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ID

12835

Descrizione

A Prospective, Randomized, Phase III Trial of FLAC (5-Fluorouracil, Leucovorin, Adriamycin, Cytoxan) Chemotherapy With GM-CSF (Granulocyte-Macrophage Colony-Stimulating Factor) Versus PIXY 321 in Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00001338

collegamento

https://clinicaltrials.gov/show/NCT00001338

Keywords

versioni (1)
  1. 29/12/15 29/12/15 -
Caricato su

29 dicembre 2015

DOI

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Licenza

Creative Commons BY 4.0
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    Eligibility Breast Neoplasms NCT00001338

    Inglese

    Eligibility Breast Neoplasms NCT00001338

    1 moduli  
    Criteria
    Descrizione

    Criteria

    patients who have had prior radiation therapy providing there was not more than 20% of the bone marrow has been irradiated.
    Descrizione

    patients who have had prior radiation therapy providing there was not more than 20% of the bone marrow has been irradiated.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1522449
    patients who have received less than or equal to 360mg/m2 of adriamycin as adjuvant therapy.
    Descrizione

    patients who have received less than or equal to 360mg/m2 of adriamycin as adjuvant therapy.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0677850
    UMLS CUI [1,2]
    C0085752
    patients must be previously untreated with chemotherapy for metastatic disease.
    Descrizione

    patients must be previously untreated with chemotherapy for metastatic disease.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C0027627
    there must be no history of previous malignancy except for cured non-melanoma skin cancer (basal or squamous cell carcinoma), cervical cancer in situ, or a past malignancy that has been inactive for over 5 years.
    Descrizione

    there must be no history of previous malignancy except for cured non-melanoma skin cancer (basal or squamous cell carcinoma), cervical cancer in situ, or a past malignancy that has been inactive for over 5 years.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    performance status (karnofsky scale) must be greater than 70; ecog 0-2.
    Descrizione

    performance status (karnofsky scale) must be greater than 70; ecog 0-2.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    absolute granulocyte count greater than 1500 microliters and platelet count greater than 100,000/mm3.
    Descrizione

    absolute granulocyte count greater than 1500 microliters and platelet count greater than 100,000/mm3.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0857490
    UMLS CUI [2]
    C0005821
    liver function tests (sgot, and total bilirubin) should be less than 2x the upper limits of normal unless there is evidence of hepatic involvement with tumor. serum creatinine should be less than 1.7 or creatinine clearance should be greater than 45 ml/min.
    Descrizione

    liver function tests (sgot, and total bilirubin) should be less than 2x the upper limits of normal unless there is evidence of hepatic involvement with tumor. serum creatinine should be less than 1.7 or creatinine clearance should be greater than 45 ml/min.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0004002
    UMLS CUI [2]
    C1278039
    UMLS CUI [3]
    C0201976
    UMLS CUI [4]
    C0373595
    patients must be greater than or equal to 18 years of age.
    Descrizione

    patients must be greater than or equal to 18 years of age.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    the patient must be able to give informed consent, and to return to nci for treatment and adequate follow-up for the period the protocol requires.
    Descrizione

    the patient must be able to give informed consent, and to return to nci for treatment and adequate follow-up for the period the protocol requires.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2,1]
    C0814423
    UMLS CUI [2,2]
    C1522577
    no patients who are poor medical or psychiatric risks because of nonmalignant systemic disease which would preclude them from being subjected to any treatments in this protocol.
    Descrizione

    no patients who are poor medical or psychiatric risks because of nonmalignant systemic disease which would preclude them from being subjected to any treatments in this protocol.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    patients should not currently require therapy for cardiac arrhythmias, congestive heart failure, or coronary artery disease. patients who have received prior adriamycin or have any history of cardiac disease must have a lvef greater than 45 percent by muga.
    Descrizione

    patients should not currently require therapy for cardiac arrhythmias, congestive heart failure, or coronary artery disease. patients who have received prior adriamycin or have any history of cardiac disease must have a lvef greater than 45 percent by muga.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0003811
    UMLS CUI [2]
    C0018802
    UMLS CUI [3]
    C1956346
    UMLS CUI [4]
    C0428772
    no history of cns metastasis, or know seizure disorder.
    Descrizione

    no history of cns metastasis, or know seizure disorder.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0686377
    UMLS CUI [2]
    C0014544
    no allergy to any study medication.
    Descrizione

    no allergy to any study medication.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013227
    no pregnant or lactating women.
    Descrizione

    no pregnant or lactating women.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0006147
    no patients requiring ongoing therapy for asthma.
    Descrizione

    no patients requiring ongoing therapy for asthma.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0004096
    no patients with bleeding disorders for study entry as are patients requiring chronic anticoagulation.
    Descrizione

    no patients with bleeding disorders for study entry as are patients requiring chronic anticoagulation.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C3251812
    no patients with active infection or are known to be hiv positive.
    Descrizione

    no patients with active infection or are known to be hiv positive.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    UMLS CUI [2]
    C0019682
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    Similar models

