Anterior Temporal Lobectomy in Temporal Glioblastoma

The ATLAS/NOA-29 trial is a prospective, multicenter, phase III randomized controlled study evaluating whether anterior temporal lobectomy (ATL), a standardized resection technique adapted from epilepsy surgery, improves clinical outcomes in patients with newly diagnosed glioblastoma of the anterior temporal lobe compared to conventional gross-total resection (GTR). The rationale is based on the concept of glioblastoma as a diffusely connected tumor network, with infiltrative spread extending beyond MRI-detectable tumor margins. ATL offers a reproducible supramarginal resection approach within anatomical boundaries that are routinely respected in epilepsy surgery. Patients are randomized intraoperatively in a 1:1 ratio following histopathological confirmation via intraoperative frozen section procedure. The trial's primary objective is to demonstrate superiority of ATL in overall survival (OS), while confirming non-inferiority in health-related quality of life (QoL), measured by the global health status scale of the European Organisation for Research and Treatment of Cancer (EORTC) - Quality of Life Questionnaire Core 30 (QLQ-C30). Secondary outcomes include progression-free survival (PFS), seizure control, neurocognitive functioning, and longitudinal assessments of selected EORTC QLQ-C30 and BN20 domains. A total of 178 patients will be enrolled over three years, with a minimum follow-up of three years. An interim safety analysis after inclusion of 57 patients will assess functional outcome differences using the modified Rankin Scale (mRS) at 6 months postoperatively. The study is powered (\>80%) to detect a survival benefit assuming a median OS increase from 17 to 27.5 months. If proven superior to GTR, ATL could emerge as the preferred surgical strategy for isolated temporal lobe glioblastoma, offering robust evidence in favor of extending supramarginal resection principles to the broader context of glioblastoma care.

NCT Number	NCT07021339
Lead Sponsor	University Hospital, Bonn Collaborators: University Hospital, Aachen, Kantonsspital Aarau, Department of Neurosurgery, Dortmund Hospital, Neurosurgical Department, Helios Kliniken, Erfurt, Department of Neurosurgery, University Hospital, Essen, University Hospital Frankfurt, Department of Neurosurgery, University Hospital Giessen, Department of Neurosurgery, University Medical Center Göttingen, Department of Neurosurgery, Universitätsklinikum Hamburg-Eppendorf, University Hospital Heidelberg, Jena University Hospital, University of Cologne, Center of Neurosurgery Department of General Neurosurgery, University Hospital Leipzig, Department of Neurosurgery, University Medical Center Schleswig-Holstein/Lübeck, Department of Neurosurgery, Medical Faculty University Hospital Magdeburg, University Clinic for Neurosurgery, University Medical Center Mainz, Department of Neurosurgery, University Hospital Mannheim, Medical Faculty Mannheim, Department of Neurosurgery, Technical University of Munich, LMU University Hospital, Department of Neurosurgery, University Hospital of Münster, Department of Neurosurgery, University Hospital Regensburg, University Medical Center Rostock, University Hospital Tübingen, Department of Neurosurgery, University Hospital Ulm/Günzburg, University of Ulm, Department of Neurosurgery, Medical University of Vienna, Department of Neurosurgery
Conditions	Newly-diagnosed Glioblastoma, Temporal Lobe
Enrollment	178 participants
Start Date	2024-11-28
Primary Completion	2028-02-28 (estimated)
Study Completion	2031-02-28 (estimated)
Updated on ClinicalTrials.gov	2025-06-13