ID

44187

Beskrivning

Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen Inclusion Criteria: - Stage D2 metastatic prostate cancer - Progression after one prior chemotherapy - ECOG Performance status equal / less than 2 - Life expectancy > 3 months - Surgical or medical castration - Adequate bone marrow, hepatic and renal functions - Informed consent Exclusion Criteria: - More than one prior chemotherapy - Prior platinum containing compounds - Prior malignancy - Prior significant RT/radionuclide therapy - Major GI surgery or GI disease affecting absorption - Disease with contraindication to steroids - Brain metastases

Nyckelord

Versioner (3)
  1. 2013-12-09 2013-12-09 - Martin Dugas
  2. 2021-04-13 2021-04-13 - Dr. rer. medic Philipp Neuhaus
  3. 2021-09-20 2021-09-20 -
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20 september 2021

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Creative Commons BY-NC 3.0 Legacy
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Eligibility DRKS00009656 NCT00069745 Prostate Cancer

Tysk Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beskrivning

Einschlusskriterien

Metastatic Prostate cancer
Beskrivning

Metastatic Prostate cancer

Datatyp

boolean

Progression
Beskrivning

Progression

Datatyp

boolean

ECOG
Beskrivning

ECOG

Datatyp

boolean

Life expectancy
Beskrivning

Life expectancy

Datatyp

boolean

Castration
Beskrivning

Castration

Datatyp

boolean

Bone marrow, hepatic, renal
Beskrivning

Bone marrow, hepatic, renal

Datatyp

boolean

Ausschlusskriterien
Beskrivning

Ausschlusskriterien

Previous chemotherapy
Beskrivning

Previous chemotherapy

Datatyp

boolean

Prior platinum
Beskrivning

Prior platinum

Datatyp

boolean

Prior malignancy
Beskrivning

Prior malignancy

Datatyp

boolean

Prior radiotherapy
Beskrivning

Prior radiotherapy

Datatyp

boolean

GI absorption
Beskrivning

GI absorption

Datatyp

boolean

Contraindications to steroids
Beskrivning

Contraindications to steroids

Datatyp

boolean

Brain metastases
Beskrivning

Brain metastases

Datatyp

boolean

Medizinische Konzepte
Beskrivning

Medizinische Konzepte

Diagnosis
Beskrivning

Diagnosis

Datatyp

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
Metastatic prostate cancer
Beskrivning

Metastatic prostate cancer

Datatyp

string

Alias
UMLS CUI
C0936223
MedDRA 13.1
10036909
Diagnostic Neoplasm Staging
Beskrivning

Diagnostic Neoplasm Staging

Datatyp

string

Alias
UMLS CUI
C0027646
SNOMED CT 2010_0731
254292007
LOINC Version 232
LP78422-0
Chemotherapy
Beskrivning

Chemotherapy

Datatyp

string

Alias
UMLS CUI
C0392920
SNOMED CT 2010_0731
150415003
Tumor progression
Beskrivning

Tumor progression

Datatyp

string

Alias
UMLS CUI
C0178874
MedDRA 13.1
10053563
SNOMED CT 2010_0731
419835002
ECOG performance status
Beskrivning

ECOG performance status

Datatyp

string

Alias
SNOMED CT 2010_0731
423740007
Life expectancy
Beskrivning

Life expectancy

Datatyp

string

Alias
UMLS CUI
C0023671
LOINC Version 232
LP75025-4
Castration
Beskrivning

Castration

Datatyp

string

Alias
UMLS CUI
C0007347
SNOMED CT 2010_0731
275234001
WBC
Beskrivning

WBC

Datatyp

string

Alias
SNOMED CT 2010_0731
767002
LOINC
6690-2
Platelet count - finding
Beskrivning

Platelet count - finding

Datatyp

string

Alias
SNOMED CT 2010_0731
365632008
UMLS CUI
C1287267
LOINC
777-3
Hemoglobin
Beskrivning

Hemoglobin

Datatyp

string

Alias
SNOMED CT 2010_0731
38082009
UMLS CUI
C0019046
MedDRA 13.1
10019481
LOINC
LP14449-0
Creatinine
Beskrivning

Creatinine

Datatyp

string

Alias
UMLS CUI
C0010294
SNOMED CT 2010_0731
15373003
LOINC
38483-4
MedDRA 13.1
10011358
Bilirubin
Beskrivning

Bilirubin

Datatyp

string

Alias
SNOMED CT 2010_0731
79706000
UMLS CUI
C0011221
LOINC
1975-2
Malignancy
Beskrivning

