ID

16326

Descrição

Gemcitabine + Carboplatin in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00450762

Link

https://clinicaltrials.gov/show/NCT00450762

Palavras-chave

  1. 11/07/2016 11/07/2016 -
Transferido a

11 de julho de 2016

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0

Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Comentários do grupo de itens para :

Comentários do item para :


    Sem comentários

    Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

    Eligibility Breast Cancer NCT00450762

    Eligibility Breast Cancer NCT00450762

    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    histologically confirmed metastatic breast cancer
    Descrição

    metastatic breast cancer

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0278488
    all patients were required to give written informed consent.
    Descrição

    informed consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    prior treatment with chemotherapy, hormonal therapy, immunotherapy or local radiotherapy was allowed (except gemcitabine or platinum agents).
    Descrição

    Previous treatment

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2114510
    patients were required to have at least one bidimensionally measurable lesion outside a previous radiation port.
    Descrição

    Measurable lesion outside a previous radiation port

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C1282506
    age ≥ 18 years
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    karnofsky performance status ≥ 70 %
    Descrição

    karnofsky performance status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0206065
    minimal life expectancy of 12 weeks
    Descrição

    Life expectancy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    adequate haematological, renal, cardiac and hepatic function:
    Descrição

    Organ function

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0678852
    1. leukocyte count ≥ 3.0 x 109/l
    Descrição

    leukocyte count

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023508
    2. absolute neutrophil count ≥ 2.0 x 109/l
    Descrição

    absolute neutrophil count

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0948762
    3. platelet count ≥ 100 x 109/l
    Descrição

    platelet count

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0005821
    4. haemoglobin ≥ 8 g/dl
    Descrição

    haemoglobin

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0518015
    5. total serum bilirubin ≤ 1.25 x upper limit of normal (uln) in presence of liver metastasis ≤ 3 x uln
    Descrição

    total serum bilirubin

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    UMLS CUI [2]
    C0494165
    6. transaminase (alt,ast) level ≤ 3 x uln in presence of liver metastasis ≤ 5 x uln
    Descrição

    transaminases

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0002594
    UMLS CUI [2]
    C0494165
    7. alkaline phosphatase level ≤ 2.5 x uln
    Descrição

    alkaline phosphatase level

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1272113
    8. creatinine clearance was required to exceed 60 ml/min.
    Descrição

    creatinine clearance

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0373595
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    prior treatment with gemcitabine or platinum agents
    Descrição

    Gemcitabine or platinum agents

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0045093
    UMLS CUI [2]
    C2266918
    inadequate creatinine clearance (< 60 ml/min)
    Descrição

    creatinine clearance

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0373595
    only bone metastases
    Descrição

    bone metastases

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0153690
    symptomatic brain metastases
    Descrição

    brain metastases

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0220650
    UMLS CUI [1,2]
    C0231220
    women who are pregnant, lactating or refuse effective contraception
    Descrição

    women who are pregnant, lactating or refuse effective contraception

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0425965
    UMLS CUI [2]
    C0549206
    UMLS CUI [3]
    C2828358
    secondary malignancy
    Descrição

    secondary malignancy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3266877
    history of another primary malignant disease other than in situ carcinoma of the uterine cervix or adequately treated basal cell skin cancer
    Descrição

    another primary malignant disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0751623
    active infection
    Descrição

    active infection

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0205177
    any other concomitant severe clinical condition making implementation of the protocol including pre-hydration difficult.
    Descrição

    comorbidity

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0205082

    Similar models

    Eligibility Breast Cancer NCT00450762

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    metastatic breast cancer
    Item
    histologically confirmed metastatic breast cancer
    boolean
    C0278488 (UMLS CUI [1])
    informed consent
    Item
    all patients were required to give written informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Previous treatment
    Item
    prior treatment with chemotherapy, hormonal therapy, immunotherapy or local radiotherapy was allowed (except gemcitabine or platinum agents).
    boolean
    C2114510 (UMLS CUI [1])
    Measurable lesion outside a previous radiation port
    Item
    patients were required to have at least one bidimensionally measurable lesion outside a previous radiation port.
    boolean
    C1513041 (UMLS CUI [1,1])
    C1282506 (UMLS CUI [1,2])
    Age
    Item
    age ≥ 18 years
    boolean
    C0001779 (UMLS CUI [1])
    karnofsky performance status
    Item
    karnofsky performance status ≥ 70 %
    boolean
    C0206065 (UMLS CUI [1])
    Life expectancy
    Item
    minimal life expectancy of 12 weeks
    boolean
    C0023671 (UMLS CUI [1])
    Organ function
    Item
    adequate haematological, renal, cardiac and hepatic function:
    boolean
    C0678852 (UMLS CUI [1])
    leukocyte count
    Item
    1. leukocyte count ≥ 3.0 x 109/l
    boolean
    C0023508 (UMLS CUI [1])
    absolute neutrophil count
    Item
    2. absolute neutrophil count ≥ 2.0 x 109/l
    boolean
    C0948762 (UMLS CUI [1])
    platelet count
    Item
    3. platelet count ≥ 100 x 109/l
    boolean
    C0005821 (UMLS CUI [1])
    haemoglobin
    Item
    4. haemoglobin ≥ 8 g/dl
    boolean
    C0518015 (UMLS CUI [1])
    total serum bilirubin
    Item
    5. total serum bilirubin ≤ 1.25 x upper limit of normal (uln) in presence of liver metastasis ≤ 3 x uln
    boolean
    C1278039 (UMLS CUI [1])
    C0494165 (UMLS CUI [2])
    transaminases
    Item
    6. transaminase (alt,ast) level ≤ 3 x uln in presence of liver metastasis ≤ 5 x uln
    boolean
    C0002594 (UMLS CUI [1])
    C0494165 (UMLS CUI [2])
    alkaline phosphatase level
    Item
    7. alkaline phosphatase level ≤ 2.5 x uln
    boolean
    C1272113 (UMLS CUI [1])
    creatinine clearance
    Item
    8. creatinine clearance was required to exceed 60 ml/min.
    boolean
    C0373595 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Gemcitabine or platinum agents
    Item
    prior treatment with gemcitabine or platinum agents
    boolean
    C0045093 (UMLS CUI [1])
    C2266918 (UMLS CUI [2])
    creatinine clearance
    Item
    inadequate creatinine clearance (< 60 ml/min)
    boolean
    C0373595 (UMLS CUI [1])
    bone metastases
    Item
    only bone metastases
    boolean
    C0153690 (UMLS CUI [1])
    brain metastases
    Item
    symptomatic brain metastases
    boolean
    C0220650 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    women who are pregnant, lactating or refuse effective contraception
    Item
    women who are pregnant, lactating or refuse effective contraception
    boolean
    C0425965 (UMLS CUI [1])
    C0549206 (UMLS CUI [2])
    C2828358 (UMLS CUI [3])
    secondary malignancy
    Item
    secondary malignancy
    boolean
    C3266877 (UMLS CUI [1])
    another primary malignant disease
    Item
    history of another primary malignant disease other than in situ carcinoma of the uterine cervix or adequately treated basal cell skin cancer
    boolean
    C0751623 (UMLS CUI [1])
    active infection
    Item
    active infection
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205177 (UMLS CUI [1,2])
    comorbidity
    Item
    any other concomitant severe clinical condition making implementation of the protocol including pre-hydration difficult.
    boolean
    C0009488 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial