[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548216":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":51,"locations":61,"responsibleParty":79,"collaborators":83,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":29,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":29,"overallStatus":64,"whyStopped":29,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Hospital San Carlos, Madrid","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental","EXPERIMENTAL","Stereotactic biopsy will be performed on patients in the experimental group, who will then be discharged. If the histopathological diagnosis is not wildtype IDH non-mutated glioblastoma, the patient will be withdrawn from the study and receive conventional treatment. If wildtype IDH non-mutated glioblastoma is diagnosed, ten days after the biopsy, patients will undergo conformal hypofractionated stereotactic radiotherapy to the FLAIR hyperintense signal, including the contrast-enhancing tumor on T1, with a total dose of 3990 cGy at the margin in 15 fractions of 266 cGy, one session per day, five days a week, and concurrent temozolomide (TMZ) at 75 mg\u002Fm2\u002Fday for 7 days\u002Fweek during the irradiation period (GEINO, 2016). Five weeks later, patients will undergo supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring. Starting from 4 weeks post-surgery, TMZ will be administered for 6 months according to the Stupp protocol.",[13,14,15,16],"Radiation: hypofractionated stereotactic radiotherapy","Procedure: Stereotactic biopsy","Procedure: resection","Drug: Chemotherapy",{"label":18,"type":6,"description":19,"interventionNames":20},"Stupp Protocol","The Stupp protocol is a standard treatment regimen for glioblastoma, which involves a combination of radiotherapy and chemotherapy.",[15,21,22],"Radiation: radiotherapy Stupp protocol","Drug: Chemotherapy Stupp Protocol",[24,30,34,38,43,47],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"RADIATION","hypofractionated stereotactic radiotherapy","conformal hypofractionated stereotactic radiotherapy to the FLAIR hyperintense signal, including the contrast-enhancing tumor on T1, with a total dose of 3990 cGy at the margin in 15 fractions of 266 cGy, one session per day, five days a week, and concurrent temozolomide (TMZ) at 75 mg\u002Fm2\u002Fday for 7 days\u002Fweek during the irradiation period",[9],null,{"type":31,"name":32,"description":32,"armGroupLabels":33,"otherNames":29},"PROCEDURE","Stereotactic biopsy",[9],{"type":31,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"resection","supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring",[9,18],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":29},"DRUG","Chemotherapy","4 weeks post-surgery, temozolomide (TMZ) will be administered for 6 months",[9],{"type":25,"name":44,"description":45,"armGroupLabels":46,"otherNames":29},"radiotherapy Stupp protocol","radiotherapy + TMZ concurrently after 4 weeks of resection surgery, as per usual protocol: Three-dimensional radiotherapy planning to deliver a total dose of 60 Gy, with a fractionation of 2 Gy\u002Fday, 5 days\u002Fweek, encompassing a 1-2 cm margin around the contrast-enhancing region defined on T1 imaging or the entire abnormal volume defined on T2 or FLAIR imaging (Li et al., 2016) + TMZ at 75 mg\u002Fm2\u002Fday for 7 days\u002Fweek, for 6 weeks during radiotherapy.",[18],{"type":39,"name":48,"description":49,"armGroupLabels":50,"otherNames":29},"Chemotherapy Stupp Protocol","temozolomide (TMZ) will be administered for 6 months according to the Stupp protocol.",[18],[52,57],{"name":53,"role":54,"phone":55,"phoneExt":29,"email":56},"Juan Antonio Barcia","CONTACT","+34 913303506","jabarcia@ucm.es",{"name":58,"role":54,"phone":59,"phoneExt":29,"email":60},"Mª Rebeca Lliguin León","+34 622059861","rebeca.lliguin.leon@gmail.com",[62],{"facility":63,"status":64,"city":65,"state":29,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Hospital Clínico San Carlos","RECRUITING","Madrid","28040","Spain","ES",{"type":70,"coordinates":71},"Point",[72,73],-3.70256,40.4165,{"lat":73,"lon":72},[76,77],{"name":53,"role":54,"phone":55,"phoneExt":29,"email":56},{"name":58,"role":54,"phone":78,"phoneExt":29,"email":60},"622059861",{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Juan Antonio Barcia Albacar","Professor",[84],{"name":85,"class":86},"Asociación de Afectados Por Tumores Cerebrales en España (ASATE)","UNKNOWN","100548216","phase-1-neoadjuvant-radio-chemotherapy-safety-pilot-study-in-patients-with-glioblastoma-100548216",false,"NCT06418113","Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma","GLINERA","Inclusion Criteria:\n\n* Age between 18 and 75 years.\n* Unifocal disease.\n* Unilobar tumor.\n* Clinical-radiological diagnosis of supratentorial unicentric high-grade glioma, eligible for macroscopically complete resection.\n\nExclusion Criteria:\n\n* Multilobar tumor, interhemispheric or infratentorial extension, or multifocal disease.\n* Midline shift greater than 1 cm.\n* Intracranial hypertension symptoms requiring corticosteroid treatment.\n* Synchronous neoplasia.\n* Any contraindication for surgery, radiotherapy, or TMZ treatment.\n* Cognitive impairment.\n* Rejection of informed consent.\n* Inability to follow up for 2 years.\n* Women of childbearing potential according to the Clinical Trial Facilitation Group (CTFG) criteria. (https:\u002F\u002Fwww.hma.eu\u002Ffileadmin\u002Fdateien\u002FHuman\\_Medicines\u002F01-About\\_HMA\u002FWorking\\_Groups\u002FCTFG\u002F2020\\_09\\_HMA\\_CTFG\\_Contraception\\_guidance\\_Version\\_1.1.pdf)\n* Hypersensitivity to the active ingredient or any excipients of the investigational drug.","ALL","18 Years","75 Years",{"count":98,"type":99},12,"ESTIMATED","INTERVENTIONAL",[102],"PHASE1","The goal of this clinical trial is to evaluate the safety and efficacy of neoadjuvant radiochemotherapy in the surgical resection of glioblastoma (GBM). The main questions it aims to answer are:\n\n* What is the safety profile of neoadjuvant radiochemotherapy in terms of neurological deficit, radionecrosis, edema, headache, wound dehiscence, infection, and cerebrospinal fluid fistula?\n* What is the efficacy of neoadjuvant radiochemotherapy in terms of progression-free survival, overall survival, cognitive function, and quality of life?\n\nParticipants will undergo the following tasks and treatments:\n\n* Stereotactic biopsy and diagnosis confirmation.\n* Conformal hypofractionated stereotactic radiotherapy with concurrent temozolomide.\n* Supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring.\n* Maintenance temozolomide administration for 6 months.\n\nResearchers will compare the group receiving neoadjuvant radiochemotherapy to the control group following the standard Stupp protocol to assess safety and efficacy outcomes.",[105,106,107,108,109],"Glioblastoma","Glioblastoma Multiforme","Glioblastoma, IDH-wildtype","Radiotherapy; Complications","Cancer Brain","2024-05-13",{"date":112,"type":113},"2024-05-16","ACTUAL",{"date":115,"type":113},"2024-03-21",{"date":117,"type":99},"2027-03-21",{"name":5,"class":6},1]