ID

13775

Descrição

Neoadjuvant Erlotinib for Operable Stage II or IIIA NSCLC With EGFR Mutations; ODM derived from: https://clinicaltrials.gov/show/NCT01470716

Link

https://clinicaltrials.gov/show/NCT01470716

Palavras-chave

  1. 06/03/2016 06/03/2016 -
Transferido a

6 de março de 2016

DOI

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Licença

Creative Commons BY 4.0

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    Eligibility Non-small Cell Lung Cancer Stage II NCT01470716

    Eligibility Non-small Cell Lung Cancer Stage II NCT01470716

    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    pathologically confirmed stage ii & iiia non-small cell lung cancer
    Descrição

    tumor stage non-small cell lung cancer

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1300072
    UMLS CUI [1,2]
    C0007131
    egfr exon 19 or 21 mutations
    Descrição

    EGFR gene mutation

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3266992
    age ≥ 18 years and ecog performance 0~1
    Descrição

    age; ecog

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C1520224
    has measurable lesion by recist 1.1
    Descrição

    lesion

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0221198
    no previous chemotherapy or radiation therapy
    Descrição

    chemotherapy; radiation therapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C1522449
    adequate organ function by following; anc ≥1,500/ul, hemoglobin ≥9.0g/dl, platelet ≥100,000/ul, pao2 ≥ 60 mmhg, serum cr < 1 x unl or creatinine clearance > 60 ml/min, serum bilirubin < 1 x unl, ast (sgot) and alt (sgpt) < 2.5 x unl, alkaline phosphatase < 5 x unl
    Descrição

    Absolute neutrophil count; hemoglobin; platelet; pao2; Serum creatine; creatinine clearance; serum bilirubin; ast and alt; alkaline phosphatase

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0948762
    UMLS CUI [2]
    C0518015
    UMLS CUI [3]
    C0032181
    UMLS CUI [4]
    C0202155
    UMLS CUI [5]
    C0858112
    UMLS CUI [6]
    C0373595
    UMLS CUI [7]
    C0428441
    UMLS CUI [8]
    C3831581
    UMLS CUI [9]
    C0002059
    written informed consent form
    Descrição

    informed consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    previous chemotherapy or radiation therapy
    Descrição

    chemotherapy; radiation therapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C1522449
    previous history of malignancy within 5 years from study entry except treated non-melanomatous skin cancer or uterine cervical cancer in situ
    Descrição

    medical history malignancy; skin cancer; cervical cancer in situ

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0006826
    UMLS CUI [2]
    C0007114
    UMLS CUI [3]
    C0742130
    known allergic history of erlotinib
    Descrição

    hypersensitivity erlotinib

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C1135135
    interstitial lung disease or fibrosis on chest radiogram
    Descrição

    interstitial lung disease; Chest x-ray findings; Interstitial lung fibrosis

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0206062
    UMLS CUI [2]
    C1821150
    UMLS CUI [3]
    C3887486
    active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis)
    Descrição

    infection; cardiopulmonary insufficiency; arrhythmias; hepatitis

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3714514
    UMLS CUI [2]
    C0920033
    UMLS CUI [3]
    C0003811
    UMLS CUI [4]
    C0019158
    pregnant or nursing women
    Descrição

    pregnancy; lactating

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147

    Similar models

    Eligibility Non-small Cell Lung Cancer Stage II NCT01470716

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    tumor stage non-small cell lung cancer
    Item
    pathologically confirmed stage ii & iiia non-small cell lung cancer
    boolean
    C1300072 (UMLS CUI [1,1])
    C0007131 (UMLS CUI [1,2])
    EGFR gene mutation
    Item
    egfr exon 19 or 21 mutations
    boolean
    C3266992 (UMLS CUI [1])
    age; ecog
    Item
    age ≥ 18 years and ecog performance 0~1
    boolean
    C0001779 (UMLS CUI [1])
    C1520224 (UMLS CUI [2])
    lesion
    Item
    has measurable lesion by recist 1.1
    boolean
    C0221198 (UMLS CUI [1])
    chemotherapy; radiation therapy
    Item
    no previous chemotherapy or radiation therapy
    boolean
    C0392920 (UMLS CUI [1])
    C1522449 (UMLS CUI [2])
    Absolute neutrophil count; hemoglobin; platelet; pao2; Serum creatine; creatinine clearance; serum bilirubin; ast and alt; alkaline phosphatase
    Item
    adequate organ function by following; anc ≥1,500/ul, hemoglobin ≥9.0g/dl, platelet ≥100,000/ul, pao2 ≥ 60 mmhg, serum cr < 1 x unl or creatinine clearance > 60 ml/min, serum bilirubin < 1 x unl, ast (sgot) and alt (sgpt) < 2.5 x unl, alkaline phosphatase < 5 x unl
    boolean
    C0948762 (UMLS CUI [1])
    C0518015 (UMLS CUI [2])
    C0032181 (UMLS CUI [3])
    C0202155 (UMLS CUI [4])
    C0858112 (UMLS CUI [5])
    C0373595 (UMLS CUI [6])
    C0428441 (UMLS CUI [7])
    C3831581 (UMLS CUI [8])
    C0002059 (UMLS CUI [9])
    informed consent
    Item
    written informed consent form
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    chemotherapy; radiation therapy
    Item
    previous chemotherapy or radiation therapy
    boolean
    C0392920 (UMLS CUI [1])
    C1522449 (UMLS CUI [2])
    medical history malignancy; skin cancer; cervical cancer in situ
    Item
    previous history of malignancy within 5 years from study entry except treated non-melanomatous skin cancer or uterine cervical cancer in situ
    boolean
    C0262926 (UMLS CUI [1,1])
    C0006826 (UMLS CUI [1,2])
    C0007114 (UMLS CUI [2])
    C0742130 (UMLS CUI [3])
    hypersensitivity erlotinib
    Item
    known allergic history of erlotinib
    boolean
    C0020517 (UMLS CUI [1,1])
    C1135135 (UMLS CUI [1,2])
    interstitial lung disease; Chest x-ray findings; Interstitial lung fibrosis
    Item
    interstitial lung disease or fibrosis on chest radiogram
    boolean
    C0206062 (UMLS CUI [1])
    C1821150 (UMLS CUI [2])
    C3887486 (UMLS CUI [3])
    infection; cardiopulmonary insufficiency; arrhythmias; hepatitis
    Item
    active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis)
    boolean
    C3714514 (UMLS CUI [1])
    C0920033 (UMLS CUI [2])
    C0003811 (UMLS CUI [3])
    C0019158 (UMLS CUI [4])
    pregnancy; lactating
    Item
    pregnant or nursing women
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])

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