ID

17234

Beschrijving

Pemetrexed as Second-Line Therapy in Treating Patients With Hormone Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00216099

Link

https://clinicaltrials.gov/show/NCT00216099

Trefwoorden

Versies (1)
  1. 01-09-16 01-09-16 -
Geüploaded op

1 september 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00216099

Engels

Eligibility Prostate Cancer NCT00216099

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically documented adenocarcinoma of the prostate
Beschrijving

adenocarcinoma of prostate

Datatype

boolean

Alias
UMLS CUI [1]
C0007112
clinically refractory or resistant to hormone therapy as assessed by progression following at least one hormonal therapy (orchiectomy or luteinizing hormone-releasing hormone (lhrh) agonist)
Beschrijving

Clinically refractory or resistant to hormone therapy (orchiectomy or luteinizing hormone-releasing hormone agonist)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205269
UMLS CUI [1,2]
C0029189
UMLS CUI [2,1]
C0205269
UMLS CUI [2,2]
C1518041
one prior taxane based chemotherapy regimen for hrpc
Beschrijving

taxane based chemotherapy regimen

Datatype

boolean

Alias
UMLS CUI [1]
C0796419
documented progression of disease after one taxane based prior chemotherapy regimen for hrpc. progression is defined as at least one of the following:
Beschrijving

Progression of disease

Datatype

boolean

Alias
UMLS CUI [1]
C0242656
an increase in psa > 50% over nadir value on prior taxane-based therapy
Beschrijving

PSA Measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201544
progression of measurable disease as defined by recist
Beschrijving

Recist

Datatype

boolean

Alias
UMLS CUI [1]
C1709926
progression of bone disease as defined by the appearance of one or more new bone lesions or worsening symptoms
Beschrijving

progression of bone disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0238792
UMLS CUI [1,2]
C0242656
orchiectomy or testosterone levels < 50 ng/dl maintained by lhrh agonist
Beschrijving

orchiectomy; testosterone level

Datatype

boolean

Alias
UMLS CUI [1]
C0029189
UMLS CUI [2]
C0523912
prior chemotherapy, or other experimental anticancer agents must be completed > 4 weeks prior to being registered for protocol therapy
Beschrijving

chemotherapy or other experimental anticancer agents

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0013230
palliative radiotherapy must be completed at least 14 days prior to registration.
Beschrijving

Palliative radiotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C3898008
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
intravenous radio-isotopes therapy must be completed at least 6 weeks prior to registration
Beschrijving

Radioisotope therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0203608
no brain metastasis that are untreated and/or not controlled and/or still requiring corticosteroids
Beschrijving

Brain metastasis (untreated/uncontrolled/requiring corticosteroids)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0332155
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C0001617
no history of other malignancies within 5 years prior to being registered for protocol therapy, except for adequately treated basal or squamous cell skin cancer
Beschrijving

Malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
no history of uncontrolled psychiatric illness or serious systemic disease, including active infection, uncontrolled hypertension
Beschrijving

Psychiatric illness or serious systemic disease, including active infection, uncontrolled hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0442893
UMLS CUI [3]
C0009450
UMLS CUI [4]
C1868885
no surgery or significant traumatic injury within 21 days prior to being registered for protocol therapy
Beschrijving

Surgery or significant traumatic injury

Datatype

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C3263723
patients must be willing to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (8 day period for long acting agents such as piroxicam)
Beschrijving

NSAID

Datatype

boolean

Alias
UMLS CUI [1]
C0003211
patients must be willing to take folic acid or vitamin b12 supplementation
Beschrijving

must be willing to take folic acid or vitamin b12 supplementation

Datatype

boolean

Alias
UMLS CUI [1]
C0556110
UMLS CUI [2]
C3661610
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Similar models

Eligibility Prostate Cancer NCT00216099

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
adenocarcinoma of prostate
Item
histologically documented adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Clinically refractory or resistant to hormone therapy (orchiectomy or luteinizing hormone-releasing hormone agonist)
Item
clinically refractory or resistant to hormone therapy as assessed by progression following at least one hormonal therapy (orchiectomy or luteinizing hormone-releasing hormone (lhrh) agonist)
boolean
C0205269 (UMLS CUI [1,1])
C0029189 (UMLS CUI [1,2])
C0205269 (UMLS CUI [2,1])
C1518041 (UMLS CUI [2,2])
taxane based chemotherapy regimen
Item
one prior taxane based chemotherapy regimen for hrpc
boolean
C0796419 (UMLS CUI [1])
Progression of disease
Item
documented progression of disease after one taxane based prior chemotherapy regimen for hrpc. progression is defined as at least one of the following:
boolean
C0242656 (UMLS CUI [1])
PSA Measurement
Item
an increase in psa > 50% over nadir value on prior taxane-based therapy
boolean
C0201544 (UMLS CUI [1])
Recist
Item
progression of measurable disease as defined by recist
boolean
C1709926 (UMLS CUI [1])
progression of bone disease
Item
progression of bone disease as defined by the appearance of one or more new bone lesions or worsening symptoms
boolean
C0238792 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
orchiectomy; testosterone level
Item
orchiectomy or testosterone levels < 50 ng/dl maintained by lhrh agonist
boolean
C0029189 (UMLS CUI [1])
C0523912 (UMLS CUI [2])
chemotherapy or other experimental anticancer agents
Item
prior chemotherapy, or other experimental anticancer agents must be completed > 4 weeks prior to being registered for protocol therapy
boolean
C0392920 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Palliative radiotherapy
Item
palliative radiotherapy must be completed at least 14 days prior to registration.
boolean
C3898008 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Radioisotope therapy
Item
intravenous radio-isotopes therapy must be completed at least 6 weeks prior to registration
boolean
C0203608 (UMLS CUI [1])
Brain metastasis (untreated/uncontrolled/requiring corticosteroids)
Item
no brain metastasis that are untreated and/or not controlled and/or still requiring corticosteroids
boolean
C0220650 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0220650 (UMLS CUI [3,1])
C0001617 (UMLS CUI [3,2])
Malignancy
Item
no history of other malignancies within 5 years prior to being registered for protocol therapy, except for adequately treated basal or squamous cell skin cancer
boolean
C0006826 (UMLS CUI [1])
Psychiatric illness or serious systemic disease, including active infection, uncontrolled hypertension
Item
no history of uncontrolled psychiatric illness or serious systemic disease, including active infection, uncontrolled hypertension
boolean
C0004936 (UMLS CUI [1])
C0442893 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
C1868885 (UMLS CUI [4])
Surgery or significant traumatic injury
Item
no surgery or significant traumatic injury within 21 days prior to being registered for protocol therapy
boolean
C0543467 (UMLS CUI [1])
C3263723 (UMLS CUI [2])
NSAID
Item
patients must be willing to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (8 day period for long acting agents such as piroxicam)
boolean
C0003211 (UMLS CUI [1])
must be willing to take folic acid or vitamin b12 supplementation
Item
patients must be willing to take folic acid or vitamin b12 supplementation
boolean
C0556110 (UMLS CUI [1])
C3661610 (UMLS CUI [2])
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