[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635453":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":37,"eligibilityCriteria":38,"healthyVolunteers":33,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":20,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":53,"overallStatus":59,"whyStopped":20,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":20},{"fullName":5,"class":6},"Jiangxi Provincial Cancer Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Endoscopic Pseudomembrane Removal","EXPERIMENTAL","Participants with recurrent nasopharyngeal carcinoma who develop pseudomembrane reaction during or after re-irradiation will receive endoscopic nasopharyngeal pseudomembrane removal.",[13],"Procedure: Endoscopic Nasopharyngeal Pseudomembrane Removal",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Endoscopic Nasopharyngeal Pseudomembrane Removal","Endoscopic visualization of nasopharynx, identification of pseudomembrane, and complete removal using endoscopic instruments.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Ziwei Tu","CONTACT","13755793552","tuziwei198803@163.com",{"type":28,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Shiyi Peng","Chief Physician, Department of Radiation Oncology","100635453","pseudomembrane-removal-for-post-rt-nasopharyngeal-necrosis-100635453",false,"NCT07552883","Pseudomembrane Removal for Post-RT Nasopharyngeal Necrosis","Endoscopic Nasopharyngeal Pseudomembrane Removal for Prevention of Radiation-Induced Nasopharyngeal Necrosis After Re-irradiation in Recurrent Nasopharyngeal Carcinoma: A Single-Arm, Multicenter Interventional Study","EPoRN","Inclusion Criteria:\n\n* Voluntarily sign the informed consent form.\n* Age between 18 and 80 years.\n* ECOG performance status ≤ 2.\n* Prior radical radiotherapy with total dose ≥ 66 Gy.\n* Imaging or histopathology confirmed local recurrence and\u002For retropharyngeal lymph node recurrence, with or without cervical lymph node recurrence.\n* Re-irradiation with single dose \\\u003C 2.3 Gy and total dose ≥ 50 Gy.\n* Presence of pseudomembrane reaction on nasopharyngeal mucosa during or after re-irradiation.\n* Expected survival \\> 1 year.\n* Induction chemotherapy, immunotherapy, concurrent chemotherapy, adjuvant chemotherapy, or radiotherapy alone are all permitted.\n\nExclusion Criteria:\n\n* History of other malignancies within the past 5 years, except cured non-melanoma skin cancer or carcinoma in situ of the cervix.\n* Severe uncontrolled systemic diseases (e.g., uncontrolled infection, severe cardiovascular disease, uncontrolled diabetes).\n* Pregnant or breastfeeding women.\n* Known allergy to any equipment or medication used during endoscopy.\n* Inability to tolerate endoscopic procedure due to anatomical or medical reasons.\n* Concurrent participation in another interventional clinical trial.\n* Any condition that, in the investigator's judgment, would interfere with study compliance or outcome assessment.","ALL","18 Years","80 Years",{"count":43,"type":44},40,"ESTIMATED","INTERVENTIONAL",[47],"NA","This study aims to evaluate the effectiveness and safety of endoscopic nasopharyngeal pseudomembrane removal in reducing radiation-induced nasopharyngeal necrosis in patients with recurrent nasopharyngeal carcinoma who have received re-irradiation. This is a prospective, single-arm, multicenter interventional study. Participants with recurrent nasopharyngeal carcinoma who develop pseudomembrane reaction during or after re-irradiation will receive endoscopic pseudomembrane removal. Based on published literature, the 2-year incidence of radiation-induced nasopharyngeal necrosis after re-irradiation is approximately 40%. This study expects to reduce the incidence to 20%. The primary outcome measure is the 2-year incidence of nasopharyngeal necrosis after re-irradiation. Secondary outcome measures include: necrosis-free survival, overall survival, progression-free survival, local regional recurrence-free survival, distant metastasis-free survival, as well as safety and adverse events. A total of 40 participants will be enrolled from multiple hospitals in China.",[50,51,52],"Nasopharyngeal Carcinoma (NPC)","Radiation Injuries","Necrosis",[54,55,56,57,58],"recurrent NPC","re-RT","radiation necrosis","pseudomembrane","endoscopy","NOT_YET_RECRUITING","2026-04-20",{"date":62,"type":63},"2026-04-27","ACTUAL",{"date":65,"type":44},"2026-04-30",{"date":67,"type":44},"2031-04-30",{"name":5,"class":6}]