0 Ratings

ID

5286

Description

EWING 2008, EudraCT 2008-003658-13, http://clinicaltrials.gov/ct2/show/NCT00824083

Link

http://clinicaltrials.gov/ct2/show/NCT00824083

Keywords

  1. 8/4/14 8/4/14 - Martin Dugas
Uploaded on

August 4, 2014

DOI

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License

Creative Commons BY 4.0

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    Ewing Study Randomisierung DRKS00003588

    Randomisierung

    1. StudyEvent: SE
      1. Randomisierung
    Show identification of patient
    Description

    Show identification of patient

    Patient
    Description

    Dummy item in ItemGroup 'Display patient'

    Data type

    text

    Anforderung/Risikogruppe
    Description

    Anforderung/Risikogruppe

    Randomization of patient?
    Description

    Randi ja nein

    Data type

    integer

    Risk group
    Description

    Therapiearm

    Data type

    integer

    Reason for non-randomization
    Description

    Grund für Nichtrandomisation

    Data type

    integer

    R1
    Description

    R1

    Rearrangement of chromosome 22
    Description

    Rearrangement von Chromosom 22?

    Data type

    integer

    MIC2 positivity (CD99)
    Description

    MIC2 positiv (CD99)?

    Data type

    integer

    Metatases at diagnosis (must be no!)
    Description

    Primäre Metastasierung

    Data type

    integer

    Clinical response of primary tumor to initial chemotherapy (RECIST guidlines)
    Description

    Klinisches Ansprechen des Primärtumors auf Induktionschemotherapie?

    Data type

    integer

    Local therapy (planned or completed)
    Description

    Lokaltherapie (geplant oder durchgeführt)

    Data type

    integer

    Please specify
    Description

    Text

    Data type

    text

    Number of VIDE courses completed
    Description

    Anzahl VIDE

    Data type

    integer

    Medical contraindication for planned chemotherapy
    Description

    Medizinische Kontraindikationen gegen die geplante Chemtherarapie?

    Data type

    integer

    Please specify
    Description

    Welche?

    Data type

    text

    Informed consent for randomization signed
    Description

    Einverständniserklärung unterzeichnet

    Data type

    integer

    Slides sent to reference pathologist
    Description

    Material an Referenzpathologen versandt

    Data type

    integer

    R2loc
    Description

    R2loc

    Rearrangement of chromosome 22
    Description

    Rearrangement von Chromosom 22?

    Data type

    integer

    MIC2 positivity (CD99)
    Description

    MIC2 positiv (CD99)?

    Data type

    integer

    Metatases at diagnosis (must be no!)
    Description

    Primäre Metastasierung

    Data type

    integer

    Criteria for R1 randomisation? (must be no!)
    Description

    Kriterien für R1

    Data type

    integer

    Clinical response of primary tumor to initial chemotherapy (RECIST guidlines)
    Description

    Klinisches Ansprechen des Primärtumors auf Induktionschemotherapie?

    Data type

    integer

    Local therapy (planned or completed)
    Description

    Lokaltherapie (geplant oder durchgeführt)

    Data type

    integer

    Please specify
    Description

    Text

    Data type

    text

    Number of VIDE courses completed
    Description

    Anzahl VIDE

    Data type

    integer

    Medical contraindication for planned chemotherapy
    Description

    Medizinische Kontraindikationen gegen die geplante Chemtherarapie?

    Data type

    integer

    Please specify
    Description

    Welche?

    Data type

    text

    Informed consent for randomization signed
    Description

    Einverständniserklärung unterzeichnet

    Data type

    integer

    Slides sent to reference pathologist
    Description

    Material an Referenzpathologen versandt

    Data type

    integer

    R2pulm
    Description

    R2pulm

    Rearrangement of chromosome 22
    Description

    Rearrangement von Chromosom 22?

    Data type

    integer

    MIC2 positivity (CD99)
    Description

    MIC2 positiv (CD99)?

    Data type

    integer

    Primary lung metastases (must be yes!)
    Description

    Primäre Lungenmetastasen

    Data type

    integer

    Primary extrapulmonary metastases (must be no!)
    Description

    Primäre extrapulmonale Metastasen

    Data type

    integer

    Clinical response of primary tumor to initial chemotherapy (RECIST guidlines)
    Description

    Klinisches Ansprechen des Primärtumors auf Induktionschemotherapie?

