The ATLAS/NOA-29 study protocol: a phase III randomized controlled trial of anterior temporal lobectomy versus gross-total resection in newly-diagnosed temporal lobe glioblastoma
BMC Cancer, vol. 25, pp. 306
Abstract
BACKGROUND: The discovery of cellular tumor networks in glioblastoma, with routes of malignant communication extending far beyond the detectable tumor margins, has highlighted the potential of supramarginal resection strategies. Retrospective data suggest that these approaches may improve long-term disease control. However, their application is limited by the proximity of critical brain regions and vasculature, posing challenges for validation in randomized trials. Anterior temporal lobectomy (ATL) is a standardized surgical procedure commonly performed in patients with pharmacoresistant temporal lobe epilepsy. Translating the ATL approach from epilepsy surgery to the neuro-oncological field may provide a model for investigating supramarginal resection in glioblastomas located in the anterior temporal lobe. METHODS: The ATLAS/NOA-29 trial is a prospective, multicenter, multinational, phase III randomized controlled trial designed to compare ATL with standard gross-total resection (GTR) in patients with newly-diagnosed anterior temporal lobe glioblastoma. The primary endpoint is overall survival (OS), with superiority defined by significant improvements in OS and non-inferiority in the co-primary endpoint, quality of life (QoL; "global health" domain of the European organization for research and treatment of cancer (EORTC) QLQ-C30 questionnaire). Secondary endpoints include progression-free survival (PFS), seizure outcomes, neurocognitive performance, and the longitudinal assessment of six selected domains from the EORTC QLQ-C30 and BN20 questionnaires. Randomization will be performed intraoperatively upon receipt of the fresh frozen section result. A total of 178 patients will be randomized in a 1:1 ratio over a 3-year recruitment period and followed-up for a minimum of 3 years. The trial will be supervised by a Data Safety Monitoring Board, with an interim safety analysis planned after the recruitment of the 57th patient to assess potential differences in modified Rankin Scale (mRS) scores between the treatment arms 6 months after resection. Assuming a median improvement in OS from 17 to 27.5 months, the trial is powered at > 80% to detect OS differences with a two-sided log-rank test at a 5% significance level. DISCUSSION: The ATLAS/NOA-29 trial aims to determine whether ATL provides superior outcomes at equal patients' Qol compared to GTR in anterior temporal lobe glioblastoma, potentially establishing ATL as the surgical approach of choice for isolated temporal glioblastoma and redefining the standard of care for this patient population. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00035314), registered on October 18, 2024.
Authors 74
-
Matthias B. Schneider corresponding
Affiliation as printed
Brain Tumor Translational Research Group, University Hospital Bonn, Bonn, Germany. matthias.schneider@ukbonn.de
Department of Neurosurgery, University Hospital Bonn, Venusberg Campus 1, Bonn, 53127, Germany. matthias.schneider@ukbonn.de
Brain Tumor Translational Research Group, University Hospital Bonn, Bonn, Germany
Department of Neurosurgery, University Hospital Bonn, Venusberg Campus 1, Bonn, 53127, Germany
-
Affiliation as printed
Brain Tumor Translational Research Group, University Hospital Bonn, Bonn, Germany
Department of Neurosurgery, University Hospital Bonn, Venusberg Campus 1, Bonn, 53127, Germany
-
Affiliation as printed
Department of Neurosurgery and Spine Surgery, University Hospital Essen, Essen, Germany
-
Affiliation as printed
Department of Neurosurgery, University Hospital Bonn, Venusberg Campus 1, Bonn, 53127, Germany
-
Universitätsklinikum Aachen · RWTH Aachen University
Affiliation as printed
Department of Neurosurgery, RWTH Aachen University Hospital, Aachen, Germany
-
TUM Klinikum · Technical University of Munich
Affiliation as printed
Department of Radiation Oncology, Klinikum Rechts Der Isar, Technical University of Munich (TUM), Munich, Germany
-
Affiliation as printed
Department of Neurosurgery, University Hospital Frankfurt, Frankfurt, Germany
-
University Medical Center Hamburg-Eppendorf
Affiliation as printed
Department of Neurosurgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
-
University Medical Centre Mannheim
Affiliation as printed
Department of Neurosurgery, University Hospital Mannheim, Mannheim, Germany
-
Affiliation as printed
Department of Neurosurgery, University Medical Center Rostock, Rostock, Germany
