About this trial
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.
Eligibility criteria
Qualifiers
Suspected glioblastoma with contrast-enhancement in preoperative MRI
Diffuse high-grade glioma in frozen section procedure, newly-diagnosed
Tumor localization (in gadolinium-enhanced MRI): solely temporal, non-dominant side (right hemisphere in right-handed patients, or left-handed patients after testing for dominance): within 6.5 cm from the temporal pole; dominant side (left hemisphere in right-handed patients, all left-handed patients unless additional testing for dominance performed): within 4.0 cm from the temporal pole, as determined dorsally along the Sylvian fissure.
Macroscopic complete resection (no remaining contrast-enhancing tumoral lesion on early postoperative MRI) is achievable (decision of the treating neurosurgeon)
Disqualifiers
None
Trial design
Treatments tested in this trial
- Anterior temporal lobectomy (ATL)
- Gross Total Resection (GTR)
Treatment groups
Sponsors and collaborators
University Hospital, Bonn
Lead sponsor
University Hospital, Aachen
Collaborator
Kantonsspital Aarau, Department of Neurosurgery
Collaborator
Dortmund Hospital, Neurosurgical Department
Collaborator
Helios Kliniken, Erfurt, Department of Neurosurgery
Collaborator
University Hospital, Essen
Collaborator
University Hospital Frankfurt, Department of Neurosurgery
Collaborator
University Hospital Giessen, Department of Neurosurgery
Collaborator
University Medical Center Göttingen, Department of Neurosurgery
Collaborator
Universitätsklinikum Hamburg-Eppendorf
Collaborator
University Hospital Heidelberg
Collaborator
Jena University Hospital
Collaborator
University of Cologne, Center of Neurosurgery Department of General Neurosurgery
Collaborator
University Hospital Leipzig, Department of Neurosurgery
Collaborator
University Medical Center Schleswig-Holstein/Lübeck, Department of Neurosurgery
Collaborator
Medical Faculty University Hospital Magdeburg, University Clinic for Neurosurgery
Collaborator
University Medical Center Mainz, Department of Neurosurgery
Collaborator
University Hospital Mannheim, Medical Faculty Mannheim, Department of Neurosurgery
Collaborator
Technical University of Munich
Collaborator
LMU University Hospital, Department of Neurosurgery
Collaborator
University Hospital of Münster, Department of Neurosurgery
Collaborator
University Hospital Regensburg
Collaborator
University Medical Center Rostock
Collaborator
University Hospital Tübingen, Department of Neurosurgery
Collaborator
University Hospital Ulm/Günzburg, University of Ulm, Department of Neurosurgery
Collaborator
Medical University of Vienna, Department of Neurosurgery
Collaborator