ID

37242

Descripción

Nimotuzumab Plus Nab-paclitaxel and Cisplatin in Treating Patients With Advanced Esophageal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02034968

Link

https://clinicaltrials.gov/show/NCT02034968

Palabras clave

  1. 11/7/19 11/7/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

11 de julio de 2019

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Stage IV Esophageal Squamous Cell Carcinoma NCT02034968

Eligibility Stage IV Esophageal Squamous Cell Carcinoma NCT02034968

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient who was confirmed stage iv esophageal carcinoma by pathologic histology or cytology.
Descripción

Esophageal carcinoma TNM clinical staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0152018
UMLS CUI [1,2]
C3258246
males or females aged ≥18 years, < 75 years.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status 0-2.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy ≥12 weeks.
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
adequate bone marrow, renal, and liver function are required.
Descripción

Bone Marrow function | Renal function | Liver function

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
Descripción

Protocol Compliance | Ability Receive Oral medication

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C0175795
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
Descripción

Systemic disease Unstable | Communicable Disease | Uncontrolled hypertension | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia Serious | Pharmaceutical Preparations Required | Liver disease | Kidney Disease | Metabolic Disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0009450
UMLS CUI [3]
C1868885
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0018802
UMLS CUI [6]
C0027051
UMLS CUI [7,1]
C0003811
UMLS CUI [7,2]
C0205404
UMLS CUI [8,1]
C0013227
UMLS CUI [8,2]
C1514873
UMLS CUI [9]
C0023895
UMLS CUI [10]
C0022658
UMLS CUI [11]
C0025517
allergy to anti-egfr antibody.
Descripción

Hypersensitivity EGFR Antibody

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C4055105
female subjects should not be pregnant or breast-feeding.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
adequate hematological function: absolute neutrophil count (anc) ≥1.5 x 109/l, and platelet count ≥100 x 109/l. adequate renal function: serum creatinine ≤ 1.5 x uln, or ≥ 50 ml/min. adequate liver function: total bilirubin < 1.5 x upper limit of normal (uln) and alanine aminotransferase (alt) and aspartate aminotransferase (ast) < 2.5 x uln in the absence of liver metastases, or < 5 x uln in case of liver metastases.
Descripción

Hematologic function | Absolute neutrophil count | Platelet Count measurement | Renal function | Creatinine measurement, serum | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0232804
UMLS CUI [5]
C0201976
UMLS CUI [6]
C0232741
UMLS CUI [7]
C1278039
UMLS CUI [8]
C0201836
UMLS CUI [9]
C0201899
UMLS CUI [10,1]
C0494165
UMLS CUI [10,2]
C0332197
UMLS CUI [11]
C0494165
patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Descripción

Protocol Compliance Unable | Protocol Compliance Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080

Similar models

Eligibility Stage IV Esophageal Squamous Cell Carcinoma NCT02034968

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Esophageal carcinoma TNM clinical staging
Item
patient who was confirmed stage iv esophageal carcinoma by pathologic histology or cytology.
boolean
C0152018 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Age
Item
males or females aged ≥18 years, < 75 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy ≥12 weeks.
boolean
C0023671 (UMLS CUI [1])
Bone Marrow function | Renal function | Liver function
Item
adequate bone marrow, renal, and liver function are required.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Protocol Compliance | Ability Receive Oral medication
Item
able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
boolean
C0525058 (UMLS CUI [1])
C0085732 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C0175795 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Systemic disease Unstable | Communicable Disease | Uncontrolled hypertension | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia Serious | Pharmaceutical Preparations Required | Liver disease | Kidney Disease | Metabolic Disease
Item
any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
boolean
C0442893 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C1868885 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
C0027051 (UMLS CUI [6])
C0003811 (UMLS CUI [7,1])
C0205404 (UMLS CUI [7,2])
C0013227 (UMLS CUI [8,1])
C1514873 (UMLS CUI [8,2])
C0023895 (UMLS CUI [9])
C0022658 (UMLS CUI [10])
C0025517 (UMLS CUI [11])
Hypersensitivity EGFR Antibody
Item
allergy to anti-egfr antibody.
boolean
C0020517 (UMLS CUI [1,1])
C4055105 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
female subjects should not be pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hematologic function | Absolute neutrophil count | Platelet Count measurement | Renal function | Creatinine measurement, serum | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver
Item
adequate hematological function: absolute neutrophil count (anc) ≥1.5 x 109/l, and platelet count ≥100 x 109/l. adequate renal function: serum creatinine ≤ 1.5 x uln, or ≥ 50 ml/min. adequate liver function: total bilirubin < 1.5 x upper limit of normal (uln) and alanine aminotransferase (alt) and aspartate aminotransferase (ast) < 2.5 x uln in the absence of liver metastases, or < 5 x uln in case of liver metastases.
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0232804 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0232741 (UMLS CUI [6])
C1278039 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
C0201899 (UMLS CUI [9])
C0494165 (UMLS CUI [10,1])
C0332197 (UMLS CUI [10,2])
C0494165 (UMLS CUI [11])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])

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