    Data type

    integer

    Clinical response of lung metastases to initial chemotherapy (RECIST guidlines)
    Description

    Klinisches Ansprechen der Lungenmetastasen auf Induktionschemotherapie?

    Data type

    integer

    Local therapy (planned or completed)
    Description

    Lokaltherapie (geplant oder durchgeführt)

    Data type

    integer

    Please specify
    Description

    Text

    Data type

    text

    Number of VIDE courses completed
    Description

    Anzahl VIDE

    Data type

    integer

    Medical contraindication for planned chemotherapy
    Description

    Medizinische Kontraindikationen gegen die geplante Chemtherarapie?

    Data type

    integer

    Please specify
    Description

    Welche?

    Data type

    text

    Informed consent for randomization signed
    Description

    Einverständniserklärung unterzeichnet

    Data type

    integer

    Slides sent to reference pathologist
    Description

    Material an Referenzpathologen versandt

    Data type

    integer

    R3
    Description

    R3

    Rearrangement of chromosome 22
    Description

    Rearrangement von Chromosom 22?

    Data type

    integer

    MIC2 positivity (CD99)
    Description

    MIC2 positiv (CD99)?

    Data type

    integer

    Primary extrapulmonary metastases (must be yes!)
    Description

    Primäre extrapulmonale Metastasen

    Data type

    integer

    Clinical response of primary tumor to initial chemotherapy (RECIST guidlines)
    Description

    Klinisches Ansprechen des Primärtumors auf Induktionschemotherapie?

    Data type

    integer

    Clinical response of metastases (worst grade) to initial chemotherapy (RECIST guidlines)
    Description

    Klinisches Ansprechen der extrapulmonalen Metastasen auf Induktionschemotherapie?

    Data type

    integer

    Local therapy (planned or completed)
    Description

    Lokaltherapie (geplant oder durchgeführt)

    Data type

    integer

    Please specify
    Description

    Text

    Data type

    text

    Number of VIDE courses completed
    Description

    Anzahl VIDE

    Data type

    integer

    Medical contraindication for planned chemotherapy
    Description

    Medizinische Kontraindikationen gegen die geplante Chemtherarapie?

    Data type

    integer

    Please specify
    Description

    Welche?

