[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537797":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":44,"studyPopulation":34,"armGroups":45,"interventions":58,"overallOfficials":68,"centralContacts":72,"locations":77,"responsibleParty":94,"collaborators":34,"id":97,"slug":34,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":34,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":34,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":34,"overallStatus":80,"whyStopped":34,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Zhongshan People's Hospital, Guangdong, China","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Regional recurrence free survival","From the date of randomization to regional recurrence or any death","3 years",[14,17,20,23,26,30],{"measure":15,"description":16,"timeFrame":12},"Overall survival","From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up",{"measure":18,"description":19,"timeFrame":12},"Local recurrence free survival","From the date of randomization to local recurrence or any death",{"measure":21,"description":22,"timeFrame":12},"Distant metastasis-free survival","From the date of randomization to distant metastasis or any death",{"measure":24,"description":25,"timeFrame":12},"Progression free survival","From the date of randomization to local or regional recurrence, distant metastasis or any death",{"measure":27,"description":28,"timeFrame":29},"Acute toxicities","Assessed with CTCAE v5.0","From the start of treatment until 3 months post treatment",{"measure":31,"description":32,"timeFrame":33},"Late toxicities","Assessed with Radiation Therapy Oncology Group criteria and the CTCAE v5.0","3 years post treatment",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":40,"maskingDescription":34,"whoMasked":41},"DOUBLE",[42,43],"PARTICIPANT","OUTCOMES_ASSESSOR","Xerostomia remains one of the most common radiation-induced toxicities, and approximately 80% to 90% of NPC patients still experience varying degrees of xerostomia post-IMRT. Among the major salivary glands, the parotid gland is the largest and produces 60% to 65% of the oral saliva output. Studies have revealed that xerostomia post-IMRT is mainly dependent on the irradiation dose of the parotid glands. Clinical target volumes (CTV) for the cervical nodal region starting from skull base have been the standard in nasopharyngeal carcinoma for several decades. Consequently, the parotid glands overlap with the target volumes and irradiation dose reaches 31.7 Gy to 43.9 Gy in most reports. Retrospective studies reveal that the lateral process of C1 is a suitable cranial edge for neck CTV delineation; therefore, the volume of the parotid glands exposed to high radiation doses can be greatly reduced. we conducted this trial comparing outcomes ,toxicities and QoL of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in nasopharyngeal carcinoma.",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"Study Group","EXPERIMENTAL","optimised neck CTV delineation",[51],"Radiation: Optimised neck CTV",{"label":53,"type":54,"description":55,"interventionNames":56},"Control Group","ACTIVE_COMPARATOR","standard neck CTV delineation",[57],"Radiation: standard neck CTV",[59,64],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":34},"RADIATION","Optimised neck CTV","neck CTV delineation extends from the lateral process of C1",[47],{"type":60,"name":65,"description":66,"armGroupLabels":67,"otherNames":34},"standard neck CTV","neck CTV delineation extends from skull base",[53],[69],{"name":70,"affiliation":5,"role":71},"Gui-qiong Xu, MD","PRINCIPAL_INVESTIGATOR",[73],{"name":70,"role":74,"phone":75,"phoneExt":34,"email":76},"CONTACT","+8613528109888","donna_shee@163.com",[78],{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Zhongshan City People's Hospital","RECRUITING","Zhongshan","Guangdong","528403","China","CN",{"type":87,"coordinates":88},"Point",[89,90],113.37912,22.52306,{"lat":90,"lon":89},[93],{"name":70,"role":74,"phone":75,"phoneExt":34,"email":76},{"type":71,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Gui-Qiong Xu","Chief Physician","100537797",false,"NCT06282497","Xerostomia-optimised IMRT Versus Standard IMRT in NPC","Xerostomia-optimised Intensity-modulated Radiotherapy Versus Standard Intensity-modulated Radiotherapy in Nasopharyngeal Carcinoma Patients:a Multicenter Non-inferior Randomized Controlled Phase III Clinical Trial","Inclusion Criteria:\n\n* Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II\u002FIII);\n* All genders, range from 18-70 years old;\n* ECOG score 0-1;\n* Clinical stage I-IVa (AJCC\u002FUICC 8th);\n* Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy);\n* No contraindications to chemotherapy or radiotherapy;\n* Adequate organ function: white blood cell count ≥ 4×109\u002FL, neutrophile granulocyte count ≥ 1.5×109\u002FL, hemoglobin ≥ 90g\u002FL, platelet count ≥ 100×109\u002FL; alanine aminotransferase or aspartate aminotransferase \\\u003C 2.5×upper limit of normal; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine clearance ≥ 60ml\u002Fmin (Cockcroft-Gault formula);\n* Sign the consent form.\n\nExclusion Criteria:\n\n* Level II involvement with extracapsular extension (ECE), and\u002For had a maximum nodal axial diameter (MAD) of greater than 3cm in level II ;\n\n  -≥4 nodal regions of ipsilateral neck involvement;\n* Radiologically suspicious or confirmed involvement in level II area between skull base and the lateral process of C1;\n* Parotid lymph node and\u002For parotid gland involvement;\n* History of parotid disease or surgery;\n* Previous malignancy or other concomitant malignant disease;\n* Pregnancy or lactation.","ALL","18 Years","70 Years",{"count":107,"type":108},524,"ESTIMATED","INTERVENTIONAL",[111],"NA","This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in NPC patients",[114],"Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy","2024-04-28",{"date":117,"type":118},"2024-05-01","ACTUAL",{"date":120,"type":118},"2023-10-23",{"date":122,"type":108},"2029-10-23",{"name":5,"class":6},1]