ID

42929

Descrição

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

Link

https://clinicaltrials.gov/show/NCT00155272

Palavras-chave

Versões (2)
  1. 15/08/2016 15/08/2016 -
  2. 17/09/2021 17/09/2021 -
Transferido a

17 de setembro de 2021

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Hepatocellular Carcinoma NCT00155272

Inglês

Eligibility Hepatocellular Carcinoma NCT00155272

1 Formulários  
Inclusion Criteria
Descrição

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.
Descrição

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

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

Serum a-fetoprotein

Tipo de dados

boolean

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

no local or systemic therapy for hcc

Tipo de dados

boolean

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

Age

Tipo de dados

boolean

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

ECOG

Tipo de dados

boolean

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

child-pugh score

Tipo de dados

boolean

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

Serum total bilirubin

Tipo de dados

boolean

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

ALT

Tipo de dados

boolean

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

Platelet count

Tipo de dados

boolean

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

WBC

Tipo de dados

boolean

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

Serum creatinine

Tipo de dados

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
Descrição

local tumors less than one half of the whole liver

Tipo de dados

boolean

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

Informed Consent

Tipo de dados

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.
Descrição

Contraception, Thalidomide

Tipo de dados

boolean

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

Pregnancy test

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032976
Exclusion Criteria
Descrição

Exclusion Criteria

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

Extrahepatic metastasis

Tipo de dados

boolean

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

Previous radiotherapy to abdominal area

Tipo de dados

boolean

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

Thalidomide

Tipo de dados

boolean

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

Other investigational drug treatment

Tipo de dados

boolean

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

nci grade 2 or greater peripheral neuropathy

Tipo de dados

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).
Descrição

Glucocorticosteroid or immunosuppressant agent

Tipo de dados

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.
Descrição

major systemic diseases inappropriate for radiotherapy or thalidomide therapy

Tipo de dados

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
Voltar ao início da página

Similar models

Eligibility Hepatocellular Carcinoma NCT00155272

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial