NCT07021339: ATLAS/NOA-29

Anterior Temporal Lobectomy in Temporal Glioblastoma

Recruiting now Phase 3 Last updated 13 June 2025

What this trial tests

Phase 3 trial testing Anterior temporal lobectomy (ATL) in Newly-diagnosed Glioblastoma in 178 participants. Currently enrolling.

Timeline

28 November 2024

Primary endpoint
28 February 2028

28 February 2031

Quick facts

Lead sponsor	University Hospital, Bonn
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	178
Start date	28 November 2024
Primary completion	28 February 2028
Estimated completion	28 February 2031
Sites	1 location across Germany

Drugs / interventions tested

• Anterior temporal lobectomy (ATL)
• Gross Total Resection (GTR)

Conditions studied

• Newly-diagnosed Glioblastoma — all drugs for Newly-diagnosed Glioblastoma →
• Temporal Lobe — all drugs for Temporal Lobe →

Sponsor

University Hospital, Bonn

Who can join

Adults 18 to 74, any sex, with Newly-diagnosed Glioblastoma or Temporal Lobe. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.