ID

15845

Description

Stereotactic Body Radiotherapy vs Intensity-modulated Radiotherapy in Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02339701

Link

https://clinicaltrials.gov/show/NCT02339701

Keywords

Versions (1)
  1. 6/15/16 6/15/16 -
Uploaded on

June 15, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02339701

English

Eligibility Prostate Cancer NCT02339701

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological confirmation of prostate adenocarcinoma
Description

Adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0007112
low or intermediate risk prostate cancer patients (i.e. t1-t2c and psa 20 and gleason score < 8) with the risk of pelvic node metastasis 15% as calculated by roach's formula
Description

Prostate carcinoma Low Risk | Prostate carcinoma Intermediate Risk | TNM tumor staging system | Prostate specific antigen measurement | Gleason score | Risk pelvic lymph node Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C3538919
UMLS CUI [2,1]
C0600139
UMLS CUI [2,2]
C3640764
UMLS CUI [3]
C0475284
UMLS CUI [4]
C0201544
UMLS CUI [5]
C3203027
UMLS CUI [6,1]
C0035647
UMLS CUI [6,2]
C1280315
UMLS CUI [6,3]
C0027627
ecog performance score 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
age ≥ 18
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
history/physical examination within 2 weeks prior to registration
Description

Physical Examination

Data type

boolean

Alias
UMLS CUI [1]
C0031809
able to 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 previous diagnosis of cancer other than prostate cancer and non-melanoma skin cancer.
Description

Prior diagnosis Malignant Neoplasms | Prostate carcinoma | Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0332132
UMLS CUI [1,2]
C0006826
UMLS CUI [2]
C0600139
UMLS CUI [3]
C0699893
evidence of distant metastases
Description

distant metastases

Data type

boolean

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

Regional Lymph Node Involvement

Data type

boolean

Alias
UMLS CUI [1]
C1332837
previous radical surgery (prostatectomy), cryosurgery, or hifu for prostate cancer
Description

H/O: surgery Radical | Prostatectomy | Cryosurgery | High intensity focused ultrasound Prostate carcinoma

Data type

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
previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
Description

Pelvis Therapeutic radiology procedure Previous | Brachytherapy to prostate | Bilateral orchiectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0030797
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0205156
UMLS CUI [2]
C0854662
UMLS CUI [3]
C0007347
previous hormonal therapy, such as lhrh agonists (e.g., goserelin, leuprolide) or lhrhantagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g.des), or surgical castration (orchiectomy)
Description

Prior Hormone Therapy | Luteinizing Hormone-releasing Hormone Agonist | Goserelin | Leuprolide | Luteinizing hormone releasing hormone antagonist product | degarelix | Androgen Antagonists | Flutamide | bicalutamide | Estrogens | Diethylstilbestrol | Castration | Orchiectomy

Data type

boolean

Alias
UMLS CUI [1]
C1514460
UMLS CUI [2]
C1518041
UMLS CUI [3]
C0120107
UMLS CUI [4]
C0085272
UMLS CUI [5]
C1276926
UMLS CUI [6]
C1455035
UMLS CUI [7]
C0002842
UMLS CUI [8]
C0016384
UMLS CUI [9]
C0285590
UMLS CUI [10]
C0014939
UMLS CUI [11]
C0012203
UMLS CUI [12]
C0007344
UMLS CUI [13]
C0029189
unstable angina and/or congestive heart failure requiring hospitalization, transmural myocardial infarction within the last 6 months, acute bacterial or fungal infection requiring intravenous antibiotics, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiringhospitalization or precluding study therapy at the time of registration
Description

Angina, Unstable | Congestive heart failure | Hospitalization | Transmural myocardial infarction | Bacterial Infections | Mycoses | Antibiotics Intravenous | COPD exacerbation | Respiration Disorders Preventing Therapy, Investigational

Data type

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0019993
UMLS CUI [4]
C1400513
UMLS CUI [5]
C0004623
UMLS CUI [6]
C0026946
UMLS CUI [7,1]
C0003232
UMLS CUI [7,2]
C1522726
UMLS CUI [8]
C0740304
UMLS CUI [9,1]
C0035204
UMLS CUI [9,2]
C1292733
UMLS CUI [9,3]
C0949266
patients who have received prior chemotherapy.
Description

Prior Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
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Similar models

