Anterior Temporal Lobectomy in Temporal Glioblastoma

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-74
SponsorUniversity Hospital, Bonn

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

178 Participants
are divided into 2 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