[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520357":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":26,"locations":31,"responsibleParty":49,"collaborators":11,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":11,"enrollmentInfo":61,"targetDuration":11,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":11,"overallStatus":34,"whyStopped":11,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Centro di Riferimento Oncologico - Aviano","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pulsed low dose-rate radiotherapy (pLDRT)","EXPERIMENTAL",null,[13],"Radiation: Pulsed low dose-rate radiotherapy (pLDRT)",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"RADIATION","Radiation treatment will be carried out with high-energy photons (6MV) using intensity modulated radiation therapy (IMRT) or volumetric arc radiation therapy (VMAT). The daily dose is 2 Gy, divided into 10 subfractions of 0.2 Gy spaced by 3 minutes. The cumulative dose will be individualized for each patient and can range from a minimum of 40 Gy to a maximum of 60 Gy.",[9],[20,24],{"name":21,"affiliation":22,"role":23},"Lorenzo Vinante, MD","Centro di Riferimento Oncologico di Aviano (CRO)","PRINCIPAL_INVESTIGATOR",{"name":25,"affiliation":22,"role":23},"Lorena Baboci, PhD",[27],{"name":21,"role":28,"phone":29,"phoneExt":11,"email":30},"CONTACT","0434659855","lorenzo.vinante@cro.it",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"IRCCS-Centro di Riferimento Oncologico (CRO) di Aviano","RECRUITING","Aviano","Pordenone","33081","Italy","IT",{"type":41,"coordinates":42},"Point",[43,44],12.59472,46.07056,{"lat":44,"lon":43},[47],{"name":21,"role":28,"phone":48,"phoneExt":11,"email":30},"+390434659855",{"type":50,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100520357","use-of-pulsed-low-dose-rate-re-irradiation-for-recurrent-glioma-pulsar-100520357",false,"NCT06055517","Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR)","A Phase-2 Trial to Investigate the Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR)","PULSAR","Inclusion Criteria:\n\n* Age ≥18 years;\n* Ability to express appropriate informed consent to treatment;\n* Diagnosis of cerebral glioma;\n* Histological\u002Fradiological confirmation of disease recurrence\u002Frelapse;\n* Previous brain-level radiation therapy completed a minimum of 6 months;\n* Performance status: ECOG=0-2.\n\nExclusion Criteria:\n\n* Refusal to radiation treatment (i.e., absence of informed consent signed);\n* Concomitant chemotherapy;\n* Leptomeningeal spread of disease and localization in both cerebral hemispheres;\n* Current pregnancy.","ALL","18 Years",{"count":62,"type":63},29,"ESTIMATED","INTERVENTIONAL",[66],"NA","Re-irradiation in gliomas is a therapeutic option at recurrence before of 2nd-line chemotherapy. The dose of re-irradiation with conventional fractionation is unfortunately limited by the risk of symptomatic radionecrosis that is significant for cumulative doses above 100 Gy. The use of unconventional low dose rate pulsed radiotherapy (pLDRT) can reduce the risk of radiotoxicity while taking advantage of the cellular hyper-radiosensitivity that occurs at low dose-rates. The present study therefore aims at evaluating whether the use of pLDRT in the re-irradiation of recurrences of gliomas allows maintaining a low risk of symptomatic radionecrosis even for cumulative doses greater than 100 Gy.",[69],"Glioma","2023-09-20",{"date":72,"type":73},"2023-09-26","ACTUAL",{"date":75,"type":73},"2023-05-26",{"date":77,"type":63},"2028-05-26",{"name":5,"class":6},1]