[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537907":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":52,"centralContacts":56,"locations":65,"responsibleParty":179,"collaborators":183,"id":195,"slug":196,"hasResults":197,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":197,"sex":203,"minAge":204,"maxAge":205,"enrollmentInfo":206,"targetDuration":10,"studyType":209,"phases":10,"briefSummary":210,"conditions":211,"keywords":220,"overallStatus":68,"whyStopped":10,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":239},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Re-resection",null,"Resection of the recurrent tumor",[13],"Procedure: Re-resection",{"label":15,"type":10,"description":16,"interventionNames":17},"Best oncological treatment","Best oncological treatment consisting of re-challenge temozolomide, re-irradiation, experimental therapy, or best supportive care",[18,19,20,21,22],"Drug: Temozolomide","Drug: Lomustine","Radiation: Re-irradiation","Procedure: Experimental therapy","Other: Best supportive care",[24,27,32,36,41,48],{"type":25,"name":9,"description":11,"armGroupLabels":26,"otherNames":10},"PROCEDURE",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"DRUG","Temozolomide","Re-challenge Temozolomide chemotherapy",[15],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"Lomustine","Second line chemotherapy with Lomustine",[15],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"RADIATION","Re-irradiation","Re-irradiation with single dose, fractionated, or hypofractionated radiation of the recurrent tumor",[15],{"type":25,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Experimental therapy","Experimental phase I therapy with oncolytic virotherapy or immunotherapy (this list is not exhaustive)",[15],[46,47],"Immunotherapy","Oncolytic virotherapy",{"type":6,"name":49,"description":50,"armGroupLabels":51,"otherNames":10},"Best supportive care","Best supportive care, focused on alleviating symptoms",[15],[53],{"name":54,"affiliation":5,"role":55},"Jasper Gerritsen, MD PhD","PRINCIPAL_INVESTIGATOR",[57,61],{"name":54,"role":58,"phone":59,"phoneExt":10,"email":60},"CONTACT","31107036130","j.gerritsen@erasmusmc.nl",{"name":62,"role":58,"phone":63,"phoneExt":10,"email":64},"Arnaud Vincent, MD PhD","31107034211","a.vincent@erasmusmc.nl",[66,83,96,109,122,134,152,166],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"University of California, San Francisco","RECRUITING","San Francisco","California","94143","United States","US",{"type":75,"coordinates":76},"Point",[77,78],-122.41942,37.77493,{"lat":78,"lon":77},[81],{"name":82,"role":58,"phone":10,"phoneExt":10,"email":10},"Mitchel Berger, MD PhD",{"facility":84,"status":68,"city":85,"state":86,"zip":87,"country":72,"countryCode":73,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":75,"coordinates":89},[90,91],-71.05977,42.35843,{"lat":91,"lon":90},[94],{"name":95,"role":58,"phone":10,"phoneExt":10,"email":10},"Brian Nahed, MD PhD",{"facility":97,"status":68,"city":98,"state":10,"zip":10,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"University Hospital Leuven","Leuven","Belgium","BE",{"type":75,"coordinates":102},[103,104],4.70093,50.87959,{"lat":104,"lon":103},[107],{"name":108,"role":58,"phone":10,"phoneExt":10,"email":10},"Steven De Vleeschouwer, MD PhD",{"facility":110,"status":68,"city":111,"state":10,"zip":10,"country":112,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"University Hospital Heidelberg","Heidelberg","Germany","DE",{"type":75,"coordinates":115},[116,117],8.69079,49.40768,{"lat":117,"lon":116},[120],{"name":121,"role":58,"phone":10,"phoneExt":10,"email":10},"Christine Jungk, Dr. med.",{"facility":123,"status":124,"city":125,"state":10,"zip":10,"country":112,"countryCode":113,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Technical University Munich","NOT_YET_RECRUITING","Munich",{"type":75,"coordinates":127},[128,129],11.57549,48.13743,{"lat":129,"lon":128},[132],{"name":133,"role":58,"phone":10,"phoneExt":10,"email":10},"Arthur Wagner, MD",{"facility":135,"status":68,"city":136,"state":137,"zip":138,"country":139,"countryCode":140,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Erasmus MC","Rotterdam","South Holland","3015 