ID

16243

Beskrivning

Docetaxel, Cisplatin and Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00155259

Länk

https://clinicaltrials.gov/show/NCT00155259

Nyckelord

Versioner (1)
  1. 2016-07-06 2016-07-06 -
Uppladdad den

6 juli 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00155259

Engelsk

Eligibility Breast Cancer NCT00155259

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with histological proven labc, without metastasis, and no prior therapy. labc is defined as follows：
Beskrivning

Gender | Locally advanced breast cancer | No metastases | Prior Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C3495949
UMLS CUI [3]
C0445092
UMLS CUI [4]
C1514463
1. tumor more than 5 cm in diameter
Beskrivning

Tumor size Diameter

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C1301886
2. tumor involvement of chest wall (ribs or intercostals or serratus anterior muscles) or skin (ipsilateral cutaneous edema, ulceration, or satellite nodules)
Beskrivning

Malignant Neoplasms Involvement with Chest wall | Malignant Neoplasms Involvement with rib | Malignant Neoplasms Involvement with intercostal muscle | Malignant Neoplasms Involvement with serratus anterior muscle | Malignant Neoplasms Involvement with Skin | Edematous skin Ipsilateral | Ulceration | Satellite Nodule

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0205076
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0035561
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C1314939
UMLS CUI [3,3]
C0021724
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C1314939
UMLS CUI [4,3]
C0224349
UMLS CUI [5,1]
C0006826
UMLS CUI [5,2]
C1314939
UMLS CUI [5,3]
C1123023
UMLS CUI [6,1]
C0521464
UMLS CUI [6,2]
C0441989
UMLS CUI [7]
C3887532
UMLS CUI [8]
C1710016
3. clinical evident inflammatory carcinoma
Beskrivning

Inflammatory carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0334385
4. ipsilateral fixed axillary adenopathy
Beskrivning

Axillary lymphadenopathy Fixed Ipsilateral

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0578735
UMLS CUI [1,2]
C3714578
UMLS CUI [1,3]
C0441989
measurable disease by physical examination, breast sonography and other image study
Beskrivning

Measurable Disease Physical Examination | Ultrasonography, Mammary | Diagnostic Imaging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0031809
UMLS CUI [2]
C0080264
UMLS CUI [3]
C0011923
kps≧ 70%
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
adequate bone marrow reserve, defined as white blood cell (wbc)≧ 3,500/ mm3, absolute neutrophil count (anc)≧ 1,500/mm3, platelets ≧ 100,000/mm3
Beskrivning

Bone Marrow Mature Neutrophils Adequate | White Blood Cell Count procedure | Absolute neutrophil count | Blood Platelets

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C1708947
UMLS CUI [1,3]
C0205411
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0005821
adequate liver and kidney function: total bilirubin ≦ 2.0 mg/dl, serum alanine transaminases (alt) and aspartate transaminase (ast) ≦ 3 times upper normal limit, serum creatinine ≦ 1.5 mg/dl
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0201913
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201976
patients must be ≦ 65 years old
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
signed informed consent
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have received prior treatment (including hormonal therapy, chemotherapy, radiotherapy or biological therapy) for labc. concomitant use of above therapy will no be allowed.
Beskrivning

Prior Therapy Locally advanced breast cancer | Hormone Therapy | Chemotherapy | Therapeutic radiology procedure | Biological Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C3495949
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0392920
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0005527
pregnant or lactating woman
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
metastases disease other than regional lymph node metastases (supraclavicular lymph node metastases is not eligible)
Beskrivning

Metastatic Neoplasm | Secondary malignant neoplasm of lymph node regional | Secondary malignant neoplasm of lymph node supraclavicular

Datatyp

boolean

Alias
UMLS CUI [1]
C2939420
UMLS CUI [2,1]
C0686619
UMLS CUI [2,2]
C0205147
UMLS CUI [3,1]
C0686619
UMLS CUI [3,2]
C0229730
prior serious cardiac conditions such as angina, myocardial infarction, cardiomyopathy, severe cardiovascular disease or cardiac arrhythmias
Beskrivning

Heart Diseases Serious | Angina Pectoris | Myocardial Infarction | Cardiomyopathies | Cardiovascular Diseases Severe | Cardiac Arrhythmia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0878544
UMLS CUI [5,1]
C0007222
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C0003811
serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
Beskrivning

Systemic disease Serious Inappropriate Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1548788
UMLS CUI [1,4]
C2348563
secondary malignancy in past five years before entry of the study (except in situ carcinoma of the cervix, or adequately treated basal cell carcinoma of the skin)
Beskrivning

Secondary Malignant Neoplasm | Carcinoma in situ of uterine adnexa | Basal cell carcinoma Treated

Datatyp

boolean

Alias
UMLS CUI [1]
C3266877
UMLS CUI [2]
C0686259
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C1522326
active infection (at the discretion of the investigator)
Beskrivning

Communicable Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
significant neurological (such as seizures) or psychiatric disorder
Beskrivning

nervous system disorder Significant | Seizures | Mental disorders

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0036572
UMLS CUI [3]
C0004936
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Similar models

