[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556780":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":68,"collaborators":71,"id":86,"slug":43,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":43,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":43,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":52,"whyStopped":43,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"surgery plus target reduction Chemoradiotherapy","ACTIVE_COMPARATOR","Surgery:\n\nEndoscopic Nasopharyngectomy:Radical Reaction of the Primary Lesion Using Nasal Endoscopy.\n\nRetropharyngeal lymphadenectomy: Radical retropharyngeal LNs reaction using nasal endoscopy.\n\nNeck lymph node dissection Selection of region where the possitive lymph nodes are located.\n\nIntensity modulated radiotherapy with GTV and CTV1 Reduction:\n\nCTV2:50.00Gy\u002F25Fr\u002F2.00Gy. Chemotherapy: cisplatin-based regimens.",[13],"Radiation: Surgery combined with Target-reduction intensity-modulated radiotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"surgery plus dose reduction Chemoradiotherapy","EXPERIMENTAL","Surgery:\n\nEndoscopic Nasopharyngectomy: Radical Reaction of the Primary Lesion Using Nasal Endoscopy.\n\nRetropharyngeal lymphadenectomy: Radical retropharyngeal LNs reaction using nasal endoscopy.\n\nNeck lymph node dissection Selection of region where the possitive lymph nodes are located.\n\nIntensity modulated radiotherapy with CTV1 and CTV2 dose Reduction:\n\nCTV1：48.00-50.00Gy\u002F20Fr\u002F2.40-2.50Gy； CTV2：40.00Gy\u002F20Fr\u002F2.00Gy. Chemotherapy: cisplatin-based regimens.",[19],"Radiation: Surgery combined with Dose-reduction intensity-modulated radiotherapy",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Surgery combined with Target-reduction intensity-modulated radiotherapy","in control arm",[9],[27],"Target-reduction intensity-modulated radiotherapy",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Surgery combined with Dose-reduction intensity-modulated radiotherapy","in experimental arm",[15],[33],"Dose-reduction intensity-modulated radiotherapy",[35],{"name":36,"affiliation":37,"role":38},"Ming-Yuan Chen, MD,PhD","SUN yet-sen University","PRINCIPAL_INVESTIGATOR",[40,45],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","86-13903052650",null,"chmingy@email.sysu.edu.cn",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"You-Ping Liu, PhD","86-137517763276","liuyp78@email.sysu.edu.cn",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"The Fifth Affiliated Hospital of Sun Yat-sen University","RECRUITING","Zhuhai","Guangdong","519000","China","CN",{"type":59,"coordinates":60},"Point",[61,62],113.56778,22.27694,{"lat":62,"lon":61},[65],{"name":66,"role":41,"phone":67,"phoneExt":43,"email":44},"Ming-Yuan Chen","+8613903052650",{"type":69,"investigatorFullName":66,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"SPONSOR_INVESTIGATOR","Professior",[72,74,75,77,79,81,83],{"name":73,"class":6},"Fifth Affiliated Hospital, Sun Yat-Sen University",{"name":5,"class":6},{"name":76,"class":6},"Fifth Affiliated Hospital of Guangzhou Medical University",{"name":78,"class":6},"Huazhong University of Science and Technology Union Shenzhen Hospital",{"name":80,"class":6},"The First Affiliated Hospital of University of South China",{"name":82,"class":6},"People's Hospital of Guangxi Zhuang Autonomous Region",{"name":84,"class":85},"Nanchang City First Hospital","UNKNOWN","100556780",false,"NCT06529562","Surgery Plus Reduced Target Chemoradiotherapy vs Surgery Plus Reduced Dose Chemoradiotherapy for Newly Diagnosed Operable Nasopharyngeal Carcinoma.","Surgery Plus Reduced Target Chemoradiotherapy Versus Surgery Plus Reduced Dose Chemoradiotherapy for Newly Diagnosed Operable Nasopharyngeal Carcinoma : a Prospective, Multicenter, Radomized Control Trial","Inclusion Criteria:\n\n* Performance Status Score 0-1 points.\n* Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) confirmed histologically and\u002For cytologically.\n* Patients with primary nasopharyngeal lesions evaluated as surgically resectable, including T1 (tumor limited to nasopharynx), T2 (tumor limited to the surface of parapharyngeal space) and T3 (tumor limited to the bottom wall of sphenoid sinus) and tumor diameter ≤1.5cm. Resectable retropharyngeal lymph nodes were defined as; The diameter was ≤ 1.5cm, the tissue space was intact, and there was no obvious extranodal invasion; The resectable cervical lymph nodes were defined as ≤ 3cm in diameter, located above the lower edge of the cricoid cartilage, with moderate mobility and no obvious extranodal invasion. Clinical stage: T1-3N1-2M0, T2-3N0M0 (Stage II-III) according to AJCC 8th staging edition.\n* Adequate organ function: WBC ≥ 4×10\\^9 \u002FL, NEUT ≥ 2×10\\^6 \u002FL, HGB ≥ 9 g\u002FdL, PLT count ≥ 100×10\\^9\u002FL, TBIL ≤1.5 ULN (TBIL ≤3 ULN for patients with Gilbert Disease), ALT ≤3 ULN, AST ≤3 ULN, ALP ≤3 ULN, ALB ≥ 3 g\u002FdL, INR or APTT≤1.5 ULN, Scr ≤1.5 ULN or Ccr ≥ 60 mL\u002Fmin.\n* Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol.\n\nExclusion Criteria:\n\n* Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy.\n* Suffering severe organ dysfunction or physical disorder which could not tolerate surgery or radiotherapy or chemotherapy.\n* Retropharyngeal lymph node diameter\\>1.5cm, or extranodal invasion, such as invasion of internal carotid artery, muscle, or extensive extracapsular dissemination.\n* Cervical lymph node diameter\\>3cm, or in the area below the lower margin of the cricoid cartilage, or with extranodal invasion, such as invasion of the internal carotid artery, skin, muscle, mediastinal structure, prevertebral fascia or cervical spine, or extensive extra-capsular spread, subcutaneous metastasis, etc.\n* Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.\n* During pregnancy or lactation.\n* Other patients that the chief physician considered as illegal for this trial.","ALL","18 Years","70 Years",{"count":96,"type":97},384,"ESTIMATED","INTERVENTIONAL",[100],"NA","The goal of this clinical trial is to compare surgery plus reduced target chemoradiotherapy with surgery plus reduced dose chemoradiotherapy in newly diagnosed operable Nasopharyngeal Carcinoma.The main questions it aims to answer are:whether endoscopic surgery combined with reduced dose chemoradiotherapy vs surgery plus target reduction chemoradiotherapy can bring substantial survival benefits, lower toxicity, and shorter treatment cycle for patients with operable nasopharyngeal carcinoma .",[103],"Nasopharyngeal Carcinoma",[105,106,107,108],"Surgery","Target-Reduction Chemoradiotherapy","Dose-Reduction Chemoradiotherapy","Locally Resectable Nasopharyngeal Carcinoma","2024-07-30",{"date":111,"type":112},"2024-07-31","ACTUAL",{"date":114,"type":112},"2022-11-01",{"date":116,"type":97},"2032-11-01",{"name":66,"class":6},1]