protocolSection identificationModule nctId: NCT06283927, orgStudyIdInfo id: MEC-2020-0812-5, briefTitle: The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302), acronym: RECSUR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2027-01-01, completionDateStruct date: 2028-01-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Jasper Gerritsen, class: OTHER, collaborators name: Haaglanden Medical Centre, collaborators name: Universitaire Ziekenhuizen KU Leuven, collaborators name: University Hospital Heidelberg, collaborators name: Technical University of Munich, collaborators name: Insel Gruppe AG, University Hospital Bern, collaborators name: Massachusetts General Hospital, collaborators name: University of California, San Francisco, descriptionModule briefSummary: 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.This 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.The study has been approved by the Medical Ethics Committee (METC Zuid-West Holland/Erasmus Medical Center; MEC-2020-0812). The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media., conditionsModule conditions: Glioblastoma, conditions: Glioblastoma Multiforme, conditions: Glioblastoma, IDH-wildtype, conditions: Glioblastoma Multiforme of Brain, conditions: Glioblastoma Multiforme, Adult, conditions: Recurrent Glioblastoma, conditions: Astrocytoma, Malignant, conditions: Astrocytoma of Brain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 464, type: ESTIMATED, armsInterventionsModule interventions name: Re-resection, interventions name: Temozolomide, interventions name: Lomustine, interventions name: Re-irradiation, interventions name: Experimental therapy, interventions name: Best supportive care, outcomesModule primaryOutcomes measure: Overall survival, primaryOutcomes measure: Neurological morbidity at 6 weeks, secondaryOutcomes measure: Neurological morbidity at 3 months, secondaryOutcomes measure: Neurological morbidity at 6 months, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Residual tumor volume, secondaryOutcomes measure: Quality of life at 6 weeks (EORTC QLQ C30), secondaryOutcomes measure: Quality of life at 3 months (EORTC QLQ C30), secondaryOutcomes measure: Quality of life at 6 months (EORTC QLQ C30), secondaryOutcomes measure: Quality of life at 6 weeks (EORTC QLQ BN20), secondaryOutcomes measure: Quality of life at 3 months (EORTC QLQ BN20), secondaryOutcomes measure: Quality of life at 6 months (EORTC QLQ BN20), secondaryOutcomes measure: Quality of life at 6 weeks (EQ-5D), secondaryOutcomes measure: Quality of life at 3 months (EQ-5D), secondaryOutcomes measure: Quality of life at 6 months (EQ-5D), secondaryOutcomes measure: Serious Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California, San Francisco, status: RECRUITING, city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Mitchel Berger, MD PhD, role: CONTACT, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Massachusetts General Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Brian Nahed, MD PhD, role: CONTACT, geoPoint lat: 42.35843, lon: -71.05977, locations facility: University Hospital Leuven, status: RECRUITING, city: Leuven, country: Belgium, contacts name: Steven De Vleeschouwer, MD PhD, role: CONTACT, geoPoint lat: 50.87959, lon: 4.70093, locations facility: University Hospital Heidelberg, status: RECRUITING, city: Heidelberg, country: Germany, contacts name: Christine Jungk, Dr. med., role: CONTACT, geoPoint lat: 49.40768, lon: 8.69079, locations facility: Technical University Munich, status: NOT_YET_RECRUITING, city: Munich, country: Germany, contacts name: Arthur Wagner, MD, role: CONTACT, geoPoint lat: 48.13743, lon: 11.57549, locations facility: Erasmus MC, status: RECRUITING, city: Rotterdam, state: Zuid-Holland, zip: 3015 CE, country: Netherlands, contacts name: Arnaud Vincent, MD PhD, role: CONTACT, phone: +31639428949, email: a.vincent@erasmusmc.nl, contacts name: Jasper Gerritsen, MD, role: CONTACT, phone: +31629119553, email: j.gerritsen@erasmusmc.nl, geoPoint lat: 51.9225, lon: 4.47917, locations facility: Medical Center Haaglanden, status: RECRUITING, city: The Hague, state: Zuid-Holland, zip: 2261 CP, country: Netherlands, contacts name: Marike Broekman, MD PhD, role: CONTACT, phone: +31639758253, email: m.broekman@haaglandenmc.nl, geoPoint lat: 52.07667, lon: 4.29861, locations facility: Inselspital Universitätsspital Bern, status: NOT_YET_RECRUITING, city: Bern, country: Switzerland, contacts name: Philippe Schucht, MD PhD, role: CONTACT, geoPoint lat: 46.94809, lon: 7.44744, hasResults: False