ID

21057

Descrição

Sequential vs Upfront Intensified Neoadjuvant Chemotherapy in Patients With Large Resectable or Locally Advanced Breast Cancer.; ODM derived from: https://clinicaltrials.gov/show/NCT00314977

Link

https://clinicaltrials.gov/show/NCT00314977

Palavras-chave

Versões (1)
  1. 06/04/2017 06/04/2017 -
Transferido a

6 de abril de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00314977

Inglês

Eligibility Breast Cancer NCT00314977

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
women presenting with large resectable or locally advanced breast cancer (t2 ≥3 cm, t3, or t4, and/or ln positive)
Descrição

breast cancer stage

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0027646
measurable disease (breast and/or lymph nodes)
Descrição

measurable disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1513041
no prior surgery other than biopsy and no prior chemotherapy or radiation therapy
Descrição

no prior therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514463
age ≥18 years and age ≤70 years
Descrição

age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky performance score ≥70%
Descrição

karnofsky performance score

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0206065
estrogen and/or progesterone receptor analysis performed on the primary tumour in the biopsy material
Descrição

hormone receptor status

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0019929
UMLS CUI [1,3]
C0449438
in case the tumor is er/pgr ³ 50% positive, (neo)adjuvant hormonal therapy in stead of chemotherapy should be considered (e.g. in team ii study)
Descrição

hormone receptor status

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0019929
UMLS CUI [1,3]
C0449438
her2/neu receptor analysis performed on the primary tumour in the biopsy material
Descrição

her2/neu status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1512413
adequate bone marrow function (within 14 days prior to registration): wbc ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
Descrição

bone marrow function

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1254358
UMLS CUI [1,2]
C0005953
UMLS CUI [2]
C002350
UMLS CUI [3]
C0200633
UMLS CUI [4]
C0032181
adequate liver function (within 4 weeks prior to start treatment): bilirubin ≤1.5 x upper limit of normal (unl) range, alat and/or asat ≤2.5 x unl, alkaline phosphatase ≤5 x unl
Descrição

liver function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201913
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201850
adequate renal function (within 4 weeks prior to start treatment): the calculated creatinine clearance should be ≥50 ml/min
Descrição

renal function

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0151280
patients must be accessible for treatment and follow-up
Descrição

availability treatment and follow-up

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0087111
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C1522577
written informed consent according to the local ethics committee requirements
Descrição

written informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with advanced pulmonary disease of any cause (oxygen dependent)- peripheral neuropathy > grade 2 whatever the cause
Descrição

peripheral neuropathy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0031117
serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrythmias
Descrição

cardiac diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0018801
UMLS CUI [3]
C0003811
evidence of distant metastases (m1)
Descrição

distant metastases

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C3258247
patients with a history of breast cancer
Descrição

history of breast cancer

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0678222
patients with a history of another malignancy (except basal cell skin carcinoma and carcinoma-in-situ of the uterine cervix) within 5 years of study entry- pregnant or lactating women, or potentially fertile women not using adequate contraception
Descrição

history of other malignancy, pregnancy, breast feeding, child bearing potential

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4]
C1960468
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Similar models

Eligibility Breast Cancer NCT00314977

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
breast cancer stage
Item
women presenting with large resectable or locally advanced breast cancer (t2 ≥3 cm, t3, or t4, and/or ln positive)
boolean
C0678222 (UMLS CUI [1,1])
C0027646 (UMLS CUI [1,2])
measurable disease
Item
measurable disease (breast and/or lymph nodes)
boolean
C0678222 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
no prior therapy
Item
no prior surgery other than biopsy and no prior chemotherapy or radiation therapy
boolean
C1514463 (UMLS CUI [1])
age
Item
age ≥18 years and age ≤70 years
boolean
C0001779 (UMLS CUI [1])
karnofsky performance score
Item
karnofsky performance score ≥70%
boolean
C0206065 (UMLS CUI [1])
hormone receptor status
Item
estrogen and/or progesterone receptor analysis performed on the primary tumour in the biopsy material
boolean
C0678222 (UMLS CUI [1,1])
C0019929 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
hormone receptor status
Item
in case the tumor is er/pgr ³ 50% positive, (neo)adjuvant hormonal therapy in stead of chemotherapy should be considered (e.g. in team ii study)
boolean
C0678222 (UMLS CUI [1,1])
C0019929 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
her2/neu status
Item
her2/neu receptor analysis performed on the primary tumour in the biopsy material
boolean
C1512413 (UMLS CUI [1])
bone marrow function
Item
adequate bone marrow function (within 14 days prior to registration): wbc ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
boolean
C1254358 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C002350 (UMLS CUI [2])
C0200633 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
liver function
Item
adequate liver function (within 4 weeks prior to start treatment): bilirubin ≤1.5 x upper limit of normal (unl) range, alat and/or asat ≤2.5 x unl, alkaline phosphatase ≤5 x unl
boolean
C0232741 (UMLS CUI [1])
C0201913 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
renal function
Item
adequate renal function (within 4 weeks prior to start treatment): the calculated creatinine clearance should be ≥50 ml/min
boolean
C0232804 (UMLS CUI [1,1])
C0151280 (UMLS CUI [1,2])
availability treatment and follow-up
Item
patients must be accessible for treatment and follow-up
boolean
C0470187 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0470187 (UMLS CUI [2,1])
C1522577 (UMLS CUI [2,2])
written informed consent
Item
written informed consent according to the local ethics committee requirements
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
peripheral neuropathy
Item
patients with advanced pulmonary disease of any cause (oxygen dependent)- peripheral neuropathy > grade 2 whatever the cause
boolean
C0031117 (UMLS CUI [1])
cardiac diseases
Item
serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrythmias
boolean
C0027051 (UMLS CUI [1])
C0018801 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
distant metastases
Item
evidence of distant metastases (m1)
boolean
C0678222 (UMLS CUI [1,1])
C3258247 (UMLS CUI [1,2])
history of breast cancer
Item
patients with a history of breast cancer
boolean
C0262926 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
history of other malignancy, pregnancy, breast feeding, child bearing potential
Item
patients with a history of another malignancy (except basal cell skin carcinoma and carcinoma-in-situ of the uterine cervix) within 5 years of study entry- pregnant or lactating women, or potentially fertile women not using adequate contraception
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C1960468 (UMLS CUI [4])
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