ID

42929

Description

Radiotherapy Plus Thalidomide in Locally Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00155272

Link

https://clinicaltrials.gov/show/NCT00155272

Keywords

Versions (2)
  1. 8/15/16 8/15/16 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00155272

English

Eligibility Hepatocellular Carcinoma NCT00155272

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1.1 patients with measurable, locally advanced hcc that are not suitable for other local therapies, including surgery, tae, alcohol injection, or radiofrequency ablation.
Description

Patients with measurable, locally advanced hcc that are not suitable for other local therapies

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0677984
UMLS CUI [1,3]
C1517925
1.2 patients with histological confirmed hcc or patients who do not have histological diagnosis but have met all of the following criteria: 1.2.1 presence of chronic viral hepatitis and/or cirrhosis 1.2.2 presence of hepatic tumor(s) with image findings (sonography, ct scan) compatible with hcc.
Description

liver carcinoma or chronic viral hepatitis and/or cirrhosis or presence of hepatic tumor with image findings

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2]
C0276623
UMLS CUI [3]
C0023890
UMLS CUI [4,1]
C0023903
UMLS CUI [4,2]
C0011923
1.2.3 a persistent elevation of serum a-fetoprotein level ³ 400 ng/ml without any evidence of ana-fetoprotein-secreting germ cell tumor.
Description

Serum a-fetoprotein

Data type

boolean

Alias
UMLS CUI [1]
C0546833
1.3 patients without any local or systemic therapy for hcc within 4 weeks.
Description

no local or systemic therapy for hcc

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2239176
1.4 patients with age > 20 years and < 70 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
1.5 patients with a performance status of ecog score <1
Description

ECOG

Data type

boolean

Alias
UMLS CUI [1]
C1520224
1.6 patients must fulfill all of the following criteria: 1.6.1 child-pugh’s score ≦ 7.
Description

child-pugh score

Data type

boolean

Alias
UMLS CUI [1]
C4050412
1.6.2 serum total bilirubin < 1.5 times upper normal limit (unl)
Description

Serum total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
1.6.3 serum alanine transaminase (alt) < 5 times unl
Description

ALT

Data type

boolean

Alias
UMLS CUI [1]
C0201836
1.6.4 platelet count > 5.0 x 104 / mm3.
Description

Platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0032181
1.6.5 white blood cell count > 3,000 / mm3.
Description

WBC

Data type

boolean

Alias
UMLS CUI [1]
C0023508
1.6.6 serum creatinine < 2.0 mg/dl
Description

Serum creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
1.7 patient must have local tumors less than one half of the whole liver and the tumors can be encompassed within rt fields
Description

local tumors less than one half of the whole liver

Data type

boolean

Alias
UMLS CUI [1]
C0475440
1.8 signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
1.9 sexually active patients, in conjunction with their partner, must practice birth control during, and for 2 months after, thalidomide therapy.
Description

Contraception, Thalidomide

Data type

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0039736
1.10 female patients in child-bearing age must have negative pregnancy test.
Description

Pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032976
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
2.1. patients with documented extrahepatic metastasis.
Description

Extrahepatic metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517058
2.2. patients who received previous radiotherapy to abdominal area.
Description

Previous radiotherapy to abdominal area

Data type

boolean

Alias
UMLS CUI [1]
C1997554
2.3. patients who have received thalidomide treatment prior to enrollment.
Description

Thalidomide

Data type

boolean

Alias
UMLS CUI [1]
C0039736
2.4. patients who had other investigational drug treatment within 4 weeks prior to enrollment.
Description

Other investigational drug treatment

Data type

boolean

Alias
UMLS CUI [1]
C2348568
2.5. patients with nci grade 2 or greater peripheral neuropathy of any causes.
Description

nci grade 2 or greater peripheral neuropathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C3887242
2.6. patients with other systemic diseases that required concurrent usage of glucocorticosteroid or immunosuppressant agent(s).
Description

Glucocorticosteroid or immunosuppressant agent

Data type

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2]
C0021081
2.7. patients who have major systemic diseases that the attending physicians consider inappropriate for radiotherapy or thalidomide therapy.
Description

major systemic diseases inappropriate for radiotherapy or thalidomide therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0039736
UMLS CUI [2,3]
C1548788
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Similar models

