ID

13367

Description

Leuprorelin Associated With Radiotherapy Versus Leuprorelin Alone in T3 - T4 or pT3 (on Biopsy) N0, M0 Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01122121

Link

https://clinicaltrials.gov/show/NCT01122121

Keywords

Versions (1)
  1. 2/9/16 2/9/16 -
Uploaded on

February 9, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms, Locally Advanced NCT01122121

English

Eligibility Prostatic Neoplasms, Locally Advanced NCT01122121

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed locally advanced adenocarcinoma of the prostate, graded: t3 or t4 or pt3 on biopsies (presence of tumour tissue in periprostatic fat observed on biopsies), n0 (absence of metastatic), m0 (no distant metastases detectable on the following examinations: bone scan, chest x-ray, abdominal and pelvic ultrasound).
Description

prostate adenocarcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007112
UMLS CUI [2]
C1300072
patient in whom the prostatic adenocarcinoma has received no prior treatment of any type, with the possible exception of transurethral resection due to obstructive symptoms.
Description

therapy

Data type

boolean

Alias
UMLS CUI [1]
C0087111
patient with a karnofsky index greater than or equal to (≥) 70.
Description

karnofsky

Data type

boolean

Alias
UMLS CUI [1]
C0206065
patient aged under 80 years on the randomization date.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient with a life expectancy of at least 7 years.
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
patient who, after having received clear information, gave his written consent to participate and cooperate in the study.
Description

consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patient for whom a recent blood test (less than [<] 2 months) has not revealed elevated transaminases ≥ 3 times the normal laboratory range.
Description

transaminases

Data type

boolean

Alias
UMLS CUI [1]
C0002594
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient incapable of understanding the information supplied concerning the study or of giving his consent, or having refused to sign the informed consent form,
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patient for whom there is a risk that follow-up in compliance with the conditions stipulated by the protocol will not be possible,
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
patient having already received prior treatment for prostate cancer, excluding transurethral resection of the prostate to relieve obstruction,
Description

therapy

Data type

boolean

Alias
UMLS CUI [1]
C0087111
patient having undergone surgical castration, or with a history of bilateral adrenalectomy or hypophysectomy,
Description

surgical castration

Data type

boolean

Alias
UMLS CUI [1]
C0007347
patient having had another cancer within the previous 5 years (including carcinoma in situ of the bladder) excluding basocellular epithelioma or carcinoma in situ (other than in the bladder),
Description

cancer

Data type

boolean

Alias
UMLS CUI [1]
C0006826
patient with lymph node or metastatic spread of the prostatic adenocarcinoma suspected on imaging,
Description

metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
patient with a non-controlled severe active disease,
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patient with a contraindication to external prostatic radiotherapy,
Description

contraindication

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1522449
patient receiving or having received another experimental treatment within 3 months prior to inclusion in the study,
Description

study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
patient with impaired liver function or elevated transaminases ≥3 times the normal laboratory range.
Description

liver dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0086565
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Similar models

Eligibility Prostatic Neoplasms, Locally Advanced NCT01122121

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
prostate adenocarcinoma
Item
histologically confirmed locally advanced adenocarcinoma of the prostate, graded: t3 or t4 or pt3 on biopsies (presence of tumour tissue in periprostatic fat observed on biopsies), n0 (absence of metastatic), m0 (no distant metastases detectable on the following examinations: bone scan, chest x-ray, abdominal and pelvic ultrasound).
boolean
C0007112 (UMLS CUI [1])
C1300072 (UMLS CUI [2])
therapy
Item
patient in whom the prostatic adenocarcinoma has received no prior treatment of any type, with the possible exception of transurethral resection due to obstructive symptoms.
boolean
C0087111 (UMLS CUI [1])
karnofsky
Item
patient with a karnofsky index greater than or equal to (≥) 70.
boolean
C0206065 (UMLS CUI [1])
age
Item
patient aged under 80 years on the randomization date.
boolean
C0001779 (UMLS CUI [1])
life expectancy
Item
patient with a life expectancy of at least 7 years.
boolean
C0023671 (UMLS CUI [1])
consent
Item
patient who, after having received clear information, gave his written consent to participate and cooperate in the study.
boolean
C0021430 (UMLS CUI [1])
transaminases
Item
patient for whom a recent blood test (less than [<] 2 months) has not revealed elevated transaminases ≥ 3 times the normal laboratory range.
boolean
C0002594 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
informed consent
Item
patient incapable of understanding the information supplied concerning the study or of giving his consent, or having refused to sign the informed consent form,
boolean
C0021430 (UMLS CUI [1])
compliance
Item
patient for whom there is a risk that follow-up in compliance with the conditions stipulated by the protocol will not be possible,
boolean
C1321605 (UMLS CUI [1])
therapy
Item
patient having already received prior treatment for prostate cancer, excluding transurethral resection of the prostate to relieve obstruction,
boolean
C0087111 (UMLS CUI [1])
surgical castration
Item
patient having undergone surgical castration, or with a history of bilateral adrenalectomy or hypophysectomy,
boolean
C0007347 (UMLS CUI [1])
cancer
Item
patient having had another cancer within the previous 5 years (including carcinoma in situ of the bladder) excluding basocellular epithelioma or carcinoma in situ (other than in the bladder),
boolean
C0006826 (UMLS CUI [1])
metastasis
Item
patient with lymph node or metastatic spread of the prostatic adenocarcinoma suspected on imaging,
boolean
C0027627 (UMLS CUI [1])
comorbidity
Item
patient with a non-controlled severe active disease,
boolean
C0009488 (UMLS CUI [1])
contraindication
Item
patient with a contraindication to external prostatic radiotherapy,
boolean
C1301624 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
study subject participation status
Item
patient receiving or having received another experimental treatment within 3 months prior to inclusion in the study,
boolean
C2348568 (UMLS CUI [1])
liver dysfunction
Item
patient with impaired liver function or elevated transaminases ≥3 times the normal laboratory range.
boolean
C0086565 (UMLS CUI [1])
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