[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647706":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":27,"locations":33,"responsibleParty":50,"collaborators":11,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":11,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"National Medical Research Radiological Centre of the Ministry of Health of Russia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with radiological signs of single-focal high-grade glioma","EXPERIMENTAL",null,[13],"Radiation: Preoperative irradiation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"RADIATION","Preoperative irradiation","After enrollment patientswith radiological signs of HGG will be irradiated by pencil beam protons in the following regimens: 3 pts - 4 GyRBE (RBE = 1.1) x 5 Fx; 3 pts - 5 GyRBE x 5 Fx; 3pts - 6 GyRBE x 5 Fx.",[9],[21,25],{"name":22,"affiliation":23,"role":24},"Igor Gulidov","A. Tsyb MRRC","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":23,"role":24},"Alexey Goryanov",[28],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Konstantin Gordon, PhD","CONTACT","0079105184148","gordonkb@nmicr.ru",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Proton Therapy Department, A. Tsyb Medical Radiological Research Center - branch of the National Medical Radiological Research Center","RECRUITING","Obninsk","Kaluga Oblast","249036","Russia","RU",{"type":43,"coordinates":44},"Point",[45,46],36.61238,55.10993,{"lat":46,"lon":45},[49],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},{"type":24,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Konstantin Gordon","Leading Researcher","100647706","phase-1-preoperative-proton-irradiation-for-high-grade-brain-gliomas-100647706",false,"NCT07710040","Preoperative Proton Irradiation for High-grade Brain Gliomas.","Proton PREoperative STereotactic Irradiaiton for High-grade Gliomas (PPrestige): a Single-center Prospective Interventional Pahse 1 Trial","PPrestige","Inclusion Criteria:\n\n* radiologically confirmed (MRI and\u002For PET with amino-acids) diagnosis of high-grade glioma\n* single foci\n* ECOG 0-2 status\n* tumor location and volume, eligible for gross total resection (GTR)\n* signed informed consent\n\nExclusion Criteria:\n\n* multifocal disease\n* ECOG 3-4\n* inability to achieve GTR","ALL","18 Years",{"count":64,"type":65},9,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","The goal of this clinical trial is to learn if preopearative proton therapy (PPT) is tolerable in patients with High-grade brain gliomas. It will also learn about the influence on surgical procedure, clinical effects and safety of regular treatment.\n\nThe main questions it aims to answer are:\n\nDoes preoprative proton therapy well-tolerated? What maximal dose of PPT is safe?\n\nProposed Treatment Stages\n\n1. Multidisciplinary board (neurosurgeon, radiation therapist, and medical oncologist) decision of patient enrollment.\n2. Course of preoperative proton stereotactic radiotherapy (PSRT) directed at the tumor only: GTV=contrast-part of brain giloma, CTV=GTV. Dose regimens: first 3 patients - 4 Gy(RBE) × 5 fractions; subsequent 3 patients - 5 Gy(RBE) × 5 fractions; subsequent 3 patients - 6 Gy(RBE) × 5 fractions. RBE = Relative biological efficacy, equal 1.1 for protons. Should any information regarding unacceptable treatment toxicity emerge, the study will be terminated.\n3. Microsurgical resection of the contrast-enhancing portion of the tumor using fluorescence microscopy and, when indicated, neurophysiological monitoring.\n4. Contrast-enhanced MRI to assess the resection volume within the first 24-48 hours after surgery.\n5. Follow-up evaluation - clinical, morphological, and radiological assessment of the effects of the preoperative and surgical treatment stages, performed 3-4 weeks after the surgical phase.\n6. Standard treatment and follow-up: Chemoradiotherapy with a scanned proton beam combined with temozolomide 75 mg\u002Fm², given at 2 Gy × 30 fractions, to commence 4-6 weeks after surgery. Adjuvant chemotherapy with temozolomide 150-200 mg\u002Fm² on a 5\u002F23 schedule (maintenance chemotherapy), for 12 cycles or until disease progression\u002Funacceptable toxicity.\n7. Follow-up - control examinations every 1 month after completion of chemoradiotherapy, then every 3 months for the first year.",[71],"High Grade Gliomas",[73,74,75],"high grade gliomas","proton therapy","preoperative irradiation","2026-07-12",{"date":78,"type":79},"2026-07-17","ACTUAL",{"date":81,"type":65},"2026-07-01",{"date":83,"type":65},"2029-12-31",{"name":5,"class":6},1]