ID

39797

Description

Hypofractionated Proton Beam Radiotherapy for Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01643824

Link

https://clinicaltrials.gov/show/NCT01643824

Keywords

Versions (2)
  1. 2/20/20 2/20/20 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 20, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01643824

English

Eligibility Hepatocellular Carcinoma NCT01643824

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
hcc diagnosed as (i) the presence of risk factors including hepatitis b or c virus and liver cirrhosis, a serum a-fetoprotein (afp) level greater than 200 iu/ml and a radiologically compatible feature with hcc in one or more ct/mri/angiograms, or (ii) the presence of risk factors including hepatitis b or c virus and liver cirrhosis, a serum a-fetoprotein (afp) level less than 200 iu/ml, and a radiologically compatible feature with hcc in two or more ct/mri/angiograms or (iii) histological confirmation
Description

Liver carcinoma | Risk factors Present | Hepatitis B Virus | Hepatitis C virus | Liver Cirrhosis | Alpha one fetoprotein measurement | Feature Compatible with Liver carcinoma | CT | MRI | Angiogram | Histology

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C0150312
UMLS CUI [3]
C0019169
UMLS CUI [4]
C0220847
UMLS CUI [5]
C0023890
UMLS CUI [6]
C0201539
UMLS CUI [7,1]
C2348519
UMLS CUI [7,2]
C0332290
UMLS CUI [7,3]
C2239176
UMLS CUI [8]
C0040405
UMLS CUI [9]
C0024485
UMLS CUI [10]
C0002978
UMLS CUI [11]
C0344441
hcc patients who were not prospective suitable or refused for any other treatment, such as surgery or local ablation therapy, or recurrent or residual tumor after other treatments.
Description

Liver carcinoma Inappropriate Operative Surgical Procedures | Liver carcinoma Inappropriate Local Ablation Therapy | Operative Surgical Procedures Refused | Local Ablation Therapy Refused | Recurrent tumor | Residual Tumor | Status post Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0543467
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0547070
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C1705116
UMLS CUI [4,1]
C0547070
UMLS CUI [4,2]
C1705116
UMLS CUI [5]
C0521158
UMLS CUI [6]
C0543478
UMLS CUI [7,1]
C0231290
UMLS CUI [7,2]
C0087111
without evidence of extrahepatic metastasis
Description

Neoplasm Metastasis Extrahepatic Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517058
UMLS CUI [1,3]
C0332197
all target tumors must be encompassable within single irradiation field (15x15 cm maximum)
Description

Target Tumors All | Irradiation of single field Size Maximum

Data type

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0027651
UMLS CUI [1,3]
C0444868
UMLS CUI [2,1]
C2169158
UMLS CUI [2,2]
C0456389
UMLS CUI [2,3]
C0806909
no previous treatment to target tumors by other forms of rt
Description

Prior Therapy Absent Target Tumors | Prior radiation therapy Other Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1521840
UMLS CUI [1,4]
C0027651
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0332197
liver function of child-pugh class a or b7 (child-pugh score of ≤7)
Description

Liver function Child-Pugh Classification | Liver function Child-Pugh Score

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C2347612
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C4055253
age of ≥18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
performance status of 0 to 2 on the eastern cooperative oncology group (ecog) score
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
wbc count ≥ 2,000/mm3; hemoglobin level ≥ 7.5 g/dl; platelet count ≥ 25,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dl; ast and alt < 5.0× upper limit of normal; no ascites)
Description

White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Ascites Absent

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0232741
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201836
UMLS CUI [8,1]
C0003962
UMLS CUI [8,2]
C0332197
no serious comorbidities other than liver cirrhosis
Description

Comorbidity Serious Absent | Exception Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0023890
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of extrahepatic metastasis
Description

Neoplasm Metastasis Extrahepatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517058
age < 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
liver function of child-pugh class b8-9 and c (child-pugh score of >7)
Description

Liver function Child-Pugh Classification | Liver function Child-Pugh Score

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C2347612
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C4055253
previous history of other forms of rt adjacent to target tumors
Description

Prior radiation therapy Other Target Tumors

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1521840
UMLS CUI [1,4]
C0027651
poor performance status of 3 to 4 on the eastern cooperative oncology group (ecog) score
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
multicentric hccs, except for those with the following two conditions: *multinodular aggregating hcc that could be encompassed by single clinical target volume and within single irradiation field (15x15 cm maximum) *lesions other than targeted tumor that were judged as controlled with prior surgery and/or local ablation therapy.
Description

Liver carcinoma Multicentric | Exception Liver carcinoma Multinodular | Exception Irradiation of single field Size Maximum | Exception Prior surgery Lesion | Exception Local Ablation Therapy Lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0439743
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2239176
UMLS CUI [2,3]
C0205416
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2169158
UMLS CUI [3,3]
C0456389
UMLS CUI [3,4]
C0806909
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0455610
UMLS CUI [4,3]
C0221198
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0547070
UMLS CUI [5,3]
C0221198
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Similar models

