ID

38381

Description

A Dose-escalation Study of Lipotecan® Plus Radiotherapy in Locally Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01425996

Link

https://clinicaltrials.gov/show/NCT01425996

Keywords

Versions (1)
  1. 10/14/19 10/14/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 14, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Hepatocellular NCT01425996

English

Eligibility Carcinoma, Hepatocellular NCT01425996

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
females or males 20-70 years of age (inclusive)
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients with histological confirmed hcc or other conditions
Description

Liver carcinoma | Condition Other

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0205394
patients with locally advanced hcc and pvtt that is not suitable for other local therapies
Description

Liver carcinoma Advanced Locally | Portal vein Tumor thrombus | Tumor thrombus Inappropriate Local Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2,1]
C1305775
UMLS CUI [2,2]
C3163918
UMLS CUI [3,1]
C3163918
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C1517925
other inclusion criteria also apply
Description

Inclusion criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1524062
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
females who are pregnant/lactating or planning to be pregnant, or patients of childbearing potential who are not using medically recognized method of contraception.
Description

Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
patients with documented extrahepatic metastasis
Description

Neoplasm Metastasis Extrahepatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517058
patients with stage iii-iv encephalopathy or tense ascites
Description

Encephalopathy Stage | Tense ascites

Data type

boolean

Alias
UMLS CUI [1,1]
C0085584
UMLS CUI [1,2]
C1306673
UMLS CUI [2]
C0741244
patients who have received any local or systemic therapy for hcc within 4 weeks prior to the initiation of study treatment
Description

Local Therapy Liver carcinoma | Systemic therapy Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1517925
UMLS CUI [1,2]
C2239176
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C2239176
patients who have received lipotecan® treatment prior to the initiation of study treatment
Description

Lipotecan

Data type

boolean

Alias
UMLS CUI [1]
C2698966
other exclusion criteria also apply
Description

Exclusion Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Carcinoma, Hepatocellular NCT01425996

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
females or males 20-70 years of age (inclusive)
boolean
C0001779 (UMLS CUI [1])
Liver carcinoma | Condition Other
Item
patients with histological confirmed hcc or other conditions
boolean
C2239176 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Liver carcinoma Advanced Locally | Portal vein Tumor thrombus | Tumor thrombus Inappropriate Local Therapy
Item
patients with locally advanced hcc and pvtt that is not suitable for other local therapies
boolean
C2239176 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C1305775 (UMLS CUI [2,1])
C3163918 (UMLS CUI [2,2])
C3163918 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C1517925 (UMLS CUI [3,3])
Inclusion criteria Additional
Item
other inclusion criteria also apply
boolean
C1512693 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent
Item
females who are pregnant/lactating or planning to be pregnant, or patients of childbearing potential who are not using medically recognized method of contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Neoplasm Metastasis Extrahepatic
Item
patients with documented extrahepatic metastasis
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
Encephalopathy Stage | Tense ascites
Item
patients with stage iii-iv encephalopathy or tense ascites
boolean
C0085584 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
C0741244 (UMLS CUI [2])
Local Therapy Liver carcinoma | Systemic therapy Liver carcinoma
Item
patients who have received any local or systemic therapy for hcc within 4 weeks prior to the initiation of study treatment
boolean
C1517925 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
Lipotecan
Item
patients who have received lipotecan® treatment prior to the initiation of study treatment
boolean
C2698966 (UMLS CUI [1])
Exclusion Criteria Additional
Item
other exclusion criteria also apply
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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