Malignancy

Datatyp

string

Alias
UMLS CUI
C0006826
LOINC Version 232
LP20701-6
Radiotherapy
Beskrivning

Radiotherapy

Datatyp

string

Alias
UMLS CUI
C1522449
SNOMED CT 2010_0731
302505005
Malabsorption
Beskrivning

Malabsorption

Datatyp

string

Alias
SNOMED CT 2010_0731
155841000
UMLS CUI
C0024523
MedDRA 13.1
10025476
CTCAE Version 4.03
E10867
ICD-10-CM Version 2010
K90.4
Contraindication to medical treatment
Beskrivning

Contraindication to medical treatment

Datatyp

string

Alias
UMLS CUI
C1301624
MedDRA 13.1
10010833
Steroids
Beskrivning

Steroids

Datatyp

string

Alias
UMLS CUI
C0038317
SNOMED CT 2010_0731
116566001
Brain metastases
Beskrivning

Brain metastases

Datatyp

string

Alias
UMLS CUI
C0220650
MedDRA 13.1
10006128
Metastasis
Beskrivning

Metastasis

Datatyp

string

Alias
UMLS CUI
C0027627
SNOMED CT 2010_0731
128462008
MedDRA 13.1
10027449
LOINC Version 232
LP35033-7
Therapeutic procedure
Beskrivning

Therapeutic procedure

Datatyp

string

Alias
UMLS CUI
C0087111
Tillbaka till toppen

Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Einschlusskriterien
Metastatic Prostate cancer
Item
boolean
Progression
Item
boolean
ECOG
Item
boolean
Life expectancy
Item
boolean
Castration
Item
boolean
Bone marrow, hepatic, renal
Item
boolean
Item Group
Ausschlusskriterien
Previous chemotherapy
Item
boolean
Prior platinum
Item
boolean
Prior malignancy
Item
boolean
Prior radiotherapy
Item
boolean
GI absorption
Item
boolean
Contraindications to steroids
Item
boolean
Brain metastases
Item
boolean
Item Group
Medizinische Konzepte
Diagnosis
Item
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
Metastatic prostate cancer
Item
string
C0936223 (UMLS CUI)
10036909 (MedDRA 13.1)
Diagnostic Neoplasm Staging
Item
string
C0027646 (UMLS CUI)
254292007 (SNOMED CT 2010_0731)
LP78422-0 (LOINC Version 232)
Chemotherapy
Item
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
Tumor progression
Item
string
C0178874 (UMLS CUI)
10053563 (MedDRA 13.1)
419835002 (SNOMED CT 2010_0731)
ECOG performance status
Item
string
423740007 (SNOMED CT 2010_0731)
Life expectancy
Item
string
C0023671 (UMLS CUI)
LP75025-4 (LOINC Version 232)
Castration
Item
string
C0007347 (UMLS CUI)
275234001 (SNOMED CT 2010_0731)
WBC
Item
string
767002 (SNOMED CT 2010_0731)
6690-2 (LOINC)
Platelet count - finding
Item
string
365632008 (SNOMED CT 2010_0731)
C1287267 (UMLS CUI)
777-3 (LOINC)
Hemoglobin
Item
string
38082009 (SNOMED CT 2010_0731)
C0019046 (UMLS CUI)
10019481 (MedDRA 13.1)
LP14449-0 (LOINC)
Creatinine
Item
string
C0010294 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
38483-4 (LOINC)
10011358 (MedDRA 13.1)
Bilirubin
Item
string
79706000 (SNOMED CT 2010_0731)
C0011221 (UMLS CUI)
1975-2 (LOINC)
Malignancy
Item
string
C0006826 (UMLS CUI)
LP20701-6 (LOINC Version 232)
Radiotherapy
Item
string
C1522449 (UMLS CUI)
302505005 (SNOMED CT 2010_0731)
Malabsorption
Item
string
155841000 (SNOMED CT 2010_0731)
C0024523 (UMLS CUI)
10025476 (MedDRA 13.1)
E10867 (CTCAE Version 4.03)
K90.4 (ICD-10-CM Version 2010)
Contraindication to medical treatment
Item
string
C1301624 (UMLS CUI)
10010833 (MedDRA 13.1)
Steroids
Item
string
C0038317 (UMLS CUI)
116566001 (SNOMED CT 2010_0731)
Brain metastases
Item
string
C0220650 (UMLS CUI)
10006128 (MedDRA 13.1)
Metastasis
Item
string
C0027627 (UMLS CUI)
128462008 (SNOMED CT 2010_0731)
10027449 (MedDRA 13.1)
LP35033-7 (LOINC Version 232)
Therapeutic procedure
Item
string
C0087111 (UMLS CUI)
Tillbaka till toppen 

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