ID

17461

Description

Adjuvant Capecitabine in Elderly Patients With Breast Cancer: a Phase II Study; ODM derived from: https://clinicaltrials.gov/show/NCT00263705

Link

https://clinicaltrials.gov/show/NCT00263705

Keywords

Versions (5)
  1. 9/8/16 9/8/16 -
  2. 9/8/16 9/8/16 -
  3. 9/9/16 9/9/16 -
  4. 9/13/16 9/13/16 -
  5. 9/16/16 9/16/16 - Julian Varghese
Uploaded on

September 16, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Elderly Patients NCT00263705

English

Eligibility Elderly Patients NCT00263705

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. women aged ³70 years
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. histologic diagnosis of early breast cancer for which the treating physician considers adjuvant chemotherapy to be beneficial. recommended situations are for example:
Description

Early-Stage Breast Carcinoma | Adjuvant Chemotherapy Recommended

Data type

boolean

Alias
UMLS CUI [1]
C2986665
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C0034866
endocrine non responsive (er- and pgr -) and pt>1 cm, any t if n+ or
Description

Hormone Therapy Absent response to treatment | Estrogen receptor negative | progesterone receptor negative | TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0438286
UMLS CUI [2]
C0279756
UMLS CUI [3]
C0279766
UMLS CUI [4]
C3258246
endocrine responsiveness doubtful (er and/or pgr- or poor [3 to-5 according to harvey score (12) or £ 30% of positive cells by immunohistochemistry) and other risk factors (pt³2 cm or n+ or g3 or her-2/neu positive, etc.) or
Description

Hormone Therapy Response to treatment doubtful | Estrogen receptor negative | progesterone receptor negative | Estrogen Receptors Poor | Progesterone Receptors Poor | percent positive cells | Immunohistochemistry | risk factors | TNM clinical staging | ERBB2 gene Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0521982
UMLS CUI [1,3]
C0750558
UMLS CUI [2]
C0279756
UMLS CUI [3]
C0279766
UMLS CUI [4,1]
C0034804
UMLS CUI [4,2]
C0542537
UMLS CUI [5,1]
C0034833
UMLS CUI [5,2]
C0542537
UMLS CUI [6]
C0439178
UMLS CUI [7]
C0021044
UMLS CUI [8]
C0035648
UMLS CUI [9]
C3258246
UMLS CUI [10,1]
C0242957
UMLS CUI [10,2]
C1514241
endocrine responsive (er and pgr > 5 according to harvey score or > 30% of positive cells by immunohistochemistry) and at least two risk factors (pt³ 2 cm, n+, g3, her-2/neu positive, etc.) or
Description

Hormone Therapy Response to treatment | Estrogen receptor positive | progesterone receptor positive | percent positive cells | Immunohistochemistry | risk factors Quantity | TNM clinical staging | ERBB2 gene Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0521982
UMLS CUI [2]
C0279754
UMLS CUI [3]
C0279759
UMLS CUI [4]
C0439178
UMLS CUI [5]
C0021044
UMLS CUI [6,1]
C0035648
UMLS CUI [6,2]
C1265611
UMLS CUI [7]
C3258246
UMLS CUI [8,1]
C0242957
UMLS CUI [8,2]
C1514241
very high risk (n>3) any er/pgr.
Description

TNM clinical staging | Estrogen Receptor Any | Progesterone Receptor Any

Data type

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2,1]
C0034804
UMLS CUI [2,2]
C1552551
UMLS CUI [3,1]
C0034833
UMLS CUI [3,2]
C1552551
3. ecog performance status £ 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
4. no previous exposition to chemotherapy in the neoadjuvant setting
Description

Chemotherapy Exposure to | Neoadjuvant Therapy Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C0332157
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C3665472
5. adequate organ function including:
Description

organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
1. neutrophils ³ 1.5 x 109 /l
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
2. platelets ³100 x 109 / l
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
3. bilirubin < 1.25 x upper normal limit for the institution
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
4. transaminases < 2.5 x upper normal limit for the institution
Description

Transaminases

Data type

boolean

Alias
UMLS CUI [1]
C0002594
5. calculated creatinine clearance of > 30ml/min (using the crockoft and gault formula)
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C2711451
6. absence of
Description

Absence

Data type

boolean

Alias
UMLS CUI [1]
C0332197
symptomatic ventricular arrhythmias;
Description

Ventricular arrhythmia Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0085612
UMLS CUI [1,2]
C0231220
clinically significant congestive heart failure;
Description

Congestive heart failure Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C2826293
clinical and/or ecg evidence of myocardial infarction within the last 12 months;
Description

Myocardial Infarction Evidence Clinical | Myocardial Infarction Evidence Electrocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205210
UMLS CUI [2,1]
C0027051
UMLS CUI [2,2]
C3887511
UMLS CUI [2,3]
C1623258
coronary artery disease requiring medication.
Description

Coronary Artery Disease Requirement Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013227
6. absence of any psychological, familial or sociological condition or comorbidities that may affect compliance
Description

Condition Compliance behavior Limited | Comorbidity Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C0439801
7. written informed consent obtained according to local ethics committee guidelines -
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
No exclusion criteria existing
Description

