ID

36700

Beschreibung

Percutaneous High-dose Radiotherapy in Patients With Oligometastases of Prostate Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02264379

Link

https://clinicaltrials.gov/show/NCT02264379

Stichworte

Versionen (1)
  1. 03.06.19 03.06.19 -
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See clinicaltrials.gov

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3. Juni 2019

DOI

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Eligibility Oligometastases NCT02264379

Englisch

Eligibility Oligometastases NCT02264379

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient with good general condition (who 0-1)
Beschreibung

General health good WHO performance status scale

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1277245
UMLS CUI [1,2]
C1298650
no comorbidities which limit the further life expectancy of the patient to <5 years (opinion of the physician)
Beschreibung

Absence Comorbidity Limiting Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0009488
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C0023671
histologically confirmed prostate cancer
Beschreibung

Prostate carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0600139
state after definitive local therapy, such as radical prostatectomy or definitive radiotherapy (even after neo-/-adjuvant hormone therapy, after postoperative radiotherapy)
Beschreibung

Status post Local Therapy | Radical prostatectomy | Therapeutic radiology procedure | Hormone Therapy Neoadjuvant | Hormone Therapy Adjuvant | Postoperative course of radiotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C1517925
UMLS CUI [2]
C0194810
UMLS CUI [3]
C1522449
UMLS CUI [4,1]
C0279025
UMLS CUI [4,2]
C0600558
UMLS CUI [5,1]
C0279025
UMLS CUI [5,2]
C1522673
UMLS CUI [6]
C0436206
psa relapse after primary therapy or radiological unique metastasis, present complete staging (up to 8 weeks old) by ct thorax/ abdomen/ pelvis and bone scan alternatively a hybrid imaging pet (positron emission tomography) (acetate pet, pet-psma, nafl-pet) and ct / mri is sufficient
Beschreibung

PSA Relapse | Status post First line treatment | Neoplasm Metastasis Unique Radiology | Clinical stage finding Complete Chest CT | Clinical stage finding Complete CT of abdomen | Clinical stage finding Complete CT of Pelvis | Clinical stage finding Complete Radioisotope scan of bone | Scanning Systems, Computed Tomography/Positron Emission Tomography | whole body PET with concurrent CT using C-acetate | Positron-Emission Tomography Glutamate Carboxypeptidase II | F-18 Sodium Fluoride Positron Emission Tomography | PET/CT | PET/MRI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0138741
UMLS CUI [1,2]
C0035020
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1708063
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C1710548
UMLS CUI [3,3]
C0043299
UMLS CUI [4,1]
C0205563
UMLS CUI [4,2]
C0205197
UMLS CUI [4,3]
C0202823
UMLS CUI [5,1]
C0205563
UMLS CUI [5,2]
C0205197
UMLS CUI [5,3]
C0412620
UMLS CUI [6,1]
C0205563
UMLS CUI [6,2]
C0205197
UMLS CUI [6,3]
C0412628
UMLS CUI [7,1]
C0205563
UMLS CUI [7,2]
C0205197
UMLS CUI [7,3]
C0203668
UMLS CUI [8]
C1139717
UMLS CUI [9]
C4271887
UMLS CUI [10,1]
C0032743
UMLS CUI [10,2]
C0067685
UMLS CUI [11]
C2985493
UMLS CUI [12]
C1699633
UMLS CUI [13]
C3641326
imaging detection of individual metastases (up to 5, depending on the situation) that a radiation therapy are available (histological confirmation of the met is not required)
Beschreibung

Neoplasm Metastasis Quantity Imaging | Therapeutic radiology procedure Available

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0011923
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0470187
no parallel participation to further clinical therapeutic trials to 4 weeks and after radiation
Beschreibung

Study Subject Participation Status | Clinical Trials Additional Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C1524062
UMLS CUI [2,3]
C0332197
consent of the patient and written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe comorbidity which limit the further life expectancy of the patient to <5 years (opinion of the physician)
Beschreibung

Comorbidity Severe | Life Expectancy Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0023671
UMLS CUI [2,2]
C0439801
psa in psa relapse> 10ng/ml
Beschreibung

Prostate specific antigen measurement | PSA Relapse

Datentyp

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2,1]
C0138741
UMLS CUI [2,2]
C0035020
ongoing androgen deprivation at the time of study inclusion
Beschreibung

Androgen deprivation

Datentyp

boolean

Alias
UMLS CUI [1]
C1515985
pre-irradiation in the field of metastases
Beschreibung

Therapeutic radiology procedure Field Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1882536
UMLS CUI [1,3]
C0027627
not been carried out local therapy
Beschreibung

Local Therapy Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1517925
UMLS CUI [1,2]
C0332197
no histological confirmation of prostate cancer
Beschreibung

Confirmation of Prostate carcinoma Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521091
UMLS CUI [1,2]
C0600139
UMLS CUI [1,3]
C0332197
lack of compliance
Beschreibung

