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ID

29806

Description

Palliative Radiotherapy (RT) for Liver Metastases (Mets) and Hepatocellular Carcinoma (HCC)(COLD 4); ODM derived from: https://clinicaltrials.gov/show/NCT00923897

Link

https://clinicaltrials.gov/show/NCT00923897

Keywords

Versions (1)
  1. 4/20/18 4/20/18 -
Copyright Holder

See clinicaltrials.gov

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April 20, 2018

DOI

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License

Creative Commons BY 4.0
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    Eligibility Hepatocellular Carcinoma NCT00923897

    English

    Eligibility Hepatocellular Carcinoma NCT00923897

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients with hepatocellular carcinoma or hepatic metastases from a solid malignancy, unsuitable for radical therapy (including resection, transplant, conformal high dose radiotherapy), confirmed by biopsy or imaging
    Description

    Liver carcinoma Biopsy | Secondary malignant neoplasm of liver Solid tumour Biopsy | Liver carcinoma Imaging | Secondary malignant neoplasm of liver Solid tumour Imaging | Neoplasms Inappropriate Radical therapy | Excision | Transplantation | Conformal Radiotherapy High dose

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2239176
    UMLS CUI [1,2]
    C0005558
    UMLS CUI [2,1]
    C0494165
    UMLS CUI [2,2]
    C0280100
    UMLS CUI [2,3]
    C0005558
    UMLS CUI [3,1]
    C2239176
    UMLS CUI [3,2]
    C0011923
    UMLS CUI [4,1]
    C0494165
    UMLS CUI [4,2]
    C0280100
    UMLS CUI [4,3]
    C0011923
    UMLS CUI [5,1]
    C0027651
    UMLS CUI [5,2]
    C1548788
    UMLS CUI [5,3]
    C0260176
    UMLS CUI [6]
    C0728940
    UMLS CUI [7]
    C0040732
    UMLS CUI [8,1]
    C0600521
    UMLS CUI [8,2]
    C0444956
    symptoms of hepatic pain, discomfort, nausea, or fatigue requiring palliation
    Description

    Symptoms Liver pain Requirement Palliative Care | Symptoms Discomfort Requirement Palliative Care | Symptoms Nausea Requirement Palliative Care | Symptoms Fatigue Requirement Palliative Care

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0522067
    UMLS CUI [1,3]
    C1514873
    UMLS CUI [1,4]
    C0030231
    UMLS CUI [2,1]
    C1457887
    UMLS CUI [2,2]
    C0231218
    UMLS CUI [2,3]
    C1514873
    UMLS CUI [2,4]
    C0030231
    UMLS CUI [3,1]
    C1457887
    UMLS CUI [3,2]
    C0027497
    UMLS CUI [3,3]
    C1514873
    UMLS CUI [3,4]
    C0030231
    UMLS CUI [4,1]
    C1457887
    UMLS CUI [4,2]
    C0015672
    UMLS CUI [4,3]
    C1514873
    UMLS CUI [4,4]
    C0030231
    kps>60
    Description

    Karnofsky Performance Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0206065
    expected survival of greater than 3 months
    Description

    Life Expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    platelet count > 25 bil/l, hemoglobin > 70 g/l, inr<3, bilirubin<100 umol/l, ast < 350 u/l or alt< 400 u/l
    Description

    Platelet Count measurement | Hemoglobin measurement | International Normalized Ratio | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    UMLS CUI [2]
    C0518015
    UMLS CUI [3]
    C0525032
    UMLS CUI [4]
    C1278039
    UMLS CUI [5]
    C0201899
    UMLS CUI [6]
    C0201836
    have signed an informed consent form approved by the research ethics board (reb) at princess margaret hospital
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    chemotherapy or novel drug within the past 2 weeks
    Description

    Chemotherapy | Investigational New Drugs

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C0013230
    tace(transarterial chemoembolization)within the past 1 month
    Description

    Transarterial Chemoembolization

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3539919
    plan for active treatment of the hepatocellular carcinoma or hepatic metastases, including tace or rfa or etoh injection
    Description

    Therapeutic procedure Planned Liver carcinoma | Therapeutic procedure Planned Secondary malignant neoplasm of liver | Transarterial Chemoembolization | Radiofrequency ablation | Percutaneous ethanol injection therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C1301732
    UMLS CUI [1,3]
    C2239176
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C1301732
    UMLS CUI [2,3]
    C0494165
    UMLS CUI [3]
    C3539919
    UMLS CUI [4]
    C0850292
    UMLS CUI [5]
    C1535909
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    Similar models

