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ID

30268

Description

Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00852644

Link

https://clinicaltrials.gov/show/NCT00852644

Keywords

Versions (1)
  1. 26/05/2018 26/05/2018 -
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26 mai 2018

DOI

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Creative Commons BY 4.0
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    Eligibility Lung Cancer NCT00852644

    English

    Eligibility Lung Cancer NCT00852644

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    disease characteristics:
    Description

    Disease characteristics

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0599878
    histologically confirmed non-small cell lung cancer
    Description

    Non-Small Cell Lung Carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0007131
    stage i or ii disease (t1-3, n0, m0)
    Description

    Disease TNM clinical staging

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C3258246
    t2 or t3 tumor ≤ 5 cm
    Description

    Tumor Size TNM clinical staging

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0027651
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C3258246
    no t3 tumors involving the central chest or mediastinum (only chest wall involvement allowed)
    Description

    Exclusion Criteria | Tumor TNM clinical staging Involvement with Chest Central | Tumor TNM clinical staging Involvement with Mediastinum | Involvement with Chest wall allowed

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    UMLS CUI [2,1]
    C0027651
    UMLS CUI [2,2]
    C3258246
    UMLS CUI [2,3]
    C1314939
    UMLS CUI [2,4]
    C0817096
    UMLS CUI [2,5]
    C0205099
    UMLS CUI [3,1]
    C0027651
    UMLS CUI [3,2]
    C3258246
    UMLS CUI [3,3]
    C1314939
    UMLS CUI [3,4]
    C0025066
    UMLS CUI [4,1]
    C1314939
    UMLS CUI [4,2]
    C0205076
    UMLS CUI [4,3]
    C0683607
    tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, and patient deemed "medically inoperable"
    Description

    Tumor Resectable | Patient assessment Inoperable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0027651
    UMLS CUI [1,2]
    C1514888
    UMLS CUI [2,1]
    C0679830
    UMLS CUI [2,2]
    C0205187
    patients with fdg-avidity in mediastinal lymph nodes are eligible provided they are able to undergo mediastinoscopy to confirm n0 status
    Description

    FDG Avidity Mediastinal lymph nodes | Ability Mediastinoscopy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0046056
    UMLS CUI [1,2]
    C1510996
    UMLS CUI [1,3]
    C0588055
    UMLS CUI [2,1]
    C0085732
    UMLS CUI [2,2]
    C0025065
    patient characteristics:
    Description

    Client Characteristics

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0815172
    ecog performance status 0-2
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    not pregnant or nursing
    Description

    Pregnancy Absent | Breast Feeding Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [2,1]
    C0006147
    UMLS CUI [2,2]
    C0332197
    fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
    Description

    Fertility Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0015895
    UMLS CUI [1,2]
    C0700589
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    no history of contrast allergy
    Description

    Contrast media allergy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0570562
    no psychological issues that would preclude the completion of study treatment
    Description

    Mental problem Excludes Treatment completion

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0848067
    UMLS CUI [1,2]
    C0332196
    UMLS CUI [1,3]
    C0580352
    prior concurrent therapy:
    Description

    Therapeutic procedure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0087111
    no prior radiotherapy or chemotherapy
    Description

    Therapeutic radiology procedure | Chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1522449
    UMLS CUI [2]
    C0392920
    no suspected nodal metastasis that cannot be falsified by mediastinoscopy (i.e., hilar or mediastinal nodes that are either fludeoxyglucose f 18 [fdg]-avid or measure > 1 cm in short axis diameter on ct scan)
    Description

    Secondary malignant neoplasm of lymph node Suspected | Mediastinoscopy Unsuccessful | Hilar lymph node FDG Avidity | Mediastinal lymph nodes FDG Avidity | Hilar lymph node Diameter Size CT scan | Mediastinal lymph nodes Diameter Size CT scan

