[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brain-neoplasm-primary\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brain-neoplasm-primary":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":38,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100525206","the-supramax-study-supramaximal-resection-versus-maximal-resection-for-high-grade-glioma-patients-encram-2201-100525206",false,"NCT06118723","The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)","The SUPRAMAX-study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)","SUPRAMAX","Inclusion Criteria:\n\n1. Age ≥18 years and ≤90 years\n2. Tumor diagnosed as HGG (WHO grade III\u002FIV) on MRI as assessed by the neurosurgeon\n3. Written informed consent\n\nExclusion Criteria:\n\n1. Tumors of the cerebellum, brainstem or midline\n2. Multifocal contrast enhancing lesions\n3. Medical reasons precluding MRI (e.g. pacemaker)\n4. Inability to give written informed consent\n5. Secondary high-grade glioma due to malignant transformation from low-grade glioma\n6. Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin","ALL","18 Years","90 Years",{"count":21,"type":22},784,"ESTIMATED","OBSERVATIONAL","A greater extent of resection of the contrast-enhancing (CE) tumor part has been associated with improved outcomes in high-grade glioma patients. Recent results suggest that resection of the non-contrast-enhancing (NCE) part might yield even better survival outcomes (supramaximal resection, SMR). Therefore, this study evaluates the efficacy and safety of SMR with and without mapping techniques in HGG patients in terms of survival, functional, neurological, cognitive, and quality of life outcomes. Furthermore, it evaluates which patients benefit the most from SMR, and how they could be identified preoperatively.\n\nThis study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be operated with supramaximal resection or maximal resection at a 1:3 ratio. Primary endpoints are: 1) overall survival and 2) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months postoperatively. Secondary endpoints are 1) residual CE and NCE tumor volume on postoperative T1-contrast and FLAIR MRI scans 2) progression-free survival; 3) onco-functional outcome, and 4) quality of life at 6 weeks, 3 months, and 6 months postoperatively.\n\nThe study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).",[26,27,28,29,30,31,32,33,34,35,36,37],"Glioblastoma","High-grade Glioma","Glioblastoma, IDH-wildtype","Glioblastoma, IDH-mutant","Glioblastoma Multiforme, Adult","Astrocytoma, Grade IV","Astrocytoma, Grade III","Astrocytoma, Malignant","Brain Neoplasms","Brain Neoplasm, Primary","Brain Neoplasms, Adult","Brain Neoplasm, Malignant",[26,39,40,41,42,43,44,45],"Supramaximal resection","FLAIRectomy","Non-contrast enhancement","Neurological morbidity","Quality of life","Overall survival","Progression-free survival","RECRUITING","2024-02-20",{"date":49,"type":50},"2024-02-22","ACTUAL",{"date":52,"type":50},"2022-01-01",{"date":54,"type":22},"2028-01-01",{"name":56,"class":57},"Jasper Gerritsen","OTHER",8]