ID

22585

Beschreibung

A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD; ODM derived from: https://clinicaltrials.gov/show/NCT00378690

Link

https://clinicaltrials.gov/show/NCT00378690

Stichworte

Versionen (1)
  1. 08.06.17 08.06.17 -
Hochgeladen am

8. Juni 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostate Cancer DRKS00004016 NCT00378690

Englisch

Eligibility Prostate Cancer NCT00378690

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
at study entry (visit 1):
Beschreibung

Clinical Trial Start time

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C1301880
written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
male subjects aged >=18 and <80 years old
Beschreibung

Gender | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
locally advanced (stage t3 or t4) prostate cancer or relapsing prostate cancer following radical prostatectomy or,relapsing prostate cancer following radiotherapy
Beschreibung

Prostate carcinoma Advanced Local TNM clinical staging | Prostate cancer recurrent Post Radical prostatectomy | Prostate cancer recurrent Post Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C0278838
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0194810
UMLS CUI [3,1]
C0278838
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C1522449
gleason score of >=6
Beschreibung

Gleason score

Datentyp

boolean

Alias
UMLS CUI [1]
C3203027
ecog performance status of 0-2.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy at least 5 years
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
at randomization (visit 4):
Beschreibung

Randomization Timepoint

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C2348792
two successive decreasing serum psa levels <=1 ng/ml
Beschreibung

Prostatic specific antigen decreased Levels Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0178414
UMLS CUI [1,2]
C0441889
UMLS CUI [1,3]
C1265611
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
at study entry (visit 1):
Beschreibung

Clinical Trial Start time

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C1301880
any suspected second primary tumors
Beschreibung

Second Primary Cancers Suspected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0751623
UMLS CUI [1,2]
C0750491
evidence of metastatic disease
Beschreibung

Neoplasm Metastasis Evidence of

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332120
other malignancy within the last 5 years except
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
acute spinal cord compression, uni- or bilateral ureteric obstruction
Beschreibung

Compression of spinal cord | Ureteral obstruction Unilateral | Ureteral obstruction Bilateral

Datentyp

boolean

Alias
UMLS CUI [1]
C0037926
UMLS CUI [2,1]
C0041956
UMLS CUI [2,2]
C0205092
UMLS CUI [3,1]
C0041956
UMLS CUI [3,2]
C0238767
any concurrent biological response modifier therapy
Beschreibung

Biological Response Modifier Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0005527
concurrent chemotherapy
Beschreibung

Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
less than 1 year since any prior neoadjuvant or adjuvant hormonal therapy
Beschreibung

Hormone Therapy Neoadjuvant | Hormone Therapy Adjuvant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0600558
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C1522673
less than 6 months since prior 5-alpha reductase inhibitor treatment
Beschreibung

5-alpha Reductase Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C2936788
other concurrent hormonal therapy
Beschreibung

Hormone Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0279025
any concurrent radiotherapy
Beschreibung

Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
testosterone at screening <= 1.7 mm or 50 ng/dl
Beschreibung

Testosterone measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0523912
clinically significant elevation of serum creatinine or liver enzymes
Beschreibung

Serum creatinine raised | Elevated liver enzymes

Datentyp

boolean

Alias
UMLS CUI [1]
C0700225
UMLS CUI [2]
C0235996
hypersensitivity to gnrh or other gnrh analogues or leuprorelin acetate
Beschreibung

Hypersensitivity GnRH | Hypersensitivity GnRH Analog | Hypersensitivity Leuprorelin Acetate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0023610
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1518041
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0700596
hypersensitivity to casodexâ 50 mg.
Beschreibung

Hypersensitivity Casodex

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0591237
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Ähnliche Modelle

Eligibility Prostate Cancer NCT00378690

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Clinical Trial Start time
Item
at study entry (visit 1):
boolean
C0008976 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Gender | Age
Item
male subjects aged >=18 and <80 years old
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Prostate carcinoma Advanced Local TNM clinical staging | Prostate cancer recurrent Post Radical prostatectomy | Prostate cancer recurrent Post Therapeutic radiology procedure
Item
locally advanced (stage t3 or t4) prostate cancer or relapsing prostate cancer following radical prostatectomy or,relapsing prostate cancer following radiotherapy
boolean
C0600139 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0278838 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0194810 (UMLS CUI [2,3])
C0278838 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
Gleason score
Item
gleason score of >=6
boolean
C3203027 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0-2.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy at least 5 years
boolean
C0023671 (UMLS CUI [1])
Randomization Timepoint
Item
at randomization (visit 4):
boolean
C0034656 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Prostatic specific antigen decreased Levels Quantity
Item
two successive decreasing serum psa levels <=1 ng/ml
boolean
C0178414 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Clinical Trial Start time
Item
at study entry (visit 1):
boolean
C0008976 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Second Primary Cancers Suspected
Item
any suspected second primary tumors
boolean
C0751623 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
Neoplasm Metastasis Evidence of
Item
evidence of metastatic disease
boolean
C0027627 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Malignant Neoplasms
Item
other malignancy within the last 5 years except
boolean
C0006826 (UMLS CUI [1])
Compression of spinal cord | Ureteral obstruction Unilateral | Ureteral obstruction Bilateral
Item
acute spinal cord compression, uni- or bilateral ureteric obstruction
boolean
C0037926 (UMLS CUI [1])
C0041956 (UMLS CUI [2,1])
C0205092 (UMLS CUI [2,2])
C0041956 (UMLS CUI [3,1])
C0238767 (UMLS CUI [3,2])
Biological Response Modifier Therapy
Item
any concurrent biological response modifier therapy
boolean
C0005527 (UMLS CUI [1])
Chemotherapy
Item
concurrent chemotherapy
boolean
C0392920 (UMLS CUI [1])
Hormone Therapy Neoadjuvant | Hormone Therapy Adjuvant
Item
less than 1 year since any prior neoadjuvant or adjuvant hormonal therapy
boolean
C0279025 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
5-alpha Reductase Inhibitors
Item
less than 6 months since prior 5-alpha reductase inhibitor treatment
boolean
C2936788 (UMLS CUI [1])
Hormone Therapy
Item
other concurrent hormonal therapy
boolean
C0279025 (UMLS CUI [1])
Therapeutic radiology procedure
Item
any concurrent radiotherapy
boolean
C1522449 (UMLS CUI [1])
Testosterone measurement
Item
testosterone at screening <= 1.7 mm or 50 ng/dl
boolean
C0523912 (UMLS CUI [1])
Serum creatinine raised | Elevated liver enzymes
Item
clinically significant elevation of serum creatinine or liver enzymes
boolean
C0700225 (UMLS CUI [1])
C0235996 (UMLS CUI [2])
Hypersensitivity GnRH | Hypersensitivity GnRH Analog | Hypersensitivity Leuprorelin Acetate
Item
hypersensitivity to gnrh or other gnrh analogues or leuprorelin acetate
boolean
C0020517 (UMLS CUI [1,1])
C0023610 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1518041 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0700596 (UMLS CUI [3,2])
Hypersensitivity Casodex
Item
hypersensitivity to casodexâ 50 mg.
boolean
C0020517 (UMLS CUI [1,1])
C0591237 (UMLS CUI [1,2])
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