Eligibility Localized Squamous Cell Carcinoma of the Esophagus NCT02017600

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of esophagus
Item
patients must have been histologically proven esophageal carcinoma (squamous cell carcinoma).
boolean
C0279626 (UMLS CUI [1])
Locally Advanced Malignant Neoplasm TNM clinical staging
Item
the tumor had to be locally advanced (stage t2-3/n0, t1-3/n+, if technically resectable with curative intent).
boolean
C0677984 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Age
Item
patients must be 20 years of age.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
patients must have an ecog performance status score 2.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
patients must have a life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Patient Available Therapeutic procedure | Patients Available Follow-up
Item
patients must be accessible for treatment and follow-up at least for one year.
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Informed Consent
Item
patients must sign the informed consent form.
boolean
C0021430 (UMLS CUI [1])
Hemoglobin measurement | Neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
patient must have:hemoglobin level 9 g/dl; neutrophil count 1,500/mm3; platelets count 100,000/mm3; serum bilirubin level 1.0 uln; serum transaminase (got, gpt) levels 2.0 uln; serum alkaline phosphatase levels 2.0 uln; serum creatinine level 1.5 mg/dl or creatinine clearance rate(crcl)60 ml/min for the institution (calculated by the cockcroft- gault equation).
boolean
C0518015 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0201850 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
C2711451 (UMLS CUI [9])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure Esophageal carcinoma | Chemotherapy Esophageal carcinoma | Cancer treatment Esophageal carcinoma
Item
patient who are receiving or had received concurrent radiotherapy, chemotherapy or other anticancer treatment for esophageal carcinoma.
boolean
C1522449 (UMLS CUI [1,1])
C0152018 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0152018 (UMLS CUI [2,2])
C0920425 (UMLS CUI [3,1])
C0152018 (UMLS CUI [3,2])
Severe allergy Pharmaceutical Preparations | Severe allergy Polysorbate 80
Item
patients with known history of severe hypersensitivity reactions to any medicine or to drugs formulated with polysorbate 80.
boolean
C2945656 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C0032601 (UMLS CUI [2,2])
Major surgery | Exception Port-A-Cath | Exception Jejunostomy feeding
Item
major surgery within two weeks prior to entering the study, excluding port-a insertion or feeding jejunostomy surgery.
boolean
C0679637 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C3495140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0192715 (UMLS CUI [3,2])
CNS metastases | Suspicion CNS metastases
Item
patients with cns metastasis, including clinical suspicion.
boolean
C0686377 (UMLS CUI [1])
C0242114 (UMLS CUI [2,1])
C0686377 (UMLS CUI [2,2])
Peripheral Neuropathy CTCAE Grades
Item
patients with clinically detectable peripheral neuropathy 2 on the ctc criteria.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Mental state unfit Clinical Trial
Item
mental statuses of patients are not fit for clinical trial.
boolean
C0278060 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Females & males of reproductive potential | Exception Contraceptive methods
Item
fertile men and women unless using a reliable and appropriate contraceptive method.
boolean
C4034483 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Gender considering Pregnancy | Possible pregnancy | Contraceptive methods Absent
Item
patients with pregnancy or lactating, women considering pregnancy, possible pregnancy that without using effective contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0750591 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
C0425965 (UMLS CUI [4])
C0700589 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Comorbidity Serious | Heart Disease | Congestive heart failure | Angina Pectoris | Cardiac Arrhythmia | Cardiomyopathy | Communicable Disease Uncontrolled | Body fluid retention | Pleural effusion | Ascites | Pericardial effusion | Edema Treatment required for | Cancer Other | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of esophagus
Item
patients who have serious concomitant illness that might be aggravated by chemotherapy, as below included:active cardiac disease (e.g. congestive heart failure, angina, arrhythmia, acute myocardial disease or other types of heart disease requiring treatment) within 6 months period preceding entry into the study; uncontrolled infection (e.g. active infection that uncontrolled for 2 weeks under antibiotic therapy); retention of body fluid (e.g. pleural effusion, ascites, pericardial effusion, and edema needing treatment); history of other than esophageal cancer, except curatively treated non-melanoma skin cancer or in situ carcinoma of the esophagus; and other conditions which will be judged by physician's discretion.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0002962 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0878544 (UMLS CUI [6])
C0009450 (UMLS CUI [7,1])
C0205318 (UMLS CUI [7,2])
C0268000 (UMLS CUI [8])
C0032227 (UMLS CUI [9])
C0003962 (UMLS CUI [10])
C0031039 (UMLS CUI [11])
C0013604 (UMLS CUI [12,1])
C0332121 (UMLS CUI [12,2])
C1707251 (UMLS CUI [13])
C1705847 (UMLS CUI [14,1])
C1273390 (UMLS CUI [14,2])
C0699893 (UMLS CUI [14,3])
C1705847 (UMLS CUI [15,1])
C1273390 (UMLS CUI [15,2])
C0154059 (UMLS CUI [15,3])

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