Eligibility Prostate Cancer NCT02339701

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histological confirmation of prostate adenocarcinoma
boolean
C0007112 (UMLS CUI [1])
Prostate carcinoma Low Risk | Prostate carcinoma Intermediate Risk | TNM tumor staging system | Prostate specific antigen measurement | Gleason score | Risk pelvic lymph node Neoplasm Metastasis
Item
low or intermediate risk prostate cancer patients (i.e. t1-t2c and psa 20 and gleason score < 8) with the risk of pelvic node metastasis 15% as calculated by roach's formula
boolean
C0600139 (UMLS CUI [1,1])
C3538919 (UMLS CUI [1,2])
C0600139 (UMLS CUI [2,1])
C3640764 (UMLS CUI [2,2])
C0475284 (UMLS CUI [3])
C0201544 (UMLS CUI [4])
C3203027 (UMLS CUI [5])
C0035647 (UMLS CUI [6,1])
C1280315 (UMLS CUI [6,2])
C0027627 (UMLS CUI [6,3])
ECOG performance status
Item
ecog performance score 0-1
boolean
C1520224 (UMLS CUI [1])
Age
Item
age ≥ 18
boolean
C0001779 (UMLS CUI [1])
Physical Examination
Item
history/physical examination within 2 weeks prior to registration
boolean
C0031809 (UMLS CUI [1])
Informed consent
Item
able to sign informed-consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior diagnosis Malignant Neoplasms | Prostate carcinoma | Skin carcinoma
Item
patients with previous diagnosis of cancer other than prostate cancer and non-melanoma skin cancer.
boolean
C0332132 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0600139 (UMLS CUI [2])
C0699893 (UMLS CUI [3])
distant metastases
Item
evidence of distant metastases
boolean
C3258247 (UMLS CUI [1])
Regional Lymph Node Involvement
Item
regional lymph node involvement
boolean
C1332837 (UMLS CUI [1])
H/O: surgery Radical | Prostatectomy | Cryosurgery | High intensity focused ultrasound Prostate carcinoma
Item
previous radical surgery (prostatectomy), cryosurgery, or hifu for prostate cancer
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])
Pelvis Therapeutic radiology procedure Previous | Brachytherapy to prostate | Bilateral orchiectomy
Item
previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
boolean
C0030797 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0854662 (UMLS CUI [2])
C0007347 (UMLS CUI [3])
Prior Hormone Therapy | Luteinizing Hormone-releasing Hormone Agonist | Goserelin | Leuprolide | Luteinizing hormone releasing hormone antagonist product | degarelix | Androgen Antagonists | Flutamide | bicalutamide | Estrogens | Diethylstilbestrol | Castration | Orchiectomy
Item
previous hormonal therapy, such as lhrh agonists (e.g., goserelin, leuprolide) or lhrhantagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g.des), or surgical castration (orchiectomy)
boolean
C1514460 (UMLS CUI [1])
C1518041 (UMLS CUI [2])
C0120107 (UMLS CUI [3])
C0085272 (UMLS CUI [4])
C1276926 (UMLS CUI [5])
C1455035 (UMLS CUI [6])
C0002842 (UMLS CUI [7])
C0016384 (UMLS CUI [8])
C0285590 (UMLS CUI [9])
C0014939 (UMLS CUI [10])
C0012203 (UMLS CUI [11])
C0007344 (UMLS CUI [12])
C0029189 (UMLS CUI [13])
Angina, Unstable | Congestive heart failure | Hospitalization | Transmural myocardial infarction | Bacterial Infections | Mycoses | Antibiotics Intravenous | COPD exacerbation | Respiration Disorders Preventing Therapy, Investigational
Item
unstable angina and/or congestive heart failure requiring hospitalization, transmural myocardial infarction within the last 6 months, acute bacterial or fungal infection requiring intravenous antibiotics, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiringhospitalization or precluding study therapy at the time of registration
boolean
C0002965 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C0019993 (UMLS CUI [3])
C1400513 (UMLS CUI [4])
C0004623 (UMLS CUI [5])
C0026946 (UMLS CUI [6])
C0003232 (UMLS CUI [7,1])
C1522726 (UMLS CUI [7,2])
C0740304 (UMLS CUI [8])
C0035204 (UMLS CUI [9,1])
C1292733 (UMLS CUI [9,2])
C0949266 (UMLS CUI [9,3])
Prior Chemotherapy
Item
patients who have received prior chemotherapy.
boolean
C1514457 (UMLS CUI [1])
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