ID

19000

Beschrijving

Safety and Effectiveness Study of Docetaxel and ZD1839 Followed by Removal of the Prostate to Treat Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00242918

Link

https://clinicaltrials.gov/show/NCT00242918

Trefwoorden

Versies (1)
  1. 29-11-16 29-11-16 -
Geüploaded op

29 november 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00242918

Engels

Eligibility Prostate Cancer NCT00242918

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
prostate carcinoma: clinical stage t2b-3 or serum psa>20 ng/ml or gleason sum score 8-10.
Beschrijving

Prostate carcinoma TNM clinical staging | Prostate specific antigen measurement | Gleason score

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0201544
UMLS CUI [3]
C3203027
clinical t2 patients are eligible if endorectal coil mri shows t3 disease, or gleason 4+3 cancer in 5 or more biopsies (minimum of 10 biopsies total required)
Beschrijving

TNM clinical staging | Magnetic Resonance Imaging Coils, Endorectal | Gleason score | Biopsy Quantity

Datatype

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2]
C3857139
UMLS CUI [3]
C3203027
UMLS CUI [4,1]
C0005558
UMLS CUI [4,2]
C1265611
ecog performance status of 0, 1 or 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematological, liver and renal function
Beschrijving

Hematologic function Liver function Renal function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0232741
UMLS CUI [1,3]
C0232804
existing peripheral neuropathy < grade 1
Beschrijving

Peripheral Neuropathy CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
ability to tolerate oral medications.
Beschrijving

oral medication Receive Ability

Datatype

boolean

Alias
UMLS CUI [1,1]
C0175795
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0085732
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
concurrent or prior treatment with radiation, cytotoxic, biologic therapy for prostate cancer
Beschrijving

Therapeutic radiology procedure Prostate carcinoma | Cytotoxic therapy Prostate carcinoma | Biological treatment Prostate carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C0677881
UMLS CUI [2,2]
C0600139
UMLS CUI [3,1]
C1531518
UMLS CUI [3,2]
C0600139
any major surgery within four weeks
Beschrijving

major surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
prior hormonal therapy (except finasteride for obstructive voiding symptoms--evidence of metastatic disease, confirmed by physical examination, computed tomography of the abdomen and pelvis within 45 days and by bone scan within 60 days of signing informed consent
Beschrijving

Hormone Therapy | Finasteride | Voiding Disorder Obstructive | Neoplasm Metastasis | Physical Examination | CT of abdomen | Computed Tomography (CT) of Pelvis | Scan of bone | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0060389
UMLS CUI [3,1]
C4053857
UMLS CUI [3,2]
C0549186
UMLS CUI [4]
C0027627
UMLS CUI [5]
C0031809
UMLS CUI [6]
C0412620
UMLS CUI [7]
C0412628
UMLS CUI [8]
C0203668
UMLS CUI [9]
C0021430
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Similar models

Eligibility Prostate Cancer NCT00242918

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma TNM clinical staging | Prostate specific antigen measurement | Gleason score
Item
prostate carcinoma: clinical stage t2b-3 or serum psa>20 ng/ml or gleason sum score 8-10.
boolean
C0600139 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0201544 (UMLS CUI [2])
C3203027 (UMLS CUI [3])
TNM clinical staging | Magnetic Resonance Imaging Coils, Endorectal | Gleason score | Biopsy Quantity
Item
clinical t2 patients are eligible if endorectal coil mri shows t3 disease, or gleason 4+3 cancer in 5 or more biopsies (minimum of 10 biopsies total required)
boolean
C3258246 (UMLS CUI [1])
C3857139 (UMLS CUI [2])
C3203027 (UMLS CUI [3])
C0005558 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
ECOG performance status
Item
ecog performance status of 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Hematologic function Liver function Renal function
Item
adequate hematological, liver and renal function
boolean
C0221130 (UMLS CUI [1,1])
C0232741 (UMLS CUI [1,2])
C0232804 (UMLS CUI [1,3])
Peripheral Neuropathy CTCAE Grades
Item
existing peripheral neuropathy < grade 1
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
oral medication Receive Ability
Item
ability to tolerate oral medications.
boolean
C0175795 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure Prostate carcinoma | Cytotoxic therapy Prostate carcinoma | Biological treatment Prostate carcinoma
Item
concurrent or prior treatment with radiation, cytotoxic, biologic therapy for prostate cancer
boolean
C1522449 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0677881 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C1531518 (UMLS CUI [3,1])
C0600139 (UMLS CUI [3,2])
major surgery
Item
any major surgery within four weeks
boolean
C0679637 (UMLS CUI [1])
Hormone Therapy | Finasteride | Voiding Disorder Obstructive | Neoplasm Metastasis | Physical Examination | CT of abdomen | Computed Tomography (CT) of Pelvis | Scan of bone | Informed Consent
Item
prior hormonal therapy (except finasteride for obstructive voiding symptoms--evidence of metastatic disease, confirmed by physical examination, computed tomography of the abdomen and pelvis within 45 days and by bone scan within 60 days of signing informed consent
boolean
C0279025 (UMLS CUI [1])
C0060389 (UMLS CUI [2])
C4053857 (UMLS CUI [3,1])
C0549186 (UMLS CUI [3,2])
C0027627 (UMLS CUI [4])
C0031809 (UMLS CUI [5])
C0412620 (UMLS CUI [6])
C0412628 (UMLS CUI [7])
C0203668 (UMLS CUI [8])
C0021430 (UMLS CUI [9])
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