ID

18125

Beschrijving

Phase II Trial of Docetaxel and Celecoxib in Patients With Androgen Independent Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00494338

Link

https://clinicaltrials.gov/show/NCT00494338

Trefwoorden

  1. 21-10-16 21-10-16 -
Geüploaded op

21 oktober 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Metastatic Prostate Cancer NCT00494338

Eligibility Metastatic Prostate Cancer NCT00494338

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically confirmed maipc
Beschrijving

Androgen Insensitive Prostatic Neoplasms Metastatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C3658267
UMLS CUI [1,2]
C0036525
documented progressive disease in bone, soft tissue or psa despite castrate levels of testosterone
Beschrijving

Progressive Disease bone | Progressive Disease soft tissue | Prostate-Specific Antigen | Testosterone level

Datatype

boolean

Alias
UMLS CUI [1,1]
C1335499
UMLS CUI [1,2]
C0262950
UMLS CUI [2,1]
C1335499
UMLS CUI [2,2]
C0225317
UMLS CUI [3]
C0138741
UMLS CUI [4]
C0428412
if lhrh agonist were used previously it must be kept
Beschrijving

Luteinizing Hormone-releasing Hormone Agonist

Datatype

boolean

Alias
UMLS CUI [1]
C1518041
previous anti-androgen should be held at least 4 weeks for flutamida or cyproterone and 6 weeks for bycalumida
Beschrijving

Androgen Antagonists | Flutamide | Cyproterone

Datatype

boolean

Alias
UMLS CUI [1]
C0002842
UMLS CUI [2]
C0016384
UMLS CUI [3]
C0010621
previous des should be held for at least 4 weeks before partcipating in the trial
Beschrijving

Diethylstilbestrol

Datatype

boolean

Alias
UMLS CUI [1]
C0012203
chemotherapy naive patients
Beschrijving

Chemotherapy naive

Datatype

boolean

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C0919936
no prior radioisotope
Beschrijving

Radioisotopes

Datatype

boolean

Alias
UMLS CUI [1]
C0034595
less than 25% of bone marrow should be irradiated for prior palliative radiotherapy
Beschrijving

Palliative course of radiotherapy Bone Marrow Percentage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0475092
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
kps> 70%
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
adequate hematologic, hepatic and renal function
Beschrijving

Hematologic function | Liver function | Renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with serious medical illness
Beschrijving

Illness Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
history of significant active cardiac disease
Beschrijving

Heart Disease Significant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0750502
history of gastrointestinal ulceration, bleeding or perforation
Beschrijving

Gastrointestinal ulceration | Gastrointestinal Hemorrhage | Gastrointestinal perforation

Datatype

boolean

Alias
UMLS CUI [1]
C1963975
UMLS CUI [2]
C0017181
UMLS CUI [3]
C0151664
history of myocardial infarctin within past 12 months
Beschrijving

Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
allergy to sulfonamides or to celecoxib or history of urticaria to any nsaid
Beschrijving

Allergy to sulfonamides | Hypersensitivity celecoxib | Urticaria Due to NSAIDS

Datatype

boolean

Alias
UMLS CUI [1]
C0038757
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0538927
UMLS CUI [3,1]
C0042109
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0003211
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Metastatic Prostate Cancer NCT00494338

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Androgen Insensitive Prostatic Neoplasms Metastatic
Item
patients with histologically confirmed maipc
boolean
C3658267 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Progressive Disease bone | Progressive Disease soft tissue | Prostate-Specific Antigen | Testosterone level
Item
documented progressive disease in bone, soft tissue or psa despite castrate levels of testosterone
boolean
C1335499 (UMLS CUI [1,1])
C0262950 (UMLS CUI [1,2])
C1335499 (UMLS CUI [2,1])
C0225317 (UMLS CUI [2,2])
C0138741 (UMLS CUI [3])
C0428412 (UMLS CUI [4])
Luteinizing Hormone-releasing Hormone Agonist
Item
if lhrh agonist were used previously it must be kept
boolean
C1518041 (UMLS CUI [1])
Androgen Antagonists | Flutamide | Cyproterone
Item
previous anti-androgen should be held at least 4 weeks for flutamida or cyproterone and 6 weeks for bycalumida
boolean
C0002842 (UMLS CUI [1])
C0016384 (UMLS CUI [2])
C0010621 (UMLS CUI [3])
Diethylstilbestrol
Item
previous des should be held for at least 4 weeks before partcipating in the trial
boolean
C0012203 (UMLS CUI [1])
Chemotherapy naive
Item
chemotherapy naive patients
boolean
C3665472 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Radioisotopes
Item
no prior radioisotope
boolean
C0034595 (UMLS CUI [1])
Palliative course of radiotherapy Bone Marrow Percentage
Item
less than 25% of bone marrow should be irradiated for prior palliative radiotherapy
boolean
C0475092 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Karnofsky Performance Status
Item
kps> 70%
boolean
C0206065 (UMLS CUI [1])
Hematologic function | Liver function | Renal function
Item
adequate hematologic, hepatic and renal function
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Illness Serious
Item
patients with serious medical illness
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Heart Disease Significant
Item
history of significant active cardiac disease
boolean
C0018799 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Gastrointestinal ulceration | Gastrointestinal Hemorrhage | Gastrointestinal perforation
Item
history of gastrointestinal ulceration, bleeding or perforation
boolean
C1963975 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
C0151664 (UMLS CUI [3])
Myocardial Infarction
Item
history of myocardial infarctin within past 12 months
boolean
C0027051 (UMLS CUI [1])
Allergy to sulfonamides | Hypersensitivity celecoxib | Urticaria Due to NSAIDS
Item
allergy to sulfonamides or to celecoxib or history of urticaria to any nsaid
boolean
C0038757 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0538927 (UMLS CUI [2,2])
C0042109 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0003211 (UMLS CUI [3,3])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])

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