protocolSection identificationModule nctId: NCT06273176, orgStudyIdInfo id: MEC-2020-0812, briefTitle: The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma, acronym: RECMAP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2027-01-01, completionDateStruct date: 2028-01-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, 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: Resection of glioblastoma in or near functional brain tissue is challenging because of the proximity of important structures to the tumor site. To pursue maximal resection in a safe manner, mapping methods have been developed to test for motor and language function during the operation. Previous evidence suggests that these techniques are beneficial for maximum safe resection in newly diagnosed grade 2-4 astrocytoma, grade 2-3 oligodendroglioma, and recently, glioblastoma. However, their effects in recurrent glioblastoma are still poorly understood. The aim of this study, therefore, is to compare the effects of awake mapping and asleep mapping with no mapping in resections for recurrent glioblastoma.This study is an international, multicenter, prospective 3-arm cohort study of observational nature. Recurrent glioblastoma patients will be operated with mapping or no mapping techniques with a 1:1 ratio. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months after surgery and 2) residual tumor volume of the contrast-enhancing and non-contrast-enhancing part as assessed by a neuroradiologist on postoperative contrast MRI scans. Secondary endpoints are: 1) overall survival (OS), 2) progression-free survival (PFS), 4) 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 will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM)., conditionsModule conditions: Glioblastoma, IDH-wildtype, conditions: Glioblastoma, conditions: Glioblastoma Multiforme of Brain, conditions: Astrocytoma, Malignant, conditions: Brain Neoplasms, conditions: Brain Neoplasms, Adult, Malignant, conditions: Brain Neoplasms, Adult, conditions: Recurrent Adult Brain Tumor, conditions: Recurrent Glioblastoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 225, type: ESTIMATED, armsInterventionsModule interventions name: Awake mapping under local anesthesia, interventions name: Asleep mapping under general anesthesia, interventions name: Resection under general anesthesia without mapping, outcomesModule primaryOutcomes measure: Residual volume, primaryOutcomes measure: Neurological morbidity at 6 weeks, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Onco-functional outcome (OFO), secondaryOutcomes measure: Serious Adverse Events, secondaryOutcomes measure: Neurological morbidity at 3 months, secondaryOutcomes measure: Neurological morbidity at 6 months, secondaryOutcomes measure: Overall functioning at 6 weeks, secondaryOutcomes measure: Overall functioning at 3 months, secondaryOutcomes measure: Overall functioning at 6 months, 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), eligibilityModule sex: ALL, maximumAge: 90 Years, stdAges: CHILD, 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: Universitätsklinikum Heidelberg, status: RECRUITING, city: Heidelberg, country: Germany, contacts name: Christine Jungk, MD PhD, role: CONTACT, contacts name: Sandro Krieg, MD PhD, 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 Medical Center, status: RECRUITING, city: Rotterdam, state: Zuid-Holland, zip: 3015 GD, country: Netherlands, contacts name: Jasper Gerritsen, MD PhD, role: CONTACT, geoPoint lat: 51.9225, lon: 4.47917, locations facility: Haaglanden Medical Center, status: RECRUITING, city: The Hague, country: Netherlands, contacts name: Marike Broekman, MD PhD, role: CONTACT, 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