ID

13388

Descrição

Navelbine, Taxol, Herceptin and Neupogen in Stage IV Breast Cancer: A Phase I - II Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00041470

Link

https://clinicaltrials.gov/show/NCT00041470

Palavras-chave

  1. 10/02/2016 10/02/2016 -
Transferido a

10 de fevereiro de 2016

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.

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 Breast Cancer NCT00041470

Eligibility Breast Cancer NCT00041470

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Have stage iv carcinoma of the breast that has been microscopically confirmed
Descrição

breast carcinoma stage IV

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C0278488
Be age > 18
Descrição

age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
Be fully active or ambulatory with symptoms but able to do light work
Descrição

fully active

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1828078
Have a life expectancy of > 16 weeks
Descrição

life expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
Be > 2 weeks from prior surgery; > 3 weeks from radiation therapy to the pelvis, spine or long bones; > 3 weeks from prior chemotherapy (> 6 weeks for mitomycin c or nitrosureas) and > 2 weeks from prior hormonal therapy
Descrição

prior cancer theraypy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1272706
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0332152
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0279025
Have had one or less prior regimens for metastatic disease
Descrição

prior regimens for metastatic disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2]
C0392920
Have measurable (bidimensionally) or evaluable disease that is in an area that has not been radiated
Descrição

evaluable disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Have rapidly progressing liver or lung metastases or uncontrolled central nervous system metastases
Descrição

uncontrolled metastases

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0023884
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0024109
UMLS CUI [3,1]
C0279130
UMLS CUI [3,2]
C0205318
Are medically unstable
Descrição

medically unstable

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0443343
Are pregnant, nursing or unwilling to employ adequate contraception
Descrição

pregnancy and contraceptive use

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C1999124
Have pre-existing clinically significant peripheral neuropathy except for abnormalities due to cancer
Descrição

peripheral neuropathy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2985739
Have psychological, familial, sociological or geographical conditions that do not permit weekly medical follow-up and compliance with the study protocol
Descrição

compliance factors

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2,1]
C0814423
UMLS CUI [2,2]
C1522577
Have hypersensitivity to e. coli-derived proteins, filgrastim, or any of its components
Descrição

hypersensitivity to ecoli-derived proteins

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0033684
UMLS CUI [1,3]
C1441547
UMLS CUI [1,4]
C0014834
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0210630
Have had prior therapy with navelbine
Descrição

prior therapy with navelbine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0131965

Similar models

Eligibility Breast Cancer NCT00041470

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
breast carcinoma stage IV
Item
Have stage iv carcinoma of the breast that has been microscopically confirmed
boolean
C0027651 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0278488 (UMLS CUI [1,3])
age
Item
Be age > 18
boolean
C0001779 (UMLS CUI [1])
fully active
Item
Be fully active or ambulatory with symptoms but able to do light work
boolean
C1828078 (UMLS CUI [1])
life expectancy
Item
Have a life expectancy of > 16 weeks
boolean
C0023671 (UMLS CUI [1])
prior cancer theraypy
Item
Be > 2 weeks from prior surgery; > 3 weeks from radiation therapy to the pelvis, spine or long bones; > 3 weeks from prior chemotherapy (> 6 weeks for mitomycin c or nitrosureas) and > 2 weeks from prior hormonal therapy
boolean
C1272706 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
prior regimens for metastatic disease
Item
Have had one or less prior regimens for metastatic disease
boolean
C0027627 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
evaluable disease
Item
Have measurable (bidimensionally) or evaluable disease that is in an area that has not been radiated
boolean
C1513041 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
uncontrolled metastases
Item
Have rapidly progressing liver or lung metastases or uncontrolled central nervous system metastases
boolean
C0027627 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0024109 (UMLS CUI [2,2])
C0279130 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
medically unstable
Item
Are medically unstable
boolean
C0443343 (UMLS CUI [1])
pregnancy and contraceptive use
Item
Are pregnant, nursing or unwilling to employ adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C1999124 (UMLS CUI [3])
peripheral neuropathy
Item
Have pre-existing clinically significant peripheral neuropathy except for abnormalities due to cancer
boolean
C0031117 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
compliance factors
Item
Have psychological, familial, sociological or geographical conditions that do not permit weekly medical follow-up and compliance with the study protocol
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0814423 (UMLS CUI [2,1])
C1522577 (UMLS CUI [2,2])
hypersensitivity to ecoli-derived proteins
Item
Have hypersensitivity to e. coli-derived proteins, filgrastim, or any of its components
boolean
C0020517 (UMLS CUI [1,1])
C0033684 (UMLS CUI [1,2])
C1441547 (UMLS CUI [1,3])
C0014834 (UMLS CUI [1,4])
C0020517 (UMLS CUI [2,1])
C0210630 (UMLS CUI [2,2])
prior therapy with navelbine
Item
Have had prior therapy with navelbine
boolean
C0131965 (UMLS CUI [1])

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

Campos marcados com * são obrigatórios.

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