    Data type

    text

    Informed consent for randomization signed
    Description

    Einverständniserklärung unterzeichnet

    Data type

    integer

    Slides sent to reference pathologist
    Description

    Material an Referenzpathologen versandt

    Data type

    integer

    Similar models

    Randomisierung

    1. StudyEvent: SE
      1. Randomisierung
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Dummy item in ItemGroup 'Display patient'
    Item
    Patient
    text
    Item
    Randomization of patient?
    integer
    Code List
    Randomization of patient?
    CL Item
    No (0)
    CL Item
    Yes (1)
    Item
    Risk group
    integer
    Code List
    Risk group
    CL Item
    R1 (1)
    CL Item
    R2loc (2)
    CL Item
    R2pulm (3)
    CL Item
    R3 (4)
    Item
    Reason for non-randomization
    integer
    Code List
    Reason for non-randomization
    CL Item
    Progress (1)
    CL Item
    Medical containdication/toxicity (2)
    CL Item
    Refusal patient/parents (3)
    CL Item
    Physician's decision (4)
    CL Item
    Organisational reasons (5)
    CL Item
    Other (6)
    Item Group
    Item
    Rearrangement of chromosome 22
    integer
    Code List
    Rearrangement of chromosome 22
    CL Item
    Positive verification (1)
    CL Item
    No positive verification or no positive verification available! (0)
    Item
    MIC2 positivity (CD99)
    integer
    Code List
    MIC2 positivity (CD99)
    CL Item
    Positive verification (1)
    CL Item
    No positive verification or no positive verification available! (0)
    Item
    Metatases at diagnosis (must be no!)
    integer
    Code List
    Metatases at diagnosis (must be no!)
    CL Item
    No (0)
    CL Item
    Yes (1)
    Item
    Clinical response of primary tumor to initial chemotherapy (RECIST guidlines)
    integer
    Code List
    Clinical response of primary tumor to initial chemotherapy (RECIST guidlines)
    CL Item
    CR or PR (1)
    CL Item
    SD (2)
    CL Item
    PD (3)
    Item
    Local therapy (planned or completed)
    integer
    Code List
    Local therapy (planned or completed)
    CL Item
    Resection after chemotherapy alone: any tumor volume and good histological response (1)
    CL Item
    Resection after chemotherapy and early radiotherapy: tumor volume at diagnosis <200ml and good histological response (2)
    CL Item
    Resection at diagnosis: tumor volume at diagnosis <200ml (3)
    CL Item
    Radiotherapy alone (tumor unresectable): tumor volume at diagnosis <200ml and at least partial clinical response, excluding progressive disease (4)
    CL Item
    Other (0)
    Text
    Item
    Please specify
    text
    Anzahl VIDE
    Item
    Number of VIDE courses completed
    integer
    Item
    Medical contraindication for planned chemotherapy
    integer
    Code List
    Medical contraindication for planned chemotherapy
    CL Item
    No (0)
    CL Item
    Yes (1)
    Welche?
    Item
    Please specify
    text
    Item
    Informed consent for randomization signed
    integer
    Code List
    Informed consent for randomization signed
    CL Item
    No (0)
    CL Item
    Yes (1)
    Item
    Slides sent to reference pathologist
    integer
    Code List
    Slides sent to reference pathologist
    CL Item
    No (0)
    CL Item
    Yes (1)
    Item Group
    Item
    Rearrangement of chromosome 22
    integer
    Code List
    Rearrangement of chromosome 22
    CL Item
    Positive verification (1)
    CL Item
    No positive verification or no positive verification available! (0)
    Item
    MIC2 positivity (CD99)
    integer
    Code List
    MIC2 positivity (CD99)
    CL Item
    Positive verification (1)
    CL Item
    No positive verification or no positive verification available! (0)
    Item
    Metatases at diagnosis (must be no!)
    integer
    Code List
    Metatases at diagnosis (must be no!)
    CL Item
    No (0)
    CL Item
    Yes (1)
    Item
    Criteria for R1 randomisation? (must be no!)
    integer
    Code List
    Criteria for R1 randomisation? (must be no!)
    CL Item
    No (0)
    CL Item
    Yes (1)
    Item
    Clinical response of primary tumor to initial chemotherapy (RECIST guidlines)
    integer
    Code List
    Clinical response of primary tumor to initial chemotherapy (RECIST guidlines)
    CL Item
    CR or PR (1)
    CL Item
    SD (2)
    CL Item
    PD (3)
    Item
    Local therapy (planned or completed)
    integer
    Code List
    Local therapy (planned or completed)
    CL Item
    Resection after chemotherapy alone: any tumor volume and poor histological response (1)
    CL Item
    Resection after chemotherapy and early radiotherapy: extremity site and tumor volume at diagnosis >=200ml and poor histological response (2)
    CL Item
    Resection at diagnosis: tumor volume at diagnosis >=200ml (3)
    CL Item
    Radiotherapy alone, early radiotherapy (tumor unresectable): extremity site and any tumor volume + poor clinical response and no progression (4)
    CL Item
    Radiotherapy alone, late radiotherapy: tumor volume at diagnosis >=200ml and no progression (5)
    CL Item
    Radiotherapy alone, late radiotherapy (tumor unresectable): tumor volume at diagnosis <200ml, poor clinical response and no progression (6)
    CL Item
    Other (0)
    Text
    Item
    Please specify
    text
    Anzahl VIDE
    Item
    Number of VIDE courses completed
    integer
    Item
    Medical contraindication for planned chemotherapy