Eligibility Hepatocellular Carcinoma NCT00155272

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patients with measurable, locally advanced hcc that are not suitable for other local therapies
Item
1.1 patients with measurable, locally advanced hcc that are not suitable for other local therapies, including surgery, tae, alcohol injection, or radiofrequency ablation.
boolean
C2239176 (UMLS CUI [1,1])
C0677984 (UMLS CUI [1,2])
C1517925 (UMLS CUI [1,3])
liver carcinoma or chronic viral hepatitis and/or cirrhosis or presence of hepatic tumor with image findings
Item
1.2 patients with histological confirmed hcc or patients who do not have histological diagnosis but have met all of the following criteria: 1.2.1 presence of chronic viral hepatitis and/or cirrhosis 1.2.2 presence of hepatic tumor(s) with image findings (sonography, ct scan) compatible with hcc.
boolean
C2239176 (UMLS CUI [1])
C0276623 (UMLS CUI [2])
C0023890 (UMLS CUI [3])
C0023903 (UMLS CUI [4,1])
C0011923 (UMLS CUI [4,2])
Serum a-fetoprotein
Item
1.2.3 a persistent elevation of serum a-fetoprotein level ³ 400 ng/ml without any evidence of ana-fetoprotein-secreting germ cell tumor.
boolean
C0546833 (UMLS CUI [1])
no local or systemic therapy for hcc
Item
1.3 patients without any local or systemic therapy for hcc within 4 weeks.
boolean
C0087111 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
Age
Item
1.4 patients with age > 20 years and < 70 years.
boolean
C0001779 (UMLS CUI [1])
ECOG
Item
1.5 patients with a performance status of ecog score <1
boolean
C1520224 (UMLS CUI [1])
child-pugh score
Item
1.6 patients must fulfill all of the following criteria: 1.6.1 child-pugh’s score ≦ 7.
boolean
C4050412 (UMLS CUI [1])
Serum total bilirubin
Item
1.6.2 serum total bilirubin < 1.5 times upper normal limit (unl)
boolean
C1278039 (UMLS CUI [1])
ALT
Item
1.6.3 serum alanine transaminase (alt) < 5 times unl
boolean
C0201836 (UMLS CUI [1])
Platelet count
Item
1.6.4 platelet count > 5.0 x 104 / mm3.
boolean
C0032181 (UMLS CUI [1])
WBC
Item
1.6.5 white blood cell count > 3,000 / mm3.
boolean
C0023508 (UMLS CUI [1])
Serum creatinine
Item
1.6.6 serum creatinine < 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
local tumors less than one half of the whole liver
Item
1.7 patient must have local tumors less than one half of the whole liver and the tumors can be encompassed within rt fields
boolean
C0475440 (UMLS CUI [1])
Informed Consent
Item
1.8 signed informed consent
boolean
C0021430 (UMLS CUI [1])
Contraception, Thalidomide
Item
1.9 sexually active patients, in conjunction with their partner, must practice birth control during, and for 2 months after, thalidomide therapy.
boolean
C0700589 (UMLS CUI [1])
C0039736 (UMLS CUI [2])
Pregnancy test
Item
1.10 female patients in child-bearing age must have negative pregnancy test.
boolean
C0032976 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Extrahepatic metastasis
Item
2.1. patients with documented extrahepatic metastasis.
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
Previous radiotherapy to abdominal area
Item
2.2. patients who received previous radiotherapy to abdominal area.
boolean
C1997554 (UMLS CUI [1])
Thalidomide
Item
2.3. patients who have received thalidomide treatment prior to enrollment.
boolean
C0039736 (UMLS CUI [1])
Other investigational drug treatment
Item
2.4. patients who had other investigational drug treatment within 4 weeks prior to enrollment.
boolean
C2348568 (UMLS CUI [1])
nci grade 2 or greater peripheral neuropathy
Item
2.5. patients with nci grade 2 or greater peripheral neuropathy of any causes.
boolean
C0031117 (UMLS CUI [1,1])
C3887242 (UMLS CUI [1,2])
Glucocorticosteroid or immunosuppressant agent
Item
2.6. patients with other systemic diseases that required concurrent usage of glucocorticosteroid or immunosuppressant agent(s).
boolean
C0038317 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
major systemic diseases inappropriate for radiotherapy or thalidomide therapy
Item
2.7. patients who have major systemic diseases that the attending physicians consider inappropriate for radiotherapy or thalidomide therapy.
boolean
C0009488 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0039736 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
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