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0686619
    UMLS CUI [1,2]
    C0750491
    UMLS CUI [2,1]
    C0025065
    UMLS CUI [2,2]
    C1272705
    UMLS CUI [3,1]
    C1305372
    UMLS CUI [3,2]
    C0046056
    UMLS CUI [3,3]
    C1510996
    UMLS CUI [4,1]
    C0588055
    UMLS CUI [4,2]
    C0046056
    UMLS CUI [4,3]
    C1510996
    UMLS CUI [5,1]
    C1305372
    UMLS CUI [5,2]
    C1301886
    UMLS CUI [5,3]
    C0456389
    UMLS CUI [5,4]
    C0040405
    UMLS CUI [6,1]
    C0588055
    UMLS CUI [6,2]
    C1301886
    UMLS CUI [6,3]
    C0456389
    UMLS CUI [6,4]
    C0040405
    no tumor within or touching the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main stem bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
    Description

    Neoplasm Bronchial tree | Tumor Volume Bronchial tree Proximal | Neoplasm Carina | Neoplasm of right main stem bronchus | Neoplasm of left main stem bronchus | Neoplasm of bronchus of right upper lobe | Neoplasm of bronchus of left upper lobe | Neoplasm Interlobar bronchus | Neoplasm of bronchus of right middle lobe | Neoplasm lingular bronchus | Neoplasm of bronchus of right lower lobe | Neoplasm of bronchus of left lower lobe

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0027651
    UMLS CUI [1,2]
    C0819141
    UMLS CUI [2,1]
    C0475276
    UMLS CUI [2,2]
    C0819141
    UMLS CUI [2,3]
    C0205107
    UMLS CUI [3,1]
    C0027651
    UMLS CUI [3,2]
    C1278906
    UMLS CUI [4]
    C2063962
    UMLS CUI [5]
    C2063967
    UMLS CUI [6]
    C1290359
    UMLS CUI [7]
    C1290360
    UMLS CUI [8,1]
    C0027651
    UMLS CUI [8,2]
    C0502383
    UMLS CUI [9]
    C1290361
    UMLS CUI [10,1]
    C0027651
    UMLS CUI [10,2]
    C1280914
    UMLS CUI [11]
    C1290362
    UMLS CUI [12]
    C1290363
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    Similar models

