ID

38510

Beskrivning

Effectiveness and Safety of the Simultaneous Radiotherapy and Hyperthermia After Transarterial Chemoembolization in Hepatocellular Carcinoma Patients Combined With Portal Vein Tumor Thrombosis; ODM derived from: https://clinicaltrials.gov/show/NCT01911000

Länk

https://clinicaltrials.gov/show/NCT01911000

Nyckelord

Versioner (2)
  1. 2019-10-23 2019-10-23 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 oktober 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Carcinoma. Hepatocellular NCT01911000

Engelsk

Eligibility Carcinoma. Hepatocellular NCT01911000

1 Formulär  
Inclusion Criteria
Beskrivning

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
Beskrivning

Liver carcinoma | Nodule of liver High risk | Alpha fetoprotein measurement | Liver carcinoma Patterns Quantity Dynamic Enhanced CT | Liver carcinoma Patterns Quantity Dynamic contrast-enhanced MRI | Liver carcinoma Patterns Quantity Angiography | Nodule size Liver Cirrhosis

Datatyp

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]
C1512095
UMLS CUI [5,1]
C2239176
UMLS CUI [5,2]
C0449774
UMLS CUI [5,3]
C1265611
UMLS CUI [5,4]
C1831914
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
Beskrivning

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

Datatyp

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]
C0199232
UMLS CUI [2,4]
C0040405
UMLS CUI [3,1]
C2349975
UMLS CUI [3,2]
C0221464
UMLS CUI [3,3]
C0199232
UMLS CUI [3,4]
C0024485
UMLS CUI [4,1]
C1710661
UMLS CUI [4,2]
C0199232
UMLS CUI [4,3]
C0040405
UMLS CUI [5,1]
C1710661
UMLS CUI [5,2]
C0199232
UMLS CUI [5,3]
C0024485
3. eastern cooperative oncology group performance status 0 1 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
4. age ≥ 20
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
5. unsuitable for resection or transplant or rfa
Beskrivning

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

Datatyp

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)
Beskrivning

Patient Inappropriate Transarterial Chemoembolization | Unresponsive to Transarterial Chemoembolization | Patient Inappropriate Drug-eluting Embolic Bead | Unresponsive to Drug-eluting Embolic Bead

Datatyp

boolean

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

Informed Consent

Datatyp

boolean

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

Assessment Radiation Oncologist | Assessment Oncologist | Assessment Hepatologist

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C1514693
UMLS CUI [2,1]
C1516048
UMLS CUI [2,2]
C0259990
UMLS CUI [3,1]
C1516048
UMLS CUI [3,2]
C4280018
9. child-pugh score a-b within 7 days prior to study entry
Beskrivning

Child-Pugh Classification

Datatyp

boolean

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

Liver Volume

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0449468
11. blood work requirements
Beskrivning

Hematologic Tests Required

Datatyp

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
Beskrivning

Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datatyp

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
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0023901
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
Beskrivning

Creatinine measurement, serum | Creatinine clearance measurement

Datatyp

boolean

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

Gender | Consent Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C1511481
UMLS CUI [2,2]
C0700589
13. childbearing potential woman, consent contraception at least 6 months
Beskrivning

Childbearing Potential Contraceptive methods

Datatyp

boolean

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

Life Expectancy

Datatyp

boolean

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

Respiration Stable Duration

Datatyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. complete obstruction of main portal vein
Beskrivning

Complete obstruction Portal vein Main

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001168
UMLS CUI [1,2]
C1305775
UMLS CUI [1,3]
C1542147
2. pregnant and/or breastfeeding woman
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. previous upper abdominal rt history
Beskrivning

Therapeutic radiology procedure Upper abdomen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C2937240
4. uncontrolled active co-morbidity
Beskrivning

Comorbidity Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
5. another primary cancer history within 2 years
Beskrivning

Second Primary Cancer

Datatyp

boolean

Alias
UMLS CUI [1]
C0751623
6. uncontrolled ascites or hepatic encephalopathy
Beskrivning

Ascites Uncontrolled | Hepatic Encephalopathy Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0019151
UMLS CUI [2,2]
C0205318
7. connective tissue disease which known as radiation hypersensitivity
Beskrivning

Connective Tissue Disease | Hypersensitivity Radiation

Datatyp

boolean

Alias
UMLS CUI [1]
C0009782
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1522449
8. uncontrolled moderate to severe gastroduodenal ulcer or esophagogastric varices
Beskrivning

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

Datatyp

boolean

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

Eligibility Carcinoma. Hepatocellular NCT01911000

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma | Nodule of liver High risk | Alpha fetoprotein measurement | Liver carcinoma Patterns Quantity Dynamic Enhanced CT | Liver carcinoma Patterns Quantity Dynamic contrast-enhanced MRI | 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])
C1512095 (UMLS CUI [4,4])
C2239176 (UMLS CUI [5,1])
C0449774 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C1831914 (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 Multiphasic CT | Enhancement Arterial Multiphasic MRI | Washout Multiphasic CT | Washout Multiphasic MRI
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])
C0199232 (UMLS CUI [2,3])
C0040405 (UMLS CUI [2,4])
C2349975 (UMLS CUI [3,1])
C0221464 (UMLS CUI [3,2])
C0199232 (UMLS CUI [3,3])
C0024485 (UMLS CUI [3,4])
C1710661 (UMLS CUI [4,1])
C0199232 (UMLS CUI [4,2])
C0040405 (UMLS CUI [4,3])
C1710661 (UMLS CUI [5,1])
C0199232 (UMLS CUI [5,2])
C0024485 (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
boolean
C0001779 (UMLS CUI [1])
Patient Inappropriate Excision | Patient Inappropriate Transplantation | Patient Inappropriate Radiofrequency ablation
Item
5. unsuitable for resection or transplant or 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 Transarterial Chemoembolization | Unresponsive to Transarterial Chemoembolization | Patient Inappropriate Drug-eluting Embolic Bead | Unresponsive to 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])
C0205269 (UMLS CUI [2,1])
C3539919 (UMLS CUI [2,2])
C0030705 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C3273294 (UMLS CUI [3,3])
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 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])
C0259990 (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 Volume
Item
10. normal liver (liver minus gross tumor volume) ≥ 700 cc
boolean
C0023884 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
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 Tests | 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
C0023901 (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 | Consent Contraceptive methods
Item
12. male, consent contraception at least 6 months
boolean
C0079399 (UMLS CUI [1])
C1511481 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
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])
Respiration 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)
Complete obstruction Portal vein Main
Item
1. complete obstruction of main portal vein
boolean
C0001168 (UMLS CUI [1,1])
C1305775 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
2. pregnant and/or breastfeeding woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Therapeutic radiology procedure Upper abdomen
Item
3. previous upper abdominal rt history
boolean
C1522449 (UMLS CUI [1,1])
C2937240 (UMLS CUI [1,2])
Comorbidity Uncontrolled
Item
4. uncontrolled active co-morbidity
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Second Primary Cancer
Item
5. another primary cancer history within 2 years
boolean
C0751623 (UMLS CUI [1])
Ascites Uncontrolled | Hepatic Encephalopathy Uncontrolled
Item
6. uncontrolled ascites or hepatic encephalopathy
boolean
C0003962 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0019151 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Connective Tissue Disease | Hypersensitivity Radiation
Item
7. connective tissue disease which known as radiation hypersensitivity
boolean
C0009782 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
Peptic Ulcer Moderate Uncontrolled | Peptic Ulcer Severe Uncontrolled | Varices Esophagogastric 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])
C0030920 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0042345 (UMLS CUI [3,1])
C0475468 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
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