[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"astrocytoma-malignant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:astrocytoma-malignant":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,58,93],{"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":34,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"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":21,"type":22},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.",[26,27,28,29,30,31,32,33],"Glioblastoma","Glioblastoma Multiforme","Glioblastoma, IDH-wildtype","Glioblastoma Multiforme of Brain","Glioblastoma Multiforme, Adult","Recurrent Glioblastoma","Astrocytoma, Malignant","Astrocytoma of Brain",[26,35,36,37,38,39,40,41,42,43,44],"Radiotherapy","Chemotherapy","Re-resection","Resection","Overall survival","Progression-free survival","Neurological morbidity","Safety","Serious Adverse Events","Quality of life","RECRUITING","2024-02-21",{"date":48,"type":49},"2024-02-28","ACTUAL",{"date":51,"type":49},"2023-01-01",{"date":53,"type":22},"2028-01-01",{"name":55,"class":56},"Jasper Gerritsen","OTHER",8,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":19,"enrollmentInfo":66,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":68,"conditions":69,"keywords":74,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":91,"locationsCount":57},"100537080","the-recmap-study-resection-with-or-without-intraoperative-mapping-for-recurrent-glioblastoma-100537080","NCT06273176","The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma","The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma: Study Protocol for An International Multicenter Prospective Cohort Study (ENCRAM 2301)","RECMAP","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. Tumors situated in or near eloquent areas; motor cortex, sensory cortex, subcortical pyramidal tract, speech areas or visual areas as indicated on MRI (Sawaya Grading II and II)19\n4. The tumor is suitable for resection (according to neurosurgeon)\n5. 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. Clinical data unavailable for the newly diagnosed setting",{"count":67,"type":22},225,"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.\n\nThis 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.\n\nThe study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).",[28,26,29,32,70,71,72,73,31],"Brain Neoplasms","Brain Neoplasms, Adult, Malignant","Brain Neoplasms, Adult","Recurrent Adult Brain Tumor",[26,75,37,38,76,77,78,79,80,81,39,40,41,44,82,83,84,85],"Recurrent","Intraoperative mapping","Awake mapping","Awake craniotomy","Asleep mapping","Motor mapping","Language mapping","Functional area","Eloquent","Extent of resection","Residual tumor volume","2024-02-20",{"date":88,"type":49},"2024-02-22",{"date":51,"type":49},{"date":53,"type":22},{"name":92,"class":56},"Erasmus Medical Center",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":103,"conditions":104,"keywords":111,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":119,"locationsCount":57},"100525206","the-supramax-study-supramaximal-resection-versus-maximal-resection-for-high-grade-glioma-patients-encram-2201-100525206","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",{"count":102,"type":22},784,"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).",[26,105,28,106,30,107,108,32,70,109,72,110],"High-grade Glioma","Glioblastoma, IDH-mutant","Astrocytoma, Grade IV","Astrocytoma, Grade III","Brain Neoplasm, Primary","Brain Neoplasm, Malignant",[26,112,113,114,41,44,39,40],"Supramaximal resection","FLAIRectomy","Non-contrast enhancement",{"date":88,"type":49},{"date":117,"type":49},"2022-01-01",{"date":53,"type":22},{"name":55,"class":56}]