other protocol-defined inclusion/exclusion-criteria may apply"

Link

https://clinicaltrials.gov/show/NCT01563354

Palabras clave

Versiones (1)
  1. 10/11/20 10/11/20 -
Titular de derechos de autor

see on clinicaltrials.gov

Subido en

10 de noviembre de 2020

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility Neuroendocrine Carcinoma of the Lung and Thymus NCT01563354

    Inglés

    Eligibility Neuroendocrine Carcinoma of the Lung and Thymus NCT01563354

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    histological confirmed advanced well differentiated typical and atypical carcinoid tumors of the lung or thymus
    Descripción

    histological confirmed advanced well differentiated carcinoid tumors of the lung or thymus

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0449575
    UMLS CUI [1,2]
    C0205615
    UMLS CUI [1,3]
    C0280089
    UMLS CUI [1,4]
    C0205179
    UMLS CUI [2,1]
    C0449575
    UMLS CUI [2,2]
    C0205615
    UMLS CUI [2,3]
    C0007095
    UMLS CUI [2,4]
    C0040113
    UMLS CUI [2,5]
    C0205179
    patients of all treatment lines including naive patients can be enrolled
    Descripción

    patients of all treatment lines including naive patients

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C2200127
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0206695
    UMLS CUI [2,3]
    C0040113
    UMLS CUI [3,1]
    C0332155
    UMLS CUI [3,2]
    C2200127
    UMLS CUI [4,1]
    C0332155
    UMLS CUI [4,2]
    C0206695
    UMLS CUI [4,3]
    C0040113
    at least one measurable lesion of disease on ct scan or mri
    Descripción

    at least one measurable lesion of disease on ct scan or mri

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C0040405
    UMLS CUI [1,3]
    C2200127
    UMLS CUI [2,1]
    C1513041
    UMLS CUI [2,2]
    C0024485
    UMLS CUI [2,3]
    C2200127
    UMLS CUI [3,1]
    C1513041
    UMLS CUI [3,2]
    C0040405
    UMLS CUI [3,3]
    C0206695
    UMLS CUI [3,4]
    C0040113
    UMLS CUI [4,1]
    C1513041
    UMLS CUI [4,2]
    C0024485
    UMLS CUI [4,3]
    C0206695
    UMLS CUI [4,4]
    C0040113
    radiological documentation of disease progression within 12 months prior to randomization
    Descripción

    radiological documentation of disease progression prior to randomization

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0332185
    UMLS CUI [1,2]
    C1290916
    UMLS CUI [1,3]
    C0242656
    adequate liver, renal and bone marrow function
    Descripción

    adequate liver, renal and bone marrow function

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0205410
    UMLS CUI [1,2]
    C0232741
    UMLS CUI [2,1]
    C0205410
    UMLS CUI [2,2]
    C0232804
    UMLS CUI [3,1]
    C0205410
    UMLS CUI [3,2]
    C0005953
    UMLS CUI [3,3]
    C0678852
    who performance status 0-2
    Descripción

    who performance status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1298650
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    poorly differentiated neuroendocrine carcinoma
    Descripción

    poorly differentiated neuroendocrine carcinoma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0205617
    UMLS CUI [1,2]
    C0206695
    non-neuroendocrine thymoma
    Descripción

    non-neuroendocrine thymoma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0040100
    UMLS CUI [1,2]
    C0332300
    UMLS CUI [1,3]
    C0206695
    patients with severe functional disease requiring symptomatic treatment with somatostatin analogs
    Descripción

    patients with severe functional disease requiring treatment with somatostatin analogs

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0277785
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C1514873
    UMLS CUI [1,4]
    C0732165
    prior therapy with mtor inhibitors
    Descripción

    prior therapy with mtor inhibitors

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C2746052
    history of liver disease
    Descripción

    history of liver disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0023895
    baseline qtcf> 470 msec
    Descripción

    baseline qtcf

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1442488
    UMLS CUI [1,2]
    C1882513
    uncontrolled diabetes mellitus despite adequate therapy
    Descripción

    uncontrolled diabetes mellitus despite adequate therapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0011849
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [1,3]
    C0087111
    UMLS CUI [1,4]
    C0205411
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    Similar models

