ID

15865

Beschreibung

Feasibility Study of Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer: Cyberknife vs. VMAT; ODM derived from: https://clinicaltrials.gov/show/NCT02344667

Link

https://clinicaltrials.gov/show/NCT02344667

Stichworte

Versionen (1)
  1. 17.06.16 17.06.16 -
Hochgeladen am

17. Juni 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT02344667

Englisch

Eligibility Prostatic Neoplasms NCT02344667

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed diagnosis of adenocarcinoma of the prostate
Beschreibung

Adenocarcinoma of prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C0007112
histological evaluation of prostate biopsy with assignment of a gleason score to the biopsy material; gleason scores ≤ 7
Beschreibung

Biopsy of prostate | Evaluation Histologic | Gleason score

Datentyp

boolean

Alias
UMLS CUI [1]
C0194804
UMLS CUI [2,1]
C0220825
UMLS CUI [2,2]
C0205462
UMLS CUI [3]
C3203027
clinical stage t1-2b (ajcc 7th edition)
Beschreibung

TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1]
C3258246
psa ≤ 10 ng/ml. psa should not be obtained within 10 days after prostate biopsy.
Beschreibung

Prostate specific antigen measurement | Biopsy of prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2]
C0194804
ecog performance status 0-1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years.
Beschreibung

invasive cancer | Skin carcinoma | Lymphoma | Malignant Neoplasms hematogenous

Datentyp

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0024299
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C1512376
evidence of distant metastases
Beschreibung

distant metastases

Datentyp

boolean

Alias
UMLS CUI [1]
C3258247
regional lymph node involvement
Beschreibung

Lymph Node Involvement regional

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0806692
UMLS CUI [1,2]
C0205147
previous radical surgery (prostatectomy), cryosurgery, or hifu for prostate cancer. previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
Beschreibung

H/O: surgery Radical | Prostatectomy | Cryosurgery | High intensity focused ultrasound Prostate carcinoma | Pelvis Therapeutic radiology procedure Previous | Brachytherapy to prostate | Male Castration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0455610
UMLS CUI [1,2]
C0439807
UMLS CUI [2]
C0033573
UMLS CUI [3]
C0010408
UMLS CUI [4,1]
C0441583
UMLS CUI [4,2]
C0600139
UMLS CUI [5,1]
C0030797
UMLS CUI [5,2]
C1522449
UMLS CUI [5,3]
C0205156
UMLS CUI [6]
C0854662
UMLS CUI [7]
C0007347
previous hormonal therapy, such as lhrh agonists or lhrh antagonists, anti-androgens, estrogens, or surgical castration
Beschreibung

Prior Hormone Therapy | LHRH Agonist | LHRH antagonist | Androgen Antagonists | Estrogens | Castration

Datentyp

boolean

Alias
UMLS CUI [1]
C1514460
UMLS CUI [2]
C1518041
UMLS CUI [3]
C1276926
UMLS CUI [4]
C0002842
UMLS CUI [5]
C0014939
UMLS CUI [6]
C0007344
use of finasteride or dutasteride within 30 days prior to registration. psa should not be obtained prior to 30 days after stopping finasteride or dutasteride.
Beschreibung

Finasteride Use | Dutasteride Use | Prostate-Specific Antigen

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0060389
UMLS CUI [1,2]
C1524063
UMLS CUI [2,1]
C0754659
UMLS CUI [2,2]
C1524063
UMLS CUI [3]
C0138741
previous or concurrent cytotoxic chemotherapy for prostate cancer
Beschreibung

Cytotoxic Chemotherapy Prostate carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0600139
age < 18
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patient unable to provide study-specific informed consent
Beschreibung

Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
inability to complete the expanded prostate cancer index composite (epic) questionnaire
Beschreibung

Expanded Prostate Cancer Index Composite Questionnaire | Completion Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3810535
UMLS CUI [1,2]
C0034394
UMLS CUI [2,1]
C0205197
UMLS CUI [2,2]
C1299582
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Ähnliche Modelle

Eligibility Prostatic Neoplasms NCT02344667

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histologically confirmed diagnosis of adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Biopsy of prostate | Evaluation Histologic | Gleason score
Item
histological evaluation of prostate biopsy with assignment of a gleason score to the biopsy material; gleason scores ≤ 7
boolean
C0194804 (UMLS CUI [1])
C0220825 (UMLS CUI [2,1])
C0205462 (UMLS CUI [2,2])
C3203027 (UMLS CUI [3])
TNM clinical staging
Item
clinical stage t1-2b (ajcc 7th edition)
boolean
C3258246 (UMLS CUI [1])
Prostate specific antigen measurement | Biopsy of prostate
Item
psa ≤ 10 ng/ml. psa should not be obtained within 10 days after prostate biopsy.
boolean
C0201544 (UMLS CUI [1])
C0194804 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
invasive cancer | Skin carcinoma | Lymphoma | Malignant Neoplasms hematogenous
Item
prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years.
boolean
C0677898 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0024299 (UMLS CUI [3])
C0006826 (UMLS CUI [4,1])
C1512376 (UMLS CUI [4,2])
distant metastases
Item
evidence of distant metastases
boolean
C3258247 (UMLS CUI [1])
Lymph Node Involvement regional
Item
regional lymph node involvement
boolean
C0806692 (UMLS CUI [1,1])
C0205147 (UMLS CUI [1,2])
H/O: surgery Radical | Prostatectomy | Cryosurgery | High intensity focused ultrasound Prostate carcinoma | Pelvis Therapeutic radiology procedure Previous | Brachytherapy to prostate | Male Castration
Item
previous radical surgery (prostatectomy), cryosurgery, or hifu for prostate cancer. previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
boolean
C0455610 (UMLS CUI [1,1])
C0439807 (UMLS CUI [1,2])
C0033573 (UMLS CUI [2])
C0010408 (UMLS CUI [3])
C0441583 (UMLS CUI [4,1])
C0600139 (UMLS CUI [4,2])
C0030797 (UMLS CUI [5,1])
C1522449 (UMLS CUI [5,2])
C0205156 (UMLS CUI [5,3])
C0854662 (UMLS CUI [6])
C0007347 (UMLS CUI [7])
Prior Hormone Therapy | LHRH Agonist | LHRH antagonist | Androgen Antagonists | Estrogens | Castration
Item
previous hormonal therapy, such as lhrh agonists or lhrh antagonists, anti-androgens, estrogens, or surgical castration
boolean
C1514460 (UMLS CUI [1])
C1518041 (UMLS CUI [2])
C1276926 (UMLS CUI [3])
C0002842 (UMLS CUI [4])
C0014939 (UMLS CUI [5])
C0007344 (UMLS CUI [6])
Finasteride Use | Dutasteride Use | Prostate-Specific Antigen
Item
use of finasteride or dutasteride within 30 days prior to registration. psa should not be obtained prior to 30 days after stopping finasteride or dutasteride.
boolean
C0060389 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0754659 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0138741 (UMLS CUI [3])
Cytotoxic Chemotherapy Prostate carcinoma
Item
previous or concurrent cytotoxic chemotherapy for prostate cancer
boolean
C0677881 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Age
Item
age < 18
boolean
C0001779 (UMLS CUI [1])
Informed Consent Unable
Item
patient unable to provide study-specific informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Expanded Prostate Cancer Index Composite Questionnaire | Completion Unable
Item
inability to complete the expanded prostate cancer index composite (epic) questionnaire
boolean
C3810535 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0205197 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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