Anterior Temporal Lobectomy in Temporal Glioblastoma

Summary

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.

Conditions

• Newly-diagnosed Glioblastoma
• Temporal Lobe

Interventions

PROCEDURE

Anterior temporal lobectomy (ATL)

Patients assigned to the experimental group will undergo an anterior temporal lobectomy (ATL) according to established protocols adapted from epilepsy surgery. ATL is a reproducible and anatomically well-defined procedure routinely performed in patients with pharmacoresistant temporal lobe epilepsy. On the non-dominant hemisphere, the neocortical resection typically extends 6.5 cm posteriorly from the temporal pole, while on the dominant side, the resection length is limited to 4.0 cm, both measured along the superior temporal gyrus and guided by the Sylvian fissure. Language dominance is determined based on handedness, as specified in the inclusion criteria. In most cases, the lateral neocortical segment can be removed en bloc. The mesial component of ATL encompasses resection of the uncus, amygdala, and the anterior hippocampus, typically including both the head and body. Resection is carried out to the level of the tectal plate or, at minimum, to the lateral mesencephalic sulcus.

PROCEDURE

Gross Total Resection (GTR)

Patients will be surgically treated with GTR in terms of removing 100% of the tumor tissue in gadolinium-enhanced MRI.

Sponsors & Collaborators

• University Hospital RWTH Aachen, Department of Neurosurgery

  collaborator UNKNOWN

• Kantonsspital Aarau, Department of Neurosurgery

  collaborator UNKNOWN

• University Hospital Bonn, Department of Neurosurgery

  collaborator UNKNOWN

• Dortmund Hospital, Neurosurgical Department

  collaborator UNKNOWN

• Helios Kliniken, Erfurt, Department of Neurosurgery

  collaborator UNKNOWN

• University Hospital Essen, Department of Neurosurgery and Spine Surgery

  collaborator UNKNOWN

• University Hospital Frankfurt, Department of Neurosurgery

  collaborator UNKNOWN

• University Hospital Giessen, Department of Neurosurgery

  collaborator UNKNOWN

• University Medical Center Göttingen, Department of Neurosurgery

  collaborator UNKNOWN

• University Medical Center Hamburg-Eppendorf, Department of Neurosurgery

  collaborator UNKNOWN

• Heidelberg University Hospital, Department of Neurosurgery

  collaborator UNKNOWN

• Jena University Hospital, Department of Neurosurgery

  collaborator UNKNOWN

• University of Cologne, Center of Neurosurgery Department of General Neurosurgery

  collaborator UNKNOWN

• University Hospital Leipzig, Department of Neurosurgery

  collaborator UNKNOWN

• University Medical Center Schleswig-Holstein/Lübeck, Department of Neurosurgery

  collaborator UNKNOWN

• Medical Faculty University Hospital Magdeburg, University Clinic for Neurosurgery

  collaborator UNKNOWN

• University Medical Center Mainz, Department of Neurosurgery

  collaborator UNKNOWN

• University Hospital Mannheim, Medical Faculty Mannheim, Department of Neurosurgery

  collaborator UNKNOWN

• Klinikum Rechts der Isar, Technical University of Munich, Department of Neurosurgery

  collaborator UNKNOWN

• LMU University Hospital, Department of Neurosurgery

  collaborator UNKNOWN

• University Hospital of Münster, Department of Neurosurgery

  collaborator UNKNOWN

• University Hospital Regensburg, Department of Neurosurgery

  collaborator UNKNOWN

• University Medical Centre Rostock, Department of Neurosurgery

  collaborator UNKNOWN

• University Hospital Tübingen, Department of Neurosurgery

  collaborator UNKNOWN

• University Hospital Ulm/Günzburg, University of Ulm, Department of Neurosurgery

  collaborator UNKNOWN

• Medical University of Vienna, Department of Neurosurgery

  collaborator UNKNOWN

• University Hospital, Bonn

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-28

Primary Completion

2028-02-28

Completion

2031-02-28

Countries

• Germany

Study Locations