    Eligibility Hepatocellular Carcinoma NCT00923897

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Liver carcinoma Biopsy | Secondary malignant neoplasm of liver Solid tumour Biopsy | Liver carcinoma Imaging | Secondary malignant neoplasm of liver Solid tumour Imaging | Neoplasms Inappropriate Radical therapy | Excision | Transplantation | Conformal Radiotherapy High dose
    Item
    patients with hepatocellular carcinoma or hepatic metastases from a solid malignancy, unsuitable for radical therapy (including resection, transplant, conformal high dose radiotherapy), confirmed by biopsy or imaging
    boolean
    C2239176 (UMLS CUI [1,1])
    C0005558 (UMLS CUI [1,2])
    C0494165 (UMLS CUI [2,1])
    C0280100 (UMLS CUI [2,2])
    C0005558 (UMLS CUI [2,3])
    C2239176 (UMLS CUI [3,1])
    C0011923 (UMLS CUI [3,2])
    C0494165 (UMLS CUI [4,1])
    C0280100 (UMLS CUI [4,2])
    C0011923 (UMLS CUI [4,3])
    C0027651 (UMLS CUI [5,1])
    C1548788 (UMLS CUI [5,2])
    C0260176 (UMLS CUI [5,3])
    C0728940 (UMLS CUI [6])
    C0040732 (UMLS CUI [7])
    C0600521 (UMLS CUI [8,1])
    C0444956 (UMLS CUI [8,2])
    Symptoms Liver pain Requirement Palliative Care | Symptoms Discomfort Requirement Palliative Care | Symptoms Nausea Requirement Palliative Care | Symptoms Fatigue Requirement Palliative Care
    Item
    symptoms of hepatic pain, discomfort, nausea, or fatigue requiring palliation
    boolean
    C1457887 (UMLS CUI [1,1])
    C0522067 (UMLS CUI [1,2])
    C1514873 (UMLS CUI [1,3])
    C0030231 (UMLS CUI [1,4])
    C1457887 (UMLS CUI [2,1])
    C0231218 (UMLS CUI [2,2])
    C1514873 (UMLS CUI [2,3])
    C0030231 (UMLS CUI [2,4])
    C1457887 (UMLS CUI [3,1])
    C0027497 (UMLS CUI [3,2])
    C1514873 (UMLS CUI [3,3])
    C0030231 (UMLS CUI [3,4])
    C1457887 (UMLS CUI [4,1])
    C0015672 (UMLS CUI [4,2])
    C1514873 (UMLS CUI [4,3])
    C0030231 (UMLS CUI [4,4])
    Karnofsky Performance Status
    Item
    kps>60
    boolean
    C0206065 (UMLS CUI [1])
    Life Expectancy
    Item
    expected survival of greater than 3 months
    boolean
    C0023671 (UMLS CUI [1])
    Platelet Count measurement | Hemoglobin measurement | International Normalized Ratio | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
    Item
    platelet count > 25 bil/l, hemoglobin > 70 g/l, inr<3, bilirubin<100 umol/l, ast < 350 u/l or alt< 400 u/l
    boolean
    C0032181 (UMLS CUI [1])
    C0518015 (UMLS CUI [2])
    C0525032 (UMLS CUI [3])
    C1278039 (UMLS CUI [4])
    C0201899 (UMLS CUI [5])
    C0201836 (UMLS CUI [6])
    Informed Consent
    Item
    have signed an informed consent form approved by the research ethics board (reb) at princess margaret hospital
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Chemotherapy | Investigational New Drugs
    Item
    chemotherapy or novel drug within the past 2 weeks
    boolean
    C0392920 (UMLS CUI [1])
    C0013230 (UMLS CUI [2])
    Transarterial Chemoembolization
    Item
    tace(transarterial chemoembolization)within the past 1 month
    boolean
    C3539919 (UMLS CUI [1])
    Therapeutic procedure Planned Liver carcinoma | Therapeutic procedure Planned Secondary malignant neoplasm of liver | Transarterial Chemoembolization | Radiofrequency ablation | Percutaneous ethanol injection therapy
    Item
    plan for active treatment of the hepatocellular carcinoma or hepatic metastases, including tace or rfa or etoh injection
    boolean
    C0087111 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    C2239176 (UMLS CUI [1,3])
    C0087111 (UMLS CUI [2,1])
    C1301732 (UMLS CUI [2,2])
    C0494165 (UMLS CUI [2,3])
    C3539919 (UMLS CUI [3])
    C0850292 (UMLS CUI [4])
    C1535909 (UMLS CUI [5])
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