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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