-
Helios Kliniken · Helios Klinikum Erfurt
Affiliation as printed
Department of Neurosurgery, Helios Kliniken, Erfurt, Germany
-
Affiliation as printed
Department of Neurosurgery, University Medical Center Rostock, Rostock, Germany
-
University Medical Centre Mannheim
Affiliation as printed
Department of Radiation Oncology, University Hospital Mannheim, Mannheim, Germany
-
University of Bonn · University Hospital Bonn
Affiliation as printed
Department of Radiation Oncology, University Hospital Bonn, Bonn, Germany
-
Affiliation as printed
Department of General Neurosurgery, Center of Neurosurgery, University of Cologne, Cologne, Germany
-
Affiliation as printed
Department of Neurosurgery, University Hospital Leipzig, Leipzig, Germany
-
Universitätsklinikum Aachen · RWTH Aachen University
Affiliation as printed
Department of Neurosurgery, RWTH Aachen University Hospital, Aachen, Germany
-
University Hospital Regensburg
Affiliation as printed
Department of Neurology and Wilhelm Sander-Therapy Unit, Regensburg University Medical Center, Regensburg, Germany
-
Heidelberg University · University Hospital Heidelberg
Affiliation as printed
Department of Neurosurgery, Heidelberg University Hospital, Heidelberg, Germany
-
University Medical Center of the Johannes Gutenberg University Mainz
Affiliation as printed
Department of Neurosurgery, University Medical Center Mainz, Mainz, Germany
-
Affiliation as printed
Department of Neurosurgery, University Medical Center Schleswig-Holstein/Lübeck, Lübeck, Germany
-
University of Münster · University Hospital Münster
Affiliation as printed
Department of Neurosurgery, University Hospital of Münster, Münster, Germany
-
Affiliation as printed
Department of Neurosurgery, University of Ulm, Günzburg, Germany
-
Affiliation as printed
Department of Neurosurgery, University Hospital Frankfurt, Frankfurt, Germany
-
Affiliation as printed
Department of Neurosurgery, University Medical Center Schleswig-Holstein/Lübeck, Lübeck, Germany
-
Heidelberg University · University Hospital Heidelberg
Affiliation as printed
Department of Neurosurgery, Heidelberg University Hospital, Heidelberg, Germany
-
Affiliation as printed
Department of Neurosurgery, Jena University Hospital, Jena, Germany
-
University of Bonn · University Hospital Bonn
Affiliation as printed
Department of Radiation Oncology, University Hospital Bonn, Bonn, Germany
Institute of Experimental Oncology, University Hospital Bonn, Bonn, Germany
-
München Klinik Bogenhausen · München Klinik
Affiliation as printed
Department of Neurosurgery, München Klinik Bogenhausen, Munich, Germany
-
Affiliation as printed
Department of Neurosurgery, University Medical Center Göttingen, Göttingen, Germany
-
TUM Klinikum · Technical University of Munich
Affiliation as printed
Department of Neurosurgery, Klinikum Rechts Der Isar, Technical University of Munich (TUM), Munich, Germany
-
University Medical Center Hamburg-Eppendorf
Affiliation as printed
Department of Neurosurgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
-
Universitätsklinikum Knappschaftskrankenhaus Bochum · Ruhr University Bochum
Affiliation as printed
Department of Neurosurgery, University Hospital Knappschaftskrankenhaus Bochum, Ruhr University Bochum, Bochum, Germany
-
Affiliation as printed
Neurosurgical Department, Dortmund Hospital, Dortmund, Germany
-
Affiliation as printed
Department of Neurosurgery, Kantonspital Aarau, Aarau, Switzerland
-
Affiliation as printed
Department of Neurosurgery, University Hospital Magdeburg, Magdeburg, Germany
-
LMU Klinikum · Ludwig-Maximilians-Universität München
Affiliation as printed
Department of Neurosurgery, Ludwig Maximilian University (LMU) Hospital, Munich, Germany
-
Affiliation as printed
Department of Neurosurgery, University Hospital Tübingen, Tübingen, Germany
-
Affiliation as printed
Department of Neurosurgery, University Medical Center Göttingen, Göttingen, Germany
-
Affiliation as printed
Department of Neurosurgery, University Hospital Magdeburg, Magdeburg, Germany
-
Affiliation as printed
Department of Neurooncology, Center of Neurology, University Hospital Bonn, Bonn, Germany
-
Universitätsklinikum Knappschaftskrankenhaus Bochum · Ruhr University Bochum
Affiliation as printed
Department of Neurology, University Hospital Knappschaftskrankenhaus Bochum, Ruhr University Bochum, Bochum, Germany
-
University Hospital Regensburg
Affiliation as printed
Department of Neurosurgery, University Hospital Regensburg, Regensburg, Germany
-
Universitätsklinikum Aachen · Kantonsspital Aarau · RWTH Aachen University
Affiliation as printed
