Eligibility Esophageal Carcinoma NCT01034683

Study of Lobaplatin,5-Fluorouracil and Leucovorin for the Treatment of Esophageal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01034683

Eligibility Esophageal Carcinoma NCT01034683

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of esophagus | Cardiac Carcinoma
Item
histologically proven squamous cell carcinoma of the esophagus(include cardiac cancer)
boolean
C0279626 (UMLS CUI [1])
C1959584 (UMLS CUI [2])
Patients Newly Diagnosed | Operative Surgical Procedure Unable | Operative Surgical Procedure Unwilling
Item
newly diagnosed patients should be unable or unwilling to surgery
boolean
C0030705 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
Recurrence Post Operative Surgical Procedure | Adjuvant Chemotherapy Absent | Adjuvant Radiation Therapy Absent
Item
recurrence after surgery must have no adjuvant chemotherapy or radiotherapy are allowed
boolean
C0034897 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0085533 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1706721 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Measurable Disease Dimension Spiral Computed Tomography | Measurement Longest Diameter
Item
patients are required to have dimensionally measurable disease,with an objective measurable focus:preferably the use of spiral computed tomography(ct)and measurements of maximum diameter≥1cm.
boolean
C1513041 (UMLS CUI [1,1])
C0439534 (UMLS CUI [1,2])
C0860888 (UMLS CUI [1,3])
C0242485 (UMLS CUI [2,1])
C0552406 (UMLS CUI [2,2])
ECOG performance status | Karnofsky Performance Status
Item
cooperative oncology group performance status 0-2 or kps score ≥60,survival time ≥3 months
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Absolute neutrophil count | Platelet Count measurement
Item
neutrophils(anc)≥1.5×109/l; blood platelets counts(bpc)≥80×109/l
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Hemoglobin measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
hemoglobin(hgb)≥90g/l ,serum total bilirubin ≤1.0 times the upper normal limit(uln): alanine aminotransferase and glutamic-oxalacetic transaminase (alt and ast)≤2.5 uln
boolean
C0518015 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
Creatinine measurement, serum
Item
serum creatinine (cr)≤1.5uln
boolean
C0201976 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or nursing women;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent
Item
female patients at child-bearing age, without taking effective contraceptive methods;
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Cancer Other | Leiomyosarcoma | Lymphoma
Item
patients who have pathologic confirmation of other types of tumors (eg, leiomyosarcoma, malignant lymphoma) rather than esophageal cancer;
boolean
C1707251 (UMLS CUI [1])
C0023269 (UMLS CUI [2])
C0024299 (UMLS CUI [3])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
patients with tumors other than esophageal cancer ,except cervical carcinoma in situ and skin basal cancer or squamous cell carcinoma received adequate treatment;
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Cerebral metastasis | Metastatic Malignant Neoplasm to the Leptomeninges | Intestinal Obstruction | Peripheral Neuropathy Symptomatic CTCAE Grades
Item
patients with cerebral or meningeal metastasis, intestinal obstruction, or symptomatic pathologic changes of peripheral nerve,ncic-ctg standard >grade 2
boolean
C0555278 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
C0021843 (UMLS CUI [3])
C0031117 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C1516728 (UMLS CUI [4,3])
Complications Serious | Heart Disease Serious | Unstable status Post Therapeutic procedure | Myocardial Infarction | Congestive heart failure | Angina, Unstable | Pericardial effusion | Cardiac Arrhythmia Unstable | Neuropathy | Psychotic Disorder | Dementia | Epilepsy | Communicable Disease Uncontrolled | Disseminated Intravascular Coagulation | Diabetic - poor control | Serum fasting glucose measurement
Item
patients with serious complications such as: serious heart disease remained unstable after treatment, or myocardial infarction, congestive heart failure, unstable angina, frank pericardial effusion or unstable arrhythmias in 6 months before being enrolled into the group; confirmed neuropathy or psychosis, including dementia or epilepsia; uncontrolled infection;active disseminated intravascular coagulation;uncontrolled diabetes, fasting serum glucose> 7.8mmol / l
boolean
C0009566 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0443343 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0027051 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
C0002965 (UMLS CUI [6])
C0031039 (UMLS CUI [7])
C0003811 (UMLS CUI [8,1])
C0443343 (UMLS CUI [8,2])
C0442874 (UMLS CUI [9])
C0033975 (UMLS CUI [10])
C0497327 (UMLS CUI [11])
C0014544 (UMLS CUI [12])
C0009450 (UMLS CUI [13,1])
C0205318 (UMLS CUI [13,2])
C0012739 (UMLS CUI [14])
C0421258 (UMLS CUI [15])
C0583334 (UMLS CUI [16])