0 Bedömningar

ID

16252

Beskrivning

Three Doses of TAS-108 to Treat Recurrent or Recurrent Inoperable Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00166543

Länk

https://clinicaltrials.gov/show/NCT00166543

Nyckelord

  1. 2016-07-07 2016-07-07 -
Uppladdad den

7 juli 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Breast Cancer NCT00166543

    Eligibility Breast Cancer NCT00166543

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    postmenopausal females
    Beskrivning

    Postmenopausal state

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0232970
    histologically or cytologically confirmed diagnosis of breast carcinoma
    Beskrivning

    Breast Carcinoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0678222
    locally advanced or locally recurrent inoperable or metastatic breast carcinoma with documented disease progression
    Beskrivning

    Locally advanced breast cancer | Breast cancer recurrent Locally Inoperable | Carcinoma breast stage IV | Disease Progression

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3495949
    UMLS CUI [2,1]
    C0278493
    UMLS CUI [2,2]
    C1517927
    UMLS CUI [2,3]
    C0205187
    UMLS CUI [3]
    C0278488
    UMLS CUI [4]
    C0242656
    has laboratory documentation of positive estrogen receptor (er) and/or progesterone receptor (pgr) status, and has responded to the standard first or second line hormonal anti-tumor therapy given
    Beskrivning

    Estrogen Receptor and/or Progesterone Receptor Positive | Response to Cancer hormonal therapy First line | Response to Cancer hormonal therapy Second line

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3640067
    UMLS CUI [2,1]
    C0521982
    UMLS CUI [2,2]
    C0877050
    UMLS CUI [2,3]
    C1708063
    UMLS CUI [3,1]
    C0521982
    UMLS CUI [3,2]
    C0877050
    UMLS CUI [3,3]
    C1710038
    has received and whose disease progressed after one or two prior systemic hormonal anti-tumor therapies
    Beskrivning

    Cancer hormonal therapy Systemic | Disease Progression

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0877050
    UMLS CUI [1,2]
    C0205373
    UMLS CUI [2]
    C0242656
    performance status of greater than or equal to 2 on the zubrod scale
    Beskrivning

    Zubrod Performance Status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3714786
    predicted life expectancy of greater than or equal to 12 weeks
    Beskrivning

    Life Expectancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    must give written informed consent
    Beskrivning

    Informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    measurable disease according to the response evaluation criteria in solid tumors (recist) criteria
    Beskrivning

    Measurable Disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    absolute granulocyte count of greater than 1,500/meql, platelet count greater than 75,000/meql, and a hemoglobin of greater than 10 g/dl
    Beskrivning

    Absolute neutrophil count | Platelet Count measurement | Hemoglobin

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0948762
    UMLS CUI [2]
    C0032181
    UMLS CUI [3]
    C0019046
    adequate liver and renal function as defined by a bilirubin of less than 1.5 times the upper limit of normal and a creatinine of less than 1.5 times the upper limit of normal
    Beskrivning

    Liver function | Renal function | Serum total bilirubin measurement | Creatinine measurement, serum

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C0232804
    UMLS CUI [3]
    C1278039
    UMLS CUI [4]
    C0201976
    transaminases must be less than 2.5 times the upper limit of normal except for patients with liver metastases who may have transaminases less than 5 times the upper limit of normal.
    Beskrivning

    Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201836
    UMLS CUI [2]
    C0201899
    UMLS CUI [3]
    C0494165
    the patient has recovered from all previous anti-cancer treatment related to toxicities to at least grade 1.
    Beskrivning

    cancer treatment Due to Toxicities | Patient recovered

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0920425
    UMLS CUI [1,2]
    C0678226
    UMLS CUI [1,3]
    C0600688
    UMLS CUI [2]
    C1115804
    all previous investigational drugs must be stopped at least four weeks before commencement of treatment with tas-108.
    Beskrivning

    Investigational New Drugs Previous Stop | TS 108 Start

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013230
    UMLS CUI [1,2]
    C0205156
    UMLS CUI [1,3]
    C0850893
    UMLS CUI [2,1]
    C1435232
    UMLS CUI [2,2]
    C0439659

