[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100210533":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":41,"centralContacts":30,"locations":46,"responsibleParty":59,"collaborators":30,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":30,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":30,"enrollmentInfo":69,"targetDuration":30,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":30,"overallStatus":78,"whyStopped":30,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Nang Kuang Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Induction Chemotherapy DCF followed by Surgery","EXPERIMENTAL","All eligible patients will receive ND-420, Cisplatin and fluorouracil every 3 weeks for 2 cycles. After induction chemotherapy, patients will be planned to receive Surgery.",[13,14,15,16],"Drug: ND-420","Procedure: Surgery","Drug: Cisplatin","Drug: fluorouracil",[18,25,31,35],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","ND-420","ND-420 50 mg\u002Fm2 on day1",[9],[24],"ND-420(Nangkuang)",{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"PROCEDURE","Surgery","After induction chemotherapy, participants will be receive right or left thoracotomy for curative resection by total or subtotal thoracic esophagectomy.",[9],null,{"type":19,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Cisplatin","cisplatin 70 mg\u002Fm2 on day1",[9],{"type":19,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"fluorouracil","fluorouracil 700 mg\u002Fm2 daily, day1 to day4",[9],[40],"5-FU",[42],{"name":43,"affiliation":44,"role":45},"Ming-Huang Chen, M.D.","Taipei Veterans General Hospital, Taiwan","PRINCIPAL_INVESTIGATOR",[47],{"facility":48,"status":30,"city":49,"state":30,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":30},"Taipei Veterans General Hospital","Taipei","112","Taiwan","TW",{"type":54,"coordinates":55},"Point",[56,57],121.52639,25.05306,{"lat":57,"lon":56},{"type":60,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100210533","phase-2-a-phase-ii-trial-of-induction-chemotherapy-with-nd-420-cisplatin-and-fluorouracil-followed-by-surgery-in-the-treatment-of-patients-with-localized-squamous-cell-carcinoma-of-the-esophagus-100210533",false,"NCT02017600","A Phase II Trial of Induction Chemotherapy With ND-420, Cisplatin and Fluorouracil Followed by Surgery in the Treatment of Patients With Localized Squamous Cell Carcinoma of the Esophagus","Inclusion Criteria:\n\n* Patients must have been histologically proven esophageal carcinoma (squamous cell carcinoma).\n* The tumor had to be locally advanced (stage T2-3\u002FN0, T1-3\u002FN+, if technically resectable with curative intent).\n* Patients must be 20 years of age.\n* Patients must have an ECOG performance status score 2.\n* Patients must have a life expectancy of at least 12 weeks.\n* Patients must be accessible for treatment and follow-up at least for one year.\n* Patients must sign the informed consent form.\n* Patient must have:Hemoglobin level 9 g\u002Fdl; Neutrophil count 1,500\u002Fmm3; Platelets count 100,000\u002Fmm3; 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\u002Fdl or Creatinine clearance rate(CrCl)60 ml\u002Fmin for the institution (calculated by the Cockcroft- Gault equation).\n\nExclusion Criteria:\n\n* Patient who are receiving or had received concurrent radiotherapy, chemotherapy or other anticancer treatment for esophageal carcinoma.\n* Patients with known history of severe hypersensitivity reactions to any medicine or to drugs formulated with polysorbate 80.\n* Major surgery within two weeks prior to entering the study, excluding port-A insertion or feeding jejunostomy surgery.\n* Patients with CNS metastasis, including clinical suspicion.\n* Patients with clinically detectable peripheral neuropathy 2 on the CTC criteria.\n* Mental statuses of patients are not fit for clinical trial.\n* Fertile men and women unless using a reliable and appropriate contraceptive method.\n* Patients with pregnancy or lactating, women considering pregnancy, possible pregnancy that without using effective contraception.\n* 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.","ALL","20 Years",{"count":70,"type":71},48,"ACTUAL","INTERVENTIONAL",[74],"PHASE2","Investigator will assign 53 patients who had been histologically proven localized squamous cell carcinoma of esophagus to receive the induction chemotherapy regimen of ND-420 50 mg\u002Fm2 on day 1, cisplatin 70 mg\u002Fm2 on day1, plus fluorouracil 700 mg\u002Fm2 daily, day1 to day4, every 3 weeks for 2 cycles and then followed by surgical resection. The successful rate of complete treatment per protocol and complete resection will be the primary variant to evaluate in our study.",[77],"Localized Squamous Cell Carcinoma of the Esophagus","TERMINATED","2020-05-18",{"date":81,"type":71},"2020-05-20",{"date":83,"type":30},"2013-08",{"date":85,"type":71},"2015-04-04",{"name":5,"class":6},1]