Actively Recruiting

Phase 3
Age: 18Years - 74Years
All Genders
NCT07021339

Anterior Temporal Lobectomy in Temporal Glioblastoma

Led by University Hospital, Bonn · Updated on 2025-06-13

178

Participants Needed

1

Research Sites

326 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Bonn

Lead Sponsor

U

University Hospital, Aachen

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Anterior Temporal Lobectomy in Temporal Glioblastoma

Who Can Participate

Age: 18Years - 74Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Suspected glioblastoma with contrast-enhancement on preoperative MRI
  • Newly diagnosed diffuse high-grade glioma confirmed by frozen section
  • Tumor solely in temporal lobe within 6.5 cm from temporal pole on non-dominant side or 4.0 cm on dominant side as defined
  • Complete tumor removal achievable based on surgeon's assessment
  • No tumor lesions beyond resection margins that are attributable to cancer
  • Age 18 to less than 75 years
  • Karnofsky Performance Score of at least 70%
  • Estimated life expectancy of 6 months or more
  • Able to provide informed consent
  • Cognitive ability to understand study and treatments
  • Compliance and proximity for follow-up visits
  • Negative pregnancy test for patients with childbearing potential and commitment to use effective contraception
  • Adequate bone marrow, liver, and kidney function for surgery and chemotherapy
  • Normal blood clotting parameters and safe to stop anticoagulants as required
Not Eligible

You will not qualify if you...

  • Tumor not located solely in the temporal lobe within specified distances
  • Inability to achieve complete tumor removal
  • Poor performance status (Karnofsky below 70%)
  • Life expectancy less than 6 months
  • Inability to understand or comply with study requirements
  • Pregnancy or inability to use contraception if applicable
  • Inadequate organ function or blood clotting abnormalities preventing surgery or chemotherapy
  • Unjustifiable continuation of anticoagulant therapy during perioperative period

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Hospital Bonn

Bonn, North Rhine-Westphalia, Germany, 53127

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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