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

Uploaded on

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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