Eligibility Esophageal Squamous Cell Carcinoma Resectable NCT01688700

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

Eligibility Esophageal Squamous Cell Carcinoma Resectable NCT01688700

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])