ID

16444

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00154817

Palabras clave

Versiones (1)
  1. 16/7/16 16/7/16 -
Subido en

16 de julio de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Hepatocellular Carcinoma NCT00154817

Inglés

Eligibility Hepatocellular Carcinoma NCT00154817

1 formularios  
Inclusion Criteria
Descripción

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.
Descripción

measurable, locally advanced hcc not suitable for other local therapies

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

elevation of serum a-fetoprotein level

Tipo de datos

boolean

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

local or systemic therapy for hcc

Tipo de datos

boolean

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

age

Tipo de datos

boolean

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

ecog performance status

Tipo de datos

boolean

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

1.6 patients must fulfill all of the following criteria:.

Tipo de datos

boolean

1.6.1 child-pugh’s score ≦ 7
Descripción

child-pugh’s score

Tipo de datos

boolean

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

serum total bilirubin

Tipo de datos

boolean

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

serum alanine transaminase

Tipo de datos

boolean

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

platelet count

Tipo de datos

boolean

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

white blood cell count

Tipo de datos

boolean

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

serum creatinine

Tipo de datos

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
Descripción

local tumors less than one half of the whole liver

Tipo de datos

boolean

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

signed informed consent

Tipo de datos

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.
Descripción

contraceptive methods; thalidomide therapy

Tipo de datos

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.
Descripción

negative pregnancy test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0427780
Exclusion criteria
Descripción

Exclusion criteria

2.1. patients with documented extrahepatic metastasis
Descripción

documented extrahepatic metastasis

Tipo de datos

boolean

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

previous radiotherapy

Tipo de datos

boolean

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

prior thalidomide treatment

Tipo de datos

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.
Descripción

other investigational drug treatment

Tipo de datos

boolean

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

nci grade 2 or greater peripheral neuropathy

Tipo de datos

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).
Descripción

concurrent usage of glucocorticosteroid or immunosuppressant agent(s)

Tipo de datos

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.
Descripción

comorbidity precluding radiotherapy or thalidomide therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0810947
UMLS CUI [1,3]
C1522449
UMLS CUI [1,4]
C0039736
Volver a la parte superior de la página

Similar models

Eligibility Hepatocellular Carcinoma NCT00154817

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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