ID

16445

Description

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

Keywords

Versions (1)
  1. 7/16/16 7/16/16 -
Uploaded on

July 16, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hormone-Refractory Prostate Cancer NCT00201357

English

Eligibility Hormone-Refractory Prostate Cancer NCT00201357

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

18 years of age or older

Data type

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.
Description

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

Data type

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.
Description

progression on previous anti-androgen therapy

Data type

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).
Description

measurable disease or evaluable disease

Data type

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.
Description

karnofsky performance status

Data type

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.
Description

creatinine, bilirubine, alt/ast measurement

Data type

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.
Description

thyroid replacement

Data type

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).
Description

from the effect of recent surgery

Data type

boolean

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

ability to complete quality of life questionnaires

Data type

boolean

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

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

advanced second primary malignancy

Data type

boolean

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

patients with brain metastases

Data type

boolean

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

patients with hypersensitivity to thalidomide

Data type

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.
Description

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

Data type

boolean

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

patients with orthostatic hypotension before therapy

Data type

boolean

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

nci grade or peripheral neuropathy

Data type

boolean

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

active infection, including positive serology for hiv

Data type

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.
Description

prior chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
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Similar models

Eligibility Hormone-Refractory Prostate Cancer NCT00201357

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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