ID

16385

Description

Randomized Phase III Trial Comparing Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Axillary Lymph Node (+) Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00431080

Link

https://clinicaltrials.gov/show/NCT00431080

Keywords

Versions (1)
  1. 7/14/16 7/14/16 -
Uploaded on

July 14, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00431080

English

Eligibility Breast Cancer NCT00431080

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
Description

Gender | Breast adenocarcinoma Ductal Invasive Unilateral | Breast adenocarcinoma Lobular

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0858252
UMLS CUI [2,2]
C1512083
UMLS CUI [2,3]
C0205281
UMLS CUI [2,4]
C0205092
UMLS CUI [3,1]
C0858252
UMLS CUI [3,2]
C0205417
within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
Description

Excision primary tumor | Surgical margin uninvolved by tumor | Excision of axillary lymph nodes Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C0677930
UMLS CUI [2]
C0332648
UMLS CUI [3,1]
C0193867
UMLS CUI [3,2]
C1265611
tumor involvement of at least one axillary lymph node
Description

Axillary lymph nodes Involvement with Neoplasm

Data type

boolean

Alias
UMLS CUI [1,1]
C0729594
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0027651
absence of any clinical or radiological evidence of local or metastatic disease
Description

Local disease Evidence Absent | Metastatic Neoplasm Evidence Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0277565
UMLS CUI [1,2]
C0332120
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C2939420
UMLS CUI [2,2]
C0332120
UMLS CUI [2,3]
C0332197
premenopausal or postmenopausal women aged 18-75 years old
Description

Premenopausal | Postmenopausal state | Age

Data type

boolean

Alias
UMLS CUI [1]
C0279752
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0001779
adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
Description

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0019046
adequate liver (bilirubin <1.0 times upper limit of normal and sgot/sgpt <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0232804
UMLS CUI [6]
C0201976
adequate cardiac function (lvef>50%)
Description

Cardiac function | Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0428772
written informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive pregnancy test.
Description

Pregnancy test positive

Data type

boolean

Alias
UMLS CUI [1]
C0240802
psychiatric illness or social situation that would preclude study compliance.
Description

Mental disorders Compliance behavior Limited | social situation Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C0439801
other concurrent uncontrolled illness.
Description

Illness Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents.
Description

Antineoplastic Therapy | Hormone Therapy | Therapeutic radiology procedure | Chemotherapy | Biological Factors

Data type

boolean

Alias
UMLS CUI [1]
C2346834
UMLS CUI [2]
C0279025
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0392920
UMLS CUI [5]
C0005515
previous history of other invasive malignancy other than non-melanomatous skin cancer.
Description

Malignant Neoplasms Invasive | Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205281
UMLS CUI [2]
C0699893
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Similar models

Eligibility Breast Cancer NCT00431080

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast adenocarcinoma Ductal Invasive Unilateral | Breast adenocarcinoma Lobular
Item
women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
boolean
C0079399 (UMLS CUI [1])
C0858252 (UMLS CUI [2,1])
C1512083 (UMLS CUI [2,2])
C0205281 (UMLS CUI [2,3])
C0205092 (UMLS CUI [2,4])
C0858252 (UMLS CUI [3,1])
C0205417 (UMLS CUI [3,2])
Excision primary tumor | Surgical margin uninvolved by tumor | Excision of axillary lymph nodes Quantity
Item
within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
boolean
C0728940 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0332648 (UMLS CUI [2])
C0193867 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Axillary lymph nodes Involvement with Neoplasm
Item
tumor involvement of at least one axillary lymph node
boolean
C0729594 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
Local disease Evidence Absent | Metastatic Neoplasm Evidence Absent
Item
absence of any clinical or radiological evidence of local or metastatic disease
boolean
C0277565 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C2939420 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Premenopausal | Postmenopausal state | Age
Item
premenopausal or postmenopausal women aged 18-75 years old
boolean
C0279752 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin
Item
adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0019046 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
adequate liver (bilirubin <1.0 times upper limit of normal and sgot/sgpt <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Cardiac function | Left ventricular ejection fraction
Item
adequate cardiac function (lvef>50%)
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy test positive
Item
positive pregnancy test.
boolean
C0240802 (UMLS CUI [1])
Mental disorders Compliance behavior Limited | social situation Compliance behavior Limited
Item
psychiatric illness or social situation that would preclude study compliance.
boolean
C0004936 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Illness Uncontrolled
Item
other concurrent uncontrolled illness.
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Antineoplastic Therapy | Hormone Therapy | Therapeutic radiology procedure | Chemotherapy | Biological Factors
Item
prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents.
boolean
C2346834 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C0005515 (UMLS CUI [5])
Malignant Neoplasms Invasive | Skin carcinoma
Item
previous history of other invasive malignancy other than non-melanomatous skin cancer.
boolean
C0006826 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0699893 (UMLS CUI [2])
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