ID

31668

Beschrijving

A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors; ODM derived from: https://clinicaltrials.gov/show/NCT02225262

Link

https://clinicaltrials.gov/show/NCT02225262

Trefwoorden

Versies (2)
  1. 18-09-18 18-09-18 -
  2. 18-09-18 18-09-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

18 september 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02225262

Engels

Eligibility Prostate Cancer NCT02225262

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male age ≥ 21
Beschrijving

Gender | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
histologically proven prostate adenocarcinoma
Beschrijving

Adenocarcinoma of prostate

Datatype

boolean

Alias
UMLS CUI [1]
C0007112
clinical stage t1b-t2b, n0-nx, m0-mx (ajcc 6th edition)
Beschrijving

TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1]
C3258246
psa ≤ 20 ng/ml
Beschrijving

Prostate specific antigen measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201544
prostate volume ≤ 100 cc
Beschrijving

Prostate volume

Datatype

boolean

Alias
UMLS CUI [1]
C1441416
patients belonging in one of the following risk groups:
Beschrijving

Risk Groups

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0441833
low:
Beschrijving

Low Risk

Datatype

boolean

Alias
UMLS CUI [1]
C3538919
cs t1b-t2a and gleason 2-6 and psa ≤ 10
Beschrijving

TNM clinical staging | Gleason score | Prostate specific antigen measurement

Datatype

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2]
C3203027
UMLS CUI [3]
C0201544
intermediate:
Beschrijving

Intermediate Risk

Datatype

boolean

Alias
UMLS CUI [1]
C3640764
cs t2b and gleason 2-6 and psa ≤ 10, or
Beschrijving

TNM clinical staging | Gleason score | Prostate specific antigen measurement

Datatype

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2]
C3203027
UMLS CUI [3]
C0201544
cs t1b-t2b, and gleason 2-6 and psa ≤ 20 ng/ml or gleason 7 and psa ≤ 10 ng/ml
Beschrijving

TNM clinical staging | Gleason score | Prostate specific antigen measurement

Datatype

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2]
C3203027
UMLS CUI [3]
C0201544
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
any histology other than adenocarcinoma
Beschrijving

Histology Any | Exception Adenocarcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0344441
UMLS CUI [1,2]
C1552551
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0001418
age < 21
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
kps <= 40 <70
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
ecog performance status ≥ 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
patient weight >350 lbs. (table limitation)
Beschrijving

Body Weight

Datatype

boolean

Alias
UMLS CUI [1]
C0005910
prior xrt to prostate or lower pelvis
Beschrijving

Prostate external beam radiation therapy | External Radiation Therapy Pelvis Lower

Datatype

boolean

Alias
UMLS CUI [1]
C0860348
UMLS CUI [2,1]
C1517033
UMLS CUI [2,2]
C0030797
UMLS CUI [2,3]
C0441994
prior surgery or cryotherapy to prostate
Beschrijving

Operation on prostate | Cryotherapy of prostate

Datatype

boolean

Alias
UMLS CUI [1]
C0194790
UMLS CUI [2]
C3544233
implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
Beschrijving

Materials Implanted Preventing Treatment Plan | Materials Implanted Preventing Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0520510
UMLS CUI [1,2]
C0021102
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0599880
UMLS CUI [2,1]
C0520510
UMLS CUI [2,2]
C0021102
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0087111
chemotherapy for a malignancy in the last 5 years
Beschrijving

Chemotherapy Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0006826
history of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years
Beschrijving

Invasive cancer | Exception Prostate carcinoma | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Datatype

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0600139
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
hormone ablation for 2 months prior to enrollment, or during treatment
Beschrijving

Antiandrogen therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0279492
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Similar models

Eligibility Prostate Cancer NCT02225262

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
male age ≥ 21
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Adenocarcinoma of prostate
Item
histologically proven prostate adenocarcinoma
boolean
C0007112 (UMLS CUI [1])
TNM clinical staging
Item
clinical stage t1b-t2b, n0-nx, m0-mx (ajcc 6th edition)
boolean
C3258246 (UMLS CUI [1])
Prostate specific antigen measurement
Item
psa ≤ 20 ng/ml
boolean
C0201544 (UMLS CUI [1])
Prostate volume
Item
prostate volume ≤ 100 cc
boolean
C1441416 (UMLS CUI [1])
Risk Groups
Item
patients belonging in one of the following risk groups:
boolean
C0035647 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
Low Risk
Item
low:
boolean
C3538919 (UMLS CUI [1])
TNM clinical staging | Gleason score | Prostate specific antigen measurement
Item
cs t1b-t2a and gleason 2-6 and psa ≤ 10
boolean
C3258246 (UMLS CUI [1])
C3203027 (UMLS CUI [2])
C0201544 (UMLS CUI [3])
Intermediate Risk
Item
intermediate:
boolean
C3640764 (UMLS CUI [1])
TNM clinical staging | Gleason score | Prostate specific antigen measurement
Item
cs t2b and gleason 2-6 and psa ≤ 10, or
boolean
C3258246 (UMLS CUI [1])
C3203027 (UMLS CUI [2])
C0201544 (UMLS CUI [3])
TNM clinical staging | Gleason score | Prostate specific antigen measurement
Item
cs t1b-t2b, and gleason 2-6 and psa ≤ 20 ng/ml or gleason 7 and psa ≤ 10 ng/ml
boolean
C3258246 (UMLS CUI [1])
C3203027 (UMLS CUI [2])
C0201544 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Histology Any | Exception Adenocarcinoma
Item
any histology other than adenocarcinoma
boolean
C0344441 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0001418 (UMLS CUI [2,2])
Age
Item
age < 21
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
kps <= 40 <70
boolean
C0206065 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status ≥ 2
boolean
C1520224 (UMLS CUI [1])
Body Weight
Item
patient weight >350 lbs. (table limitation)
boolean
C0005910 (UMLS CUI [1])
Prostate external beam radiation therapy | External Radiation Therapy Pelvis Lower
Item
prior xrt to prostate or lower pelvis
boolean
C0860348 (UMLS CUI [1])
C1517033 (UMLS CUI [2,1])
C0030797 (UMLS CUI [2,2])
C0441994 (UMLS CUI [2,3])
Operation on prostate | Cryotherapy of prostate
Item
prior surgery or cryotherapy to prostate
boolean
C0194790 (UMLS CUI [1])
C3544233 (UMLS CUI [2])
Materials Implanted Preventing Treatment Plan | Materials Implanted Preventing Therapeutic procedure
Item
implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
boolean
C0520510 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0599880 (UMLS CUI [1,4])
C0520510 (UMLS CUI [2,1])
C0021102 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
Chemotherapy Malignant Neoplasms
Item
chemotherapy for a malignancy in the last 5 years
boolean
C0392920 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Invasive cancer | Exception Prostate carcinoma | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
history of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years
boolean
C0677898 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
Antiandrogen therapy
Item
hormone ablation for 2 months prior to enrollment, or during treatment
boolean
C0279492 (UMLS CUI [1])
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