[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477225":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":48,"centralContacts":53,"locations":59,"responsibleParty":106,"collaborators":109,"id":115,"slug":29,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":29,"eligibilityCriteria":120,"healthyVolunteers":116,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":29,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":93,"whyStopped":29,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Eye & ENT Hospital of Fudan University","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Induction chemotherapy group","EXPERIMENTAL","Patients initially receive induction chemotherapy consisting of docetaxel, cisplatin and capecitabine (TPC), q3w, 2-3 cycles in total.\n\nPatients with regional response of complete reaction (CR)\u002Fpartial reaction (PR)≥50% after induction chemotherapy then receive concomitant chemoradiotherapy for both the primary and regional sites.\n\nPatients with regional response of PR\\\u003C50%\u002Fstable disease (SD)\u002Fprogressive disease (PD) after induction chemotherapy then receive surgery for both the primary and regional sites and postoperative concomitant chemoradiotherapy.",[13,14,15,16,17],"Drug: Docetaxel","Drug: Cisplatin","Drug: Capecitabine","Radiation: Concomitant chemoradiotherapy","Procedure: Surgery",{"label":19,"type":20,"description":21,"interventionNames":22},"Surgery group","ACTIVE_COMPARATOR","Patients initially receive surgery for both the primary and regional sites and postoperative concomitant chemoradiotherapy.",[16,17],[24,30,34,38,43],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Docetaxel","60 mg\u002Fm2 i.v. day 1",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Cisplatin","60 mg\u002Fm2 i.v. day 1-3",[9],{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Capecitabine","750 mg\u002Fm2 po bid day 1-14",[9],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":29},"RADIATION","Concomitant chemoradiotherapy","Radiotherapy: using intensity-modulated radiation therapy (IMRT)\n\nGross tumor volume (GTV) for primary tumor: 66-70 Gy in total, 2.0\\~2.2 Gy per day, 5 days per week\n\nClinical target volume (CTV) for lesions closely related to the primary lesion and metastatic lymph nodes: 65\\~70 Gy in total, 1.7\\~2.0 Gy per day, 5 days per week\n\nProphylactic irradiation for sites of suspected subclinical spread: 50\\~60 Gy in total, 1.7\\~2.0 Gy per day, 5 days per week\n\nConcurrent chemotherapy: cisplatin 80 mg\u002Fm2 on days 1-3 every 3 weeks.",[9,19],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":29},"PROCEDURE","Surgery","Neck dissection and primary tumor resection",[9,19],[49],{"name":50,"affiliation":51,"role":52},"Ming Zhang, PhD","Eye & ENT Hospital, Fudan University","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":29,"email":58},"Feiran Li","CONTACT","8664377134","lifr214@163.com",[60,78,92],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Harbin Medical University Cancer Hospital","NOT_YET_RECRUITING","Harbin","Heilongjiang","150000","China","CN",{"type":69,"coordinates":70},"Point",[71,72],126.65,45.75,{"lat":72,"lon":71},[75],{"name":76,"role":56,"phone":29,"phoneExt":29,"email":77},"Susheng Miao, PhD","38898546@qq.com",{"facility":79,"status":62,"city":80,"state":81,"zip":82,"country":66,"countryCode":67,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Shandong Provincial ENT Hospital, Cheeloo College of Medicine, Shandong University","Jinan","Shandong","250012",{"type":69,"coordinates":84},[85,86],116.99722,36.66833,{"lat":86,"lon":85},[89],{"name":90,"role":56,"phone":29,"phoneExt":29,"email":91},"Zhenghua Lv, PhD","entlvzhenghua@163.com",{"facility":51,"status":93,"city":94,"state":95,"zip":96,"country":66,"countryCode":67,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"RECRUITING","Shanghai","Shanghai