ID

16445

Beschrijving

An Open Trial to Assess the Efficacy and Safety of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00201357

Link

https://clinicaltrials.gov/show/NCT00201357

Trefwoorden

Versies (1)
  1. 16-07-16 16-07-16 -
Geüploaded op

16 juli 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hormone-Refractory Prostate Cancer NCT00201357

Engels

Eligibility Hormone-Refractory Prostate Cancer NCT00201357

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age or older.
Beschrijving

18 years of age or older

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
histologically or cytologically confirmed adenocarcinoma of prostate that is metastatic, hormone-refractory (confirmed by testing serum testosterone), and clinically progressive following at least one prior hormonal regimen.
Beschrijving

confirmed adenocarcinoma of prostate (metastatic, hormonerefractory, clinically progressive)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C1328504
UMLS CUI [1,4]
C0677932
patients must have documented progression of disease on anti-androgen withdrawal, if the patient have documented progression on previous anti-androgen therapy.
Beschrijving

progression on previous anti-androgen therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677932
UMLS CUI [1,2]
C0279492
measurable (patient with measurable bi-dimensional disease) or evaluable disease (defined as the presence of a nonmeasurable abnormality on ct or on physical examination coupled with a psa ³ 30).
Beschrijving

measurable disease or evaluable disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
karnofsky performance status ³ 60%.6. adequate bone marrow functions: granulocyte count 1,000/mm3, platelets 75,000/mm3, haemoglobin 8 g/dl.
Beschrijving

karnofsky performance status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
adequate renal and liver functions: creatinine < 1.5 mg/dl, bilirubin < 2 mg/dl, alt/ast less than 2.5 times the upper limit of the reference range for the institute.
Beschrijving

creatinine, bilirubine, alt/ast measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0201975
UMLS CUI [1,2]
C0344395
UMLS CUI [1,3]
C0201836
UMLS CUI [1,4]
C0201899
patients with chemical or clinical hypothyroidism should have their thyroid replacement prior to starting study.
Beschrijving

thyroid replacement

Datatype

boolean

Alias
UMLS CUI [1]
C2242640
patients must have recovered from the effect of recent surgery (at least 4 weeks apart), radiotherapy (at least 4 weeks apart).
Beschrijving

from the effect of recent surgery

Datatype

boolean

Alias
UMLS CUI [1,1]
C2004454
UMLS CUI [1,2]
C2169607
patients have ability to complete quality of life (qol) questionnaires.
Beschrijving

ability to complete quality of life questionnaires

Datatype

boolean

Alias
UMLS CUI [1]
C1321605
patients must sign informed consent.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with advanced second primary malignancy.
Beschrijving

advanced second primary malignancy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0751623
UMLS CUI [1,2]
C0679246
patients with brain metastases.
Beschrijving

patients with brain metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
patients with hypersensitivity to thalidomide.
Beschrijving

patients with hypersensitivity to thalidomide

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039736
history of myocardial infarction within past 6 months, uncontrolled congestive heart failure or angina pectoris.
Beschrijving

history of myocardial infarction, uncontrolled congestive heart failure or angina pectoris.

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0742746
UMLS CUI [3]
C0002962
patients with orthostatic hypotension before therapy.
Beschrijving

patients with orthostatic hypotension before therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0020651
patients with nci ctc grade 3 or greater peripheral neuropathy of any cause that is clinically detectable.
Beschrijving

nci grade or peripheral neuropathy

Datatype

boolean

Alias
UMLS CUI [1]
C3887242
UMLS CUI [2]
C0031117
patients with active infection, including positive serology for hiv.
Beschrijving

active infection, including positive serology for hiv

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0019693
patients who have received chemotherapy before for treatment of metastases of prostate cancer, or received other investigational agents or corticosteroids within 4 weeks prior to enrollment of study.
Beschrijving

prior chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C1514457
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Similar models

Eligibility Hormone-Refractory Prostate Cancer NCT00201357

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
18 years of age or older
Item
18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
confirmed adenocarcinoma of prostate (metastatic, hormonerefractory, clinically progressive)
Item
histologically or cytologically confirmed adenocarcinoma of prostate that is metastatic, hormone-refractory (confirmed by testing serum testosterone), and clinically progressive following at least one prior hormonal regimen.
boolean
C0007112 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C1328504 (UMLS CUI [1,3])
C0677932 (UMLS CUI [1,4])
progression on previous anti-androgen therapy
Item
patients must have documented progression of disease on anti-androgen withdrawal, if the patient have documented progression on previous anti-androgen therapy.
boolean
C0677932 (UMLS CUI [1,1])
C0279492 (UMLS CUI [1,2])
measurable disease or evaluable disease
Item
measurable (patient with measurable bi-dimensional disease) or evaluable disease (defined as the presence of a nonmeasurable abnormality on ct or on physical examination coupled with a psa ³ 30).
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
karnofsky performance status
Item
karnofsky performance status ³ 60%.6. adequate bone marrow functions: granulocyte count 1,000/mm3, platelets 75,000/mm3, haemoglobin 8 g/dl.
boolean
C0206065 (UMLS CUI [1])
creatinine, bilirubine, alt/ast measurement
Item
adequate renal and liver functions: creatinine < 1.5 mg/dl, bilirubin < 2 mg/dl, alt/ast less than 2.5 times the upper limit of the reference range for the institute.
boolean
C0201975 (UMLS CUI [1,1])
C0344395 (UMLS CUI [1,2])
C0201836 (UMLS CUI [1,3])
C0201899 (UMLS CUI [1,4])
thyroid replacement
Item
patients with chemical or clinical hypothyroidism should have their thyroid replacement prior to starting study.
boolean
C2242640 (UMLS CUI [1])
from the effect of recent surgery
Item
patients must have recovered from the effect of recent surgery (at least 4 weeks apart), radiotherapy (at least 4 weeks apart).
boolean
C2004454 (UMLS CUI [1,1])
C2169607 (UMLS CUI [1,2])
ability to complete quality of life questionnaires
Item
patients have ability to complete quality of life (qol) questionnaires.
boolean
C1321605 (UMLS CUI [1])
informed consent
Item
patients must sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
advanced second primary malignancy
Item
patients with advanced second primary malignancy.
boolean
C0751623 (UMLS CUI [1,1])
C0679246 (UMLS CUI [1,2])
patients with brain metastases
Item
patients with brain metastases.
boolean
C0220650 (UMLS CUI [1])
patients with hypersensitivity to thalidomide
Item
patients with hypersensitivity to thalidomide.
boolean
C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
history of myocardial infarction, uncontrolled congestive heart failure or angina pectoris.
Item
history of myocardial infarction within past 6 months, uncontrolled congestive heart failure or angina pectoris.
boolean
C0027051 (UMLS CUI [1])
C0742746 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
patients with orthostatic hypotension before therapy
Item
patients with orthostatic hypotension before therapy.
boolean
C0020651 (UMLS CUI [1])
nci grade or peripheral neuropathy
Item
patients with nci ctc grade 3 or greater peripheral neuropathy of any cause that is clinically detectable.
boolean
C3887242 (UMLS CUI [1])
C0031117 (UMLS CUI [2])
active infection, including positive serology for hiv
Item
patients with active infection, including positive serology for hiv.
boolean
C0009450 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
prior chemotherapy
Item
patients who have received chemotherapy before for treatment of metastases of prostate cancer, or received other investigational agents or corticosteroids within 4 weeks prior to enrollment of study.
boolean
C1514457 (UMLS CUI [1])
Terug naar het begin van de pagina 

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