ID

16011

Descrição

Docetaxel vs. Docetaxel-Gemcitabine in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00191243

Link

https://clinicaltrials.gov/show/NCT00191243

Palavras-chave

  1. 02/05/2016 02/05/2016 -
  2. 26/06/2016 26/06/2016 -
Transferido a

26 de junho de 2016

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00191243

Eligibility Breast Cancer NCT00191243

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically verified diagnosis of breast carcinoma, at first diagnosis
Descrição

diagnosis of breast cancer

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0678222
restricted previous adjuvant chemotherapy (completed >6 months prior the study)
Descrição

previous adjuvant chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085533
measurable and/or non-measurable disease
Descrição

Measurable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
previous radiotherapy is allowed if:terminated at least 10 days prior the sudy therapy, at least one target lesion for evaluation of tumor response has not been irradiated
Descrição

previous radiotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1522449
performance status 0-2 (who, zubrod)
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow reserve defined
Descrição

bone marrow status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005956
adequate liver / renal functions defined
Descrição

liver and renal function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022658
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
any prior systematic chemotherapy for metastatic breast cancer
Descrição

Prior Chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514457
expected survival time less than 12 weeks
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
past or current history of malignant neoplasm other than breast carcinoma
Descrição

other malignant neoplasm

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085183
except for cured non-melanoma skin cancer or curatively treated in situ carcinoma of the cervix uteri
Descrição

cured non-melanoma skin cancer or curatively treated in situ carcinoma of the cervix uteri

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1880198
UMLS CUI [1,2]
C0037286
UMLS CUI [2]
C0851140
known brain metastases/leptomeningeal involvement
Descrição

brain metastases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0220650
active uncontrolled infection
Descrição

active uncontrolled infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3714514
symptomatic peripheral neuropathy > grade 2 according to nci
Descrição

peripheral neuropathy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0031117
patients whose lesions are assessable only by radionuclide scan or patients with sclerotic bone lesions as the only site of disease
Descrição

lesions only assessable by radionuclide scan / sclerotic bone lesions

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032743
UMLS CUI [2]
C0748541
concomitant illness that is contraindication to the use of corticosteroids
Descrição

contraindication to corticosteroids

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0038317
other concomitant serious illness or medical condition, which may worsen due to the treatment
Descrição

concomitant serious illness

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488

Similar models

Eligibility Breast Cancer NCT00191243

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
diagnosis of breast cancer
Item
histologically verified diagnosis of breast carcinoma, at first diagnosis
boolean
C0019638 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
previous adjuvant chemotherapy
Item
restricted previous adjuvant chemotherapy (completed >6 months prior the study)
boolean
C0085533 (UMLS CUI [1])
Measurable Disease
Item
measurable and/or non-measurable disease
boolean
C1513041 (UMLS CUI [1])
previous radiotherapy
Item
previous radiotherapy is allowed if:terminated at least 10 days prior the sudy therapy, at least one target lesion for evaluation of tumor response has not been irradiated
boolean
C1522449 (UMLS CUI [1])
ECOG performance status
Item
performance status 0-2 (who, zubrod)
boolean
C1520224 (UMLS CUI [1])
bone marrow status
Item
adequate bone marrow reserve defined
boolean
C0005956 (UMLS CUI [1])
liver and renal function
Item
adequate liver / renal functions defined
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy
Item
any prior systematic chemotherapy for metastatic breast cancer
boolean
C1514457 (UMLS CUI [1])
Life Expectancy
Item
expected survival time less than 12 weeks
boolean
C0023671 (UMLS CUI [1])
other malignant neoplasm
Item
past or current history of malignant neoplasm other than breast carcinoma
boolean
C0085183 (UMLS CUI [1])
cured non-melanoma skin cancer or curatively treated in situ carcinoma of the cervix uteri
Item
except for cured non-melanoma skin cancer or curatively treated in situ carcinoma of the cervix uteri
boolean
C1880198 (UMLS CUI [1,1])
C0037286 (UMLS CUI [1,2])
C0851140 (UMLS CUI [2])
brain metastases
Item
known brain metastases/leptomeningeal involvement
boolean
C0220650 (UMLS CUI [1])
active uncontrolled infection
Item
active uncontrolled infection
boolean
C3714514 (UMLS CUI [1])
peripheral neuropathy
Item
symptomatic peripheral neuropathy > grade 2 according to nci
boolean
C0031117 (UMLS CUI [1])
lesions only assessable by radionuclide scan / sclerotic bone lesions
Item
patients whose lesions are assessable only by radionuclide scan or patients with sclerotic bone lesions as the only site of disease
boolean
C0032743 (UMLS CUI [1])
C0748541 (UMLS CUI [2])
contraindication to corticosteroids
Item
concomitant illness that is contraindication to the use of corticosteroids
boolean
C1301624 (UMLS CUI [1,1])
C0038317 (UMLS CUI [1,2])
concomitant serious illness
Item
other concomitant serious illness or medical condition, which may worsen due to the treatment
boolean
C0009488 (UMLS CUI [1])

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