ID

36068

Descrição

Transarterial Chemoembolization (TACE) With Radiation Therapy (RT) in Advanced Hepatocellular Carcinoma (HCC); ODM derived from: https://clinicaltrials.gov/show/NCT02290977

Link

https://clinicaltrials.gov/show/NCT02290977

Palavras-chave

Versões (2)
  1. 13/04/2019 13/04/2019 -
  2. 20/09/2021 20/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

13 de abril de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT02290977

Inglês

Eligibility Hepatocellular Carcinoma NCT02290977

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have a diagnosis of hcc by at least one criterion listed below (korean liver cancer study group (klcsg) guideline 2009) 1.1 pathologically (histologically or cytologically) proven diagnosis of hcc 1.2 liver nodule in high risk group 1.2.1 if alpha fetoprotein (afp) ≥200 ng/ml , ≥ 1 typical hcc enhancing pattern on dynamic contrast enhanced ct or mri 1.2.2 if afp<200 ng/ml, ≥2 typical hcc enhancing pattern on dynamic contrast enhanced ct, mri, and angiography 1.3 ≥ 2 cm nodule in liver cirrhosis (lc), ≥ 1 typical hcc enhancing pattern on dynamic contrast enhanced ct or mri
Descrição

Liver carcinoma | Nodule of liver High risk | Alpha one fetoprotein measurement | Liver carcinoma Patterns Quantity CT scan contrast | Liver carcinoma Patterns Quantity MRI with contrast | Liver carcinoma Patterns Quantity Angiography | Nodule size Liver Cirrhosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0745761
UMLS CUI [2,2]
C4319571
UMLS CUI [3]
C0201539
UMLS CUI [4,1]
C2239176
UMLS CUI [4,2]
C0449774
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C0742919
UMLS CUI [5,1]
C2239176
UMLS CUI [5,2]
C0449774
UMLS CUI [5,3]
C1265611
UMLS CUI [5,4]
C0202671
UMLS CUI [6,1]
C2239176
UMLS CUI [6,2]
C0449774
UMLS CUI [6,3]
C1265611
UMLS CUI [6,4]
C0002978
UMLS CUI [7,1]
C0449457
UMLS CUI [7,2]
C0023890
2. patients must have a diagnosis of pvtt 2.1 early arterial enhancement and delayed washout on multiphasic ct or mri
Descrição

Portal vein Tumor thrombus | Enhancement Arterial CT Multiphasic | Enhancement Arterial MRI Multiphasic | Washout CT Multiphasic | Washout MRI Multiphasic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1305775
UMLS CUI [1,2]
C3163918
UMLS CUI [2,1]
C2349975
UMLS CUI [2,2]
C0221464
UMLS CUI [2,3]
C0040405
UMLS CUI [2,4]
C0026752
UMLS CUI [3,1]
C2349975
UMLS CUI [3,2]
C0221464
UMLS CUI [3,3]
C0024485
UMLS CUI [3,4]
C0026752
UMLS CUI [4,1]
C1710661
UMLS CUI [4,2]
C0040405
UMLS CUI [4,3]
C0026752
UMLS CUI [5,1]
C1710661
UMLS CUI [5,2]
C0024485
UMLS CUI [5,3]
C0026752
3. eastern cooperative oncology group performance status 0 1 2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
4. age ≥ 20 and 70 or less
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
5. unsuitable for resection or transplant or radiofrequency ablation (rfa)
Descrição

Patient Inappropriate Excision | Patient Inappropriate Transplantation | Patient Inappropriate Radiofrequency ablation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0728940
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0040732
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C0850292
6. unsuitable for or refractory to tace or drug eluting beads (deb)
Descrição

Patient Inappropriate TACE | Patient Inappropriate Drug-eluting Embolic Bead | Refractory TACE | Refractory Drug-eluting Embolic Bead

