ID

31567

Beskrivning

A Study of an Experimental Chemotherapy Combination to Treat Hormone Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00642018

Länk

https://clinicaltrials.gov/show/NCT00642018

Nyckelord

Versioner (1)
  1. 2018-09-05 2018-09-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 september 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00642018

Engelsk

Eligibility Prostate Cancer NCT00642018

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed adenocarcinoma of the prostate which is metastatic and/or unresectable
Beskrivning

Adenocarcinoma of the prostate metastatic | Adenocarcinoma of prostate unresectable

Datatyp

boolean

Alias
UMLS CUI [1]
C0862636
UMLS CUI [2,1]
C0007112
UMLS CUI [2,2]
C1519810
hormone refractory prostate cancer defined as progressive based by documented 2 increase psa values over a previous reference value.
Beskrivning

Hormone refractory prostate cancer Progressive | Raised prostate specific antigen Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1328504
UMLS CUI [1,2]
C0205329
UMLS CUI [2,1]
C0178415
UMLS CUI [2,2]
C1265611
ecog status 0-2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematological functions, liver and renal functions
Beskrivning

Hematologic function | Liver function | Renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hypersensitivity to docetaxel or taxane therapy
Beskrivning

Hypersensitivity Docetaxel | Hypersensitivity Taxane

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0246415
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0215136
documented central nervous system or leptomeningeal metastasis at time of study entry
Beskrivning

CNS metastases | Metastatic Malignant Neoplasm to the Leptomeninges

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C1704231
had prior treatment with chemotherapy, bone seeking radionucleides in past 6 weeks prior to enrollment, or radiotherapy involving more than 25% of marrow producing area.
Beskrivning

Prior Chemotherapy | Bone-seeking Radioisotope | Therapeutic radiology procedure Bone Marrow Percentage

Datatyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C2985504
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0005953
UMLS CUI [3,3]
C0439165
evidence of painful and/or destructive bone metastases for which radiation therapy, biophosphonates or boneseeking radionucleides are necessary.
Beskrivning

Secondary malignant neoplasm of bone Painful | Secondary malignant neoplasm of bone Destruction | Therapeutic radiology procedure Required | Diphosphonates Required | Bone-seeking Radioisotope Required

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0153690
UMLS CUI [1,2]
C0030193
UMLS CUI [2,1]
C0153690
UMLS CUI [2,2]
C1948029
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C1514873
UMLS CUI [4,1]
C0012544
UMLS CUI [4,2]
C1514873
UMLS CUI [5,1]
C2985504
UMLS CUI [5,2]
C1514873
have received treatment in the last 30 day with a drug which has not received regulatory approval for any indication at the time of study entry.
Beskrivning

Drugs, Non-Prescription

Datatyp

boolean

Alias
UMLS CUI [1]
C0013231
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Similar models

Eligibility Prostate Cancer NCT00642018

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of the prostate metastatic | Adenocarcinoma of prostate unresectable
Item
histologically or cytologically confirmed adenocarcinoma of the prostate which is metastatic and/or unresectable
boolean
C0862636 (UMLS CUI [1])
C0007112 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
Hormone refractory prostate cancer Progressive | Raised prostate specific antigen Quantity
Item
hormone refractory prostate cancer defined as progressive based by documented 2 increase psa values over a previous reference value.
boolean
C1328504 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0178415 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
ECOG performance status
Item
ecog status 0-2
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Liver function | Renal function
Item
adequate hematological functions, liver and renal functions
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Docetaxel | Hypersensitivity Taxane
Item
known hypersensitivity to docetaxel or taxane therapy
boolean
C0020517 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0215136 (UMLS CUI [2,2])
CNS metastases | Metastatic Malignant Neoplasm to the Leptomeninges
Item
documented central nervous system or leptomeningeal metastasis at time of study entry
boolean
C0686377 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
Prior Chemotherapy | Bone-seeking Radioisotope | Therapeutic radiology procedure Bone Marrow Percentage
Item
had prior treatment with chemotherapy, bone seeking radionucleides in past 6 weeks prior to enrollment, or radiotherapy involving more than 25% of marrow producing area.
boolean
C1514457 (UMLS CUI [1])
C2985504 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0005953 (UMLS CUI [3,2])
C0439165 (UMLS CUI [3,3])
Secondary malignant neoplasm of bone Painful | Secondary malignant neoplasm of bone Destruction | Therapeutic radiology procedure Required | Diphosphonates Required | Bone-seeking Radioisotope Required
Item
evidence of painful and/or destructive bone metastases for which radiation therapy, biophosphonates or boneseeking radionucleides are necessary.
boolean
C0153690 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0153690 (UMLS CUI [2,1])
C1948029 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0012544 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C2985504 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
Drugs, Non-Prescription
Item
have received treatment in the last 30 day with a drug which has not received regulatory approval for any indication at the time of study entry.
boolean
C0013231 (UMLS CUI [1])
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