Eligibility Breast Cancer NCT00155259

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Locally advanced breast cancer | No metastases | Prior Therapy
Item
women with histological proven labc, without metastasis, and no prior therapy. labc is defined as follows：
boolean
C0079399 (UMLS CUI [1])
C3495949 (UMLS CUI [2])
C0445092 (UMLS CUI [3])
C1514463 (UMLS CUI [4])
Tumor size Diameter
Item
1. tumor more than 5 cm in diameter
boolean
C0475440 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
Malignant Neoplasms Involvement with Chest wall | Malignant Neoplasms Involvement with rib | Malignant Neoplasms Involvement with intercostal muscle | Malignant Neoplasms Involvement with serratus anterior muscle | Malignant Neoplasms Involvement with Skin | Edematous skin Ipsilateral | Ulceration | Satellite Nodule
Item
2. tumor involvement of chest wall (ribs or intercostals or serratus anterior muscles) or skin (ipsilateral cutaneous edema, ulceration, or satellite nodules)
boolean
C0006826 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0205076 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0035561 (UMLS CUI [2,3])
C0006826 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C0021724 (UMLS CUI [3,3])
C0006826 (UMLS CUI [4,1])
C1314939 (UMLS CUI [4,2])
C0224349 (UMLS CUI [4,3])
C0006826 (UMLS CUI [5,1])
C1314939 (UMLS CUI [5,2])
C1123023 (UMLS CUI [5,3])
C0521464 (UMLS CUI [6,1])
C0441989 (UMLS CUI [6,2])
C3887532 (UMLS CUI [7])
C1710016 (UMLS CUI [8])
Inflammatory carcinoma
Item
3. clinical evident inflammatory carcinoma
boolean
C0334385 (UMLS CUI [1])
Axillary lymphadenopathy Fixed Ipsilateral
Item
4. ipsilateral fixed axillary adenopathy
boolean
C0578735 (UMLS CUI [1,1])
C3714578 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
Measurable Disease Physical Examination | Ultrasonography, Mammary | Diagnostic Imaging
Item
measurable disease by physical examination, breast sonography and other image study
boolean
C1513041 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0080264 (UMLS CUI [2])
C0011923 (UMLS CUI [3])
Karnofsky Performance Status
Item
kps≧ 70%
boolean
C0206065 (UMLS CUI [1])
Bone Marrow Mature Neutrophils Adequate | White Blood Cell Count procedure | Absolute neutrophil count | Blood Platelets
Item
adequate bone marrow reserve, defined as white blood cell (wbc)≧ 3,500/ mm3, absolute neutrophil count (anc)≧ 1,500/mm3, platelets ≧ 100,000/mm3
boolean
C0005953 (UMLS CUI [1,1])
C1708947 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,3])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0005821 (UMLS CUI [4])
Liver function | Renal function | Bilirubin, total measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum
Item
adequate liver and kidney function: total bilirubin ≦ 2.0 mg/dl, serum alanine transaminases (alt) and aspartate transaminase (ast) ≦ 3 times upper normal limit, serum creatinine ≦ 1.5 mg/dl
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0201913 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Age
Item
patients must be ≦ 65 years old
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Locally advanced breast cancer | Hormone Therapy | Chemotherapy | Therapeutic radiology procedure | Biological Therapy
Item
patients who have received prior treatment (including hormonal therapy, chemotherapy, radiotherapy or biological therapy) for labc. concomitant use of above therapy will no be allowed.
boolean
C1514463 (UMLS CUI [1,1])
C3495949 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0005527 (UMLS CUI [5])
Pregnancy | Breast Feeding
Item
pregnant or lactating woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Metastatic Neoplasm | Secondary malignant neoplasm of lymph node regional | Secondary malignant neoplasm of lymph node supraclavicular
Item
metastases disease other than regional lymph node metastases (supraclavicular lymph node metastases is not eligible)
boolean
C2939420 (UMLS CUI [1])
C0686619 (UMLS CUI [2,1])
C0205147 (UMLS CUI [2,2])
C0686619 (UMLS CUI [3,1])
C0229730 (UMLS CUI [3,2])
Heart Diseases Serious | Angina Pectoris | Myocardial Infarction | Cardiomyopathies | Cardiovascular Diseases Severe | Cardiac Arrhythmia
Item
prior serious cardiac conditions such as angina, myocardial infarction, cardiomyopathy, severe cardiovascular disease or cardiac arrhythmias
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0878544 (UMLS CUI [4])
C0007222 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0003811 (UMLS CUI [6])
Systemic disease Serious Inappropriate Study Protocol
Item
serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
boolean
C0442893 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
Secondary Malignant Neoplasm | Carcinoma in situ of uterine adnexa | Basal cell carcinoma Treated
Item
secondary malignancy in past five years before entry of the study (except in situ carcinoma of the cervix, or adequately treated basal cell carcinoma of the skin)
boolean
C3266877 (UMLS CUI [1])
C0686259 (UMLS CUI [2])
C0007117 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
Communicable Diseases
Item
active infection (at the discretion of the investigator)
boolean
C0009450 (UMLS CUI [1])
nervous system disorder Significant | Seizures | Mental disorders
Item
significant neurological (such as seizures) or psychiatric disorder
boolean
C0027765 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0036572 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
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