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C3539919
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C3273294
UMLS CUI [3,1]
C0205269
UMLS CUI [3,2]
C3539919
UMLS CUI [4,1]
C0205269
UMLS CUI [4,2]
C3273294
7. agreement of study-specific informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
8. assessment by radiation oncologist and medical oncologist or hepatologist within 28 days prior to study entry?
Descrição

Assessment Radiation Oncologist | Assessment Medical oncologist | Assessment Hepatologist

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C1514693
UMLS CUI [2,1]
C1516048
UMLS CUI [2,2]
C1555767
UMLS CUI [3,1]
C1516048
UMLS CUI [3,2]
C4280018
9. child-pugh score a-b within 7 days prior to study entry
Descrição

Child-Pugh Classification

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2347612
10. normal liver (liver minus gross tumor volume) ≥ 700 cc
Descrição

Liver normal | Liver minus Gross tumor volume

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0577059
UMLS CUI [2,1]
C0023884
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C0475645
11. blood work requirements
Descrição

Hematologic Tests Required

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1514873
absolute neutrophil count (anc) ≥ 1,500 /mm3, platelet ≥ 70,000/mm3, hgb ≥ 8 g/dl
Descrição

Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
liver function test (lft): total bilirubin<3.0 mg/dl, international normalized ratio(inr) < 1.7, albumin ≥ 2.8g/dl, aspartate aminotransferase (ast)/alanine aminotransferase (alt)< 6 x normal
Descrição

Liver function | Serum total bilirubin measurement | International Normalized Ratio | Albumin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0525032
UMLS CUI [4]
C0201838
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201836
serum creatinine < 1.5 x normal, or creatinine clearance ≥ 60 ml/min
Descrição

Creatinine measurement, serum | Creatinine clearance measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
12. male, consent contraception at least 6 months
Descrição

Gender Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
13. childbearing potential woman, consent contraception at least 6 months
Descrição

Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
14. life expectancy more than 12 weeks
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
15. stable breathing more than 5 minutes
Descrição

Breathing Stable Duration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0035203
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0449238
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. complete obstruction of main portal vein 2. pregnant and/or breastfeeding woman 3. previous upper abdominal rt history 4. uncontrolled active co-morbidity 5. another primary cancer history within 2 years 6. uncontrolled ascites or hepatic encephalopathy 7. connective tissue disease which known as radiation hypersensitivity
Descrição

Main portal vein Complete obstruction | Pregnancy | Breast Feeding | Prior radiation therapy Upper abdomen | Comorbidity Uncontrolled | Second Primary Cancers | Ascites Uncontrolled | Hepatic Encephalopathy Uncontrolled | Connective Tissue Diseases | Hypersensitivity Therapeutic radiology procedure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1183135
UMLS CUI [1,2]
C0001168
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C0279134
UMLS CUI [4,2]
C2937240
UMLS CUI [5,1]
C0009488
UMLS CUI [5,2]
C0205318
UMLS CUI [6]
C0751623
UMLS CUI [7,1]
C0003962
UMLS CUI [7,2]
C0205318
UMLS CUI [8,1]
C0019151
UMLS CUI [8,2]
C0205318
UMLS CUI [9]
C0009782
UMLS CUI [10,1]
C0020517
UMLS CUI [10,2]
C1522449
8. uncontrolled moderate to severe gastroduodenal ulcer or esophagogastric varices
Descrição

Peptic Ulcer Moderate Uncontrolled | Varices Esophagogastric Moderate Uncontrolled | Peptic Ulcer Severe Uncontrolled | Varices Esophagogastric Severe Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030920
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0042345
UMLS CUI [2,2]
C0475468
UMLS CUI [2,3]
C0205081
UMLS CUI [2,4]
C0205318
UMLS CUI [3,1]
C0030920
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0205318
UMLS CUI [4,1]
C0042345
UMLS CUI [4,2]
C0475468
UMLS CUI [4,3]
C0205082
UMLS CUI [4,4]
C0205318
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Similar models

