[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100396071":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":40,"studyPopulation":33,"armGroups":41,"interventions":57,"overallOfficials":90,"centralContacts":94,"locations":103,"responsibleParty":123,"collaborators":33,"id":126,"slug":33,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":33,"eligibilityCriteria":131,"healthyVolunteers":127,"sex":132,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":33,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":106,"whyStopped":33,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Affiliated Cancer Hospital & Institute of Guangzhou Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Progress-Free Survival (PFS)","Progress-free survival is calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first.","3 years",[14,17,20,23,26,30],{"measure":15,"description":16,"timeFrame":12},"Overall Survival(OS)","The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.",{"measure":18,"description":19,"timeFrame":12},"Locoregional Relapse-Free Survival(LRRFS)","Relapse-free survival was defined as the time from random assignment to local or regional relapse, or death from any cause.",{"measure":21,"description":22,"timeFrame":12},"Distant metastasis-Free Survival(DMFS)","Distant metastasis-free survival was defined as the time from random assignment to distant metastasis, or death from any cause.",{"measure":24,"description":25,"timeFrame":12},"Quality of life (QoL)","Quality of life (QoL) was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire module for head and neck (EORTC QLQ-H\\&N35). The EORTC QLQ-H\\&N35 scale employs a 4-point response format (\"not at all\" to \"very much\"). Scale scores are transformed to a scale from 0 to 100 according to the EORTC scoring algorithm. For the functioning and the global QoL scale, a higher score indicates better health. For the symptom scales, a higher score indicates a higher level of symptom burden. Either English or Chinese version will be used according to patient's language habits.",{"measure":27,"description":28,"timeFrame":29},"Objective Response Rate (ORR)","Objective Response Rate (ORR) were assessed with nasopharyngeal and neck MRI and flexible nasopharyngoscopy, according to the Response Evaluation Criteria in Solid tumors(version 1.1)","12 weeks after the interventions",{"measure":31,"description":32,"timeFrame":29},"Disease Control Rate (DCR)","Disease Control Rate (DCR) were assessed with nasopharyngeal and neck MRI and flexible nasopharyngoscopy, according to the Response Evaluation Criteria in Solid tumors(version 1.1)",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":33},"NONE","This is a prospective, parallel, randomized, open labeled, phase III, non-inferiority clinical trial to compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma patients in endemic area - nedaplatin, docetaxel and fluorouracil as induction chemotherapy regimen combined with nedaplatin as concurrent chemoradiotherapy (DNF-N) versus cisplatin, docetaxel and fluorouracil as induction chemotherapy regimen combined with cisplatin as concurrent chemoradiotherapy (DPF-P). All patients will receive radical intense modulate radiation therapy (IMRT). The primary endpoint is progress free survival (PFS).",[42,50],{"label":43,"type":44,"description":45,"interventionNames":46},"DNF-N","EXPERIMENTAL","1. Induction chemotherapy:\n\n   three cycles of intravenous docetaxel 60 mg\u002Fm² on day 1, intravenous nedaplatin 60 mg\u002Fm² on day 1, and continuous intravenous fluorouracil 600 mg\u002Fm² per day from day 1 to day 5, every 3 weeks\n2. Concurrent chemoradiotherapy:\n\n   three cycles of 100 mg\u002Fm² nedaplatin every 3 weeks, concurrently with intensity-modulated radiotherapy\n3. Radiotherapy: radical intense modulated radiation therapy",[47,48,49],"Drug: Docetaxel, nedaplatin, fluorouracil","Drug: Nedaplatin","Radiation: Intensity modulated-radiotherapy",{"label":51,"type":52,"description":53,"interventionNames":54},"DPF-P","ACTIVE_COMPARATOR","1. Induction chemotherapy:\n\n   three cycles of intravenous docetaxel 60 mg\u002Fm² on day 1, intravenous cisplatin 60 mg\u002Fm² on day 1, and continuous intravenous fluorouracil 600 mg\u002Fm² per day from day 1 to day 5, every 3 weeks\n2. Concurrent chemoradiotherapy:\n\n   three cycles of 100 mg\u002Fm² cisplatin every 3 weeks, concurrently with intensity-modulated