[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653601":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":42,"studyPopulation":35,"armGroups":43,"interventions":60,"overallOfficials":73,"centralContacts":77,"locations":87,"responsibleParty":104,"collaborators":35,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":35,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":35,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":132,"whyStopped":35,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Fudan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"2-year Locoregional Failure-Free Survival，2-y LRFFS","The time from enrollment to the first local or regional failure or any cause of death is determined by the event that occurs first. For those who did not experience any of these events, they are censored at the last valid follow-up date.","2 year",[14,17,20,23,27,31],{"measure":15,"description":16,"timeFrame":12},"2-year Failure-Free Survival，2-y FFS","The time from enrollment to the first occurrence of local regional failure, distant metastasis, or death due to any cause is determined by the event that occurs first.",{"measure":18,"description":19,"timeFrame":12},"2-year Overall Survival，2-y OS","The time from enrollment to any cause of death; for those who were still alive at the end of the follow-up, the data are censored at the date of the last confirmed survival.",{"measure":21,"description":22,"timeFrame":12},"2-year Distant Failure-Free Survival，2-y DFFS","The time from enrollment to the first distant metastasis or any cause of death is determined by the event that occurs first.",{"measure":24,"description":25,"timeFrame":26},"Acute Adverse Events，acute AEs","The evaluation was conducted according to NCI-CTCAE v5.0 from the start of radiotherapy to 90 days after radiotherapy.","up to 90 days after radiotherapy",{"measure":28,"description":29,"timeFrame":30},"Late Adverse Events，late AEs","After 90 days of radiotherapy, the evaluation was conducted according to CTCAE v5.0 and RTOG\u002FEORTC standards for late radiation injury.","After 90 days of radiotherapy to the date of death，assessed up to 2 years or more.",{"measure":32,"description":33,"timeFrame":34},"Quality of Life，QoL (EORTC QLQ-H&N35）","Changes in QoL of participants from baseline to up to 6 months after the completion of radiotherapy. QoL will be evaluated with the questionnaires of the head-and-neck-specific module (H\\&N35) of the Quality of Life Questionnaire-Core 30 module (QLQ-C30). Higher scores mean a worse outcome.","baseline and up to one year",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":35,"primaryPurpose":39,"observationalModel":35,"timePerspective":35,"maskingInfo":40},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":41,"maskingDescription":35,"whoMasked":35},"NONE","This study focused on patients with AJCC\u002FUICC 9th edition stage IB-II（The participants were required to have no extensive skull base invasion and lymph nodes \\\u003C 4 cm before treatment）. It aimed to adaptively guide the reduction of radiation dose for nasopharyngeal carcinoma based on the response to induction chemotherapy, thereby minimizing radiation-related toxicity while ensuring local control. Cohort 1 was randomly assigned 1:1 to the 59.4 Gy\u002F27 fractions group and the 66.0 Gy\u002F30 fractions group and compared their LRFFS. The participants were required to have EBV-DNA = 0 and CR or PR \\> 50% after 2 courses of induction therapy. Those who did not meet the criteria were assigned to Cohort 2 to receive standard-dose radiotherapy combined with concurrent cisplatin to avoid excessive reduction of intensity for potentially high-risk patients.",[44,50,56],{"label":45,"type":46,"description":47,"interventionNames":48},"Experimental group","EXPERIMENTAL","reduced dose group",[49],"Radiation: reduced dose group",{"label":51,"type":52,"description":53,"interventionNames":54},"Control group","ACTIVE_COMPARATOR","standard dose group",[55],"Radiation: Standard Dose Group",{"label":57,"type":6,"description":35,"interventionNames":58},"Corhort 2",[59],"Other: concurrent chemoradiotherapy",[61,65,69],{"type":62,"name":47,"description":63,"armGroupLabels":64,"otherNames":35},"RADIATION","59.4 