Department of Neurosurgery, Kantonspital Aarau, Aarau, Switzerland
Department of Neurosurgery, RWTH Aachen University Hospital, Aachen, Germany
-
Affiliation as printed
Department of Radiation Oncology, University Hospital Leipzig, Leipzig, Germany
-
Universitätsklinikum Knappschaftskrankenhaus Bochum · Ruhr University Bochum
Affiliation as printed
Department of Neurology, University Hospital Knappschaftskrankenhaus Bochum, Ruhr University Bochum, Bochum, Germany
-
Affiliation as printed
Department of Neurosurgery, Jena University Hospital, Jena, Germany
-
Affiliation as printed
Department of Neurosurgery, Medical University of Vienna, Vienna, Austria
-
Affiliation as printed
Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Frankfurt, Germany
-
LMU Klinikum · Ludwig-Maximilians-Universität München
Affiliation as printed
Department of Neurosurgery, Ludwig Maximilian University (LMU) Hospital, Munich, Germany
-
University of Münster · University Hospital Münster
Affiliation as printed
Department of Neurosurgery, University Hospital of Münster, Münster, Germany
-
Affiliation as printed
Department of Neurosurgery and Spine Surgery, University Hospital Essen, Essen, Germany
-
Hertie Institute for Clinical Brain Research
Affiliation as printed
Department of Neurology and Interdisciplinary Neuro-Oncology, Hertie Institute for Clinical Brain Research, University Hospital Tübingen, Tübingen, Germany
-
Affiliation as printed
Department of Neurosurgery, University Hospital Tübingen, Tübingen, Germany
-
Universitätsklinikum Knappschaftskrankenhaus Bochum · Ruhr University Bochum
Affiliation as printed
Department of Neurosurgery, University Hospital Knappschaftskrankenhaus Bochum, Ruhr University Bochum, Bochum, Germany
-
Affiliation as printed
Department of General Neurosurgery, Center of Neurosurgery, University of Cologne, Cologne, Germany
-
Affiliation as printed
Department of Neurosurgery, University Hospital Leipzig, Leipzig, Germany
-
TUM Klinikum · Technical University of Munich
Affiliation as printed
Department of Neurosurgery, Klinikum Rechts Der Isar, Technical University of Munich (TUM), Munich, Germany
-
Affiliation as printed
Department of Neurosurgery, University of Ulm, Günzburg, Germany
-
München Klinik Bogenhausen · München Klinik
Affiliation as printed
Department of Neurosurgery, München Klinik Bogenhausen, Munich, Germany
-
Affiliation as printed
Brain Tumor Translational Research Group, University Hospital Bonn, Bonn, Germany
Department of Neurooncology, Center of Neurology, University Hospital Bonn, Bonn, Germany
-
Affiliation as printed
Department of Neurosurgery, Unfallkrankenhaus Berlin, Berlin, Germany
-
Affiliation as printed
Department of Epileptology, University Hospital Bonn, Bonn, Germany
-
Affiliation as printed
Clinical Study Core Unit Bonn, Institute of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Bonn, Germany
-
Brigham and Women's Hospital · Harvard University · University Hospital Bonn
Affiliation as printed
Department of Neuroradiology, University Hospital Bonn, Bonn, Germany
Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, USA
-
University Hospital Bonn · Institut für Medizinische Biometrie, Informatik und Epidemiologie
Affiliation as printed
Institute for Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany
-
Affiliation as printed
Clinical Study Core Unit Bonn, Institute of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Bonn, Germany
-
Affiliation as printed
Department of Neuropathology, University Hospital Bonn, Bonn, Germany
-
Affiliation as printed
Clinical Study Core Unit Bonn, Institute of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Bonn, Germany
-
University Hospital Bonn · Institut für Medizinische Biometrie, Informatik und Epidemiologie
Affiliation as printed
Institute for Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany
-
Affiliation as printed
Department of Epileptology, University Hospital Bonn, Bonn, Germany
-
University Hospital Bonn · Institut für Medizinische Biometrie, Informatik und Epidemiologie
Affiliation as printed
Institute for Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany
-
Affiliation as printed
Brain Tumor Translational Research Group, University Hospital Bonn, Bonn, Germany
Department of Neurooncology, Center of Neurology, University Hospital Bonn, Bonn, Germany
-
Affiliation as printed
Brain Tumor Translational Research Group, University Hospital Bonn, Bonn, Germany
Department of Neurosurgery, University Hospital Bonn, Venusberg Campus 1, Bonn, 53127, Germany
Cited by 1 stored of 1
1 result
No patents citing this paper on Lens.org (checked 2026-10-06).