[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602610":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":124,"collaborators":18,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":18,"eligibilityCriteria":133,"healthyVolunteers":129,"sex":134,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":18,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"2 courses of cisplatin chemoradiotherapy arm","EXPERIMENTAL","Patients will receive intensity modulated radiotherapy (total dose: \\> 66 Gy, split dose: 2-2.2 Gy\u002F time, once a day, 5 times a week) plus concurrent Cisplatin chemotherapy (100 mg\u002Fm2 intravenous injection,once every 3 weeks, twice in total, on days 1 and 22).",[13],"Drug: Cisplatin",{"label":15,"type":16,"description":17,"interventionNames":18},"Postoperative adjuvant radiotherapy alone","NO_INTERVENTION","Patients will receive intensity modulated radiotherapy (total dose: \\> 66 Gy, split dose: 2-2.2 Gy\u002F time, once a day, 5 times a week)",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Cisplatin","Concurrent Cisplatin chemotherapy (100 mg\u002Fm2 intravenous injection,once every 3 weeks, twice in total, on days 1 and 22) will be given plus intensity modulated radiotherapy",[9],[26],{"name":27,"affiliation":5,"role":28},"Lei Chen Principal Investigator, M.D","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Lei Chen, M.D","CONTACT","+862013570051477","chenlei@sysucc.org.cn",[36,53,62,75,89,102,111],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","523000","China","CN",{"type":45,"coordinates":46},"Point",[47,48],113.25,23.11667,{"lat":48,"lon":47},[51],{"name":31,"role":32,"phone":52,"phoneExt":18,"email":34},"+86-20-87343096",{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":54,"geoPoint":56,"contacts":57},{"type":45,"coordinates":55},[47,48],{"lat":48,"lon":47},[58],{"name":59,"role":32,"phone":60,"phoneExt":18,"email":61},"ling Ye, M.D","+8618666080933","32600972@qq.com",{"facility":63,"status":38,"city":64,"state":65,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Affiliated Hospital of Guilin Medical College","Guilin","Guangxi",{"type":45,"coordinates":67},[68,69],110.29639,25.28022,{"lat":69,"lon":68},[72],{"name":73,"role":32,"phone":74,"phoneExt":18,"email":18},"Wei Jiang, M.D","+8677313788561863",{"facility":76,"status":38,"city":77,"state":78,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Hainan General Hospital","Sanya","Hainan",{"type":45,"coordinates":80},[81,82],109.50947,18.25435,{"lat":82,"lon":81},[85],{"name":86,"role":32,"phone":87,"phoneExt":18,"email":88},"Shiping Yang, M.D","+86 18976460313","shipingyang1982@163.com",{"facility":90,"status":38,"city":91,"state":92,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Hunan Cancer Hospital","Changsha","Hunan",{"type":45,"coordinates":94},[95,96],112.97087,28.19874,{"lat":96,"lon":95},[99],{"name":100,"role":32,"phone":101,"phoneExt":18,"email":18},"Bei Yang, M.D","+8673113507403512",{"facility":103,"status":38,"city":91,"state":92,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":104,"geoPoint":106,"contacts":107},"Xiangya Hospital, Central South University",{"type":45,"coordinates":105},[95,96],{"lat":96,"lon":95},[108],{"name":109,"role":32,"phone":110,"phoneExt":18,"email":18},"Haijun Wu, M.D","+8673113975110101",{"facility":112,"status":38,"city":113,"state":114,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Jiangsu Cancer Hospital","Nanjing","Jiangsu",{"type":45,"coordinates":116},[117,118],118.77778,32.06167,{"lat":118,"lon":117},[121],{"name":122,"role":32,"phone":123,"phoneExt":18,"email":18},"Lirong Wu, M.D","+862513701588737",{"type":28,"investigatorFullName":125,"investigatorTitle":126,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Lei Chen","Clinical Professor","100602610","phase-3-comparing-postoperative-adjuvant-cisplatin-concurrent-chemoradiotherapy-with-adjuvant-radiotherapy-alone-for-intermediate-risk-head-and-neck-squamous-cell-carcinoma-100602610",false,"NCT07125755","Comparing Postoperative Adjuvant Cisplatin Concurrent Chemoradiotherapy With Adjuvant Radiotherapy Alone for Intermediate-risk Head and Neck Squamous Cell Carcinoma","A Prospective, Multicenter, Randomized Controlled Phase 3 Clinical Trial Comparing Postoperative Adjuvant Cisplatin Concurrent Chemoradiotherapy With Adjuvant Radiotherapy Alone for Intermediate-risk Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\nA. The pathological type is head and neck squamous cell carcinoma\n\n* Stages\n\nB. Radical surgery has been performed, and there are intermediary-risk factors (pT3\u002FpT4, pN2\u002FpN3, positive lymph nodes in the cervical IV\u002FV region of oral cancer, nerve invasion, and vascular invasion).\n\nC. No evidence of distant metastasis (M0).\n\nD. Functional status: Karnofsky scale (KPS) \\> 70.\n\nE. Normal bone marrow function:\n\n* white blood cell count \\> 4×109\u002FL\n* hemoglobin \\> 120g\u002FL in males, 110g\u002FL in females\n* platelet count \\> 100×109\u002FL\n\nG. Normal liver function:\n\n* alanine aminotransferase (ALT), aspartate aminotransferase (AST) \\\u003C 1.5 times the upper limit of normal (ULN)\n* alkaline phosphatase (ALP) \\\u003C 2.5×ULN\n* bilirubin \\\u003C ULN.\n\nH. Normal renal function: creatinine clearance \\> 60 ml\u002Fmin.\n\nI. Patients must be informed of the basic contents of this study and sign informed consent.\n\nExclusion Criteria:\n\nA. Age \\>70 years or \\\u003C18 years.\n\nB. Treatment is palliative.\n\nC. Previous chemotherapy (except induction chemotherapy prior to surgery).\n\nD. Previous radiation therapy.\n\nE. Women who are pregnant or breastfeeding\n\nF. Previous history of malignant tumor.\n\nG. With other serious medical conditions that may pose a greater risk or affect compliance with the test. Examples include:\n\n* unstable heart disease that requires treatment\n* kidney disease\n* chronic hepatitis\n* poorly controlled diabetes (fasting blood glucose \\> 1.5×ULN)\n* mental illness.","ALL","18 Years","70 Years",{"count":138,"type":139},386,"ESTIMATED","INTERVENTIONAL",[142],"PHASE3","The main objective of this trial was to determine the value of concurrent chemoradiotherapy for Intermediate-risk head and neck squamous cell carcinoma",[145],"Squamous Cell Cancer of Head and Neck (SCCHN)",[147,22,148],"Concurrent chemoradiotherapy","postoperative head and neck squamous cell carcinoma","2026-03-20",{"date":151,"type":152},"2026-03-23","ACTUAL",{"date":154,"type":152},"2025-08-15",{"date":156,"type":139},"2031-08-15",{"name":5,"class":6},7]