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ID

44513

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01643824

Nyckelord

Versioner (2)
  1. 2020-02-20 2020-02-20 -
  2. 2021-09-27 2021-09-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 september 2021

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Hepatocellular Carcinoma NCT01643824

    Engelsk

    Eligibility Hepatocellular Carcinoma NCT01643824

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    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
    Beskrivning

    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

    Datatyp

    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.
    Beskrivning

    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

    Datatyp

    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
    Beskrivning

    Neoplasm Metastasis Extrahepatic Absent

    Datatyp

    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)
    Beskrivning

    Target Tumors All | Irradiation of single field Size Maximum

    Datatyp

    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
    Beskrivning

    Prior Therapy Absent Target Tumors | Prior radiation therapy Other Absent

    Datatyp

    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)
    Beskrivning

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

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0232741
    UMLS CUI [1,2]
    C4050412
    UMLS CUI [2,1]
    C0232741
    UMLS CUI [2,2]
    C4055253
    age of ≥18 years
    Beskrivning

    Age

    Datatyp

    boolean

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

    ECOG performance status

    Datatyp

    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)
    Beskrivning

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

    Datatyp

    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
    Beskrivning

    Comorbidity Serious Absent | Exception Liver Cirrhosis

    Datatyp

    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
    Beskrivning

    Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    evidence of extrahepatic metastasis
    Beskrivning

    Neoplasm Metastasis Extrahepatic

    Datatyp

    boolean

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

    Age

    Datatyp

    boolean

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

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

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0232741
    UMLS CUI [1,2]
    C4050412
    UMLS CUI [2,1]
    C0232741
    UMLS CUI [2,2]
    C4055253
    previous history of other forms of rt adjacent to target tumors
    Beskrivning

    Prior radiation therapy Other Target Tumors

    Datatyp

    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
    Beskrivning

    ECOG performance status

    Datatyp

    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.
    Beskrivning

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

    Datatyp

    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 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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])
    C4050412 (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])
    C4050412 (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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