Schneider, Matthias and Potthoff, Anna-Laura and Ahmadipour, Yahya and Borger, Valeri and Clusmann, Hans and Combs, Stephanie E. and Czabanka, Marcus and Duehrsen, Lasse and Etminan, Nima and Freiman, Thomas M. and Gerlach, Ruediger and Gessler, Florian and Giordano, Frank A. and Gkika, Eleni and Goldbrunner, Roland and Gueresir, Erdem and Hamou, Hussam and Hau, Peter and Ille, Sebastian and Jaegersberg, Max and Keric, Naureen and Khaleghi-Ghadiri, Maryam and Koenig, Ralph and Konczalla, Juergen and Krenzlin, Harald and Krieg, Sandro and Mclean, Aaron Lawson and Layer, Julian P. and Lehmberg, Jens and Malinova, Vesna and Meyer, Bernhard and Meyer, Hanno S. and Miller, Dorothea and Mueller, Oliver and Musahl, Christian and Pregler, Barbara E. F. and Rashidi, Ali and Ringel, Florian and Roder, Constantin and Roessler, Karl and Rohde, Veit and Sandalcioglu, I. Erol and Schaefer, Niklas and Schaub, Christina and Schmidt, Nils Ole and Schubert, Gerrit A. and Seidel, Clemens and Seliger, Corinna and Senft, Christian and Shawarba, Julia and Steinbach, Joachim and Stoecklein, Veit and Stummer, Walter and Sure, Ulrich and Tabatabai, Ghazaleh and Tatagiba, Marcos and Thon, Niklas and Timmer, Marco and Wach, Johannes and Wagner, Arthur and Wirtz, Christian Rainer and Zeiler, Katharina and Zeyen, Thomas and Schuss, Patrick and Surges, Rainer and Fuhrmann, Christine and Paech, Daniel and Schmid, Matthias and Borck, Yvonne and Pietsch, Torsten and Struck, Rafael and Radbruch, Alexander and Helmstaedter, Christoph and Nemeth, Robert and Herrlinger, Ulrich and Vatter, Hartmut (2025) The ATLAS/NOA-29 study protocol: a phase III randomized controlled trial of anterior temporal lobectomy versus gross-total resection in newly-diagnosed temporal lobe glioblastoma. BMC CANCER, 25 (1): 306. ISSN , 1471-2407
Full text not available from this repository. (Request a copy)Abstract
Background The discovery of cellular tumor networks in glioblastoma, with routes of malignant communication extending far beyond the detectable tumor margins, has highlighted the potential of supramarginal resection strategies. Retrospective data suggest that these approaches may improve long-term disease control. However, their application is limited by the proximity of critical brain regions and vasculature, posing challenges for validation in randomized trials. Anterior temporal lobectomy (ATL) is a standardized surgical procedure commonly performed in patients with pharmacoresistant temporal lobe epilepsy. Translating the ATL approach from epilepsy surgery to the neuro-oncological field may provide a model for investigating supramarginal resection in glioblastomas located in the anterior temporal lobe. Methods The ATLAS/NOA-29 trial is a prospective, multicenter, multinational, phase III randomized controlled trial designed to compare ATL with standard gross-total resection (GTR) in patients with newly-diagnosed anterior temporal lobe glioblastoma. The primary endpoint is overall survival (OS), with superiority defined by significant improvements in OS and non-inferiority in the co-primary endpoint, quality of life (QoL; "global health" domain of the European organization for research and treatment of cancer (EORTC) QLQ-C30 questionnaire). Secondary endpoints include progression-free survival (PFS), seizure outcomes, neurocognitive performance, and the longitudinal assessment of six selected domains from the EORTC QLQ-C30 and BN20 questionnaires. Randomization will be performed intraoperatively upon receipt of the fresh frozen section result. A total of 178 patients will be randomized in a 1:1 ratio over a 3-year recruitment period and followed-up for a minimum of 3 years. The trial will be supervised by a Data Safety Monitoring Board, with an interim safety analysis planned after the recruitment of the 57th patient to assess potential differences in modified Rankin Scale (mRS) scores between the treatment arms 6 months after resection. Assuming a median improvement in OS from 17 to 27.5 months, the trial is powered at > 80% to detect OS differences with a two-sided log-rank test at a 5% significance level. Discussion The ATLAS/NOA-29 trial aims to determine whether ATL provides superior outcomes at equal patients' Qol compared to GTR in anterior temporal lobe glioblastoma, potentially establishing ATL as the surgical approach of choice for isolated temporal glioblastoma and redefining the standard of care for this patient population. Trial registrationGerman Clinical Trials Register (DRKS00035314), registered on October 18, 2024.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | QUALITY-OF-LIFE; MALIGNANT GLIOMA; CHRONIC EPILEPSY; VERBAL MEMORY; OPEN-LABEL; SURGERY; TEMOZOLOMIDE; RADIOTHERAPY; CLASSIFICATION; COMBINATION; Anterior temporal lobectomy; Epilepsy surgery; Temporal lobe glioblastoma; Gross-total resection; Supramarginal resection |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Neurologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 31 Mar 2026 08:32 |
| Last Modified: | 31 Mar 2026 08:32 |
| URI: | https://pred.uni-regensburg.de/id/eprint/67851 |
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