ID

16444

Beskrivning

A Phase II Study of Radiotherapy for Locally Advanced Hepatocellular Carcinoma (HCC); ODM derived from: https://clinicaltrials.gov/show/NCT00154817

Länk

https://clinicaltrials.gov/show/NCT00154817

Nyckelord

Versioner (1)
  1. 2016-07-16 2016-07-16 -
Uppladdad den

16 juli 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00154817

Engelsk

Eligibility Hepatocellular Carcinoma NCT00154817

1 Formulär  
Inclusion Criteria
Beskrivning

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.
Beskrivning

measurable, locally advanced hcc not suitable for other local therapies

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1548788
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.
Beskrivning

chronic viral hepatitis and/or cirrhosis or positive hepatic tumor image findings

Datatyp

boolean

Alias
UMLS CUI [1]
C0276623
UMLS CUI [2]
C0023890
UMLS CUI [3]
C0564668
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.
Beskrivning

elevation of serum a-fetoprotein level

Datatyp

boolean

Alias
UMLS CUI [1]
C0201539
1.3 patients without any local or systemic therapy for hcc within 4 weeks
Beskrivning

local or systemic therapy for hcc

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C2346834
1.4 patients with age > 20 years and < 70 years
Beskrivning

age

Datatyp

boolean

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

ecog performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
1.6 patients must fulfill all of the following criteria:.
Beskrivning

1.6 patients must fulfill all of the following criteria:.

Datatyp

boolean

1.6.1 child-pugh’s score ≦ 7
Beskrivning

child-pugh’s score

Datatyp

boolean

Alias
UMLS CUI [1]
C4055253
1.6.2 serum total bilirubin < 1.5 times upper normal limit (unl).
Beskrivning

serum total bilirubin

Datatyp

boolean

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

serum alanine transaminase

Datatyp

boolean

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

platelet count

Datatyp

boolean

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

white blood cell count

Datatyp

boolean

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

serum creatinine

Datatyp

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
Beskrivning

local tumors less than one half of the whole liver

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
1.8 signed informed consent
Beskrivning

signed informed consent

Datatyp

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.
Beskrivning

contraceptive methods; thalidomide therapy

Datatyp

boolean

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

negative pregnancy test

Datatyp

boolean

Alias
UMLS CUI [1]
C0427780
Exclusion criteria
Beskrivning

Exclusion criteria

2.1. patients with documented extrahepatic metastasis
Beskrivning

documented extrahepatic metastasis

Datatyp

boolean

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

previous radiotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
2.3. patients who have received thalidomide treatment prior to enrollment.
Beskrivning

prior thalidomide treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0039736
2.4. patients who had other investigational drug treatment within 4 weeks prior to enrollment.
Beskrivning

other investigational drug treatment

Datatyp

boolean

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

nci grade 2 or greater peripheral neuropathy

Datatyp

boolean

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

concurrent usage of glucocorticosteroid or immunosuppressant agent(s)

Datatyp

boolean

Alias
UMLS CUI [1]
C0149783
UMLS CUI [2]
C0021081
2.7. patients who have major systemic diseases that the attending physicians consider inappropriate for radiotherapy or thalidomide therapy.
Beskrivning

comorbidity precluding radiotherapy or thalidomide therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0810947
UMLS CUI [1,3]
C1522449
UMLS CUI [1,4]
C0039736
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Similar models

Eligibility Hepatocellular Carcinoma NCT00154817

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
measurable, locally advanced hcc 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])
C1548788 (UMLS CUI [1,2])
C1517925 (UMLS CUI [1,3])
chronic viral hepatitis and/or cirrhosis or positive hepatic tumor 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
C0276623 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C0564668 (UMLS CUI [3])
elevation of serum a-fetoprotein level
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
C0201539 (UMLS CUI [1])
local or systemic therapy for hcc
Item
1.3 patients without any local or systemic therapy for hcc within 4 weeks
boolean
C2239176 (UMLS CUI [1,1])
C2346834 (UMLS CUI [1,2])
age
Item
1.4 patients with age > 20 years and < 70 years
boolean
C0001779 (UMLS CUI [1])
ecog performance status
Item
1.5 patients with a performance status of ecog score <1
boolean
C1520224 (UMLS CUI [1])
1.6 patients must fulfill all of the following criteria:.
Item
1.6 patients must fulfill all of the following criteria:.
boolean
child-pugh’s score
Item
1.6.1 child-pugh’s score ≦ 7
boolean
C4055253 (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])
serum alanine transaminase
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])
white blood cell count
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
C2239176 (UMLS CUI [1])
signed informed consent
Item
1.8 signed informed consent
boolean
C0021430 (UMLS CUI [1])
contraceptive methods; thalidomide therapy
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 [1,1])
C0039736 (UMLS CUI [1,2])
negative pregnancy test
Item
1.10 female patients in child-bearing age must have negative pregnancy test.
boolean
C0427780 (UMLS CUI [1])
Item Group
Exclusion criteria
documented extrahepatic metastasis
Item
2.1. patients with documented extrahepatic metastasis
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
previous radiotherapy
Item
2.2. patients who received previous radiotherapy to abdominal area.
boolean
C1522449 (UMLS CUI [1])
prior thalidomide treatment
Item
2.3. patients who have received thalidomide treatment prior to enrollment.
boolean
C1514463 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
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
C3887242 (UMLS CUI [1])
C0031117 (UMLS CUI [2])
concurrent usage of glucocorticosteroid or immunosuppressant agent(s)
Item
2.6. patients with other systemic diseases that required concurrent usage of glucocorticosteroid or immunosuppressant agent(s).
boolean
C0149783 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
comorbidity precluding 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])
C0810947 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,3])
C0039736 (UMLS CUI [1,4])
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