ID

41151

Beschreibung

Stereotactic Body Radiotherapy for Unresectable Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01910909

Link

https://clinicaltrials.gov/show/NCT01910909

Stichworte

Versionen (1)
  1. 02.07.20 02.07.20 -
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See clinicaltrials.gov

Hochgeladen am

2. Juli 2020

DOI

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Eligibility Localized Non-Resectable Adult Hepatocellular Carcinoma NCT01910909

Englisch

Eligibility Localized Non-Resectable Adult Hepatocellular Carcinoma NCT01910909

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have a diagnosis of hcc by at least one criterion listed below (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 feto protein (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
Beschreibung

Liver carcinoma | Nodule of liver High risk | Alpha one fetoprotein measurement | Liver carcinoma pattern CT with Contrast | Liver carcinoma pattern MRI with contrast | Liver carcinoma pattern Angiography | Nodule size Liver Cirrhosis

Datentyp

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]
C0439712
UMLS CUI [4,3]
C0742919
UMLS CUI [5,1]
C2239176
UMLS CUI [5,2]
C0439712
UMLS CUI [5,3]
C0202671
UMLS CUI [6,1]
C2239176
UMLS CUI [6,2]
C0439712
UMLS CUI [6,3]
C0002978
UMLS CUI [7,1]
C0449457
UMLS CUI [7,2]
C0023890
2. eastern cooperative oncology group performance status 0 or 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
3. size of the hcc ≤ 3 cm or less
Beschreibung

Liver carcinoma Size

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0456389
4. age ≥ 20
Beschreibung

Age

Datentyp

boolean

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

Patients Inappropriate Excision | Patients Inappropriate Transplantation | Patients Inappropriate Radiofrequency Ablation

Datentyp

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)
Beschreibung

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

Datentyp

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
7. agreement of study-specific informed consent
Beschreibung

Informed Consent

Datentyp

boolean

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

Assessment Radiation Oncologist | Assessment Oncologist | Assessment Hepatologist

Datentyp

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 within 14 days prior to study entry
Beschreibung

Child-Pugh Clinical Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C4050412
10. normal liver (liver minus gross tumor volume) ≥ 700 cc
Beschreibung

Liver normal Volume

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0577059
UMLS CUI [1,2]
C0449468
11. target is only one viable hepatocellular carcinoma
Beschreibung

Target Liver carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C2239176
12. blood work requirements
Beschreibung

Hematologic Test Required

Datentyp

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
Beschreibung

Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datentyp

boolean

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

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

Datentyp

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 rate ≥ 60 ml/min
Beschreibung

Creatinine measurement, serum | Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
13. male, consent contraception at least 6 months childbearing potential woman, consent contraception at least 6 months
Beschreibung

Gender Contraceptive methods | Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
14. life expectancy more than 12 weeks
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
15. stable breathing more than 10 minutes
Beschreibung

Breathing Stable Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004048
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0449238
16. consent to fiducial marker insertion ( if needed )
Beschreibung

Fiducial marker placement

Datentyp

boolean

Alias
UMLS CUI [1]
C3888577
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. extrahepatic metastasis or malignant nodes
Beschreibung

Neoplasm Metastasis Extrahepatic | Lymph nodes Malignant Extrahepatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517058
UMLS CUI [2,1]
C0024204
UMLS CUI [2,2]
C0205282
UMLS CUI [2,3]
C1517058
2. pregnant and/or breastfeeding woman
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. macroscopic vascular tumor involvement
Beschreibung

Vascular Neoplasm macroscopic Involvement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027668
UMLS CUI [1,2]
C0439806
UMLS CUI [1,3]
C1314939
4. previous upper abdominal rt history
Beschreibung

Therapeutic radiology procedure Upper abdomen

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0230165
5. uncontrolled active co-morbidity
Beschreibung

Comorbidity Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
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Ähnliche Modelle

Eligibility Localized Non-Resectable Adult Hepatocellular Carcinoma NCT01910909

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma | Nodule of liver High risk | Alpha one fetoprotein measurement | Liver carcinoma pattern CT with Contrast | Liver carcinoma pattern MRI with contrast | Liver carcinoma pattern Angiography | Nodule size Liver Cirrhosis
Item
1. patients must have a diagnosis of hcc by at least one criterion listed below (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 feto protein (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])
C0439712 (UMLS CUI [4,2])
C0742919 (UMLS CUI [4,3])
C2239176 (UMLS CUI [5,1])
C0439712 (UMLS CUI [5,2])
C0202671 (UMLS CUI [5,3])
C2239176 (UMLS CUI [6,1])
C0439712 (UMLS CUI [6,2])
C0002978 (UMLS CUI [6,3])
C0449457 (UMLS CUI [7,1])
C0023890 (UMLS CUI [7,2])
ECOG performance status
Item
2. eastern cooperative oncology group performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Liver carcinoma Size
Item
3. size of the hcc ≤ 3 cm or less
boolean
C2239176 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Age
Item
4. age ≥ 20
boolean
C0001779 (UMLS CUI [1])
Patients Inappropriate Excision | Patients Inappropriate Transplantation | Patients 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])
Patients Inappropriate Transarterial Chemoembolization | Unresponsive to Transarterial Chemoembolization | Patients Inappropriate 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])
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 Clinical Classification
Item
9. child-pugh score a within 14 days prior to study entry
boolean
C4050412 (UMLS CUI [1])
Liver normal Volume
Item
10. normal liver (liver minus gross tumor volume) ≥ 700 cc
boolean
C0577059 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
Target Liver carcinoma
Item
11. target is only one viable hepatocellular carcinoma
boolean
C1521840 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
Hematologic Test Required
Item
12. 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): t. 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 rate ≥ 60 ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Gender Contraceptive methods | Childbearing Potential Contraceptive methods
Item
13. male, consent contraception at least 6 months childbearing potential woman, consent contraception at least 6 months
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Life Expectancy
Item
14. life expectancy more than 12 weeks
boolean
C0023671 (UMLS CUI [1])
Breathing Stable Duration
Item
15. stable breathing more than 10 minutes
boolean
C0004048 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Fiducial marker placement
Item
16. consent to fiducial marker insertion ( if needed )
boolean
C3888577 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis Extrahepatic | Lymph nodes Malignant Extrahepatic
Item
1. extrahepatic metastasis or malignant nodes
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C0024204 (UMLS CUI [2,1])
C0205282 (UMLS CUI [2,2])
C1517058 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
2. pregnant and/or breastfeeding woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Vascular Neoplasm macroscopic Involvement
Item
3. macroscopic vascular tumor involvement
boolean
C0027668 (UMLS CUI [1,1])
C0439806 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
Therapeutic radiology procedure Upper abdomen
Item
4. previous upper abdominal rt history
boolean
C1522449 (UMLS CUI [1,1])
C0230165 (UMLS CUI [1,2])
Comorbidity Uncontrolled
Item
5. uncontrolled active co-morbidity
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
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