Eligibility Hepatocellular Carcinoma NCT01643824

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma | Risk factors Present | Hepatitis B Virus | Hepatitis C virus | Liver Cirrhosis | Alpha one fetoprotein measurement | Feature Compatible with Liver carcinoma | CT | MRI | Angiogram | Histology
Item
hcc diagnosed as (i) the presence of risk factors including hepatitis b or c virus and liver cirrhosis, a serum a-fetoprotein (afp) level greater than 200 iu/ml and a radiologically compatible feature with hcc in one or more ct/mri/angiograms, or (ii) the presence of risk factors including hepatitis b or c virus and liver cirrhosis, a serum a-fetoprotein (afp) level less than 200 iu/ml, and a radiologically compatible feature with hcc in two or more ct/mri/angiograms or (iii) histological confirmation
boolean
C2239176 (UMLS CUI [1])
C0035648 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
C0019169 (UMLS CUI [3])
C0220847 (UMLS CUI [4])
C0023890 (UMLS CUI [5])
C0201539 (UMLS CUI [6])
C2348519 (UMLS CUI [7,1])
C0332290 (UMLS CUI [7,2])
C2239176 (UMLS CUI [7,3])
C0040405 (UMLS CUI [8])
C0024485 (UMLS CUI [9])
C0002978 (UMLS CUI [10])
C0344441 (UMLS CUI [11])
Liver carcinoma Inappropriate Operative Surgical Procedures | Liver carcinoma Inappropriate Local Ablation Therapy | Operative Surgical Procedures Refused | Local Ablation Therapy Refused | Recurrent tumor | Residual Tumor | Status post Therapy
Item
hcc patients who were not prospective suitable or refused for any other treatment, such as surgery or local ablation therapy, or recurrent or residual tumor after other treatments.
boolean
C2239176 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C2239176 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0547070 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3,1])
C1705116 (UMLS CUI [3,2])
C0547070 (UMLS CUI [4,1])
C1705116 (UMLS CUI [4,2])
C0521158 (UMLS CUI [5])
C0543478 (UMLS CUI [6])
C0231290 (UMLS CUI [7,1])
C0087111 (UMLS CUI [7,2])
Neoplasm Metastasis Extrahepatic Absent
Item
without evidence of extrahepatic metastasis
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Target Tumors All | Irradiation of single field Size Maximum
Item
all target tumors must be encompassable within single irradiation field (15x15 cm maximum)
boolean
C1521840 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
C0444868 (UMLS CUI [1,3])
C2169158 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
Prior Therapy Absent Target Tumors | Prior radiation therapy Other Absent
Item
no previous treatment to target tumors by other forms of rt
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C0027651 (UMLS CUI [1,4])
C0279134 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Liver function Child-Pugh Classification | Liver function Child-Pugh Score
Item
liver function of child-pugh class a or b7 (child-pugh score of ≤7)
boolean
C0232741 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2,1])
C4055253 (UMLS CUI [2,2])
Age
Item
age of ≥18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
performance status of 0 to 2 on the eastern cooperative oncology group (ecog) score
boolean
C1520224 (UMLS CUI [1])
White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Ascites Absent
Item
wbc count ≥ 2,000/mm3; hemoglobin level ≥ 7.5 g/dl; platelet count ≥ 25,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dl; ast and alt < 5.0× upper limit of normal; no ascites)
boolean
C0023508 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
C0003962 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
Comorbidity Serious Absent | Exception Liver Cirrhosis
Item
no serious comorbidities other than liver cirrhosis
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0023890 (UMLS CUI [2,2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis Extrahepatic
Item
evidence of extrahepatic metastasis
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
Age
Item
age < 18 years
boolean
C0001779 (UMLS CUI [1])
Liver function Child-Pugh Classification | Liver function Child-Pugh Score
Item
liver function of child-pugh class b8-9 and c (child-pugh score of >7)
boolean
C0232741 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2,1])
C4055253 (UMLS CUI [2,2])
Prior radiation therapy Other Target Tumors
Item
previous history of other forms of rt adjacent to target tumors
boolean
C0279134 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C0027651 (UMLS CUI [1,4])
ECOG performance status
Item
poor performance status of 3 to 4 on the eastern cooperative oncology group (ecog) score
boolean
C1520224 (UMLS CUI [1])
Liver carcinoma Multicentric | Exception Liver carcinoma Multinodular | Exception Irradiation of single field Size Maximum | Exception Prior surgery Lesion | Exception Local Ablation Therapy Lesion
Item
multicentric hccs, except for those with the following two conditions: *multinodular aggregating hcc that could be encompassed by single clinical target volume and within single irradiation field (15x15 cm maximum) *lesions other than targeted tumor that were judged as controlled with prior surgery and/or local ablation therapy.
boolean
C2239176 (UMLS CUI [1,1])
C0439743 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
C0205416 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C2169158 (UMLS CUI [3,2])
C0456389 (UMLS CUI [3,3])
C0806909 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0455610 (UMLS CUI [4,2])
C0221198 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0547070 (UMLS CUI [5,2])
C0221198 (UMLS CUI [5,3])
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