Eligibility Hepatocellular Carcinoma NCT02290977

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma | Nodule of liver High risk | Alpha one fetoprotein measurement | Liver carcinoma Patterns Quantity CT scan contrast | Liver carcinoma Patterns Quantity MRI with contrast | Liver carcinoma Patterns Quantity Angiography | Nodule size Liver Cirrhosis
Item
1. patients must have a diagnosis of hcc by at least one criterion listed below (korean liver cancer study group (klcsg) guideline 2009) 1.1 pathologically (histologically or cytologically) proven diagnosis of hcc 1.2 liver nodule in high risk group 1.2.1 if alpha fetoprotein (afp) ≥200 ng/ml , ≥ 1 typical hcc enhancing pattern on dynamic contrast enhanced ct or mri 1.2.2 if afp<200 ng/ml, ≥2 typical hcc enhancing pattern on dynamic contrast enhanced ct, mri, and angiography 1.3 ≥ 2 cm nodule in liver cirrhosis (lc), ≥ 1 typical hcc enhancing pattern on dynamic contrast enhanced ct or mri
boolean
C2239176 (UMLS CUI [1])
C0745761 (UMLS CUI [2,1])
C4319571 (UMLS CUI [2,2])
C0201539 (UMLS CUI [3])
C2239176 (UMLS CUI [4,1])
C0449774 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0742919 (UMLS CUI [4,4])
C2239176 (UMLS CUI [5,1])
C0449774 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C0202671 (UMLS CUI [5,4])
C2239176 (UMLS CUI [6,1])
C0449774 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
C0002978 (UMLS CUI [6,4])
C0449457 (UMLS CUI [7,1])
C0023890 (UMLS CUI [7,2])
Portal vein Tumor thrombus | Enhancement Arterial CT Multiphasic | Enhancement Arterial MRI Multiphasic | Washout CT Multiphasic | Washout MRI Multiphasic
Item
2. patients must have a diagnosis of pvtt 2.1 early arterial enhancement and delayed washout on multiphasic ct or mri
boolean
C1305775 (UMLS CUI [1,1])
C3163918 (UMLS CUI [1,2])
C2349975 (UMLS CUI [2,1])
C0221464 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C0026752 (UMLS CUI [2,4])
C2349975 (UMLS CUI [3,1])
C0221464 (UMLS CUI [3,2])
C0024485 (UMLS CUI [3,3])
C0026752 (UMLS CUI [3,4])
C1710661 (UMLS CUI [4,1])
C0040405 (UMLS CUI [4,2])
C0026752 (UMLS CUI [4,3])
C1710661 (UMLS CUI [5,1])
C0024485 (UMLS CUI [5,2])
C0026752 (UMLS CUI [5,3])
ECOG performance status
Item
3. eastern cooperative oncology group performance status 0 1 2
boolean
C1520224 (UMLS CUI [1])
Age
Item
4. age ≥ 20 and 70 or less
boolean
C0001779 (UMLS CUI [1])
Patient Inappropriate Excision | Patient Inappropriate Transplantation | Patient Inappropriate Radiofrequency ablation
Item
5. unsuitable for resection or transplant or radiofrequency ablation (rfa)
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0728940 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0040732 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0850292 (UMLS CUI [3,3])
Patient Inappropriate TACE | Patient Inappropriate Drug-eluting Embolic Bead | Refractory TACE | Refractory Drug-eluting Embolic Bead
Item
6. unsuitable for or refractory to tace or drug eluting beads (deb)
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C3539919 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C3273294 (UMLS CUI [2,3])
C0205269 (UMLS CUI [3,1])
C3539919 (UMLS CUI [3,2])
C0205269 (UMLS CUI [4,1])
C3273294 (UMLS CUI [4,2])
Informed Consent
Item
7. agreement of study-specific informed consent
boolean
C0021430 (UMLS CUI [1])
Assessment Radiation Oncologist | Assessment Medical oncologist | Assessment Hepatologist
Item
8. assessment by radiation oncologist and medical oncologist or hepatologist within 28 days prior to study entry?
boolean
C1516048 (UMLS CUI [1,1])
C1514693 (UMLS CUI [1,2])
