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ID

13623

Description

Phase III Comparison of Adjuvant Chemotherapy W/High-Dose Cyclophosphamide Plus Doxorubicin (AC) vs Sequential Doxorubicin Fol by Cyclophosphamide (A-C) in High Risk Breast Cancer Patients With 0-3 Positive Nodes (Intergroup, CALGB 9394); ODM derived from: https://clinicaltrials.gov/show/NCT00590785

Lien

https://clinicaltrials.gov/show/NCT00590785

Mots-clés

Versions (1)
  1. 21/02/2016 21/02/2016 -
Téléchargé le

21 février 2016

DOI

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Licence

Creative Commons BY 4.0
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    Eligibility High Risk NCT00590785

    Anglais

    Eligibility High Risk NCT00590785

    1 Formulaires  
    1. StudyEvent: Eligibility
      1. Eligibility High Risk NCT00590785
    Criteria
    Description

    Criteria

    patients must have undergone an axillary dissection, and at least 6 nodes must have een removed and examined. nodal involvement by tumor must be negative or must not xceed three positive nodes.
    Description

    axillary dissection, lymph nodes

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0193867
    UMLS CUI [2]
    C0024204
    disease must be considered sufficiently high-risk by the investigator to justify the use of chemotherapy. to be eligible, disease must satisfy one of the following requirements:
    Description

    high-risk, chemotherapy indicated

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0684030
    UMLS CUI [2]
    C0392920
    1. tumor is both er negative and pgr negative and greater than 1.0 cm in greatest diameter. negative is defined as c 10 fmollmg cytosol protein if measured in these units; othennrise negative is defined according to institutional standards.
    Description

    er and pgr negative, tumor size

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2919271
    UMLS CUI [2]
    C2919590
    UMLS CUI [3]
    C0475440
    2. tumor that is greater than 2.0 cm in greatest diameter irrespective of hormone receptor status (including unknown).
    Description

    tumor size

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0475440
    3. tumor involves one to three axillary lymph nodes.
    Description

    Lymph node involvment

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    breast cancer was not locally advanced at diagnosis. this is left to investigator judgement, but generally should exclude patients with fixed tumors, fixed nodes, peau d'orange skin changes, skin ulcerations or inflammatory changes (t4 disease).
    Description

    tumor stage

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1300072
    patient is currently free of breast cancer (no evidence of disease). this is also left to investigator judgement, but generally should include no evidence of distant disease on chest x-ray or mgmmogram of the opposite breast prior to registration, within 3 months prior to surgery; and no gross or microscopically positive surgical margins noted in the final surgery or pathology reports. patients with synchronous bilateral breast cancer may be considered, provided both breasts are treated with curative intent and that eligibility is based on the side with the most adverse prognostic features.
    Description

    no evidence of breast cancer, criteria for bilateral breast cancer

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0678222
    UMLS CUI [1,2]
    C0687702
    UMLS CUI [2]
    C0281267
    registration must be within 84 days of mastectomy, or within 84 days of axillary dissection if the patient's most extensive breast surgery was a breast sparing procedure. patients not having mastectomy or breast sparing surgery are ineligible. patients must not have had prior chemotherapy for this breast cancer. patients must not have had systemic therapy of any type for a previous breast cancer.
    Description

    time since mastectomy and axillary dissection, breast sparing surgery required, prior (chemo)therapy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0011008
    UMLS CUI [2]
    C0024881
    UMLS CUI [3]
    C0193867
    UMLS CUI [4]
    C0917927
    UMLS CUI [5]
    C0392920
    UMLS CUI [6]
    C1514463
    patients must not have had external beam radiotherapy for this breast cancer prior to registration. brachytherapy (interstitial radiation therapy) at the time of breast sparing procedure is acceptable and would not render the patient ineligible. (if external beam radiotherapy is planned to be given with brachytherapy, it must be delayed until after chemotherapy is complete.) patients whose most extensive breast surgery was a breast sparing procedure must be planning to receive radiotherapy after chemotherapy is complete.
    Description

    prior radiotherapy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1522449
    UMLS CUI [2]
    C0419095
    UMLS CUI [3]
    C0006098
    UMLS CUI [4]
    C0917927
    patients must have adequate hematologic, hepatic, renal and cardiac function for high dose chemotherapy and adequate health for long-term follow-up. this must include normal wbc (2 4,0001pl). neutrophll count (2 1,50o/pl), platelet count (2 institutional lower limit of normal), and lvef (left ventricular ejection fraction by institutional criteria); bilirubin within 1.5 times institutional upper limit of normal; creatinine within 1.5 times institutional upper limit of normal; and no serious disease other than breast cancer.
    Description

    health status, wbc, neutrophil count, platelet count, lvef and comorbidities

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    UMLS CUI [2]
    C0023508
    UMLS CUI [3]
    C0200633
    UMLS CUI [4]
    C0005821
    UMLS CUI [5]
    C0428772
    UMLS CUI [6]
    C1278039
    UMLS CUI [7]
    C0201976
    UMLS CUI [8]
    C0009488
    pregnant or nursing women may not participate. men are ineligible. women of childbearing potential must be planning to use effective contraception.
    Description

    pregnant or breast feeding, Gender, contraceptive methods

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C0079399
    UMLS CUI [4]
    C0700589
    all patients must be informed of the investigational nature of this study and give written informed consent in accordance with institution and federal guidelines.
    Description

    informed consent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    at the time of registration, the date of institutional review board approval for this study must be provided to the statistical center.
    Description

    date of institutional review board approval must be provided to the statistical center