    Eligibility Neuroendocrine Carcinoma of the Lung and Thymus NCT01563354

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    histological confirmed advanced well differentiated carcinoid tumors of the lung or thymus
    Item
    histological confirmed advanced well differentiated typical and atypical carcinoid tumors of the lung or thymus
    boolean
    C0449575 (UMLS CUI [1,1])
    C0205615 (UMLS CUI [1,2])
    C0280089 (UMLS CUI [1,3])
    C0205179 (UMLS CUI [1,4])
    C0449575 (UMLS CUI [2,1])
    C0205615 (UMLS CUI [2,2])
    C0007095 (UMLS CUI [2,3])
    C0040113 (UMLS CUI [2,4])
    C0205179 (UMLS CUI [2,5])
    patients of all treatment lines including naive patients
    Item
    patients of all treatment lines including naive patients can be enrolled
    boolean
    C0087111 (UMLS CUI [1,1])
    C2200127 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2,1])
    C0206695 (UMLS CUI [2,2])
    C0040113 (UMLS CUI [2,3])
    C0332155 (UMLS CUI [3,1])
    C2200127 (UMLS CUI [3,2])
    C0332155 (UMLS CUI [4,1])
    C0206695 (UMLS CUI [4,2])
    C0040113 (UMLS CUI [4,3])
    at least one measurable lesion of disease on ct scan or mri
    Item
    at least one measurable lesion of disease on ct scan or mri
    boolean
    C1513041 (UMLS CUI [1,1])
    C0040405 (UMLS CUI [1,2])
    C2200127 (UMLS CUI [1,3])
    C1513041 (UMLS CUI [2,1])
    C0024485 (UMLS CUI [2,2])
    C2200127 (UMLS CUI [2,3])
    C1513041 (UMLS CUI [3,1])
    C0040405 (UMLS CUI [3,2])
    C0206695 (UMLS CUI [3,3])
    C0040113 (UMLS CUI [3,4])
    C1513041 (UMLS CUI [4,1])
    C0024485 (UMLS CUI [4,2])
    C0206695 (UMLS CUI [4,3])
    C0040113 (UMLS CUI [4,4])
    radiological documentation of disease progression prior to randomization
    Item
    radiological documentation of disease progression within 12 months prior to randomization
    boolean
    C0332185 (UMLS CUI [1,1])
    C1290916 (UMLS CUI [1,2])
    C0242656 (UMLS CUI [1,3])
    adequate liver, renal and bone marrow function
    Item
    adequate liver, renal and bone marrow function
    boolean
    C0205410 (UMLS CUI [1,1])
    C0232741 (UMLS CUI [1,2])
    C0205410 (UMLS CUI [2,1])
    C0232804 (UMLS CUI [2,2])
    C0205410 (UMLS CUI [3,1])
    C0005953 (UMLS CUI [3,2])
    C0678852 (UMLS CUI [3,3])
    who performance status
    Item
    who performance status 0-2
    boolean
    C1298650 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    poorly differentiated neuroendocrine carcinoma
    Item
    poorly differentiated neuroendocrine carcinoma
    boolean
    C0205617 (UMLS CUI [1,1])
    C0206695 (UMLS CUI [1,2])
    non-neuroendocrine thymoma
    Item
    non-neuroendocrine thymoma
    boolean
    C0040100 (UMLS CUI [1,1])
    C0332300 (UMLS CUI [1,2])
    C0206695 (UMLS CUI [1,3])
    patients with severe functional disease requiring treatment with somatostatin analogs
    Item
    patients with severe functional disease requiring symptomatic treatment with somatostatin analogs
    boolean
    C0277785 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C1514873 (UMLS CUI [1,3])
    C0732165 (UMLS CUI [1,4])
    prior therapy with mtor inhibitors
    Item
    prior therapy with mtor inhibitors
    boolean
    C1514463 (UMLS CUI [1,1])
    C2746052 (UMLS CUI [1,2])
    history of liver disease
    Item
    history of liver disease
    boolean
    C0262926 (UMLS CUI [1,1])
    C0023895 (UMLS CUI [1,2])
    baseline qtcf
    Item
    baseline qtcf> 470 msec
    boolean
    C1442488 (UMLS CUI [1,1])
    C1882513 (UMLS CUI [1,2])
    uncontrolled diabetes mellitus despite adequate therapy
    Item
    uncontrolled diabetes mellitus despite adequate therapy
    boolean
    C0011849 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [1,3])
    C0205411 (UMLS CUI [1,4])
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