radiotherapy\n3. Radiotherapy: radical intense modulated radiation therapy",[55,56,49],"Drug: Docetaxel, cisplatin, fluorouracil","Drug: Cisplatin",[58,65,71,77,83],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"DRUG","Docetaxel, nedaplatin, fluorouracil","Induction chemotherapy. Docetaxel 60 mg\u002Fm2 intravenous day1. Nedaplatin 60 mg\u002Fm2 intravenous day1. Fluorouracil 3000 mg\u002Fm2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.",[43],[64],"DNF",{"type":59,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"Docetaxel, cisplatin, fluorouracil","Induction chemotherapy. Docetaxel 60 mg\u002Fm2 intravenous day1. Cisplatin 60 mg\u002Fm2 intravenous day1. Fluorouracil 3000 mg\u002Fm2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.",[51],[70],"DPF",{"type":59,"name":72,"description":73,"armGroupLabels":74,"otherNames":75},"Nedaplatin","Concurrent chemotherapy. Nedaplatin 100 mg\u002Fm2 intravenous at day1, 22, 43 of radiotherapy.",[43],[76],"NDP",{"type":59,"name":78,"description":79,"armGroupLabels":80,"otherNames":81},"Cisplatin","Concurrent chemotherapy. Cisplatin 100 mg\u002Fm2 intravenous at day1, 22, 43 of radiotherapy.",[51],[82],"DDP",{"type":84,"name":85,"description":86,"armGroupLabels":87,"otherNames":88},"RADIATION","Intensity modulated-radiotherapy","Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.",[43,51],[89],"IMRT",[91],{"name":92,"affiliation":5,"role":93},"Jinquan Liu, M.D","STUDY_DIRECTOR",[95,99],{"name":92,"role":96,"phone":97,"phoneExt":33,"email":98},"CONTACT","0086-137-1086-6485","609149209@qq.com",{"name":100,"role":96,"phone":101,"phoneExt":33,"email":102},"Bin Qi, M.D","0086-135-8058-0985","qibin020@126.com",[104],{"facility":105,"status":106,"city":107,"state":108,"zip":109,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":117,"contacts":118},"Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical University","RECRUITING","Guangzhou","Guangdong","510095","China","CN",{"type":113,"coordinates":114},"Point",[115,116],113.25,23.11667,{"lat":116,"lon":115},[119,120,121],{"name":92,"role":96,"phone":97,"phoneExt":33,"email":98},{"name":100,"role":96,"phone":101,"phoneExt":33,"email":102},{"name":92,"role":122,"phone":33,"phoneExt":33,"email":33},"PRINCIPAL_INVESTIGATOR",{"type":122,"investigatorFullName":124,"investigatorTitle":125,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Jin-Quan Liu","President of Affiliated Tumor Hospital of Guangzhou Medical University","100396071",false,"NCT04437329","Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma","Nedaplatin Versus Cisplatin in Induction Chemotherapy Combined With Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma：a Prospective, Parallel, Randomized, Open Labeled, Phase III Non-Inferiority Clinical Study","Inclusion Criteria:\n\n1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III\n2. Original clinical staged as III-IVa (except T3-4N0) according to the 8th edition American Joint Committee on Cancer staging system\n3. No evidence of distant metastasis (M0)\n4. Age between 18-65\n5. WBC≥4×10\\^9\u002F l, platelet ≥ 100×10\\^9\u002F l and hemoglobin ≥ 90g\u002Fl\n6. With normal liver function test (TBIL、ALT、AST ≤ 2.5×uln)\n7. With normal renal function test (creatinine ≤ 1.5×uln or ccr ≥ 60ml\u002Fmin)\n8. Satisfactory performance status: KARNOFSKY scale (KPS) \\> 70\n9. Patients must give signed informed consent\n\nExclusion Criteria:\n\n1. Histologically confirmed keratinizing nasopharyngeal carcinoma (WHO I)\n2. Age \\>65 or \\\u003C 18 years\n3. Treatment with palliative intent\n4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer\n5. History of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes\n6. History of previous radiotherapy\n7. Pregnancy or lactation\n8. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, acute exacerbation of chronic obstructive pulmonary disease or other respiratory illness requiring admission to hospital, active hepatitis, and mental disturbance","ALL","18 Years","65 Years",{"count":136,"type":137},352,"ESTIMATED","INTERVENTIONAL",[140],"PHASE3","To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.",[143],"Nasopharyngeal Carcinoma",[145,146,147,148],"induction chemotherapy","nedaplatin","cisplatin","concurrent chemoradiotherapy","2022-05-06",{"date":151,"type":152},"2022-05-10","ACTUAL",{"date":154,"type":152},"2020-08-01",{"date":156,"type":137},"2029-06-30",{"name":5,"class":6},1]