0 Evaluaciones
ID

12935

Descripción

Primary Chemotherapy With Docetaxel-Capecitabine and Doxorubicin-Cyclophosphamide in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00005908

Link

https://clinicaltrials.gov/show/NCT00005908

Palabras clave

Versiones (1)
  1. 6/1/16 6/1/16 -
Subido en

6 de enero de 2016

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility Breast Cancer NCT00005908

    Inglés

    Eligibility Breast Cancer NCT00005908

    1 formularios  
    Criteria
    Descripción

    Criteria

    stage ii or iii breast cancer with a tumor size of greater than 2 cm. patients with a previous biopsy are eligible provided adequate tumor tissue remains for biopsy in this study.
    Descripción

    breast cancer stage

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0678222
    UMLS CUI [1,2]
    C0027646
    UMLS CUI [2]
    C0005558
    at least 18 years of age.
    Descripción

    age

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    adequate hematopoietic function as defined by absolute neutrophil count greater than 1200/mm^3 and platelet count greater than 100,000/mm^3.
    Descripción

    Hematopoiesis

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0200633
    UMLS CUI [2]
    C0032181
    adequate renal function as defined by creatinine less than 1.6 mg/dl.
    Descripción

    creatinine

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    adequate hepatic function as defined by total (t.) bilirubin less than 1.4 mg/dl and serum glutamic oxaloacetic transaminase (sgot)/serum glutamic pyruvic transaminase (sgpt) less than 1.5 times the upper limit of normal and alkaline phosphatase less than 2.5 times upper limit of normal
    Descripción

    liver function

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0201899
    UMLS CUI [2]
    C0201836
    UMLS CUI [3]
    C1278039
    UMLS CUI [4]
    C0201850
    zubrod performance status 0-2.
    Descripción

    zubrod

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1518965
    UMLS CUI [1,2]
    C0449820
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    medical or psychiatric condition that, in the opinion of the principal investigator, would preclude chemotherapy administration. patients may be evaluated by psychiatry or medical subspecialties as appropriate.
    Descripción

    comorbidity

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    pregnant or lactating women
    Descripción

    pregnancy, lactating

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C2828358
    known bleeding disorders
    Descripción

    bleeding disorders

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0005779
    hypersensitivity to tween 80 (polysorbate)
    Descripción

    hypersensitivity

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0041417
    cardiac ejection fraction below normal limits, myocardial infarction within the past 12 months, or symptomatic arrhythmia requiring medical intervention.
    Descripción

    heart disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0018799
    prior chemotherapy or hormonal therapy for breast cancer. patients treated with hormonal chemoprevention (tamoxifen or raloxifene) will be eligible.
    Descripción

    chemotherapy, hormone therapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C0279025
    active malignancy diagnosed within the last 5 years. (cervical cancer or non-melanomatous skin cancer that has been treated with curative intent will be eligible).
    Descripción

    malignancy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0006826
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    Similar models

    Eligibility Breast Cancer NCT00005908

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    breast cancer stage
    Item
    stage ii or iii breast cancer with a tumor size of greater than 2 cm. patients with a previous biopsy are eligible provided adequate tumor tissue remains for biopsy in this study.
    boolean
    C0678222 (UMLS CUI [1,1])
    C0027646 (UMLS CUI [1,2])
    C0005558 (UMLS CUI [2])
    age
    Item
    at least 18 years of age.
    boolean
    C0001779 (UMLS CUI [1])
    Hematopoiesis
    Item
    adequate hematopoietic function as defined by absolute neutrophil count greater than 1200/mm^3 and platelet count greater than 100,000/mm^3.
    boolean
    C0200633 (UMLS CUI [1])
    C0032181 (UMLS CUI [2])
    creatinine
    Item
    adequate renal function as defined by creatinine less than 1.6 mg/dl.
    boolean
    C0201976 (UMLS CUI [1])
    liver function
    Item
    adequate hepatic function as defined by total (t.) bilirubin less than 1.4 mg/dl and serum glutamic oxaloacetic transaminase (sgot)/serum glutamic pyruvic transaminase (sgpt) less than 1.5 times the upper limit of normal and alkaline phosphatase less than 2.5 times upper limit of normal
    boolean
    C0201899 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    C1278039 (UMLS CUI [3])
    C0201850 (UMLS CUI [4])
    zubrod
    Item
    zubrod performance status 0-2.
    boolean
    C1518965 (UMLS CUI [1,1])
    C0449820 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    comorbidity
    Item
    medical or psychiatric condition that, in the opinion of the principal investigator, would preclude chemotherapy administration. patients may be evaluated by psychiatry or medical subspecialties as appropriate.
    boolean
    C0009488 (UMLS CUI [1])
    pregnancy, lactating
    Item
    pregnant or lactating women
    boolean
    C0032961 (UMLS CUI [1])
    C2828358 (UMLS CUI [2])
    bleeding disorders
    Item
    known bleeding disorders
    boolean
    C0005779 (UMLS CUI [1])
    hypersensitivity
    Item
    hypersensitivity to tween 80 (polysorbate)
    boolean
    C0020517 (UMLS CUI [1,1])
    C0041417 (UMLS CUI [1,2])
    heart disease
    Item
    cardiac ejection fraction below normal limits, myocardial infarction within the past 12 months, or symptomatic arrhythmia requiring medical intervention.
    boolean
    C0018799 (UMLS CUI [1])
    chemotherapy, hormone therapy
    Item
    prior chemotherapy or hormonal therapy for breast cancer. patients treated with hormonal chemoprevention (tamoxifen or raloxifene) will be eligible.
    boolean
    C0392920 (UMLS CUI [1])
    C0279025 (UMLS CUI [2])
    malignancy
    Item
    active malignancy diagnosed within the last 5 years. (cervical cancer or non-melanomatous skin cancer that has been treated with curative intent will be eligible).
    boolean
    C0006826 (UMLS CUI [1])
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