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ID

31689

Beschrijving

Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01271439 Collaborating Parties: Zhejiang Cancer Hospital Wenzhou Medical University The First Affiliate Hospital of Guangxi Medical College Xijing Hospital Hunan Cancer Hospital Jiangxi Provincial Cancer Hospital Wuhan Union Hospital, China Wuhan University Hubei Cancer Hospital Tongji University Cancer Hospital of Shantou University Shenzhen People's Hospital First People's Hospital of Foshan

Link

https://clinicaltrials.gov/show/NCT01271439

Trefwoorden

  1. 2018-09-16 2018-09-16 -
  2. 2018-09-21 2018-09-21 -
Houder van rechten

Sun Yat-sen University

Geüploaded op

21 september 2018

DOI

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Licentie

Creative Commons BY-NC 3.0

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    Eligibility Nasopharyngeal Carcinoma NCT01271439

    Eligibility Nasopharyngeal Carcinoma NCT01271439

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    histologic diagnosis of nasopharyngeal carcinoma
    Beschrijving

    Histological Diagnosis of nasopharyngeal carcinoma

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C2931822
    UMLS CUI [1,2]
    C0679557
    range from 18~69 years old
    Beschrijving

    Age group

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    t3-4,n0-2,m0 (ajcc 2009)
    Beschrijving

    TNM Stage

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0441915
    kps ≥ 80
    Beschrijving

    KPS Score

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0206065
    nonmetastatic diseases
    Beschrijving

    Nonmetastatic diseases

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0445092
    wbc count ≥ 4×10^9/l,hemoglobin ≥ 100g/l, platelet count ≥ 100×10^9/l
    Beschrijving

    WBC, hemoglobin and platelet count

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0023508
    UMLS CUI [2]
    C0518015
    UMLS CUI [3]
    C0032181
    alt or ast < 1.5×uln, bilirubin < 1.5×uln
    Beschrijving

    Alt, ast and bilirubin

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0201836
    UMLS CUI [2]
    C0201899
    UMLS CUI [3]
    C1278039
    serum creatinine < 1.5×uln
    Beschrijving

    Creatinine

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    distan metastases
    Beschrijving

    Distant metastases

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1302548
    previously treated (surgery,chemotherapy, radiation therapy,egfr targeted therapy or immunotherapy)
    Beschrijving

    Cancer previously treated with chemotherapy, surgery, immunotherapy, radiotherapy and/or egfr targeted therapy

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C2114510
    UMLS CUI [1,2]
    C0543467
    UMLS CUI [2]
    C1514457
    UMLS CUI [3]
    C1514461
    UMLS CUI [4,1]
    C2114510
    UMLS CUI [4,2]
    C1522449
    UMLS CUI [5,1]
    C2114510
    UMLS CUI [5,2]
    C1739039
    UMLS CUI [5,3]
    C2985566
    second malignancy within 5 years
    Beschrijving

    Previous malignancy

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0006826
    previous therapy with an investigational agent
    Beschrijving

    Previous therapy with investigational agent

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C2114510
    UMLS CUI [1,2]
    C1521826
    uncontrolled seizure disorder or other serious neurologic disease
    Beschrijving

    Uncontrolled seizure or serious neurologic disease

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0036572
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2,1]
    C0027765
    UMLS CUI [2,2]
    C0205082
    ≥ grade ш allergic reaction to any drug including in this study
    Beschrijving

    Allergy to drugs in the study

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0205082
    clinically significant cardiac or respiratory disease
    Beschrijving

    Cardiac or respiratory comorbidity

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0018799
    UMLS CUI [2]
    C0024115
    creatinine clearance < 30ml/min
    Beschrijving

    Creatinine clearance

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0373595
    drug or alcohol addition
    Beschrijving

    Substance abuse

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    do not have full capacity for civil acts
    Beschrijving

    Capacity for civil acts

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0683673
    UMLS CUI [1,2]
    C0332268
    severe complication, active infection
    Beschrijving

    Active infection or severe complication

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    UMLS CUI [2]
    C3495031
    concurrent immunotherapy or hormone therapy for other diseases
    Beschrijving

    Concomitant immunotherapy or hormone therapy

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0021083
    UMLS CUI [2,1]
    C2347852
    UMLS CUI [2,2]
    C0279025
    pregnancy or lactation
    Beschrijving