Gy\u002F27F",[45],{"type":62,"name":66,"description":67,"armGroupLabels":68,"otherNames":35},"Standard Dose Group","66 Gy\u002F30F",[51],{"type":6,"name":70,"description":71,"armGroupLabels":72,"otherNames":35},"concurrent chemoradiotherapy","66.0-70.4 Gy\u002F30-32F + cisplatin 80 mg\u002Fm² q3w×2",[57],[74],{"name":75,"affiliation":5,"role":76},"Xiayun He","PRINCIPAL_INVESTIGATOR",[78,83],{"name":79,"role":80,"phone":81,"phoneExt":35,"email":82},"Xiayun He, MD","CONTACT","+86021-64175590-81412","hexiayun1962@163.com",{"name":84,"role":80,"phone":85,"phoneExt":35,"email":86},"Fen Xue, MD","+8618916882304","dr_fenxue@163.com",[88],{"facility":89,"status":35,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Fudan Universtiy Shanghai Cancer Center","Shanghai","Shanghai Municipality","200032","China","CN",{"type":96,"coordinates":97},"Point",[98,99],121.45806,31.22222,{"lat":99,"lon":98},[102,103],{"name":79,"role":80,"phone":81,"phoneExt":35,"email":82},{"name":84,"role":80,"phone":35,"phoneExt":35,"email":86},{"type":76,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Chaosu Hu","Principal Investigator","100653601","phase-2-induction-chemotherapy-response-guided-reduced-dose-radiotherapy-for-nasopharyngeal-carcinoma-100653601",false,"NCT07789158","Induction Chemotherapy Response-Guided Reduced-Dose Radiotherapy for Nasopharyngeal Carcinoma","Induction Chemotherapy Response-Guided Reduced-Dose Radiotherapy for Nasopharyngeal Carcinoma: A Prospective Single-center Randomized Phase II Study","Inclusion Criteria:\n\n* Age: 18 - 65 years old.\n* Pathologically confirmed nasopharyngeal carcinoma, WHO type II or III non-keratinizing cancer.\n* AJCC\u002FUICC 9th edition stage IB-II untreated non-metastatic nasopharyngeal carcinoma (T3 requires no extensive cranial base invasion and the invasion volume should be \\\u003C 22 mL; N1-2 requires baseline lymph nodes \\\u003C 4 cm).\n* Before treatment, plasma EBV-DNA needs to be tested and dynamic monitoring of EBV-DNA can be completed.\n* ECOG performance status 0 - 1 points.\n* Main organ functions meet the following requirements: neutrophils ≥ 1.5 × 10\\^9\u002FL, platelets ≥ 100 × 10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL; ALT\u002FAST ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN; creatinine clearance rate ≥ 60 mL\u002Fmin.\n* Sign a written informed consent form and be willing to complete the treatment, follow-up and quality of life assessment according to the protocol.\n\nExclusion Criteria:\n\n* Metastasis to T4, N3 or distant sites; AJCC\u002FUICC 9th edition stage III-IV.\n* Had received chemotherapy, targeted therapy, or immunotherapy before the diagnosis of nasopharyngeal carcinoma, and had a history of radiotherapy or surgery for head and neck tumors (except for diagnostic biopsies).\n* Pregnant or lactating; non-pregnant and non-lactating subjects who do not agree to take effective contraceptive measures.\n* Had severe and uncontrollable heart, lung, liver, kidney, neurological or mental diseases, and the investigator judged that they were not suitable for radical treatment or affected compliance.\n* Had a history of other malignant tumors within the past 5 years, except for the following situations: cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, papillary thyroid carcinoma, etc.\n* Could not complete the imaging examinations, EBV-DNA tests, follow-up or quality of life assessment as required by the protocol.","ALL","18 Years","65 Years",{"count":118,"type":119},269,"ESTIMATED","INTERVENTIONAL",[122],"PHASE2","To evaluate whether the 2-year local failure-free survival (LRFFS) in Cohort 1 patients with AJCC\u002FUICC 8th edition stage IB-II nasopharyngeal carcinoma who achieved EBV-DNA = 0 after induction chemotherapy and had MRI assessment of complete response (CR) or partial response (PR) ≥50% is non-inferior when treated with reduced-dose IMRT (59.4 Gy\u002F27 fractions) compared to standard-dose IMRT (66.0 Gy\u002F30 fractions).",[125],"Nasopharyngeal Carcinoma (NPC)",[127,128,129,130,131],"Nasopharyngeal Carcinoma","EBV DNA","MRI","reduced dose radiotherapy","induction chemotherapy","NOT_YET_RECRUITING","2026-08-26",{"date":135,"type":136},"2026-08-27","ACTUAL",{"date":138,"type":119},"2026-09-01",{"date":140,"type":119},"2031-08-31",{"name":5,"class":6},1]