ID

39806

Beschrijving

Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm; ODM derived from: https://clinicaltrials.gov/show/NCT01825824

Link

https://clinicaltrials.gov/show/NCT01825824

Trefwoorden

Versies (2)
  1. 21-02-20 21-02-20 -
  2. 27-09-21 27-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

21 februari 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01825824

Engels

Eligibility Hepatocellular Carcinoma NCT01825824

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients ≥ 20 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
initially diagnosed or recurrent hepatocellular carcinoma (hcc)
Beschrijving

Liver carcinoma | Recurrent Hepatocellular Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2]
C0861876
unresectable hcc
Beschrijving

Liver carcinoma unresectable

Datatype

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1519810
cirrhotic status of child pugh class a or b7
Beschrijving

Status Cirrhotic Child-Pugh Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C0439686
UMLS CUI [1,3]
C2347612
eastern cooperative oncology group performance status 0 or 1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
single or sum of multiple tumor ≤ 5 cm
Beschrijving

Single tumor Size | Multiple tumors Size

Datatype

boolean

Alias
UMLS CUI [1,1]
C1298180
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0260037
UMLS CUI [2,2]
C0456389
hcc with 3 cm apart from gastrointestinal tract
Beschrijving

Liver carcinoma Distance Gastrointestinal tract

Datatype

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0012751
UMLS CUI [1,3]
C0017189
the volume of uninvolved must be at least 700 ml
Beschrijving

Amount Volume Uninvolved

Datatype

boolean

Alias
UMLS CUI [1,1]
C1265611
UMLS CUI [1,2]
C0449468
UMLS CUI [1,3]
C0205429
incomplete response after trans-arterial chemo-embolization of 1-5
Beschrijving

Response Incomplete | Status post Transarterial Chemoembolization

Datatype

boolean

Alias
UMLS CUI [1,1]
C1704632
UMLS CUI [1,2]
C0205257
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C3539919
a single lesion or multiple lesions including portal vein tumor thrombosis included in radiation field with one or consecutive sessions of stereotactic body radiation therapy (sbrt)
Beschrijving

Single lesion | Multiple lesions | Portal vein Tumour thrombosis | Radiation Field Stereotactic Body Radiation Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0577304
UMLS CUI [2]
C0577305
UMLS CUI [3,1]
C0032718
UMLS CUI [3,2]
C2242635
UMLS CUI [4,1]
C1882536
UMLS CUI [4,2]
C3896609
no evidence of an uncontrolled lesion at any other site
Beschrijving

Absence Lesion Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0205318
no evidence of complications of liver cirrhosis
Beschrijving

Complications Liver Cirrhosis Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0023890
UMLS CUI [1,3]
C0332197
no evidence of uncontrolled inter-current illness
Beschrijving

Comorbidity Uncontrolled Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0332197
patient or guardian must be able to provide verbal and written informed consent
Beschrijving

Informed Consent | Informed Consent Guardian

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient with previous history of abdominal radiation
Beschrijving

Radiotherapy to abdomen

Datatype

boolean

Alias
UMLS CUI [1]
C1997554
direct invasion to esophagus, stomach or colon by hcc
Beschrijving

Invasion Esophagus Liver carcinoma | Invasion Stomach Liver carcinoma | Invasion Colon Liver carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1269955
UMLS CUI [1,2]
C0014876
UMLS CUI [1,3]
C2239176
UMLS CUI [2,1]
C1269955
UMLS CUI [2,2]
C0038351
UMLS CUI [2,3]
C2239176
UMLS CUI [3,1]
C1269955
UMLS CUI [3,2]
C0009368
UMLS CUI [3,3]
C2239176
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Similar models

Eligibility Hepatocellular Carcinoma NCT01825824

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patients ≥ 20 years of age
boolean
C0001779 (UMLS CUI [1])
Liver carcinoma | Recurrent Hepatocellular Carcinoma
Item
initially diagnosed or recurrent hepatocellular carcinoma (hcc)
boolean
C2239176 (UMLS CUI [1])
C0861876 (UMLS CUI [2])
Liver carcinoma unresectable
Item
unresectable hcc
boolean
C2239176 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
Status Cirrhotic Child-Pugh Classification
Item
cirrhotic status of child pugh class a or b7
boolean
C0449438 (UMLS CUI [1,1])
C0439686 (UMLS CUI [1,2])
C2347612 (UMLS CUI [1,3])
ECOG performance status
Item
eastern cooperative oncology group performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Single tumor Size | Multiple tumors Size
Item
single or sum of multiple tumor ≤ 5 cm
boolean
C1298180 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0260037 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
Liver carcinoma Distance Gastrointestinal tract
Item
hcc with 3 cm apart from gastrointestinal tract
boolean
C2239176 (UMLS CUI [1,1])
C0012751 (UMLS CUI [1,2])
C0017189 (UMLS CUI [1,3])
Amount Volume Uninvolved
Item
the volume of uninvolved must be at least 700 ml
boolean
C1265611 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
C0205429 (UMLS CUI [1,3])
Response Incomplete | Status post Transarterial Chemoembolization
Item
incomplete response after trans-arterial chemo-embolization of 1-5
boolean
C1704632 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C3539919 (UMLS CUI [2,2])
Single lesion | Multiple lesions | Portal vein Tumour thrombosis | Radiation Field Stereotactic Body Radiation Therapy
Item
a single lesion or multiple lesions including portal vein tumor thrombosis included in radiation field with one or consecutive sessions of stereotactic body radiation therapy (sbrt)
boolean
C0577304 (UMLS CUI [1])
C0577305 (UMLS CUI [2])
C0032718 (UMLS CUI [3,1])
C2242635 (UMLS CUI [3,2])
C1882536 (UMLS CUI [4,1])
C3896609 (UMLS CUI [4,2])
Absence Lesion Uncontrolled
Item
no evidence of an uncontrolled lesion at any other site
boolean
C0332197 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Complications Liver Cirrhosis Absent
Item
no evidence of complications of liver cirrhosis
boolean
C0009566 (UMLS CUI [1,1])
C0023890 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Comorbidity Uncontrolled Absent
Item
no evidence of uncontrolled inter-current illness
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Informed Consent | Informed Consent Guardian
Item
patient or guardian must be able to provide verbal and written informed consent
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Radiotherapy to abdomen
Item
patient with previous history of abdominal radiation
boolean
C1997554 (UMLS CUI [1])
Invasion Esophagus Liver carcinoma | Invasion Stomach Liver carcinoma | Invasion Colon Liver carcinoma
Item
direct invasion to esophagus, stomach or colon by hcc
boolean
C1269955 (UMLS CUI [1,1])
C0014876 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
C1269955 (UMLS CUI [2,1])
C0038351 (UMLS CUI [2,2])
C2239176 (UMLS CUI [2,3])
C1269955 (UMLS CUI [3,1])
C0009368 (UMLS CUI [3,2])
C2239176 (UMLS CUI [3,3])
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