[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657287":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":58,"studyPopulation":59,"armGroups":54,"interventions":54,"overallOfficials":54,"centralContacts":60,"locations":66,"responsibleParty":79,"collaborators":54,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":54,"enrollmentInfo":91,"targetDuration":54,"studyType":94,"phases":54,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":101,"whyStopped":54,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"European Institute of Oncology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":54},[9],{"measure":10,"description":11,"timeFrame":12},"The presence of cognitive impairment","The primary endpoint will be the presence of cognitive impairment during the first 5 years after enrollment, as measured by a comprehensive neuropsychological assessment.","From the end of Protontherapy through study completion, an average of 1 year.",[14,18,21,24,27,30,33,36,39,42,45,48,51],{"measure":15,"description":16,"timeFrame":17},"Perceived cognitive impairment","For Functional Assessment of Cancer Therapy-cognition (FACT-cog) 37 items will be completed (score 1-4)","At baseline (pre - Protontherapy), 6 and 12 months post-treatment, and then annually for 5 years.",{"measure":19,"description":20,"timeFrame":17},"Depressive symptoms","At Beck Depression Inventory-II (BDI-II) 21 items will be completed (score 0-3)",{"measure":22,"description":23,"timeFrame":17},"Anxiety","For State-Trait Anxiety Inventory (STAI) 40 items will be completed (score 1-4)",{"measure":25,"description":26,"timeFrame":17},"Quality of Life data (QoL) - EORTC QLQ C30 questionnaires.","For EORTC QLQ C30, 30 items will be completed (score 1-4).",{"measure":28,"description":29,"timeFrame":17},"Sleep quality","For Pittsburgh Sleep Quality Index (PSQI) 24 items will be completed (score 0-3)",{"measure":31,"description":32,"timeFrame":17},"Cognitive Reserve","For Cognitive Reserve Index questionnaire (CRIq) 20 items will be completed (core 0-1)",{"measure":34,"description":35,"timeFrame":17},"Global functioning","For Montreal Cognitive Assessment (MoCA) 30 items will be completed (score 1-5).",{"measure":37,"description":38,"timeFrame":17},"Learning and Verbal Memory","For Rey Auditory Verbal Learning Test (RAVLT) 15 items will be completed (score 0-4).",{"measure":40,"description":41,"timeFrame":17},"Working memory","For Corsi Span backward\u002Fforward 18 items will be completed (score 0-4).",{"measure":43,"description":44,"timeFrame":17},"Visual memory","For Rey-Osterrieth complex figure -recall 18 items will be completed (score 0-2).",{"measure":46,"description":47,"timeFrame":17},"Visuospatial abilities","For Rey-Osterrieth complex figure -copy 18 items will be completed (score 0-2).",{"measure":49,"description":50,"timeFrame":17},"Executive function","For Frontal Assessment Battery (FAB) 30 items will be completed (score 0-3).",{"measure":52,"description":53,"timeFrame":17},"Attention","For Symbol digit modalities test (SDMT) 110 items will be completed (score 0-1)",null,{"allocation":54,"interventionModel":54,"interventionModelDescription":54,"primaryPurpose":54,"observationalModel":56,"timePerspective":57,"maskingInfo":54},"COHORT","PROSPECTIVE","In the brain, late radiotoxicities typically manifest as cognitive dysfunction, leukoencephalopathy, brain atrophy, brain tissue necrosis, cerebrovascular complications, endocrinopathies, and\u002For secondary malignant neoplasms.\n\nRadiation-induced hippocampal injury, in particular, significantly contributes to cognitive impairment, while broader central nervous system effects arise through multiple mechanisms, including vascular injury, neuronal depletion, chronic inflammation, demyelination, and tissue necrosis.\n\nThe severity of cognitive dysfunction depends on multiple factors, including the location and the volume of the tumor, the total radiation dose administered, the fractionation regimen, and the individual susceptibility of the patient, as well as comorbidities (e.g., diabetes, etc.) and concomitant drugs.\n\nThe distinct physical characteristics of proton therapy, such as a reduced entrance dose, an eliminated exit dose, and a Bragg peak, provide clear dosimetric advantages over conventional photon treatments. Pencil-beam scanning further improves on earlier passive scattering approaches by delivering modulated proton beamlets for superior target conformality and reduced neutron scatter, thereby limiting low- and intermediate- dose exposure to cranial organs at risk (OARs) while preserving adequate dose coverage within the target volume.\n\nFrom a radiobiological standpoint, these properties suggest that proton therapy may present a more favorable risk-benefit balance compared to photon-based modalities, particularly for long-term clinical outcomes. It achieves a drastic reduction in the integral dose, offering substantial benefit in decreasing radiation-induced second malignancies, making it mandatory for children when available.\n\nProton therapy is well established for treating pediatric tumors, CNS tumors such as low-grade gliomas (LGG) and meningiomas, especially if near the optic pathway or brainstem, and all the benign tumors in young patients. In these cases, the primary goal extends beyond curing the disease to preserving neurological and cognitive functions.","Patients affected by primary central nervous system tumors and eligible for protontherapy as adjuvant or radical treatment",[61],{"name":62,"role":63,"phone":64,"phoneExt":54,"email":65},"Gabriella Pravettoni","CONTACT","+39 0257489207","Gabriella.Pravettoni@ieo.it",[67],{"facility":68,"status":54,"city":69,"state":70,"zip":71,"country":70,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":54},"European Institute of Oncology, Milan","Milan","Italy","20141","IT",{"type":74,"coordinates":75},"Point",[76,77],12.59836,42.78235,{"lat":77,"lon":76},{"type":80,"investigatorFullName":54,"investigatorTitle":54,"investigatorAffiliation":54,"oldNameTitle":54,"oldOrganization":54},"SPONSOR","100657287","neurocognitive-integrity-after-proton-therapy-for-brain-tumor-100657287",false,"NCT07836478","Neurocognitive Integrity After Proton Therapy for Brain Tumor","Prospective Evaluation of Neurocognitive Integrity After Proton Therapy for Brain Tumor","PROTON MIND","Inclusion Criteria:\n\n* Primary tumors of Brain Tumor (CNS), benign and malignant\n* Age ≥ 18 years\n* Patients able to speak and read the local language(s) fluently\n* Acceptance and signature of informed consent\n* Radiological diagnosis, biopsy, or previous surgery\n* Concomitant medical therapy is allowed\n\nExclusion Criteria:\n\n* Previous brain radiotherapy (any form)\n* High-grade gliomas\n* Patients with concomitant neurological or psychiatric disorders.\n* Pregnancy","ALL","18 Years",{"count":92,"type":93},60,"ESTIMATED","OBSERVATIONAL","Radiation therapy remains a cornerstone in the management of both benign and malignant intracranial tumors, either as monotherapy or combined with surgery and\u002For chemotherapy. Despite its therapeutic benefits, it is frequently associated with potential long-term adverse effects, with neurotoxicity posing a major challenge, especially in young patients affected by benign primary tumors.",[97],"Central Nervous System Tumour",[99,100],"Primary benign and malignant tumors of CNS","Protontherapy","NOT_YET_RECRUITING","2026-09-22",{"date":104,"type":105},"2026-09-23","ACTUAL",{"date":107,"type":93},"2026-09",{"date":109,"type":93},"2036-07-01",{"name":5,"class":6},1]