ID

15502

Description

Oral Estramustine and Oral Vinorelbine in the Treatment of Hormone-Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00151086

Link

https://clinicaltrials.gov/show/NCT00151086

Keywords

  1. 6/1/16 6/1/16 -
Uploaded on

June 1, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT00151086

Eligibility Prostate Cancer NCT00151086

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
patients must have a histologic diagnosis of adenocarcinoma of the prostate. (no evidence of brain metastasis or untreated spinal cord compression.)
Description

adenocarcinoma of the prostate

Data type

boolean

Alias
UMLS CUI [1]
C0600139
patients on total androgen suppression therapy must undergo nonsteroidal antiandrogen withdrawal and demonstrate at rising psa (prostate specific antigen) 4 weeks after withdrawal for flutamide and 6 weeks after withdrawal for bicalutamide or nilutamide.
Description

androgen suppression therapy

Data type

boolean

patients must have measurable soft tissue disease or evaluable (abnormal bone scan and/or elevated psa). if psa is the only evidence of progressive disease it must be greater than or equal to 4ng/ml.
Description

measurable soft tissue disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0263978
UMLS CUI [1,2]
C1513041
adequate bone marrow, renal and liver function
Description

bone marrow renal and liver function

Data type

boolean

Alias
UMLS CUI [1]
C0005953
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
ecog (eastern cooperative oncology group) performance status of 0-2 (a measure of general well being on a scale of 0-5 where 0 represents asymptomatic and 5 represents death)
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
must be at least 18 years of age
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
must have a life expectancy of greater than or equal to 12 weeks
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
have previously received vinca alkaloid-based cytotoxic chemotherapy or radiation to greater than or equal to 50% of the total bone marrow.
Description

vinca alkaloid-based cytotoxic chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0042672
UMLS CUI [1,2]
C0392920
UMLS CUI [2]
C1522449
evidence of brain metastasis
Description

brain metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0220650
spinal cord compression
Description

spinal cord compression

Data type

boolean

Alias
UMLS CUI [1]
C0037926
prior malignancy except for in situ carcinoma, nonmelanoma skin cancer, or adequately treated malignancy that has been inactive for less than 3 years
Description

prior malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
patients with preexisting neuropathy of greater than or equal to grade 2
Description

preexisting neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0442874
active gastrointestinal disease, or a disorder that alters gastrointestinal motility or absorption
Description

active gastrointestinal disease

Data type

boolean

Alias
UMLS CUI [1]
C0017178

Similar models

Eligibility Prostate Cancer NCT00151086

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
adenocarcinoma of the prostate
Item
patients must have a histologic diagnosis of adenocarcinoma of the prostate. (no evidence of brain metastasis or untreated spinal cord compression.)
boolean
C0600139 (UMLS CUI [1])
androgen suppression therapy
Item
patients on total androgen suppression therapy must undergo nonsteroidal antiandrogen withdrawal and demonstrate at rising psa (prostate specific antigen) 4 weeks after withdrawal for flutamide and 6 weeks after withdrawal for bicalutamide or nilutamide.
boolean
measurable soft tissue disease
Item
patients must have measurable soft tissue disease or evaluable (abnormal bone scan and/or elevated psa). if psa is the only evidence of progressive disease it must be greater than or equal to 4ng/ml.
boolean
C0263978 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
bone marrow renal and liver function
Item
adequate bone marrow, renal and liver function
boolean
C0005953 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
ecog
Item
ecog (eastern cooperative oncology group) performance status of 0-2 (a measure of general well being on a scale of 0-5 where 0 represents asymptomatic and 5 represents death)
boolean
C1520224 (UMLS CUI [1])
age
Item
must be at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
life expectancy
Item
must have a life expectancy of greater than or equal to 12 weeks
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI-1)
vinca alkaloid-based cytotoxic chemotherapy
Item
have previously received vinca alkaloid-based cytotoxic chemotherapy or radiation to greater than or equal to 50% of the total bone marrow.
boolean
C0042672 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
brain metastasis
Item
evidence of brain metastasis
boolean
C0220650 (UMLS CUI [1])
spinal cord compression
Item
spinal cord compression
boolean
C0037926 (UMLS CUI [1])
prior malignancy
Item
prior malignancy except for in situ carcinoma, nonmelanoma skin cancer, or adequately treated malignancy that has been inactive for less than 3 years
boolean
C0006826 (UMLS CUI [1])
preexisting neuropathy
Item
patients with preexisting neuropathy of greater than or equal to grade 2
boolean
C0442874 (UMLS CUI [1])
active gastrointestinal disease
Item
active gastrointestinal disease, or a disorder that alters gastrointestinal motility or absorption
boolean
C0017178 (UMLS CUI [1])

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