Eligibility Stage IV Esophageal Squamous Cell Carcinoma NCT02011594

Phase II Study of Maintenance Treatment of Nimotuzumab for Advanced Esophageal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02011594

Eligibility Stage IV Esophageal Squamous Cell Carcinoma NCT02011594

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Specimen Size | Case Quantity Arm
Item
the sample size estimate: 20 cases per arm.
boolean
C0370003 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C1706256 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1522541 (UMLS CUI [2,3])
Age
Item
males or females aged ≥18 years, < 75 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status | Life Expectancy
Item
eastern cooperative oncology group (ecog) performance status 0-2. life expectancy ≥12 weeks.
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Contraceptive methods
Item
males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug.
boolean
C0700589 (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])
Informed Consent
Item
institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.
boolean
C0021430 (UMLS CUI [1])
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])