CE","Netherlands","NL",{"type":75,"coordinates":142},[143,144],4.47917,51.9225,{"lat":144,"lon":143},[147,149],{"name":62,"role":58,"phone":148,"phoneExt":10,"email":64},"+31639428949",{"name":150,"role":58,"phone":151,"phoneExt":10,"email":60},"Jasper Gerritsen, MD","+31629119553",{"facility":153,"status":68,"city":154,"state":137,"zip":155,"country":139,"countryCode":140,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Medical Center Haaglanden","The Hague","2261 CP",{"type":75,"coordinates":157},[158,159],4.29861,52.07667,{"lat":159,"lon":158},[162],{"name":163,"role":58,"phone":164,"phoneExt":10,"email":165},"Marike Broekman, MD PhD","+31639758253","m.broekman@haaglandenmc.nl",{"facility":167,"status":124,"city":168,"state":10,"zip":10,"country":169,"countryCode":170,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Inselspital Universitätsspital Bern","Bern","Switzerland","CH",{"type":75,"coordinates":172},[173,174],7.44744,46.94809,{"lat":174,"lon":173},[177],{"name":178,"role":58,"phone":10,"phoneExt":10,"email":10},"Philippe Schucht, MD PhD",{"type":180,"investigatorFullName":181,"investigatorTitle":182,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Jasper Gerritsen","Dr.",[184,186,188,189,191,193,194],{"name":185,"class":6},"Haaglanden Medical Centre",{"name":187,"class":6},"Universitaire Ziekenhuizen KU Leuven",{"name":110,"class":6},{"name":190,"class":6},"Technical University of Munich",{"name":192,"class":6},"Insel Gruppe AG, University Hospital Bern",{"name":84,"class":6},{"name":67,"class":6},"100537907","the-recsur-study-resection-versus-best-oncological-treatment-for-recurrent-glioblastoma-encram-2302-100537907",false,"NCT06283927","The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)","The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma: Study Protocol for An International Multicenter Prospective Cohort Study (ENCRAM 2302)","RECSUR","Inclusion Criteria:\n\n1. Age ≥18 years and ≤90 years\n2. Tumor recurrence according to the RANO criteria of a previously diagnosed glioblastoma based on the WHO 2021 classification for glioma\n3. The tumor is suitable for resection (according to neurosurgeon)\n4. Written informed consent\n\nExclusion Criteria:\n\n1. Tumors of the cerebellum, brainstem, or midline\n2. Medical reasons precluding MRI (e.g., pacemaker)\n3. Inability to give written informed consent\n4. Secondary high-grade glioma due to malignant transformation from low-grade glioma\n5. Clinical data unavailable for the newly diagnosed setting","ALL","18 Years","90 Years",{"count":207,"type":208},464,"ESTIMATED","OBSERVATIONAL","Previous evidence has indicated that resection for recurrent glioblastoma might benefit the prognosis of these patients in terms of overall survival. However, the demonstrated safety profile of this approach is contradictory in the literature and the specific benefits in distinct clinical and molecular patient subgroups remains ill-defined. The aim of this study, therefore, is to compare the effects of resection and best oncological treatment for recurrent glioblastoma as a whole and in clinically important subgroups.\n\nThis study is an international, multicenter, prospective observational cohort study. Recurrent glioblastoma patients will undergo tumor resection or best oncological treatment at a 1:1 ratio as decided by the tumor board. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks after surgery and 2) overall survival. Secondary endpoints are: 1) progression-free survival (PFS), 2) NIHSS deterioration at 3 months and 6 months after surgery, 3) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.\n\nThe study has been approved by the Medical Ethics Committee (METC Zuid-West Holland\u002FErasmus Medical Center; MEC-2020-0812). The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media.",[212,213,214,215,216,217,218,219],"Glioblastoma","Glioblastoma Multiforme","Glioblastoma, IDH-wildtype","Glioblastoma Multiforme of Brain","Glioblastoma Multiforme, Adult","Recurrent Glioblastoma","Astrocytoma, Malignant","Astrocytoma of Brain",[212,221,222,9,223,224,225,226,227,228,229],"Radiotherapy","Chemotherapy","Resection","Overall survival","Progression-free survival","Neurological morbidity","Safety","Serious Adverse Events","Quality of life","2024-02-21",{"date":232,"type":233},"2024-02-28","ACTUAL",{"date":235,"type":233},"2023-01-01",{"date":237,"type":208},"2028-01-01",{"name":181,"class":6},8]