ID

21057

Description

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

Keywords

Versions (1)
  1. 4/6/17 4/6/17 -
Uploaded on

April 6, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Breast Cancer NCT00314977

English

Eligibility Breast Cancer NCT00314977

1 forms  
Inclusion Criteria
Description

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)
Description

breast cancer stage

Data type

boolean

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

measurable disease

Data type

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
Description

no prior therapy

Data type

boolean

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

age

Data type

boolean

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

karnofsky performance score

Data type

boolean

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

hormone receptor status

Data type

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)
Description

hormone receptor status

Data type

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
Description

her2/neu status

Data type

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
Description

bone marrow function

Data type

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
Description

liver function

Data type

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
Description

renal function

Data type

boolean

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

availability treatment and follow-up

Data type

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
Description

written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

peripheral neuropathy

Data type

boolean

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

cardiac diseases

Data type

boolean

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

distant metastases

Data type

boolean

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

history of breast cancer

Data type

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
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4]
C1960468
Back to the top of the page

Similar models

Eligibility Breast Cancer NCT00314977

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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