ID

39277

Descrizione

Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01688700

collegamento

https://clinicaltrials.gov/show/NCT01688700

Keywords

  1. 16/12/19 16/12/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

16 dicembre 2019

DOI

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Licenza

Creative Commons BY 4.0

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Eligibility Esophageal Squamous Cell Carcinoma Resectable NCT01688700

Eligibility Esophageal Squamous Cell Carcinoma Resectable NCT01688700

Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological or cytologic diagnosis of esophageal squamous cell carcinoma
Descrizione

Squamous cell carcinoma of esophagus

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0279626
ecog performance status 0-2
Descrizione

ECOG performance status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1520224
age:18-70 years
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
joined the study voluntarily and signed informed consent form
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
patients must not have received any prior anticancer therapy
Descrizione

Cancer treatment Absent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0332197
resectable disease, stage iia-iiic, t2n0m0-t3n1m0(ajcc 2009)
Descrizione

Disease Resectable TNM clinical staging

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1514888
UMLS CUI [1,3]
C3258246
target lesions can be measured according to recist criteria
Descrizione

Target Lesion Measurable

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1513040
no serious system dysfunction and immuno-deficiency, adequate organ function including the following: hemoglobin ≥9 g/dl, wbc≥3x109/l, neutrophils (anc )≥1.5x109/l, platelet count ≥100x 109/l, tbil<1.5 x uln, alt and ast ≦ 2.5 x uln, creatinine ≦ 1.5 x uln
Descrizione

Body system Dysfunction Serious Absent | Immunodeficiency Absent | Organ function | Hemoglobin measurement | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0460002
UMLS CUI [1,2]
C3887504
UMLS CUI [1,3]
C0205404
UMLS CUI [1,4]
C0332197
UMLS CUI [2,1]
C0021051
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0678852
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0023508
UMLS CUI [6]
C0948762
UMLS CUI [7]
C0032181
UMLS CUI [8]
C1278039
UMLS CUI [9]
C0201836
UMLS CUI [10]
C0201899
UMLS CUI [11]
C0201976
use of an effective contraceptive for adults to prevent pregnancy
Descrizione

Contraceptive Agent Adult

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009871
UMLS CUI [1,2]
C0001675
life expectancy of more than 3 months
Descrizione

Life Expectancy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
not suitable to surgery
Descrizione

Patient Inappropriate Operative Surgical Procedures

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0543467
cervical esophageal carcinoma(distance of incisor tooth<19cm)
Descrizione

Carcinoma of cervical part of esophagus

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0345764
early esophageal carcinoma(stage i)
Descrizione

Esophageal carcinoma Early TNM clinical staging

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0152018
UMLS CUI [1,2]
C1279919
UMLS CUI [1,3]
C3258246
complete esophageal obstruction,esophageal perforation or hematemesis
Descrizione

ESOPHAGEAL OBSTRUCTION COMPLETE | Esophageal Perforation | Hematemesis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0743579
UMLS CUI [2]
C0014860
UMLS CUI [3]
C0018926
other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
Descrizione

Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
Descrizione

Pregnancy | Breast Feeding | Contraceptive Agents Refused

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0009871
UMLS CUI [3,2]
C1705116
uncontrolled seizures or psychiatric diseases, loss of control over their own behavior 11、 history of serious allergic or castor oil allergy 12、 patients who are not suitable to participate in the trial according to researchers
Descrizione

Seizures Uncontrolled | Mental disorders Uncontrolled | Unable to control behavior | Allergic Reaction Serious Castor Oil | Castor oil allergy | Study Subject Participation Status Inappropriate

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0582140
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0007343
UMLS CUI [5]
C0571232
UMLS CUI [6,1]
C2348568
UMLS CUI [6,2]
C1548788

Similar models

Eligibility Esophageal Squamous Cell Carcinoma Resectable NCT01688700

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of esophagus
Item
histological or cytologic diagnosis of esophageal squamous cell carcinoma
boolean
C0279626 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Age
Item
age:18-70 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
joined the study voluntarily and signed informed consent form
boolean
C0021430 (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])
Disease Resectable TNM clinical staging
Item
resectable disease, stage iia-iiic, t2n0m0-t3n1m0(ajcc 2009)
boolean
C0012634 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Target Lesion Measurable
Item
target lesions can be measured according to recist criteria
boolean
C2986546 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
Body system Dysfunction Serious Absent | Immunodeficiency Absent | Organ function | Hemoglobin measurement | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum
Item
no serious system dysfunction and immuno-deficiency, adequate organ function including the following: hemoglobin ≥9 g/dl, wbc≥3x109/l, neutrophils (anc )≥1.5x109/l, platelet count ≥100x 109/l, tbil<1.5 x uln, alt and ast ≦ 2.5 x uln, creatinine ≦ 1.5 x uln
boolean
C0460002 (UMLS CUI [1,1])
C3887504 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
C0021051 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0678852 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0023508 (UMLS CUI [5])
C0948762 (UMLS CUI [6])
C0032181 (UMLS CUI [7])
C1278039 (UMLS CUI [8])
C0201836 (UMLS CUI [9])
C0201899 (UMLS CUI [10])
C0201976 (UMLS CUI [11])
Contraceptive Agent Adult
Item
use of an effective contraceptive for adults to prevent pregnancy
boolean
C0009871 (UMLS CUI [1,1])
C0001675 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy of more than 3 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Patient Inappropriate Operative Surgical Procedures
Item
not suitable to surgery
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Carcinoma of cervical part of esophagus
Item
cervical esophageal carcinoma(distance of incisor tooth<19cm)
boolean
C0345764 (UMLS CUI [1])
Esophageal carcinoma Early TNM clinical staging
Item
early esophageal carcinoma(stage i)
boolean
C0152018 (UMLS CUI [1,1])
C1279919 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
ESOPHAGEAL OBSTRUCTION COMPLETE | Esophageal Perforation | Hematemesis
Item
complete esophageal obstruction,esophageal perforation or hematemesis
boolean
C0743579 (UMLS CUI [1])
C0014860 (UMLS CUI [2])
C0018926 (UMLS CUI [3])
Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Pregnancy | Breast Feeding | Contraceptive Agents Refused
Item
pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0009871 (UMLS CUI [3,1])
C1705116 (UMLS CUI [3,2])
Seizures Uncontrolled | Mental disorders Uncontrolled | Unable to control behavior | Allergic Reaction Serious Castor Oil | Castor oil allergy | Study Subject Participation Status Inappropriate
Item
uncontrolled seizures or psychiatric diseases, loss of control over their own behavior 11、 history of serious allergic or castor oil allergy 12、 patients who are not suitable to participate in the trial according to researchers
boolean
C0036572 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0582140 (UMLS CUI [3])
C1527304 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0007343 (UMLS CUI [4,3])
C0571232 (UMLS CUI [5])
C2348568 (UMLS CUI [6,1])
C1548788 (UMLS CUI [6,2])

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