ID

39265

Descrição

Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin for Stage Ⅱ-Ⅲ Esophageal Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01258192

Link

https://clinicaltrials.gov/show/NCT01258192

Palavras-chave

Versões (1)
  1. 14/12/2019 14/12/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

14 de dezembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Esophageal Squamous Cell Carcinoma NCT01258192

Inglês

Eligibility Esophageal Squamous Cell Carcinoma NCT01258192

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic diagnosis of squamous cell carcinoma of esophagus. preoperative stage ⅱ-ⅲ
Descrição

Squamous cell carcinoma of esophagus Preoperative TNM clinical staging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0279626
UMLS CUI [1,2]
C0445204
UMLS CUI [1,3]
C3258246
by endoscopic ultrasound, ct of the chest and abdomen,and esophagogram.
Descrição

Endoscopic Ultrasound | CT of chest and abdomen | Esophagram

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0376443
UMLS CUI [2]
C1630402
UMLS CUI [3]
C1318509
age ranges from 18 to 70 years.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patients must not have received any prior anticancer therapy.
Descrição

Cancer treatment Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0332197
performance status of 0 to 1
Descrição

Performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1518965
estimated life expectancy of at least 6 months.
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
tumor can be measured according to recist criteria
Descrição

Neoplasm Measurable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1513040
signed informed consent document on file.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
females with childbearing potential must have a negative serum pregnancy
Descrição

Childbearing Potential Serum pregnancy test negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
adequate organ function including the following:
Descrição

Organ function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0678852
bone marrow: absolute neutrophil count (anc) greater than or equal 1.5×109/l platelets greater than or equal 80×109/l haemoglobin greater than or equal 80g/l hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (uln), alanine transaminase (alt) and aspartate transaminase (ast) less than or equal to 2.5 times uln renal: calculated creatinine clearance rate≥60ml/min. test within 7 days prior to study enrollment.
Descrição

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0232741
UMLS CUI [6]
C1278039
UMLS CUI [7]
C0201836
UMLS CUI [8]
C0201899
UMLS CUI [9]
C0232804
UMLS CUI [10]
C2711451
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
carcinoma at the upper part of esophagus
Descrição

Carcinoma of upper third of esophagus

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0345779
histologic diagnosis of adenocarcinoma of esophagus.
Descrição

Adenocarcinoma Of Esophagus

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0279628
prior treatment for esophageal cancer.
Descrição

Prior Therapy Esophageal carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0152018
active infection.
Descrição

Communicable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
pregnant or breast feeding.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of significant neurological or mental disorder, including seizures or dementia.
Descrição

Nervous system disorder | Mental disorders | Seizures | Dementia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
UMLS CUI [3]
C0036572
UMLS CUI [4]
C0497327
prior invasive malignancy in 5 years (except for carcinoma in situ).
Descrição

invasive cancer | Exception Carcinoma in Situ

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007099
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Similar models

Eligibility Esophageal Squamous Cell Carcinoma NCT01258192

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of esophagus Preoperative TNM clinical staging
Item
histologic diagnosis of squamous cell carcinoma of esophagus. preoperative stage ⅱ-ⅲ
boolean
C0279626 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Endoscopic Ultrasound | CT of chest and abdomen | Esophagram
Item
by endoscopic ultrasound, ct of the chest and abdomen,and esophagogram.
boolean
C0376443 (UMLS CUI [1])
C1630402 (UMLS CUI [2])
C1318509 (UMLS CUI [3])
Age
Item
age ranges from 18 to 70 years.
boolean
C0001779 (UMLS CUI [1])
Cancer treatment Absent
Item
patients must not have received any prior anticancer therapy.
boolean
C0920425 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Performance status
Item
performance status of 0 to 1
boolean
C1518965 (UMLS CUI [1])
Life Expectancy
Item
estimated life expectancy of at least 6 months.
boolean
C0023671 (UMLS CUI [1])
Neoplasm Measurable
Item
tumor can be measured according to recist criteria
boolean
C0027651 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
Informed Consent
Item
signed informed consent document on file.
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative
Item
females with childbearing potential must have a negative serum pregnancy
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Organ function
Item
adequate organ function including the following:
boolean
C0678852 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
bone marrow: absolute neutrophil count (anc) greater than or equal 1.5×109/l platelets greater than or equal 80×109/l haemoglobin greater than or equal 80g/l hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (uln), alanine transaminase (alt) and aspartate transaminase (ast) less than or equal to 2.5 times uln renal: calculated creatinine clearance rate≥60ml/min. test within 7 days prior to study enrollment.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0232741 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
C0201899 (UMLS CUI [8])
C0232804 (UMLS CUI [9])
C2711451 (UMLS CUI [10])
Item Group
C0680251 (UMLS CUI)
Carcinoma of upper third of esophagus
Item
carcinoma at the upper part of esophagus
boolean
C0345779 (UMLS CUI [1])
Adenocarcinoma Of Esophagus
Item
histologic diagnosis of adenocarcinoma of esophagus.
boolean
C0279628 (UMLS CUI [1])
Prior Therapy Esophageal carcinoma
Item
prior treatment for esophageal cancer.
boolean
C1514463 (UMLS CUI [1,1])
C0152018 (UMLS CUI [1,2])
Communicable Disease
Item
active infection.
boolean
C0009450 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Nervous system disorder | Mental disorders | Seizures | Dementia
Item
history of significant neurological or mental disorder, including seizures or dementia.
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0036572 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
invasive cancer | Exception Carcinoma in Situ
Item
prior invasive malignancy in 5 years (except for carcinoma in situ).
boolean
C0677898 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007099 (UMLS CUI [2,2])
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