No exclusion criteria existing

Data type

text

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Similar models

Eligibility Elderly Patients NCT00263705

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
1. women aged ³70 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Early-Stage Breast Carcinoma | Adjuvant Chemotherapy Recommended
Item
2. histologic diagnosis of early breast cancer for which the treating physician considers adjuvant chemotherapy to be beneficial. recommended situations are for example:
boolean
C2986665 (UMLS CUI [1])
C0085533 (UMLS CUI [2,1])
C0034866 (UMLS CUI [2,2])
Hormone Therapy Absent response to treatment | Estrogen receptor negative | progesterone receptor negative | TNM clinical staging
Item
endocrine non responsive (er- and pgr -) and pt>1 cm, any t if n+ or
boolean
C0279025 (UMLS CUI [1,1])
C0438286 (UMLS CUI [1,2])
C0279756 (UMLS CUI [2])
C0279766 (UMLS CUI [3])
C3258246 (UMLS CUI [4])
Hormone Therapy Response to treatment doubtful | Estrogen receptor negative | progesterone receptor negative | Estrogen Receptors Poor | Progesterone Receptors Poor | percent positive cells | Immunohistochemistry | risk factors | TNM clinical staging | ERBB2 gene Positive
Item
endocrine responsiveness doubtful (er and/or pgr- or poor [3 to-5 according to harvey score (12) or £ 30% of positive cells by immunohistochemistry) and other risk factors (pt³2 cm or n+ or g3 or her-2/neu positive, etc.) or
boolean
C0279025 (UMLS CUI [1,1])
C0521982 (UMLS CUI [1,2])
C0750558 (UMLS CUI [1,3])
C0279756 (UMLS CUI [2])
C0279766 (UMLS CUI [3])
C0034804 (UMLS CUI [4,1])
C0542537 (UMLS CUI [4,2])
C0034833 (UMLS CUI [5,1])
C0542537 (UMLS CUI [5,2])
C0439178 (UMLS CUI [6])
C0021044 (UMLS CUI [7])
C0035648 (UMLS CUI [8])
C3258246 (UMLS CUI [9])
C0242957 (UMLS CUI [10,1])
C1514241 (UMLS CUI [10,2])
Hormone Therapy Response to treatment | Estrogen receptor positive | progesterone receptor positive | percent positive cells | Immunohistochemistry | risk factors Quantity | TNM clinical staging | ERBB2 gene Positive
Item
endocrine responsive (er and pgr > 5 according to harvey score or > 30% of positive cells by immunohistochemistry) and at least two risk factors (pt³ 2 cm, n+, g3, her-2/neu positive, etc.) or
boolean
C0279025 (UMLS CUI [1,1])
C0521982 (UMLS CUI [1,2])
C0279754 (UMLS CUI [2])
C0279759 (UMLS CUI [3])
C0439178 (UMLS CUI [4])
C0021044 (UMLS CUI [5])
C0035648 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C3258246 (UMLS CUI [7])
C0242957 (UMLS CUI [8,1])
C1514241 (UMLS CUI [8,2])
TNM clinical staging | Estrogen Receptor Any | Progesterone Receptor Any
Item
very high risk (n>3) any er/pgr.
boolean
C3258246 (UMLS CUI [1])
C0034804 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
C0034833 (UMLS CUI [3,1])
C1552551 (UMLS CUI [3,2])
ECOG performance status
Item
3. ecog performance status £ 1
boolean
C1520224 (UMLS CUI [1])
Chemotherapy Exposure to | Neoadjuvant Therapy Chemotherapy
Item
4. no previous exposition to chemotherapy in the neoadjuvant setting
boolean
C3665472 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0600558 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
organ function
Item
5. adequate organ function including:
boolean
C0678852 (UMLS CUI [1])
Absolute neutrophil count
Item
1. neutrophils ³ 1.5 x 109 /l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
2. platelets ³100 x 109 / l
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
3. bilirubin < 1.25 x upper normal limit for the institution
boolean
C1278039 (UMLS CUI [1])
Transaminases
Item
4. transaminases < 2.5 x upper normal limit for the institution
boolean
C0002594 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
5. calculated creatinine clearance of > 30ml/min (using the crockoft and gault formula)
boolean
C2711451 (UMLS CUI [1])
Absence
Item
6. absence of
boolean
C0332197 (UMLS CUI [1])
Ventricular arrhythmia Symptomatic
Item
symptomatic ventricular arrhythmias;
boolean
C0085612 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Congestive heart failure Clinical Significance
Item
clinically significant congestive heart failure;
boolean
C0018802 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Myocardial Infarction Evidence Clinical | Myocardial Infarction Evidence Electrocardiography
Item
clinical and/or ecg evidence of myocardial infarction within the last 12 months;
boolean
C0027051 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0027051 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
C1623258 (UMLS CUI [2,3])
Coronary Artery Disease Requirement Pharmaceutical Preparations
Item
coronary artery disease requiring medication.
boolean
C1956346 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Condition Compliance behavior Limited | Comorbidity Compliance behavior Limited
Item
6. absence of any psychological, familial or sociological condition or comorbidities that may affect compliance
boolean
C0348080 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Informed Consent
Item
7. written informed consent obtained according to local ethics committee guidelines -
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
No exclusion criteria existing
Item
text
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