Municipality","200031",{"type":69,"coordinates":98},[99,100],121.45806,31.22222,{"lat":100,"lon":99},[103],{"name":50,"role":56,"phone":104,"phoneExt":29,"email":105},"8621-64377151","ent_zhm@126.com",{"type":52,"investigatorFullName":107,"investigatorTitle":108,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Ming Zhang","Principal Investigator",[110,113],{"name":111,"class":112},"Shandong Provincial Hospital","OTHER_GOV",{"name":114,"class":6},"Harbin Medical University Third Affiliated Hospital","100477225",false,"NCT05494190","The Management of Metastatic Neck Nodes in N2\u002F3 Hypopharyngeal Squamous Cell Carcinoma","The Management of Metastatic Neck Nodes in N2\u002F3 Hypopharyngeal Squamous Cell Carcinoma: A Multi-center Randomized Controlled Prospective Study","Inclusion Criteria:\n\n1. Able to understand and willing to sign a written informed consent document.\n2. Age ≥ 18 and ≤ 75 years.\n3. Male or female.\n4. Karnofsky physical status (KPS): ≥ 80\n5. Hepatic function, renal function and normal blood test. Hepatic function: Alanine aminotransferase (ALT) ≤ 2.5 upper limit of normal, Aspartate aminotransferase (AST) ≤ 2.5 upper limit of normal. Serum total bilirubin ≤ 1.5 upper limit of normal. Kidney function: Serum creatinine \\\u003C upper limit of normal value and creatinine clearance rate \\> 60 ml\u002F(min\\*1.73m2) (Cockcroft-Gault formula). Blood test: neutrophil (Neu) ≥ 1.5×109\u002FL, platelet (PLT) ≥ 100×109\u002FL, hemoglobin (HGB) ≥ 90 g\u002FL.\n6. Pathologically diagnosed with squamous cell carcinoma of the hypopharynx.\n7. After clinical and radiographic evaluations, clinically classified as T1\u002F2 N2\u002F3 M0 stage according to American Joint Committee on Cancer (AJCC, eighth edition).\n8. Resectable regional metastatic lesion (incompletely tumor- wrapped carotid vascular).\n9. Assessable tumor lesions according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1).\n10. Radical treatment intent.\n11. Male patients with fertility and female patients with fertility and pregnancy risk must agree to use contraceptive methods throughout the study period, and continued until at least 6 months after the last dose of cisplatin. Female patients who do not have fertility (ie meet at least one of the following criteria): Have undergone hysterectomy and\u002For bilateral oophorectomy with archival records, medically confirmed ovarian function decline; In postmenopausal state. It is defined as: At least 12 months of continuous menstruation without other pathological or physiological reasons, and the status confirmed by serum follicle stimulating hormone (FSH) levels is consistent with postmenopausal status.\n12. Good compliance.\n\nExclusion Criteria:\n\n1. Distant metastatic disease\n2. Have a history of other cancers or coinstantaneous second primary tumor\n3. Previous treatment for the primary tumor, including radiotherapy, surgery except biopsy operation, chemotherapy, immunotherapy and biological targeted therapy.\n4. Patients who have participated in other clinical trials within 1 month before the test.\n5. Patients estimated to have poor tolerance to induction chemotherapy.\n6. The investigator believes that it is inappropriate for individuals to participate in the trial: having, for example, severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental illness (including recent time \\[within the past year\\] or active suicidal ideation or behavior).\n7. Palliative treatment intent.\n8. Pregnant or lactating women.","ALL","18 Years","75 Years",{"count":125,"type":126},111,"ESTIMATED","INTERVENTIONAL",[129],"NA","This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.",[132],"Hypopharyngeal Carcinoma",[134,135,136],"Metastatic Neck Nodes","Induction Chemotherapy","Neck Dissection","2025-12-22",{"date":139,"type":140},"2025-12-30","ACTUAL",{"date":142,"type":140},"2022-11-01",{"date":144,"type":126},"2027-11",{"name":5,"class":6},3]