    Pregnancy or lactation

    Datatype

    boolean

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

    Similar models

    Eligibility Nasopharyngeal Carcinoma NCT01271439

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Histological Diagnosis of nasopharyngeal carcinoma
    Item
    histologic diagnosis of nasopharyngeal carcinoma
    boolean
    C2931822 (UMLS CUI [1,1])
    C0679557 (UMLS CUI [1,2])
    Age group
    Item
    range from 18~69 years old
    boolean
    C0001779 (UMLS CUI [1])
    TNM Stage
    Item
    t3-4,n0-2,m0 (ajcc 2009)
    boolean
    C0441915 (UMLS CUI [1])
    KPS Score
    Item
    kps ≥ 80
    boolean
    C0206065 (UMLS CUI [1])
    Nonmetastatic diseases
    Item
    nonmetastatic diseases
    boolean
    C0445092 (UMLS CUI [1])
    WBC, hemoglobin and platelet count
    Item
    wbc count ≥ 4×10^9/l,hemoglobin ≥ 100g/l, platelet count ≥ 100×10^9/l
    boolean
    C0023508 (UMLS CUI [1])
    C0518015 (UMLS CUI [2])
    C0032181 (UMLS CUI [3])
    Alt, ast and bilirubin
    Item
    alt or ast < 1.5×uln, bilirubin < 1.5×uln
    boolean
    C0201836 (UMLS CUI [1])
    C0201899 (UMLS CUI [2])
    C1278039 (UMLS CUI [3])
    Creatinine
    Item
    serum creatinine < 1.5×uln
    boolean
    C0201976 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Distant metastases
    Item
    distan metastases
    boolean
    C1302548 (UMLS CUI [1])
    Cancer previously treated with chemotherapy, surgery, immunotherapy, radiotherapy and/or egfr targeted therapy
    Item
    previously treated (surgery,chemotherapy, radiation therapy,egfr targeted therapy or immunotherapy)
    boolean
    C2114510 (UMLS CUI [1,1])
    C0543467 (UMLS CUI [1,2])
    C1514457 (UMLS CUI [2])
    C1514461 (UMLS CUI [3])
    C2114510 (UMLS CUI [4,1])
    C1522449 (UMLS CUI [4,2])
    C2114510 (UMLS CUI [5,1])
    C1739039 (UMLS CUI [5,2])
    C2985566 (UMLS CUI [5,3])
    Previous malignancy
    Item
    second malignancy within 5 years
    boolean
    C0262926 (UMLS CUI [1,1])
    C0006826 (UMLS CUI [1,2])
    Previous therapy with investigational agent
    Item
    previous therapy with an investigational agent
    boolean
    C2114510 (UMLS CUI [1,1])
    C1521826 (UMLS CUI [1,2])
    Uncontrolled seizure or serious neurologic disease
    Item
    uncontrolled seizure disorder or other serious neurologic disease
    boolean
    C0036572 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0027765 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    Allergy to drugs in the study
    Item
    ≥ grade ш allergic reaction to any drug including in this study
    boolean
    C0020517 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0205082 (UMLS CUI [1,3])
    Cardiac or respiratory comorbidity
    Item
    clinically significant cardiac or respiratory disease
    boolean
    C0018799 (UMLS CUI [1])
    C0024115 (UMLS CUI [2])
    Creatinine clearance
    Item
    creatinine clearance < 30ml/min
    boolean
    C0373595 (UMLS CUI [1])
    Substance abuse
    Item
    drug or alcohol addition
    boolean
    C0038586 (UMLS CUI [1])
    Capacity for civil acts
    Item
    do not have full capacity for civil acts
    boolean
    C0683673 (UMLS CUI [1,1])
    C0332268 (UMLS CUI [1,2])
    Active infection or severe complication
    Item
    severe complication, active infection
    boolean
    C0009450 (UMLS CUI [1])
    C3495031 (UMLS CUI [2])
    Concomitant immunotherapy or hormone therapy
    Item
    concurrent immunotherapy or hormone therapy for other diseases
    boolean
    C2347852 (UMLS CUI [1,1])
    C0021083 (UMLS CUI [1,2])
    C2347852 (UMLS CUI [2,1])
    C0279025 (UMLS CUI [2,2])
    Pregnancy or lactation
    Item
    pregnancy or lactation
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])

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