ID

18932

Beschrijving

A Phase 2 Study of Trabectedin (Yondelis) in Adult Male Participants With Advanced Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00072670

Link

https://clinicaltrials.gov/show/NCT00072670

Trefwoorden

Versies (1)
  1. 24-11-16 24-11-16 -
Geüploaded op

24 november 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00072670

Engels

Eligibility Prostate Cancer NCT00072670

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed adenocarcinoma of the prostate
Beschrijving

Adenocarcinoma of prostate

Datatype

boolean

Alias
UMLS CUI [1]
C0007112
radiographically documented metastatic disease
Beschrijving

Neoplasm Metastasis

Datatype

boolean

Alias
UMLS CUI [1]
C0027627
surgical or chemical castration
Beschrijving

Male Castration | Chemical male castration

Datatype

boolean

Alias
UMLS CUI [1]
C0007347
UMLS CUI [2]
C0455189
prostate-specific antigen greater than or equal to (>=) 5 nanogram per milliliter (ng/ml)
Beschrijving

Prostate specific antigen measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201544
eastern cooperative oncology group performance status of 0, 1, or 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
androgen independent disease
Beschrijving

androgen independent prostate cancer

Datatype

boolean

Alias
UMLS CUI [1]
C1654637
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with chemotherapy or radiation therapy that was terminated at least 4 weeks before study entry
Beschrijving

Chemotherapy Discontinued | Therapeutic radiology procedure Discontinued

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1444662
treatment with extensive external beam radiation therapy or radionuclide therapy within 6 weeks of study entry (palliative radiation involving less than 20 percent of bone marrow reserves must have been completed at least 4 weeks before study entry)
Beschrijving

External Beam Radiation Therapy Extensive | Radionuclide therapy Extensive | Palliative Radiation Therapy Complete | Palliative Radiation Therapy Involving Bone Marrow Mature Neutrophils Percentage

Datatype

boolean

Alias
UMLS CUI [1,1]
C1517033
UMLS CUI [1,2]
C0205231
UMLS CUI [2,1]
C0203608
UMLS CUI [2,2]
C0205231
UMLS CUI [3,1]
C3898008
UMLS CUI [3,2]
C0205197
UMLS CUI [4,1]
C3898008
UMLS CUI [4,2]
C1314939
UMLS CUI [4,3]
C0005953
UMLS CUI [4,4]
C1708947
UMLS CUI [4,5]
C0439165
participant not employing adequate contraception
Beschrijving

Contraceptive methods Adequate Lacking

Datatype

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0205411
UMLS CUI [1,3]
C0332268
other serious illness or medical conditions as : uncontrolled congestive heart failure or history of myocardial infection or active angina pectoris within six months preceding registration; active infectious process; chronic active liver disease, including chronic hepatitis b, chronic hepatitis c, or cirrhosis
Beschrijving

Illness Serious | Medical condition | Congestive heart failure Uncontrolled | Myocardial Infarction | Angina Pectoris | INFECTIOUS PROCESS | Chronic liver disease | Hepatitis B, Chronic | Hepatitis C, Chronic | Liver Cirrhosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C3843040
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0002962
UMLS CUI [6]
C0745283
UMLS CUI [7]
C0341439
UMLS CUI [8]
C0524909
UMLS CUI [9]
C0524910
UMLS CUI [10]
C0023890
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Similar models

Eligibility Prostate Cancer NCT00072670

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histologically confirmed adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Neoplasm Metastasis
Item
radiographically documented metastatic disease
boolean
C0027627 (UMLS CUI [1])
Male Castration | Chemical male castration
Item
surgical or chemical castration
boolean
C0007347 (UMLS CUI [1])
C0455189 (UMLS CUI [2])
Prostate specific antigen measurement
Item
prostate-specific antigen greater than or equal to (>=) 5 nanogram per milliliter (ng/ml)
boolean
C0201544 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group performance status of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
androgen independent prostate cancer
Item
androgen independent disease
boolean
C1654637 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Discontinued | Therapeutic radiology procedure Discontinued
Item
treatment with chemotherapy or radiation therapy that was terminated at least 4 weeks before study entry
boolean
C0392920 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
External Beam Radiation Therapy Extensive | Radionuclide therapy Extensive | Palliative Radiation Therapy Complete | Palliative Radiation Therapy Involving Bone Marrow Mature Neutrophils Percentage
Item
treatment with extensive external beam radiation therapy or radionuclide therapy within 6 weeks of study entry (palliative radiation involving less than 20 percent of bone marrow reserves must have been completed at least 4 weeks before study entry)
boolean
C1517033 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
C0203608 (UMLS CUI [2,1])
C0205231 (UMLS CUI [2,2])
C3898008 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C3898008 (UMLS CUI [4,1])
C1314939 (UMLS CUI [4,2])
C0005953 (UMLS CUI [4,3])
C1708947 (UMLS CUI [4,4])
C0439165 (UMLS CUI [4,5])
Contraceptive methods Adequate Lacking
Item
participant not employing adequate contraception
boolean
C0700589 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Illness Serious | Medical condition | Congestive heart failure Uncontrolled | Myocardial Infarction | Angina Pectoris | INFECTIOUS PROCESS | Chronic liver disease | Hepatitis B, Chronic | Hepatitis C, Chronic | Liver Cirrhosis
Item
other serious illness or medical conditions as : uncontrolled congestive heart failure or history of myocardial infection or active angina pectoris within six months preceding registration; active infectious process; chronic active liver disease, including chronic hepatitis b, chronic hepatitis c, or cirrhosis
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0002962 (UMLS CUI [5])
C0745283 (UMLS CUI [6])
C0341439 (UMLS CUI [7])
C0524909 (UMLS CUI [8])
C0524910 (UMLS CUI [9])
C0023890 (UMLS CUI [10])
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