0 Ratings
ID

41558

Description

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

Keywords

Versions (1)
  1. 11/10/20 11/10/20 -
Copyright Holder

see on clinicaltrials.gov

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November 10, 2020

DOI

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License

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

    English

    Eligibility Neuroendocrine Carcinoma of the Lung and Thymus NCT01563354

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

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

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

    Data type

    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
    Description

    patients of all treatment lines including naive patients

    Data type

    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
    Description

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

    Data type

    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
    Description

    radiological documentation of disease progression prior to randomization

    Data type

    boolean

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

    adequate liver, renal and bone marrow function

    Data type

    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
    Description

    who performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1298650
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    poorly differentiated neuroendocrine carcinoma
    Description

    poorly differentiated neuroendocrine carcinoma

    Data type

    boolean

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

    non-neuroendocrine thymoma

    Data type

    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
    Description

    patients with severe functional disease requiring treatment with somatostatin analogs

    Data type

    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
    Description

    prior therapy with mtor inhibitors

    Data type

    boolean

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

    history of liver disease

    Data type

    boolean

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

    baseline qtcf

    Data type

    boolean

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

    uncontrolled diabetes mellitus despite adequate therapy

    Data type

    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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    Eligibility Neuroendocrine Carcinoma of the Lung and Thymus NCT01563354

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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