[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579989":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":37,"responsibleParty":49,"collaborators":25,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":25,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":77,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Tata Memorial Centre","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Photon therapy (standard arm)","Patients in the standard arm will undergo focal cranial radiotherapy using photons (X-rays) with image guidance using IMRT, VMAT, or helical intensity-modulated techniques.",[12],"Radiation: Photon Radiotherapy",{"label":14,"type":15,"description":16,"interventionNames":17},"Proton beam therapy (experimental arm)","EXPERIMENTAL","The patients in the experimental arm will undergo focal radiotherapy to an equivalent dose using proton beam therapy.",[18],"Radiation: Proton Beam Therapy",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","Proton Beam Therapy","Patients randomized to the experimental arm will be treated with proton beam therapy.",[14],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Photon Radiotherapy","Patients randomized to standard arm will be treated with photon therapy.",[9],[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Archya Dasgupta, MBBS MD","CONTACT","8097081506","02224176017602","archya1010@gmail.com",[38],{"facility":5,"status":39,"city":40,"state":25,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":25},"RECRUITING","Mumbai","India","IN",{"type":44,"coordinates":45},"Point",[46,47],72.88261,19.07283,{"lat":47,"lon":46},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Dr Archya Dasgupta","Associate Professor in Department of Radiation Oncology","100579989","proton-versus-photon-radiotherapy-in-adults-with-primary-brain-tumors-100579989",false,"NCT06831461","Proton Versus Photon Radiotherapy in Adults With Primary Brain Tumors","Proton Versus Photon Radiotherapy In Adults With Primary Brain Tumors Evaluating Functional Survival: A Phase 3 Randomized Controlled Trial (PRIDE)","PRIDE","Inclusion Criteria:\n\n* Primary brain tumors\n* Age at irradiation: 18 to 70 years\n* Karnofsky Performance Status ≥ 60\n* Diagnosis (histopathological\u002F radiological) of primary brain tumor with an expected survival of \\>5 years (e.g., grade 2-3 diffuse glioma, low-grade glial\u002F glioneuronal tumors, ependymoma, meningioma, pituitary tumors, schwannoma, craniopharyngioma, etc.)\n* Planned for focal cranial radiotherapy\n* Informed consent taken\n\nExclusion Criteria:\n\n* Re-irradiation\n* Palliative radiotherapy\n* Multifocal or multicentric disease\n* Planned for whole brain irradiation or craniospinal irradiation\n* Planned for hypo-fractionated or stereotactic radiotherapy","ALL","18 Years","70 Years",{"count":65,"type":66},156,"ESTIMATED","INTERVENTIONAL",[69],"NA","This study will be done in adults with brain tumors having good prognosis requiring treatment with radiotherapy. The current practice for brain radiotherapy involves treatment using X rays (photon radiotherapy). Proton beam therapy is a more advanced form of delivering radiation, which allows the reduction of the dose of radiation to the parts of the brain surrounding the tumor. After treatment with photon radiotherapy, certain late effects of radiation, like memory decline, hormonal deficits, hearing loss, and worsening of neurological function, can occur in some patients. From the evaluation of dose profiling, proton beam therapy has the potential to reduce the possibility of side effects by reducing the dose to critical organs. However, there is no clinical data to demonstrate whether the theoretical dose reduction translates to a clinically meaningful benefit. In the proposed study, 156 patients will be randomly allocated to either proton or photon radiotherapy in 1: 1 ratio. The primary objective of the study is to explore whether proton therapy improves functional survival, which is life expectancy without recurrence, death, or complications from radiotherapy.",[72,73,74,75,76],"Primary Brain Tumors","Diffuse Glioma","Meningioma","Pituitary Adenoma","Low Grade CNS Tumors",[22,27,78,79,80],"Brain Tumors","Neurocognition","Survival","2025-09-15",{"date":83,"type":84},"2025-09-16","ACTUAL",{"date":86,"type":84},"2025-07-01",{"date":88,"type":66},"2032-12-31",{"name":5,"class":6},1]