ID

31658

Beschreibung

GEMOX in Docetaxel-Refractory Castration-Resistant Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01487720

Link

https://clinicaltrials.gov/show/NCT01487720

Stichworte

Versionen (1)
  1. 17.09.18 17.09.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

17. September 2018

DOI

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Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT01487720

Englisch

Eligibility Prostate Cancer NCT01487720

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed adenocarcinoma of the prostate
Beschreibung

Adenocarcinoma of prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C0007112
clinical or radiologic evidence of metastatic disease
Beschreibung

Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0027627
documented disease progression during hormone therapy (adt plus antiandrogen) and no response to adt withdrawal
Beschreibung

Disease Progression During Hormone Therapy | Antiandrogen therapy | Androgen Antagonists | Antiandrogen therapy Withdrawal Without Response

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0279025
UMLS CUI [2]
C0279492
UMLS CUI [3]
C0002842
UMLS CUI [4,1]
C0279492
UMLS CUI [4,2]
C2349954
UMLS CUI [4,3]
C0332288
UMLS CUI [4,4]
C1704632
docetaxel-refractory disease defined as disease progression documented either during treatment of within 60 days after the cessation of treatment with docetaxel
Beschreibung

Docetaxel Refractory Disease | Disease Progression During Therapeutic procedure | Disease Progression Post Cessation Docetaxel

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0246415
UMLS CUI [1,2]
C1514815
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C0087111
UMLS CUI [3,1]
C0242656
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C1880019
UMLS CUI [3,4]
C0246415
prior exposure to estramustine or mitoxantrone is allowed
Beschreibung

Exposure to Estramustine | Exposure to Mitoxantrone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0014921
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0026259
kps ≥ 60
Beschreibung

Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
no prior radioisotope therapy
Beschreibung

Radioisotope therapy Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0203608
UMLS CUI [1,2]
C0332197
no prior radiotherapy 25% or more of the bone marrow
Beschreibung

Absence Therapeutic radiology procedure Bone Marrow Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0005953
UMLS CUI [1,4]
C0439165
no peripheral neuropathy grade 2 or worse
Beschreibung

Peripheral Neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
adequate organ and bone marrow function
Beschreibung

Organ function | Bone Marrow function

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
other tumor type than adenocarcinoma
Beschreibung

Cancer Other | Exception Adenocarcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0001418
presence or history of cns metastasis
Beschreibung

CNS metastases

Datentyp

boolean

Alias
UMLS CUI [1]
C0686377
other serious illness or medical conditions
Beschreibung

Illness Serious | Other medical condition Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
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Ähnliche Modelle

Eligibility Prostate Cancer NCT01487720

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histologically or cytologically confirmed adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Neoplasm Metastasis
Item
clinical or radiologic evidence of metastatic disease
boolean
C0027627 (UMLS CUI [1])
Disease Progression During Hormone Therapy | Antiandrogen therapy | Androgen Antagonists | Antiandrogen therapy Withdrawal Without Response
Item
documented disease progression during hormone therapy (adt plus antiandrogen) and no response to adt withdrawal
boolean
C0242656 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0279025 (UMLS CUI [1,3])
C0279492 (UMLS CUI [2])
C0002842 (UMLS CUI [3])
C0279492 (UMLS CUI [4,1])
C2349954 (UMLS CUI [4,2])
C0332288 (UMLS CUI [4,3])
C1704632 (UMLS CUI [4,4])
Docetaxel Refractory Disease | Disease Progression During Therapeutic procedure | Disease Progression Post Cessation Docetaxel
Item
docetaxel-refractory disease defined as disease progression documented either during treatment of within 60 days after the cessation of treatment with docetaxel
boolean
C0246415 (UMLS CUI [1,1])
C1514815 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0242656 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C1880019 (UMLS CUI [3,3])
C0246415 (UMLS CUI [3,4])
Exposure to Estramustine | Exposure to Mitoxantrone
Item
prior exposure to estramustine or mitoxantrone is allowed
boolean
C0332157 (UMLS CUI [1,1])
C0014921 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0026259 (UMLS CUI [2,2])
Karnofsky Performance Status
Item
kps ≥ 60
boolean
C0206065 (UMLS CUI [1])
Radioisotope therapy Absent
Item
no prior radioisotope therapy
boolean
C0203608 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Absence Therapeutic radiology procedure Bone Marrow Percentage
Item
no prior radiotherapy 25% or more of the bone marrow
boolean
C0332197 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
Peripheral Neuropathy CTCAE Grades
Item
no peripheral neuropathy grade 2 or worse
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Organ function | Bone Marrow function
Item
adequate organ and bone marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Exception Adenocarcinoma
Item
other tumor type than adenocarcinoma
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0001418 (UMLS CUI [2,2])
CNS metastases
Item
presence or history of cns metastasis
boolean
C0686377 (UMLS CUI [1])
Illness Serious | Other medical condition Serious
Item
other serious illness or medical conditions
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
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