ID

21657

Description

Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00956228

Link

https://clinicaltrials.gov/show/NCT00956228

Keywords

  1. 4/27/17 4/27/17 -
Uploaded on

April 27, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Prostatic Neoplasm NCT00956228

Eligibility Prostatic Neoplasm NCT00956228

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with pathologically proven prostate cancer
Description

Prostate Cancer

Data type

boolean

Alias
UMLS CUI [1]
C0600139
no evidence of distant metastases (m0) on physical examination, bone scan
Description

Metastases

Data type

boolean

Alias
UMLS CUI [1]
C0027627
ecog ps 0,1,2
Description

ECOG Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ function as evidenced by:
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
hemoglobin > 10.0 gm/dl
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
white blood count > 3000/mcl
Description

White Blood Count

Data type

boolean

Alias
UMLS CUI [1]
C0023508
platelet count > 90,000/mcl
Description

Platelet

Data type

boolean

Alias
UMLS CUI [1]
C0032181
ast < 2x normal
Description

AST

Data type

boolean

Alias
UMLS CUI [1]
C0201899
age > 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients can not be allergic to leuprolide or goserelin if the pretreatment psa > 20, gleason score > 8, t3/4, or n1 disease
Description

Hypersensitivity to leuprolide or goserelin, PSA level, Gleason Score, Tumor Stage

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0085272
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0120107
UMLS CUI [3]
C0201544
UMLS CUI [4]
C0332326
UMLS CUI [5]
C1300072
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
we anticipate enrolling at least 50 patients per year, which would bring accrual to projected total of 100 patients in 2 years
Description

Number of enrolled patients

Data type

boolean

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C2347180
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
none
Description

None

Data type

boolean

Alias
UMLS CUI [1]
C0549184

Similar models

Eligibility Prostatic Neoplasm NCT00956228

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Prostate Cancer
Item
patients with pathologically proven prostate cancer
boolean
C0600139 (UMLS CUI [1])
Metastases
Item
no evidence of distant metastases (m0) on physical examination, bone scan
boolean
C0027627 (UMLS CUI [1])
ECOG Performance Status
Item
ecog ps 0,1,2
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
adequate organ function as evidenced by:
boolean
C0678852 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin > 10.0 gm/dl
boolean
C0518015 (UMLS CUI [1])
White Blood Count
Item
white blood count > 3000/mcl
boolean
C0023508 (UMLS CUI [1])
Platelet
Item
platelet count > 90,000/mcl
boolean
C0032181 (UMLS CUI [1])
AST
Item
ast < 2x normal
boolean
C0201899 (UMLS CUI [1])
Age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
Hypersensitivity to leuprolide or goserelin, PSA level, Gleason Score, Tumor Stage
Item
patients can not be allergic to leuprolide or goserelin if the pretreatment psa > 20, gleason score > 8, t3/4, or n1 disease
boolean
C0020517 (UMLS CUI [1,1])
C0085272 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0120107 (UMLS CUI [2,2])
C0201544 (UMLS CUI [3])
C0332326 (UMLS CUI [4])
C1300072 (UMLS CUI [5])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Number of enrolled patients
Item
we anticipate enrolling at least 50 patients per year, which would bring accrual to projected total of 100 patients in 2 years
boolean
C0449788 (UMLS CUI [1,1])
C2347180 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
None
Item
none
boolean
C0549184 (UMLS CUI [1])

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