ID

44187

Description

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

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

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

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Description

Inclusion criteria

Stage D2 metastatic prostate cancer
Description

Metastatic Prostate cancer

Data type

boolean

Progression after one prior chemotherapy
Description

Progression

Data type

boolean

ECOG Performance status equal / less than 2
Description

ECOG

Data type

boolean

Life expectancy > 3 months
Description

Life expectancy

Data type

boolean

Surgical or medical castration
Description

Castration

Data type

boolean

Adequate bone marrow, hepatic and renal functions
Description

Bone marrow, hepatic, renal

Data type

boolean

Exclusion criteria
Description

Exclusion criteria

More than one prior chemotherapy
Description

Previous chemotherapy

Data type

boolean

Prior platinum containing compounds
Description

Prior platinum

Data type

boolean

Prior malignancy
Description

Prior malignancy

Data type

boolean

Prior significant RT/radionuclide therapy
Description

Prior radiotherapy

Data type

boolean

Major GI surgery or GI disease affecting absorption
Description

GI absorption

Data type

boolean

Disease with contraindication to steroids
Description

Contraindications to steroids

Data type

boolean

Brain metastases
Description

Brain metastases

Data type

boolean

Medical Concepts
Description

Medical Concepts

Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
Prostate cancer metastatic
Description

Metastatic prostate cancer

Data type

string

Alias
UMLS CUI
C0936223
MedDRA 13.1
10036909
Diagnostic Neoplasm Staging
Description

Diagnostic Neoplasm Staging

Data type

string

Alias
UMLS CUI
C0027646
SNOMED CT 2010_0731
254292007
LOINC Version 232
LP78422-0
Cancer chemotherapy
Description

Chemotherapy

Data type

string

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

Tumor progression

Data type

string

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

ECOG performance status

Data type

string

Alias
SNOMED CT 2010_0731
423740007
Life expectancy
Description

Life expectancy

Data type

string

Alias
UMLS CUI
C0023671
LOINC Version 232
LP75025-4
Male castration
Description

Castration

Data type

string

Alias
UMLS CUI
C0007347
SNOMED CT 2010_0731
275234001
White blood cell count
Description

WBC

Data type

string

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

Platelet count - finding

Data type

string

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

Hemoglobin

Data type

string

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

Creatinine

Data type

string

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

Bilirubin

Data type

string

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

Malignancy

Data type

string

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

Radiotherapy

Data type

string

Alias
UMLS CUI
C1522449
SNOMED CT 2010_0731
302505005
Malabsorption
Description

Malabsorption

Data type

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
Description

Contraindication to medical treatment

Data type

string

Alias
UMLS CUI
C1301624
MedDRA 13.1
10010833
Steroid
Description

Steroids

Data type

string

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

Brain metastases

Data type

string

Alias
UMLS CUI
C0220650
MedDRA 13.1
10006128
Metastatic malignant disease
Description

Metastasis

Data type

string

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

Therapeutic procedure

Data type

string

Alias
UMLS CUI
C0087111
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion criteria
Metastatic Prostate cancer
Item
Stage D2 metastatic prostate cancer
boolean
Progression
Item
Progression after one prior chemotherapy
boolean
ECOG
Item
ECOG Performance status equal / less than 2
boolean
Life expectancy
Item
Life expectancy > 3 months
boolean
Castration
Item
Surgical or medical castration
boolean
Bone marrow, hepatic, renal
Item
Adequate bone marrow, hepatic and renal functions
boolean
Item Group
Exclusion criteria
Previous chemotherapy
Item
More than one prior chemotherapy
boolean
Prior platinum
Item
Prior platinum containing compounds
boolean
Prior malignancy
Item
Prior malignancy
boolean
Prior radiotherapy
Item
Prior significant RT/radionuclide therapy
boolean
GI absorption
Item
Major GI surgery or GI disease affecting absorption
boolean
Contraindications to steroids
Item
Disease with contraindication to steroids
boolean
Brain metastases
Item
Brain metastases
boolean
Item Group
Medical Concepts
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
Metastatic prostate cancer
Item
Prostate cancer metastatic
string
C0936223 (UMLS CUI)
10036909 (MedDRA 13.1)
Diagnostic Neoplasm Staging
Item
Diagnostic Neoplasm Staging
string
C0027646 (UMLS CUI)
254292007 (SNOMED CT 2010_0731)
LP78422-0 (LOINC Version 232)
Chemotherapy
Item
Cancer chemotherapy
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
Tumor progression
Item
Tumor progression
string
C0178874 (UMLS CUI)
10053563 (MedDRA 13.1)
419835002 (SNOMED CT 2010_0731)
ECOG performance status
Item
ECOG performance status
string
423740007 (SNOMED CT 2010_0731)
Life expectancy
Item
Life expectancy
string
C0023671 (UMLS CUI)
LP75025-4 (LOINC Version 232)
Castration
Item
Male castration
string
C0007347 (UMLS CUI)
275234001 (SNOMED CT 2010_0731)
WBC
Item
White blood cell count
string
767002 (SNOMED CT 2010_0731)
6690-2 (LOINC)
Platelet count - finding
Item
Platelet count - finding
string
365632008 (SNOMED CT 2010_0731)
C1287267 (UMLS CUI)
777-3 (LOINC)
Hemoglobin
Item
Hemoglobin
string
38082009 (SNOMED CT 2010_0731)
C0019046 (UMLS CUI)
10019481 (MedDRA 13.1)
LP14449-0 (LOINC)
Creatinine
Item
Creatinine
string
C0010294 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
38483-4 (LOINC)
10011358 (MedDRA 13.1)
Bilirubin
Item
Bilirubin
string
79706000 (SNOMED CT 2010_0731)
C0011221 (UMLS CUI)
1975-2 (LOINC)
Malignancy
Item
Malignancy
string
C0006826 (UMLS CUI)
LP20701-6 (LOINC Version 232)
Radiotherapy
Item
Radiotherapy
string
C1522449 (UMLS CUI)
302505005 (SNOMED CT 2010_0731)
Malabsorption
Item
Malabsorption
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
Contraindication to medical treatment
string
C1301624 (UMLS CUI)
10010833 (MedDRA 13.1)
Steroids
Item
Steroid
string
C0038317 (UMLS CUI)
116566001 (SNOMED CT 2010_0731)
Brain metastases
Item
Brain metastases
string
C0220650 (UMLS CUI)
10006128 (MedDRA 13.1)
Metastasis
Item
Metastatic malignant disease
string
C0027627 (UMLS CUI)
128462008 (SNOMED CT 2010_0731)
10027449 (MedDRA 13.1)
LP35033-7 (LOINC Version 232)
Therapeutic procedure
Item
Therapeutic procedure
string
C0087111 (UMLS CUI)
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