    Eligibility Lung Cancer NCT00852644

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Disease characteristics
    Item
    disease characteristics:
    boolean
    C0599878 (UMLS CUI [1])
    Non-Small Cell Lung Carcinoma
    Item
    histologically confirmed non-small cell lung cancer
    boolean
    C0007131 (UMLS CUI [1])
    Disease TNM clinical staging
    Item
    stage i or ii disease (t1-3, n0, m0)
    boolean
    C0012634 (UMLS CUI [1,1])
    C3258246 (UMLS CUI [1,2])
    Tumor Size TNM clinical staging
    Item
    t2 or t3 tumor ≤ 5 cm
    boolean
    C0027651 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C3258246 (UMLS CUI [1,3])
    Exclusion Criteria | Tumor TNM clinical staging Involvement with Chest Central | Tumor TNM clinical staging Involvement with Mediastinum | Involvement with Chest wall allowed
    Item
    no t3 tumors involving the central chest or mediastinum (only chest wall involvement allowed)
    boolean
    C0680251 (UMLS CUI [1])
    C0027651 (UMLS CUI [2,1])
    C3258246 (UMLS CUI [2,2])
    C1314939 (UMLS CUI [2,3])
    C0817096 (UMLS CUI [2,4])
    C0205099 (UMLS CUI [2,5])
    C0027651 (UMLS CUI [3,1])
    C3258246 (UMLS CUI [3,2])
    C1314939 (UMLS CUI [3,3])
    C0025066 (UMLS CUI [3,4])
    C1314939 (UMLS CUI [4,1])
    C0205076 (UMLS CUI [4,2])
    C0683607 (UMLS CUI [4,3])
    Tumor Resectable | Patient assessment Inoperable
    Item
    tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, and patient deemed "medically inoperable"
    boolean
    C0027651 (UMLS CUI [1,1])
    C1514888 (UMLS CUI [1,2])
    C0679830 (UMLS CUI [2,1])
    C0205187 (UMLS CUI [2,2])
    FDG Avidity Mediastinal lymph nodes | Ability Mediastinoscopy
    Item
    patients with fdg-avidity in mediastinal lymph nodes are eligible provided they are able to undergo mediastinoscopy to confirm n0 status
    boolean
    C0046056 (UMLS CUI [1,1])
    C1510996 (UMLS CUI [1,2])
    C0588055 (UMLS CUI [1,3])
    C0085732 (UMLS CUI [2,1])
    C0025065 (UMLS CUI [2,2])
    Client Characteristics
    Item
    patient characteristics:
    boolean
    C0815172 (UMLS CUI [1])
    ECOG performance status
    Item
    ecog performance status 0-2
    boolean
    C1520224 (UMLS CUI [1])
    Pregnancy Absent | Breast Feeding Absent
    Item
    not pregnant or nursing
    boolean
    C0032961 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C0006147 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    Fertility Contraceptive methods
    Item
    fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
    boolean
    C0015895 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Contrast media allergy
    Item
    no history of contrast allergy
    boolean
    C0570562 (UMLS CUI [1])
    Mental problem Excludes Treatment completion
    Item
    no psychological issues that would preclude the completion of study treatment
    boolean
    C0848067 (UMLS CUI [1,1])
    C0332196 (UMLS CUI [1,2])
    C0580352 (UMLS CUI [1,3])
    Therapeutic procedure
    Item
    prior concurrent therapy:
    boolean
    C0087111 (UMLS CUI [1])
    Therapeutic radiology procedure | Chemotherapy
    Item
    no prior radiotherapy or chemotherapy
    boolean
    C1522449 (UMLS CUI [1])
    C0392920 (UMLS CUI [2])
    Secondary malignant neoplasm of lymph node Suspected | Mediastinoscopy Unsuccessful | Hilar lymph node FDG Avidity | Mediastinal lymph nodes FDG Avidity | Hilar lymph node Diameter Size CT scan | Mediastinal lymph nodes Diameter Size CT scan
    Item
    no suspected nodal metastasis that cannot be falsified by mediastinoscopy (i.e., hilar or mediastinal nodes that are either fludeoxyglucose f 18 [fdg]-avid or measure > 1 cm in short axis diameter on ct scan)
    boolean
    C0686619 (UMLS CUI [1,1])
    C0750491 (UMLS CUI [1,2])
    C0025065 (UMLS CUI [2,1])
    C1272705 (UMLS CUI [2,2])
    C1305372 (UMLS CUI [3,1])
    C0046056 (UMLS CUI [3,2])
    C1510996 (UMLS CUI [3,3])
    C0588055 (UMLS CUI [4,1])
    C0046056 (UMLS CUI [4,2])
    C1510996 (UMLS CUI [4,3])
    C1305372 (UMLS CUI [5,1])
    C1301886 (UMLS CUI [5,2])
    C0456389 (UMLS CUI [5,3])
    C0040405 (UMLS CUI [5,4])
    C0588055 (UMLS CUI [6,1])
    C1301886 (UMLS CUI [6,2])
    C0456389 (UMLS CUI [6,3])
    C0040405 (UMLS CUI [6,4])
    Neoplasm Bronchial tree | Tumor Volume Bronchial tree Proximal | Neoplasm Carina | Neoplasm of right main stem bronchus | Neoplasm of left main stem bronchus | Neoplasm of bronchus of right upper lobe | Neoplasm of bronchus of left upper lobe | Neoplasm Interlobar bronchus | Neoplasm of bronchus of right middle lobe | Neoplasm lingular bronchus | Neoplasm of bronchus of right lower lobe | Neoplasm of bronchus of left lower lobe
    Item
    no tumor within or touching the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main stem bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
    boolean
    C0027651 (UMLS CUI [1,1])
    C0819141 (UMLS CUI [1,2])
    C0475276 (UMLS CUI [2,1])
    C0819141 (UMLS CUI [2,2])
    C0205107 (UMLS CUI [2,3])
    C0027651 (UMLS CUI [3,1])
    C1278906 (UMLS CUI [3,2])
    C2063962 (UMLS CUI [4])
    C2063967 (UMLS CUI [5])
    C1290359 (UMLS CUI [6])
    C1290360 (UMLS CUI [7])
    C0027651 (UMLS CUI [8,1])
    C0502383 (UMLS CUI [8,2])
    C1290361 (UMLS CUI [9])
    C0027651 (UMLS CUI [10,1])
    C1280914 (UMLS CUI [10,2])
    C1290362 (UMLS CUI [11])
    C1290363 (UMLS CUI [12])
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