ID

44302

Description

Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01668134

Link

https://clinicaltrials.gov/show/NCT01668134

Keywords

Versions (2)
  1. 10/14/19 10/14/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Hepatocellular NCT01668134

English

Eligibility Carcinoma, Hepatocellular NCT01668134

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky performance status of ≥ 60
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
pathologically confirmed ihc or hcc. (pathology not required for hcc if the lesion enhances typically on mri and the patient is evaluated by liver transplant surgery team and thought to have hcc.)
Description

Carcinoma intrahepatic | Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0007097
UMLS CUI [1,2]
C1512948
UMLS CUI [2]
C2239176
4 or less separate intrahepatic lesions, with at least one lesion that is able to be followed by easl criteria.
Description

Lesion intrahepatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1512948
local surgical resection is not possible due to tumor or patient factors
Description

Local excision Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0278259
UMLS CUI [1,2]
C1272705
limited metastatic disease is allowed if the volume of metastatic disease does not exceed the volume of primary disease.
Description

Neoplasm Metastasis Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0439801
prior tace allowed if stopped/completed at least 2 weeks prior to enrollment
Description

Transarterial Chemoembolization Discontinued | Transarterial Chemoembolization Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C3539919
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C3539919
UMLS CUI [2,2]
C0205197
prior chemotherapy except sorafenib allowed if stopped/completed at least 2 weeks prior to enrollment
Description

Prior Chemotherapy Discontinued | Prior Chemotherapy Completed | Exception Sorafenib

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1516119
prior sorafenib allowed if stopped/completed at least seven days prior to enrollment.
Description

Sorafenib Discontinued | Sorafenib Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C1516119
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C1516119
UMLS CUI [2,2]
C0205197
able to provide signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
childs-pugh score 9 or more
Description

Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1]
C4050412
alt or ast ≥ 6 x upper limit of normal
Description

Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
prior history of abdominal irradiation
Description

Radiotherapy to abdomen

Data type

boolean

Alias
UMLS CUI [1]
C1997554
women who are pregnant or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
scheduled to undergo chemotherapy except sorafenib at the time when radiation therapy will be given, or for up to 4 weeks after completion of radiation therapy.
Description

Chemotherapy Scheduled | Exception Sorafenib

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1516119
scheduled to undergo sorafenib within seven days of when radiation therapy will be delivered, or for up to 2 weeks after completion of radiation therapy.
Description

Sorafenib Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C1516119
UMLS CUI [1,2]
C0205539
undergone prior radiation therapy to the abdomen.
Description

Radiotherapy to abdomen

Data type

boolean

Alias
UMLS CUI [1]
C1997554
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Similar models

Eligibility Carcinoma, Hepatocellular NCT01668134

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 18
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance status of ≥ 60
boolean
C0206065 (UMLS CUI [1])
Carcinoma intrahepatic | Liver carcinoma
Item
pathologically confirmed ihc or hcc. (pathology not required for hcc if the lesion enhances typically on mri and the patient is evaluated by liver transplant surgery team and thought to have hcc.)
boolean
C0007097 (UMLS CUI [1,1])
C1512948 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2])
Lesion intrahepatic
Item
4 or less separate intrahepatic lesions, with at least one lesion that is able to be followed by easl criteria.
boolean
C0221198 (UMLS CUI [1,1])
C1512948 (UMLS CUI [1,2])
Local excision Unsuccessful
Item
local surgical resection is not possible due to tumor or patient factors
boolean
C0278259 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
Neoplasm Metastasis Limited
Item
limited metastatic disease is allowed if the volume of metastatic disease does not exceed the volume of primary disease.
boolean
C0027627 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Transarterial Chemoembolization Discontinued | Transarterial Chemoembolization Completed
Item
prior tace allowed if stopped/completed at least 2 weeks prior to enrollment
boolean
C3539919 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C3539919 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Prior Chemotherapy Discontinued | Prior Chemotherapy Completed | Exception Sorafenib
Item
prior chemotherapy except sorafenib allowed if stopped/completed at least 2 weeks prior to enrollment
boolean
C1514457 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1516119 (UMLS CUI [3,2])
Sorafenib Discontinued | Sorafenib Completed
Item
prior sorafenib allowed if stopped/completed at least seven days prior to enrollment.
boolean
C1516119 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1516119 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Informed Consent
Item
able to provide signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Child-Pugh Classification
Item
childs-pugh score 9 or more
boolean
C4050412 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
alt or ast ≥ 6 x upper limit of normal
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Radiotherapy to abdomen
Item
prior history of abdominal irradiation
boolean
C1997554 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
women who are pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Chemotherapy Scheduled | Exception Sorafenib
Item
scheduled to undergo chemotherapy except sorafenib at the time when radiation therapy will be given, or for up to 4 weeks after completion of radiation therapy.
boolean
C0392920 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1516119 (UMLS CUI [2,2])
Sorafenib Scheduled
Item
scheduled to undergo sorafenib within seven days of when radiation therapy will be delivered, or for up to 2 weeks after completion of radiation therapy.
boolean
C1516119 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
Radiotherapy to abdomen
Item
undergone prior radiation therapy to the abdomen.
boolean
C1997554 (UMLS CUI [1])
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