[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100379049":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":47,"responsibleParty":98,"collaborators":101,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":26,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":26,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":129,"whyStopped":26,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Eye & ENT Hospital of Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"endonasal endoscopic surgery group","EXPERIMENTAL","143 participants in group 1 will undergo endoscopic surgery",[13],"Procedure: endonasal endoscopic surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"radiation therapy group","ACTIVE_COMPARATOR","143 participants in group 2 will undergo radiation therapy(IMRT)",[19],"Radiation: radiation therapy(IMRT)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","endonasal endoscopic surgery","143 patients will undergo endonasal endoscopic surgery",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"RADIATION","radiation therapy(IMRT)","143 patients will undergo radiation therapy.",[15],[33],{"name":34,"affiliation":35,"role":36},"Hongmeng Yu, MD","Eye&ENT Hospital,Fudan University","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"Xiaole Song, MD","CONTACT","+86 15821388769","jxfxsxl@163.com",{"name":44,"role":40,"phone":45,"phoneExt":26,"email":46},"Zhihui Pang","+86 18818211894","pangzhihui1229@126.com",[48,67,81],{"facility":49,"status":26,"city":50,"state":51,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Fujian Medical University Union Hospital","Fuzhou","Fujian","China","CN",{"type":55,"coordinates":56},"Point",[57,58],119.30611,26.06139,{"lat":58,"lon":57},[61,63,65],{"name":62,"role":40,"phone":26,"phoneExt":26,"email":26},"Desheng Wang, MD",{"name":64,"role":40,"phone":26,"phoneExt":26,"email":26},"Haichun Lai, MD",{"name":66,"role":36,"phone":26,"phoneExt":26,"email":26},"Desheng Wang",{"facility":68,"status":26,"city":69,"state":70,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"The First Affiliated Hospital of Nanchang University","Nanchang","Jiangxi",{"type":55,"coordinates":72},[73,74],115.85306,28.68396,{"lat":74,"lon":73},[77,79],{"name":78,"role":40,"phone":26,"phoneExt":26,"email":26},"Jing Ye, MD",{"name":80,"role":36,"phone":26,"phoneExt":26,"email":26},"Jing Ye",{"facility":82,"status":26,"city":83,"state":84,"zip":85,"country":52,"countryCode":53,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Fudan University Shanghai cancer center","Shanghai","Shanghai Municipality","200000",{"type":55,"coordinates":87},[88,89],121.45806,31.22222,{"lat":89,"lon":88},[92,94,96],{"name":93,"role":40,"phone":26,"phoneExt":26,"email":26},"Lin Kong, MD",{"name":95,"role":40,"phone":26,"phoneExt":26,"email":26},"Jiyi Hu, MD",{"name":97,"role":36,"phone":26,"phoneExt":26,"email":26},"Lin Kong",{"type":36,"investigatorFullName":99,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Hongmeng Yu","MD,PhD",[102,104],{"name":103,"class":6},"Chinese Academy of Medical Sciences",{"name":105,"class":106},"Shanghai Municipal Science and Technology Commission","OTHER_GOV","100379049","phase-3-early-recurrent-nasopharyngeal-cancer-the-effect-of-surgery-vs-imrt-100379049",false,"NCT04215510","Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT","A Multicenter Randomized Controlled Trial for Comparing Endonasal Surgery and Radiation Therapy (IMRT) for T1-T2 Recurrent Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n1. Diagnosed of recurrent nasopharyngeal carcinoma by pathology or imaging study;\n2. Stage T1 or T2 according to AJCC 8th edition ;\n3. Aged 18 to 70 years;\n4. Without metastasis;\n5. previously received 1 course of radiotherapy;\n6. Without radiotherapy within 1 year, without local treatment for recurrent disease;\n7. Surgical resectable and IMRT suitable;\n8. If regional recurrence presented, regional lesion can be treated with local treatments.\n9. ECOG score 0 or 1;\n10. Sufficient organ function;\n11. Acceptable approach of contraception.\n\nExclusion Criteria:\n\n1. Refuse to sign inform consent;\n2. Radiation encephalopathy or leptomeningeal disease (LMD);\n3. History of radioactive particle planting;\n4. Have uncontrolled intercurrent illnesses which will interfere with the ability to undergo therapy;\n5. With prior malignancy (excluding adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer );\n6. Any contradiction to surgery;\n7. Have any co-existing condition that would preclude full compliance or safety with the study;\n8. Presence of a significant neurological or psychiatric disease, including dementia and seizures;\n9. Uncontrolled infectious diseases;\n10. Female patients who are at pregnancy or lactation.\n11. Without personal freedom or independent civil capacity.\n12. With serious autoimmune disease.\n13. Participants of other interventional clinical trial.","ALL","18 Years","70 Years",{"count":118,"type":119},286,"ESTIMATED","INTERVENTIONAL",[122],"PHASE3","This study is a multicenter RCT to compare 3-year overall survival(OS) rate, progression free survival(PFS),local progression free survival(LPFS),regional progression free survival(RPFS),distant metastasis free survival(DMFS), and toxicities of endonasal endoscopic surgery versus IMRT.",[125],"Recurrent Nasopharyngeal Carcinoma",[23,127,128],"radiation therapy","nasopharyngeal carcinoma","NOT_YET_RECRUITING","2021-02-20",{"date":132,"type":133},"2021-02-23","ACTUAL",{"date":135,"type":119},"2021-03-01",{"date":137,"type":119},"2027-03-01",{"name":5,"class":6},3]