[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556924":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":40,"studyPopulation":32,"armGroups":41,"interventions":48,"overallOfficials":32,"centralContacts":54,"locations":65,"responsibleParty":82,"collaborators":32,"id":84,"slug":32,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":32,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":32,"studyType":96,"phases":97,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":68,"whyStopped":32,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"National Cheng-Kung University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":32},[9,13],{"measure":10,"description":11,"timeFrame":12},"Overall response rate of the treatment","Overall response rate = complete response (CR) rate + partial response (PR) rate.","At week 8, week 16, and 4 weeks after completion of concurrent chemoradiotherapy (CCRT).",{"measure":14,"description":15,"timeFrame":16},"Duration of response (DOR)","Defined as the time from CR or PR to the time of disease progression or death.","At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.",[18,22,26,29],{"measure":19,"description":20,"timeFrame":21},"Esophageal perforation rate","Detected by bronchoscopy or CT scan.","At week 8, week 16, and 4 weeks after completion of CCRT. And at anytime when participants suffer from symptoms in suspicious of esophageal perforation, eg. chest pain, hemoptysis, and fever.",{"measure":23,"description":24,"timeFrame":25},"Adverse events of treatment","Any adverse events of chemotherapy or CCRT.","During treatment (up to 24 weeks)",{"measure":27,"description":28,"timeFrame":16},"Progression-free survival","Defined as the time from diagnosis to the time of disease progression or death.",{"measure":30,"description":31,"timeFrame":16},"Overall survival time","Defined as the time from diagnosis to the time of death.",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":32,"timePerspective":32,"maskingInfo":38},"NA","SINGLE_GROUP","All participants will receive an induction chemotherapy regimen consisting of 4-8 cycles of docetaxel, cisplatin, and fluorouracil. It is followed by concurrent chemoradiotherapy if down-stage had been achieved by induction chemotherapy.","TREATMENT",{"masking":39,"maskingDescription":32,"whoMasked":32},"NONE","The treatment of T4-stage esophageal cancer is challenging because of a high esophageal perforation rate (19%) after concurrent chemoradiotherapy. This research aims to investigate whether a novel sequential chemoradiotherapy approach can improve the treatment response rate and reduce the incidence of esophageal perforation in participants with T4-stage esophageal cancer. The proposed novel treatment strategy involves induction chemotherapy for 4 to 8 cycles. It is followed by concurrent chemoradiotherapy if down-stage had been achieved by induction chemotherapy. The study will be conducted in two phases, starting with a phase I study to determine safety, followed by a phase II study to evaluate overall efficacy. Expected outcomes include improved treatment response rates and reduced esophageal perforation rates in T4-stage esophageal cancer, offering a better treatment option for these patients.",[42],{"label":43,"type":44,"description":45,"interventionNames":46},"Induction chemotherapy followed by chemoradiotherapy","EXPERIMENTAL","This is a single-arm study. All patients will be assigned to receive Induction chemotherapy followed by concurrent chemoradiotherapy.",[47],"Combination Product: \"Docetaxel\", \"Cisplatin\", \"fluorouracil\", \"Radiation\"",[49],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":32},"COMBINATION_PRODUCT","\"Docetaxel\", \"Cisplatin\", \"fluorouracil\", \"Radiation\"","Induction chemotherapy with Docetaxel, Cisplatin, and fluorouracil for 4 to 8 cycles, followed by concurrent chemoradiotherapy with Cisplatin and Radiation 30.6-40 Gy.",[43],[55,61],{"name":56,"role":57,"phone":58,"phoneExt":59,"email":60},"Wei-Lun Chang, PhD","CONTACT","+886-6-2353535","4859","weilun1@mail.ncku.edu.tw",{"name":62,"role":57,"phone":58,"phoneExt":63,"email":64},"Ching-Lin Wu, Master","3458","n027174@mail.hosp.ncku.edu.tw",[66],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":70,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"National Cheng Kung University Hospital","RECRUITING","Tainan","Taiwan","704302","TW",{"type":74,"coordinates":75},"Point",[76,77],120.21333,22.99083,{"lat":77,"lon":76},[80,81],{"name":56,"role":57,"phone":58,"phoneExt":59,"email":60},{"name":62,"role":57,"phone":58,"phoneExt":63,"email":64},{"type":83,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100556924",false,"NCT06531434","Establishing Best Treatment Strategy for T4 Esophageal Cancer","A Pilot Study to Establish Best Treatment Strategy for T4 Esophageal Cancer","Inclusion Criteria:\n\n1. Histologically confirmed esophageal squamous cell carcinoma\n2. Tumor or lymph nodes invade adjacent organs (T4 stage)\n3. Aged between 18-70 years old\n4. Patient health status score Eastern Cooperative Oncology Group (ECOG) performance status (PS) \\\u003C2\n5. Hemoglobin ≥ 10 g\u002FL, absolute neutrophil count ≥ 2×10\\^3\u002FL, platelet count ≥ 100×10\\^9\u002FL, total bilirubin ≤ 1.5 mg\u002FL, serum transaminases ≤ 105 U\u002FL, creatinine clearance ≥ 40 mL\u002Fmin.\n\nExclusion Criteria:\n\n1. Previous chemotherapy history\n2. Myocardial infarction within the last three months\n3. History of unstable angina, interstitial pneumonia, fibrotic lung disease, or severe emphysema\n4. Has other malignancies currently\n5. Uncontrolled infection\n6. Pregnancy or lactation\n7. Perforated esophagus at the time of diagnosis","ALL","18 Years","70 Years",{"count":94,"type":95},22,"ESTIMATED","INTERVENTIONAL",[98,99],"PHASE1","PHASE2","The goal of this clinical trial is to investigate the safety and efficacy of a new treatment approach for T4-stage esophageal cancer, which involves chemoradiotherapy after induction chemotherapy. The main questions it aims to answer are:\n\n* Does the new induction chemotherapy followed by chemoradiation reduce esophageal perforation rate?\n* Does the new induction chemotherapy followed by chemoradiation increase treatment response rate and patient survival? Researchers will analyze the above data to see if the new treatment approach works to treat T4 esophageal cancer.\n\nParticipants will:\n\n* Receive induction chemotherapy for 4 to 8 cycles, followed by chemoradiation therapy if downstage to T3\n* Visit the clinic once every week for checkups and tests\n* Keep a diary of their symptoms",[102],"Esophageal Cancer TNM Staging Primary Tumor (T) T4",[104,105],"T4 esophageal cancer","Induction chemotherapy","2025-09-16",{"date":108,"type":109},"2025-09-22","ACTUAL",{"date":111,"type":109},"2024-08-01",{"date":113,"type":95},"2026-04-30",{"name":5,"class":6},1]