Compliance behavior Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0332268
absence of consent of the patient
Beschreibung

Informed Consent Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332197
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Ähnliche Modelle

Eligibility Oligometastases NCT02264379

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
General health good WHO performance status scale
Item
patient with good general condition (who 0-1)
boolean
C1277245 (UMLS CUI [1,1])
C1298650 (UMLS CUI [1,2])
Absence Comorbidity Limiting Life Expectancy
Item
no comorbidities which limit the further life expectancy of the patient to <5 years (opinion of the physician)
boolean
C0332197 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0023671 (UMLS CUI [1,4])
Prostate carcinoma
Item
histologically confirmed prostate cancer
boolean
C0600139 (UMLS CUI [1])
Status post Local Therapy | Radical prostatectomy | Therapeutic radiology procedure | Hormone Therapy Neoadjuvant | Hormone Therapy Adjuvant | Postoperative course of radiotherapy
Item
state after definitive local therapy, such as radical prostatectomy or definitive radiotherapy (even after neo-/-adjuvant hormone therapy, after postoperative radiotherapy)
boolean
C0231290 (UMLS CUI [1,1])
C1517925 (UMLS CUI [1,2])
C0194810 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0279025 (UMLS CUI [4,1])
C0600558 (UMLS CUI [4,2])
C0279025 (UMLS CUI [5,1])
C1522673 (UMLS CUI [5,2])
C0436206 (UMLS CUI [6])
PSA Relapse | Status post First line treatment | Neoplasm Metastasis Unique Radiology | Clinical stage finding Complete Chest CT | Clinical stage finding Complete CT of abdomen | Clinical stage finding Complete CT of Pelvis | Clinical stage finding Complete Radioisotope scan of bone | Scanning Systems, Computed Tomography/Positron Emission Tomography | whole body PET with concurrent CT using C-acetate | Positron-Emission Tomography Glutamate Carboxypeptidase II | F-18 Sodium Fluoride Positron Emission Tomography | PET/CT | PET/MRI
Item
psa relapse after primary therapy or radiological unique metastasis, present complete staging (up to 8 weeks old) by ct thorax/ abdomen/ pelvis and bone scan alternatively a hybrid imaging pet (positron emission tomography) (acetate pet, pet-psma, nafl-pet) and ct / mri is sufficient
boolean
C0138741 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C1710548 (UMLS CUI [3,2])
C0043299 (UMLS CUI [3,3])
C0205563 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0202823 (UMLS CUI [4,3])
C0205563 (UMLS CUI [5,1])
C0205197 (UMLS CUI [5,2])
C0412620 (UMLS CUI [5,3])
C0205563 (UMLS CUI [6,1])
C0205197 (UMLS CUI [6,2])
C0412628 (UMLS CUI [6,3])
C0205563 (UMLS CUI [7,1])
C0205197 (UMLS CUI [7,2])
C0203668 (UMLS CUI [7,3])
C1139717 (UMLS CUI [8])
C4271887 (UMLS CUI [9])
C0032743 (UMLS CUI [10,1])
C0067685 (UMLS CUI [10,2])
C2985493 (UMLS CUI [11])
C1699633 (UMLS CUI [12])
C3641326 (UMLS CUI [13])
Neoplasm Metastasis Quantity Imaging | Therapeutic radiology procedure Available
Item
imaging detection of individual metastases (up to 5, depending on the situation) that a radiation therapy are available (histological confirmation of the met is not required)
boolean
C0027627 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
Study Subject Participation Status | Clinical Trials Additional Absent
Item
no parallel participation to further clinical therapeutic trials to 4 weeks and after radiation
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Informed Consent
Item
consent of the patient and written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Comorbidity Severe | Life Expectancy Limited
Item
severe comorbidity which limit the further life expectancy of the patient to <5 years (opinion of the physician)
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0023671 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Prostate specific antigen measurement | PSA Relapse
Item
psa in psa relapse> 10ng/ml
boolean
C0201544 (UMLS CUI [1])
C0138741 (UMLS CUI [2,1])
C0035020 (UMLS CUI [2,2])
Androgen deprivation
Item
ongoing androgen deprivation at the time of study inclusion
boolean
C1515985 (UMLS CUI [1])
Therapeutic radiology procedure Field Neoplasm Metastasis
Item
pre-irradiation in the field of metastases
boolean
C1522449 (UMLS CUI [1,1])
C1882536 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Local Therapy Absent
Item
not been carried out local therapy
boolean
C1517925 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Confirmation of Prostate carcinoma Absent
Item
no histological confirmation of prostate cancer
boolean
C0521091 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Compliance behavior Lacking
Item
lack of compliance
boolean
C1321605 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Informed Consent Absent
Item
absence of consent of the patient
boolean
C0021430 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
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