C1516048 (UMLS CUI [2,1])
C1555767 (UMLS CUI [2,2])
C1516048 (UMLS CUI [3,1])
C4280018 (UMLS CUI [3,2])
Child-Pugh Classification
Item
9. child-pugh score a-b within 7 days prior to study entry
boolean
C2347612 (UMLS CUI [1])
Liver normal | Liver minus Gross tumor volume
Item
10. normal liver (liver minus gross tumor volume) ≥ 700 cc
boolean
C0577059 (UMLS CUI [1])
C0023884 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0475645 (UMLS CUI [2,3])
Hematologic Tests Required
Item
11. blood work requirements
boolean
C0018941 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
absolute neutrophil count (anc) ≥ 1,500 /mm3, platelet ≥ 70,000/mm3, hgb ≥ 8 g/dl
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Liver function | Serum total bilirubin measurement | International Normalized Ratio | Albumin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
liver function test (lft): total bilirubin<3.0 mg/dl, international normalized ratio(inr) < 1.7, albumin ≥ 2.8g/dl, aspartate aminotransferase (ast)/alanine aminotransferase (alt)< 6 x normal
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0525032 (UMLS CUI [3])
C0201838 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
Creatinine measurement, serum | Creatinine clearance measurement
Item
serum creatinine < 1.5 x normal, or creatinine clearance ≥ 60 ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Gender Contraceptive methods
Item
12. male, consent contraception at least 6 months
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods
Item
13. childbearing potential woman, consent contraception at least 6 months
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Life Expectancy
Item
14. life expectancy more than 12 weeks
boolean
C0023671 (UMLS CUI [1])
Breathing Stable Duration
Item
15. stable breathing more than 5 minutes
boolean
C0035203 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Main portal vein Complete obstruction | Pregnancy | Breast Feeding | Prior radiation therapy Upper abdomen | Comorbidity Uncontrolled | Second Primary Cancers | Ascites Uncontrolled | Hepatic Encephalopathy Uncontrolled | Connective Tissue Diseases | Hypersensitivity Therapeutic radiology procedure
Item
1. complete obstruction of main portal vein 2. pregnant and/or breastfeeding woman 3. previous upper abdominal rt history 4. uncontrolled active co-morbidity 5. another primary cancer history within 2 years 6. uncontrolled ascites or hepatic encephalopathy 7. connective tissue disease which known as radiation hypersensitivity
boolean
C1183135 (UMLS CUI [1,1])
C0001168 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0279134 (UMLS CUI [4,1])
C2937240 (UMLS CUI [4,2])
C0009488 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0751623 (UMLS CUI [6])
C0003962 (UMLS CUI [7,1])
C0205318 (UMLS CUI [7,2])
C0019151 (UMLS CUI [8,1])
C0205318 (UMLS CUI [8,2])
C0009782 (UMLS CUI [9])
C0020517 (UMLS CUI [10,1])
C1522449 (UMLS CUI [10,2])
Peptic Ulcer Moderate Uncontrolled | Varices Esophagogastric Moderate Uncontrolled | Peptic Ulcer Severe Uncontrolled | Varices Esophagogastric Severe Uncontrolled
Item
8. uncontrolled moderate to severe gastroduodenal ulcer or esophagogastric varices
boolean
C0030920 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0042345 (UMLS CUI [2,1])
C0475468 (UMLS CUI [2,2])
C0205081 (UMLS CUI [2,3])
C0205318 (UMLS CUI [2,4])
C0030920 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
C0042345 (UMLS CUI [4,1])
C0475468 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
C0205318 (UMLS CUI [4,4])
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