ID

16519

Description

A Single Arm Phase 2 Study of Pemetrexed as 2nd-Line Treatment of Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00190840

Lien

https://clinicaltrials.gov/show/NCT00190840

Mots-clés

  1. 22/07/2016 22/07/2016 -
Téléchargé le

22 juillet 2016

DOI

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Licence

Creative Commons BY 4.0

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    Eligibility Carcinoma, Non-Small Cell Lung NCT00190840

    Eligibility Carcinoma, Non-Small Cell Lung NCT00190840

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    diagnosis of nsclc
    Description

    Non-Small Cell Lung Carcinoma

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0007131
    locally advanced or metastatic disease (stage iiib or iv).
    Description

    Locally Advanced Malignant Neoplasm | Metastatic Neoplasm | TNM clinical staging

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0677984
    UMLS CUI [2]
    C2939420
    UMLS CUI [3]
    C3258246
    patients must have previously received one chemotherapy regimen for palliative therapy of locally advanced or metastatic disease.
    Description

    Chemotherapy Palliative procedure Locally Advanced Malignant Neoplasm | Chemotherapy Palliative procedure Metastatic Neoplasm

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C1285158
    UMLS CUI [1,3]
    C0677984
    UMLS CUI [2,1]
    C0392920
    UMLS CUI [2,2]
    C1285158
    UMLS CUI [2,3]
    C2939420
    disease status must be that of measurable disease as defined by recist criteria
    Description

    Measurable Disease

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    performance status of 0 to 1 on the eastern cooperative oncology group (ecog) scale; and adequate organ function.
    Description

    ECOG performance status | organ function

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    UMLS CUI [2]
    C0678852
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    known or suspected brain metastasis, or second primary malignancy that is clinically detectable at the time of consideration for study enrollment
    Description

    Metastatic malignant neoplasm to brain | Second Primary Cancer

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0220650
    UMLS CUI [2]
    C0751623
    concurrent administration of any other tumor therapy.
    Description

    cancer treatment

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0920425
    history of significant neurological or mental disorder, including seizures or dementia; or any other serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study
    Description

    nervous system disorder Significant | Mental disorders Significant | Seizures | Dementia | Comorbidity Serious Affecting patient safety | Comorbidity Serious Compliance behavior Limited

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0027765
    UMLS CUI [1,2]
    C0750502
    UMLS CUI [2,1]
    C0004936
    UMLS CUI [2,2]
    C0750502
    UMLS CUI [3]
    C0036572
    UMLS CUI [4]
    C0497327
    UMLS CUI [5,1]
    C0009488
    UMLS CUI [5,2]
    C0205404
    UMLS CUI [5,3]
    C0392760
    UMLS CUI [5,4]
    C1113679
    UMLS CUI [6,1]
    C0009488
    UMLS CUI [6,2]
    C0205404
    UMLS CUI [6,3]
    C1321605
    UMLS CUI [6,4]
    C0439801
    inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (nsaids) 2 days before, the day of, and 2 days after the dose of pemetrexed.
    Description

    Aspirin Interrupt Unable | Anti-Inflammatory Agents, Non-Steroidal Interrupt Unable | pemetrexed Dose

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0004057
    UMLS CUI [1,2]
    C0443239
    UMLS CUI [1,3]
    C1299582
    UMLS CUI [2,1]
    C0003211
    UMLS CUI [2,2]
    C0443239
    UMLS CUI [2,3]
    C1299582
    UMLS CUI [3,1]
    C0210657
    UMLS CUI [3,2]
    C0178602
    inability or unwillingness to take folic acid, vitamin b12 supplementation, or dexamethasone
    Description

    Folic Acid Intake Unwilling | Vitamin B12 supplement Intake Unwilling | Dexamethasone Intake Unwilling

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0016410
    UMLS CUI [1,2]
    C1512806
    UMLS CUI [1,3]
    C0558080
    UMLS CUI [2,1]
    C3661610
    UMLS CUI [2,2]
    C1512806
    UMLS CUI [2,3]
    C0558080
    UMLS CUI [3,1]
    C0011777
    UMLS CUI [3,2]
    C1512806
    UMLS CUI [3,3]
    C0558080