    integer
    Code List
    Medical contraindication for planned chemotherapy
    CL Item
    No (0)
    CL Item
    Yes (1)
    Welche?
    Item
    Please specify
    text
    Item
    Informed consent for randomization signed
    integer
    Code List
    Informed consent for randomization signed
    CL Item
    No (0)
    CL Item
    Yes (1)
    Item
    Slides sent to reference pathologist
    integer
    Code List
    Slides sent to reference pathologist
    CL Item
    No (0)
    CL Item
    Yes (1)
    Item Group
    Item
    Rearrangement of chromosome 22
    integer
    Code List
    Rearrangement of chromosome 22
    CL Item
    Positive verification (1)
    CL Item
    No positive verification or no positive verification available! (0)
    Item
    MIC2 positivity (CD99)
    integer
    Code List
    MIC2 positivity (CD99)
    CL Item
    Positive verification (1)
    CL Item
    No positive verification or no positive verification available! (0)
    Item
    Primary lung metastases (must be yes!)
    integer
    Code List
    Primary lung metastases (must be yes!)
    CL Item
    No (0)
    CL Item
    Yes (1)
    Item
    Primary extrapulmonary metastases (must be no!)
    integer
    Code List
    Primary extrapulmonary metastases (must be no!)
    CL Item
    No (0)
    CL Item
    Yes (1)
    Item
    Clinical response of primary tumor to initial chemotherapy (RECIST guidlines)
    integer
    Code List
    Clinical response of primary tumor to initial chemotherapy (RECIST guidlines)
    CL Item
    CR or PR (1)
    CL Item
    SD (2)
    CL Item
    PD (3)
    Item
    Clinical response of lung metastases to initial chemotherapy (RECIST guidlines)
    integer
    Code List
    Clinical response of lung metastases to initial chemotherapy (RECIST guidlines)
    CL Item
    CR or PR (1)
    CL Item
    SD (2)
    CL Item
    PD (3)
    Item
    Local therapy (planned or completed)
    integer
    Code List
    Local therapy (planned or completed)
    CL Item
    Resection after chemotherapy alone +/- late radiotherapy (1)
    CL Item
    Early radiotherapy and resection, extremity site (2)
    CL Item
    Resection at diagnosis (3)
    CL Item
    Radiotherapy alone, early radiotherapy (tumor unresectable) (4)
    CL Item
    Radiotherapy alone, late radiotherapy (tumor unresectable) (5)
    CL Item
    Other (0)
    Text
    Item
    Please specify
    text
    Anzahl VIDE
    Item
    Number of VIDE courses completed
    integer
    Item
    Medical contraindication for planned chemotherapy
    integer
    Code List
    Medical contraindication for planned chemotherapy
    CL Item
    No (0)
    CL Item
    Yes (1)
    Welche?
    Item
    Please specify
    text
    Item
    Informed consent for randomization signed
    integer
    Code List
    Informed consent for randomization signed
    CL Item
    No (0)
    CL Item
    Yes (1)
    Item
    Slides sent to reference pathologist
    integer
    Code List
    Slides sent to reference pathologist
    CL Item
    No (0)
    CL Item
    Yes (1)
    Item Group
    Item
    Rearrangement of chromosome 22
    integer
    Code List
    Rearrangement of chromosome 22
    CL Item
    Positive verification (1)
    CL Item
    No positive verification or no positive verification available! (0)
    Item
    MIC2 positivity (CD99)
    integer
    Code List
    MIC2 positivity (CD99)
    CL Item
    Positive verification (1)
    CL Item
    No positive verification or no positive verification available! (0)
    Item
    Primary extrapulmonary metastases (must be yes!)
    integer
    Code List
    Primary extrapulmonary metastases (must be yes!)
    CL Item
    No (0)
    CL Item
    Yes (1)
    Item
    Clinical response of primary tumor to initial chemotherapy (RECIST guidlines)
    integer
    Code List
    Clinical response of primary tumor to initial chemotherapy (RECIST guidlines)
    CL Item
    CR or PR (1)
    CL Item
    SD (2)
    CL Item
    PD (3)
    Item
    Clinical response of metastases (worst grade) to initial chemotherapy (RECIST guidlines)
    integer
    Code List
    Clinical response of metastases (worst grade) to initial chemotherapy (RECIST guidlines)
    CL Item
    CR or PR (1)
    CL Item
    SD (2)
    CL Item
    PD (3)
    Item
    Local therapy (planned or completed)
    integer
    Code List
    Local therapy (planned or completed)
    CL Item
    Resection after chemotherapy alone +/- late radiotherapy (1)
    CL Item
    Early radiotherapy and resection, extremity site (2)
    CL Item
    Resection at diagnosis (3)
    CL Item
    Radiotherapy alone, early radiotherapy (tumor unresectable) (4)
    CL Item
    Radiotherapy alone, late radiotherapy (tumor unresectable) (5)
    CL Item
    Other (0)
    Text
    Item
    Please specify
    text
    Anzahl VIDE
    Item
    Number of VIDE courses completed
    integer
    Item
    Medical contraindication for planned chemotherapy
    integer
    Code List
    Medical contraindication for planned chemotherapy
    CL Item
    No (0)
    CL Item
    Yes (1)
    Welche?
    Item
    Please specify
    text
    Item
    Informed consent for randomization signed
    integer
    Code List
    Informed consent for randomization signed
    CL Item
    No (0)
    CL Item
    Yes (1)
    Item
    Slides sent to reference pathologist
    integer
    Code List
    Slides sent to reference pathologist
    CL Item
    No (0)
    CL Item
    Yes (1)

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