    Similar models

    Eligibility Breast Cancer NCT00166543

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Postmenopausal state
    Item
    postmenopausal females
    boolean
    C0232970 (UMLS CUI [1])
    Breast Carcinoma
    Item
    histologically or cytologically confirmed diagnosis of breast carcinoma
    boolean
    C0678222 (UMLS CUI [1])
    Locally advanced breast cancer | Breast cancer recurrent Locally Inoperable | Carcinoma breast stage IV | Disease Progression
    Item
    locally advanced or locally recurrent inoperable or metastatic breast carcinoma with documented disease progression
    boolean
    C3495949 (UMLS CUI [1])
    C0278493 (UMLS CUI [2,1])
    C1517927 (UMLS CUI [2,2])
    C0205187 (UMLS CUI [2,3])
    C0278488 (UMLS CUI [3])
    C0242656 (UMLS CUI [4])
    Estrogen Receptor and/or Progesterone Receptor Positive | Response to Cancer hormonal therapy First line | Response to Cancer hormonal therapy Second line
    Item
    has laboratory documentation of positive estrogen receptor (er) and/or progesterone receptor (pgr) status, and has responded to the standard first or second line hormonal anti-tumor therapy given
    boolean
    C3640067 (UMLS CUI [1])
    C0521982 (UMLS CUI [2,1])
    C0877050 (UMLS CUI [2,2])
    C1708063 (UMLS CUI [2,3])
    C0521982 (UMLS CUI [3,1])
    C0877050 (UMLS CUI [3,2])
    C1710038 (UMLS CUI [3,3])
    Cancer hormonal therapy Systemic | Disease Progression
    Item
    has received and whose disease progressed after one or two prior systemic hormonal anti-tumor therapies
    boolean
    C0877050 (UMLS CUI [1,1])
    C0205373 (UMLS CUI [1,2])
    C0242656 (UMLS CUI [2])
    Zubrod Performance Status
    Item
    performance status of greater than or equal to 2 on the zubrod scale
    boolean
    C3714786 (UMLS CUI [1])
    Life Expectancy
    Item
    predicted life expectancy of greater than or equal to 12 weeks
    boolean
    C0023671 (UMLS CUI [1])
    Informed consent
    Item
    must give written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Measurable Disease
    Item
    measurable disease according to the response evaluation criteria in solid tumors (recist) criteria
    boolean
    C1513041 (UMLS CUI [1])
    Absolute neutrophil count | Platelet Count measurement | Hemoglobin
    Item
    absolute granulocyte count of greater than 1,500/meql, platelet count greater than 75,000/meql, and a hemoglobin of greater than 10 g/dl
    boolean
    C0948762 (UMLS CUI [1])
    C0032181 (UMLS CUI [2])
    C0019046 (UMLS CUI [3])
    Liver function | Renal function | Serum total bilirubin measurement | Creatinine measurement, serum
    Item
    adequate liver and renal function as defined by a bilirubin of less than 1.5 times the upper limit of normal and a creatinine of less than 1.5 times the upper limit of normal
    boolean
    C0232741 (UMLS CUI [1])
    C0232804 (UMLS CUI [2])
    C1278039 (UMLS CUI [3])
    C0201976 (UMLS CUI [4])
    Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver
    Item
    transaminases must be less than 2.5 times the upper limit of normal except for patients with liver metastases who may have transaminases less than 5 times the upper limit of normal.
    boolean
    C0201836 (UMLS CUI [1])
    C0201899 (UMLS CUI [2])
    C0494165 (UMLS CUI [3])
    cancer treatment Due to Toxicities | Patient recovered
    Item
    the patient has recovered from all previous anti-cancer treatment related to toxicities to at least grade 1.
    boolean
    C0920425 (UMLS CUI [1,1])
    C0678226 (UMLS CUI [1,2])
    C0600688 (UMLS CUI [1,3])
    C1115804 (UMLS CUI [2])
    Investigational New Drugs Previous Stop | TS 108 Start
    Item
    all previous investigational drugs must be stopped at least four weeks before commencement of treatment with tas-108.
    boolean
    C0013230 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    C0850893 (UMLS CUI [1,3])
    C1435232 (UMLS CUI [2,1])
    C0439659 (UMLS CUI [2,2])

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