    Eligibility Breast Neoplasms NCT00001338

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    radiation therapy
    Item
    patients who have had prior radiation therapy providing there was not more than 20% of the bone marrow has been irradiated.
    boolean
    C1522449 (UMLS CUI [1])
    adjuvant therapy
    Item
    patients who have received less than or equal to 360mg/m2 of adriamycin as adjuvant therapy.
    boolean
    C0677850 (UMLS CUI [1,1])
    C0085752 (UMLS CUI [1,2])
    chemotherapy for metastatic disease
    Item
    patients must be previously untreated with chemotherapy for metastatic disease.
    boolean
    C0392920 (UMLS CUI [1,1])
    C0027627 (UMLS CUI [1,2])
    previous malignancy
    Item
    there must be no history of previous malignancy except for cured non-melanoma skin cancer (basal or squamous cell carcinoma), cervical cancer in situ, or a past malignancy that has been inactive for over 5 years.
    boolean
    C0006826 (UMLS CUI [1])
    performance status
    Item
    performance status (karnofsky scale) must be greater than 70; ecog 0-2.
    boolean
    C1520224 (UMLS CUI [1])
    blood results
    Item
    absolute granulocyte count greater than 1500 microliters and platelet count greater than 100,000/mm3.
    boolean
    C0857490 (UMLS CUI [1])
    C0005821 (UMLS CUI [2])
    liver function tests
    Item
    liver function tests (sgot, and total bilirubin) should be less than 2x the upper limits of normal unless there is evidence of hepatic involvement with tumor. serum creatinine should be less than 1.7 or creatinine clearance should be greater than 45 ml/min.
    boolean
    C0004002 (UMLS CUI [1])
    C1278039 (UMLS CUI [2])
    C0201976 (UMLS CUI [3])
    C0373595 (UMLS CUI [4])
    age
    Item
    patients must be greater than or equal to 18 years of age.
    boolean
    C0001779 (UMLS CUI [1])
    informed consent
    Item
    the patient must be able to give informed consent, and to return to nci for treatment and adequate follow-up for the period the protocol requires.
    boolean
    C0021430 (UMLS CUI [1])
    C0814423 (UMLS CUI [2,1])
    C1522577 (UMLS CUI [2,2])
    poor medical or psychiatric risks
    Item
    no patients who are poor medical or psychiatric risks because of nonmalignant systemic disease which would preclude them from being subjected to any treatments in this protocol.
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    cardiac function
    Item
    patients should not currently require therapy for cardiac arrhythmias, congestive heart failure, or coronary artery disease. patients who have received prior adriamycin or have any history of cardiac disease must have a lvef greater than 45 percent by muga.
    boolean
    C0003811 (UMLS CUI [1])
    C0018802 (UMLS CUI [2])
    C1956346 (UMLS CUI [3])
    C0428772 (UMLS CUI [4])
    CNS metastases
    Item
    no history of cns metastasis, or know seizure disorder.
    boolean
    C0686377 (UMLS CUI [1])
    C0014544 (UMLS CUI [2])
    allergy to study medication
    Item
    no allergy to any study medication.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    pregnancy
    Item
    no pregnant or lactating women.
    boolean
    C0032961 (UMLS CUI [1,1])
    C0006147 (UMLS CUI [1,2])
    asthma therapy
    Item
    no patients requiring ongoing therapy for asthma.
    boolean
    C0087111 (UMLS CUI [1,1])
    C0004096 (UMLS CUI [1,2])
    bleeding disorders
    Item
    no patients with bleeding disorders for study entry as are patients requiring chronic anticoagulation.
    boolean
    C3251812 (UMLS CUI [1])
    active infection
    Item
    no patients with active infection or are known to be hiv positive.
    boolean
    C0009450 (UMLS CUI [1])
    C0019682 (UMLS CUI [2])
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