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    Retour au début de la page

    Similar models

    Eligibility High Risk NCT00590785

    1 Formulaires
    1. StudyEvent: Eligibility
      1. Eligibility High Risk NCT00590785
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    axillary dissection, lymph nodes
    Item
    patients must have undergone an axillary dissection, and at least 6 nodes must have een removed and examined. nodal involvement by tumor must be negative or must not xceed three positive nodes.
    boolean
    C0193867 (UMLS CUI [1])
    C0024204 (UMLS CUI [2])
    high-risk, chemotherapy indicated
    Item
    disease must be considered sufficiently high-risk by the investigator to justify the use of chemotherapy. to be eligible, disease must satisfy one of the following requirements:
    boolean
    C0684030 (UMLS CUI [1])
    C0392920 (UMLS CUI [2])
    er and pgr negative, tumor size
    Item
    1. tumor is both er negative and pgr negative and greater than 1.0 cm in greatest diameter. negative is defined as c 10 fmollmg cytosol protein if measured in these units; othennrise negative is defined according to institutional standards.
    boolean
    C2919271 (UMLS CUI [1])
    C2919590 (UMLS CUI [2])
    C0475440 (UMLS CUI [3])
    tumor size
    Item
    2. tumor that is greater than 2.0 cm in greatest diameter irrespective of hormone receptor status (including unknown).
    boolean
    C0475440 (UMLS CUI [1])
    Lymph node involvment
    Item
    3. tumor involves one to three axillary lymph nodes.
    boolean
    C0392920 (UMLS CUI [1])
    tumor stage
    Item
    breast cancer was not locally advanced at diagnosis. this is left to investigator judgement, but generally should exclude patients with fixed tumors, fixed nodes, peau d'orange skin changes, skin ulcerations or inflammatory changes (t4 disease).
    boolean
    C1300072 (UMLS CUI [1])
    no evidence of breast cancer, criteria for bilateral breast cancer
    Item
    patient is currently free of breast cancer (no evidence of disease). this is also left to investigator judgement, but generally should include no evidence of distant disease on chest x-ray or mgmmogram of the opposite breast prior to registration, within 3 months prior to surgery; and no gross or microscopically positive surgical margins noted in the final surgery or pathology reports. patients with synchronous bilateral breast cancer may be considered, provided both breasts are treated with curative intent and that eligibility is based on the side with the most adverse prognostic features.
    boolean
    C0678222 (UMLS CUI [1,1])
    C0687702 (UMLS CUI [1,2])
    C0281267 (UMLS CUI [2])
    time since mastectomy and axillary dissection, breast sparing surgery required, prior (chemo)therapy
    Item
    registration must be within 84 days of mastectomy, or within 84 days of axillary dissection if the patient's most extensive breast surgery was a breast sparing procedure. patients not having mastectomy or breast sparing surgery are ineligible. patients must not have had prior chemotherapy for this breast cancer. patients must not have had systemic therapy of any type for a previous breast cancer.
    boolean
    C0011008 (UMLS CUI [1])
    C0024881 (UMLS CUI [2])
    C0193867 (UMLS CUI [3])
    C0917927 (UMLS CUI [4])
    C0392920 (UMLS CUI [5])
    C1514463 (UMLS CUI [6])
    prior radiotherapy
    Item
    patients must not have had external beam radiotherapy for this breast cancer prior to registration. brachytherapy (interstitial radiation therapy) at the time of breast sparing procedure is acceptable and would not render the patient ineligible. (if external beam radiotherapy is planned to be given with brachytherapy, it must be delayed until after chemotherapy is complete.) patients whose most extensive breast surgery was a breast sparing procedure must be planning to receive radiotherapy after chemotherapy is complete.
    boolean
    C1522449 (UMLS CUI [1])
    C0419095 (UMLS CUI [2])
    C0006098 (UMLS CUI [3])
    C0917927 (UMLS CUI [4])
    health status, wbc, neutrophil count, platelet count, lvef and comorbidities
    Item
    patients must have adequate hematologic, hepatic, renal and cardiac function for high dose chemotherapy and adequate health for long-term follow-up. this must include normal wbc (2 4,0001pl). neutrophll count (2 1,50o/pl), platelet count (2 institutional lower limit of normal), and lvef (left ventricular ejection fraction by institutional criteria); bilirubin within 1.5 times institutional upper limit of normal; creatinine within 1.5 times institutional upper limit of normal; and no serious disease other than breast cancer.
    boolean
    C1321605 (UMLS CUI [1])
    C0023508 (UMLS CUI [2])
    C0200633 (UMLS CUI [3])
    C0005821 (UMLS CUI [4])
    C0428772 (UMLS CUI [5])
    C1278039 (UMLS CUI [6])
    C0201976 (UMLS CUI [7])
    C0009488 (UMLS CUI [8])
    pregnant or breast feeding, Gender, contraceptive methods
    Item
    pregnant or nursing women may not participate. men are ineligible. women of childbearing potential must be planning to use effective contraception.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0079399 (UMLS CUI [3])
    C0700589 (UMLS CUI [4])
    informed consent
    Item
    all patients must be informed of the investigational nature of this study and give written informed consent in accordance with institution and federal guidelines.
    boolean
    C0021430 (UMLS CUI [1])
    date of institutional review board approval must be provided to the statistical center
    Item
    at the time of registration, the date of institutional review board approval for this study must be provided to the statistical center.
    boolean
    C1321605 (UMLS CUI [1])
    Retour au début de la page 

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