    Similar models

    Eligibility Carcinoma, Non-Small Cell Lung NCT00190840

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Non-Small Cell Lung Carcinoma
    Item
    diagnosis of nsclc
    boolean
    C0007131 (UMLS CUI [1])
    Locally Advanced Malignant Neoplasm | Metastatic Neoplasm | TNM clinical staging
    Item
    locally advanced or metastatic disease (stage iiib or iv).
    boolean
    C0677984 (UMLS CUI [1])
    C2939420 (UMLS CUI [2])
    C3258246 (UMLS CUI [3])
    Chemotherapy Palliative procedure Locally Advanced Malignant Neoplasm | Chemotherapy Palliative procedure Metastatic Neoplasm
    Item
    patients must have previously received one chemotherapy regimen for palliative therapy of locally advanced or metastatic disease.
    boolean
    C0392920 (UMLS CUI [1,1])
    C1285158 (UMLS CUI [1,2])
    C0677984 (UMLS CUI [1,3])
    C0392920 (UMLS CUI [2,1])
    C1285158 (UMLS CUI [2,2])
    C2939420 (UMLS CUI [2,3])
    Measurable Disease
    Item
    disease status must be that of measurable disease as defined by recist criteria
    boolean
    C1513041 (UMLS CUI [1])
    ECOG performance status | organ function
    Item
    performance status of 0 to 1 on the eastern cooperative oncology group (ecog) scale; and adequate organ function.
    boolean
    C1520224 (UMLS CUI [1])
    C0678852 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Metastatic malignant neoplasm to brain | Second Primary Cancer
    Item
    known or suspected brain metastasis, or second primary malignancy that is clinically detectable at the time of consideration for study enrollment
    boolean
    C0220650 (UMLS CUI [1])
    C0751623 (UMLS CUI [2])
    cancer treatment
    Item
    concurrent administration of any other tumor therapy.
    boolean
    C0920425 (UMLS CUI [1])
    nervous system disorder Significant | Mental disorders Significant | Seizures | Dementia | Comorbidity Serious Affecting patient safety | Comorbidity Serious Compliance behavior Limited
    Item
    history of significant neurological or mental disorder, including seizures or dementia; or any other serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study
    boolean
    C0027765 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    C0004936 (UMLS CUI [2,1])
    C0750502 (UMLS CUI [2,2])
    C0036572 (UMLS CUI [3])
    C0497327 (UMLS CUI [4])
    C0009488 (UMLS CUI [5,1])
    C0205404 (UMLS CUI [5,2])
    C0392760 (UMLS CUI [5,3])
    C1113679 (UMLS CUI [5,4])
    C0009488 (UMLS CUI [6,1])
    C0205404 (UMLS CUI [6,2])
    C1321605 (UMLS CUI [6,3])
    C0439801 (UMLS CUI [6,4])
    Aspirin Interrupt Unable | Anti-Inflammatory Agents, Non-Steroidal Interrupt Unable | pemetrexed Dose
    Item
    inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (nsaids) 2 days before, the day of, and 2 days after the dose of pemetrexed.
    boolean
    C0004057 (UMLS CUI [1,1])
    C0443239 (UMLS CUI [1,2])
    C1299582 (UMLS CUI [1,3])
    C0003211 (UMLS CUI [2,1])
    C0443239 (UMLS CUI [2,2])
    C1299582 (UMLS CUI [2,3])
    C0210657 (UMLS CUI [3,1])
    C0178602 (UMLS CUI [3,2])
    Folic Acid Intake Unwilling | Vitamin B12 supplement Intake Unwilling | Dexamethasone Intake Unwilling
    Item
    inability or unwillingness to take folic acid, vitamin b12 supplementation, or dexamethasone
    boolean
    C0016410 (UMLS CUI [1,1])
    C1512806 (UMLS CUI [1,2])
    C0558080 (UMLS CUI [1,3])
    C3661610 (UMLS CUI [2,1])
    C1512806 (UMLS CUI [2,2])
    C0558080 (UMLS CUI [2,3])
    C0011777 (UMLS CUI [3,1])
    C1512806 (UMLS CUI [3,2])
    C0558080 (UMLS CUI [3,3])

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