[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562111":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":20,"locations":19,"responsibleParty":26,"collaborators":19,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":19,"eligibilityCriteria":36,"healthyVolunteers":32,"sex":37,"minAge":38,"maxAge":19,"enrollmentInfo":39,"targetDuration":19,"studyType":42,"phases":43,"briefSummary":45,"conditions":46,"keywords":48,"overallStatus":52,"whyStopped":19,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":19},{"fullName":5,"class":6},"China Medical University Hospital","OTHER",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"Maintenance chemotherapy with S-1 regimen","EXPERIMENTAL",[12],"Drug: S-1",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","S-1","Treatment schedule At 4 to 8 weeks after chemotherapy and radiotherapy ended, maintenance S-1 was administered for up to 12 cycles. A cycle was 3 weeks, with S-1 administrated on days 1 to 14 in each cycle.\n\nThe initial dose of S-1 was determined according to the body surface area (BSA): 40 mg twice a day for BSA \\< 1.25 m2; 50 mg twice a day for 1.25 m2⩽ BSA \\< 1.5 m2; and 60 mg twice a day for BSA ⩾1.5 m2.\n\nMaintenance chemotherapy with S1 was administered for 12 cycles or terminated earlier if there was disease progression, intolerable toxicity, or at the patient's request.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Ming-Yu LIen, M.D. Ph.D.","CONTACT","8864+22052121","leinmirain@hotmail.com",{"type":27,"investigatorFullName":28,"investigatorTitle":29,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Ming-Yu Lien","M.D Ph.D","100562111","phase-2-maintenance-chemotherapy-with-s-1-locally-advanced-esophageal-cancer-receiving-definitive-ccrt-100562111",false,"NCT06598917","Maintenance Chemotherapy With S-1, Locally Advanced Esophageal Cancer Receiving Definitive CCRT","Phase II Study of Maintenance Chemotherapy With S-1 in Patients With Locally Advanced Esophageal Cancer Receiving Definitive Concurrent Chemoradiotherapy","Inclusion Criteria:\n\n1. an age of at least 20 years;\n2. patients with histologically confirmed diagnosis of ESCC (Esophageal squamous cell carcinoma), GEJC (gastroesophageal junction cancer), EAC (Esophageal adenocarcinoma)\n3. stage II-IVA, AJCC, 8th, locally advanced disease is suitable for dCCRT and is ineligible for curative surgery (including those who are unable or unwilling to undergo surgery)\n4. an Eastern Cooperative Oncology Group performance-status score of 0-1\n5. definitive concurrent chemoradiotherapy according to regional oncology guidelines for esophageal cancer, with the following criteria:\n\n   * patients must have received platinum-based chemotherapy (at least 2 cycles of tri-weekly regimen or at least 4 cycles of weekly regimen) and radiation therapy consistent with definitive treatment (50-64 Gy)\n   * no evidence of radiographic disease progression per RECIST v1.1, as documented by comparison of scans (pre- and post-definitive concurrent chemoradiotherapy) prior to enrollment.\n6. adequate bone marrow, hepatic, renal and cardiac function\n\nExclusion Criteria:\n\n1. patients had distant metastasis\n2. patients had esophageal perforation or esophageal fistula\n3. patients had tumor bleeding\n4. patients had severe infection\n5. History of malignancy other than esophageal cancer within 2 years prior to screening","ALL","20 Years",{"count":40,"type":41},60,"ESTIMATED","INTERVENTIONAL",[44],"PHASE2","Phase II study of definitive concurrent chemoradiotherapy follows consolidative chemotherapy with S1 for locally advanced unresectable esophageal cancer.\n\nOur treatment strategy is to perform maintenance chemotherapy with S-1 in patients with locally advanced esophageal cancer receiving dCCRT.\n\nThe aim of this study is to evaluate the efficacy and side effects of patients with locally advanced unresectable esophageal cancer after dCCRT with platinum-based chemotherapy follow maintenance therapy with S-1.\n\nThe primary endpoint is overall survival (OS) rates at 24 months, defined as the proportion of patients who have not experienced death from any cause at months. With a sample size of 60 patients, the study had a power of 80%, assuming 2-year OS of 45% in the experimental arm and 30% in the historical control, with a one-sided significance level of 5%.",[47],"Locally Advanced Unresectable Esophageal Cancer",[49,50,51],"consolidative chemotherapy","esophageal squamous cell carcinoma","S1","NOT_YET_RECRUITING","2024-09-12",{"date":55,"type":56},"2024-09-19","ACTUAL",{"date":58,"type":41},"2024-10-01",{"date":60,"type":41},"2028-10-30",{"name":5,"class":6}]