Newly-diagnosed GlioblastomaPhase 3ATLAS/NOA-29NCT07021339

Anterior Temporal Lobectomy in Temporal Glioblastoma

A Phase 3 study testing Anterior temporal lobectomy (ATL) and Gross Total Resection (GTR) in people with Newly-diagnosed Glioblastoma and Temporal Lobe, run by University Hospital, Bonn at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 74 years
Conditions the study is for: Newly-diagnosed Glioblastoma, Temporal Lobe
What is being tested?: Anterior temporal lobectomy (ATL) and Gross Total Resection (GTR)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 178 participants
Where: 1 siteGermany
Study dates: 28 Nov 2024to 28 Feb 2031
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

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)
In case further T1-contrast-enhancing and/or T2/FLAIR lesions are detected beyond the resection margins (6.5 cm on the non-dominant side and 4.0 cm on the dominant side), these lesions are not attributed to the tumor (except perifocal edema) but to other conditions according to the local treating neurosurgeon
≥ 18 and < 75 years of age
KPS ≥ 70%
Estimated life expectancy of at least 6 months
Written informed consent
Cognitive state to understand the rationale and necessity of the study therapy and procedures
Patient compliance and geographic proximity that allow adequate follow-up
For patients with childbearing potential: negative serum pregnancy test (beta-HCG) at baseline visit, patient's commitment to use an approved contraceptive method during the trial and for 3 months after (Pearl index < 1%)
Adequate organ function at baseline visit that does not preclude alkylating chemotherapy and neurosurgical procedures (all criteria required):
Adequate bone marrow reserve: white blood cell (WBC) count ≥ 3.000/µl; granulocyte count > 1.500/µl; platelets ≥ 100.000/µl; haemoglobin ≥ 10 g/dl
Adequate liver function: bilirubin < 1.5 times above upper limit of normal range (ULN); alanine transaminase (ALT/SGPT) and aspartate transaminase (AST/ALAT) < 3 times ULN
Adequate renal function: creatinine < 1.5 times ULN
Adequate blood clotting: Partial Thromboplastin Time (PTT) not exceeding the upper limit of normal range and International Normalized Ratio (INR) <1.5; in case of intake of anticoagulant medication or platelet function inhibitors, the coagulation analysis must show no detectable effect in specific blood tests (as described below) at the time of surgery, and discontinuation of the anticoagulant medication must be justifiable for at least 1 week postoperatively
Direct acting oral anticoagulants (e.g., rivaroxaban, apixaban, edoxaban, dabigatran): anti-Factor Xa (aFXa)-activity within the normal range (rivaroxaban, apixaban, edoxaban), TT/TCT (thrombin clotting time) or ecarin clotting time (ECT) not exceeding the upper limit of normal range (Dabigatran) or verification of subtherapeutic drug levels (apixaban, edoxaban, rivaroxaban, dabigatran)
Vitamin K antagonists (coumarins): INR < 1.5
Unfractionated heparin (UFH) and argatroban: activated Partial Thromboplastin Time (aPTT) not exceeding the upper limit of normal range
Fractionated heparin/low-molecular-weight heparin (e.g., dalteparin, enoxaparin), heparinoid (e.g., fondaparinux, danaparoid): aFXa-activity within the normal range
Antiplatelet agents (aspirin, clopidogrel, prasugrel, ticagrelor): platelet function analyzer (PFA) test not exceeding the upper limit of normal range (aspirin), whole blood aggregometry not below lower limits of normal range (clopidogrel, prasugrel, ticagrelor)

For details see study protocol.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Germany1 site, 1 recruiting

University Hospital Bonn
Bonn, North Rhine-Westphalia, 53127
Dr. Rafael Struck, +49 228 287 10586, rafael.struck@ukbonn.de
Dr. med. Anna-Laura Potthoff, +49 228 287 16500, anna-laura.potthoff@ukbonn.de
Recruiting

Other trials in Germany

About this study

Official title: Randomized, Controlled Trial of Anterior Temporal Lobectomy Versus Gross Total Resection in Newly-diagnosed Temporal Glioblastoma (ATLAS/NOA-29)

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
Being tested: Anterior temporal lobectomy (ATL), Gross Total Resection (GTR)
Keywords: ATLAS/NOA-29, ATLAS, NOA-29, Anterior temporal lobectomy, gross total resection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anterior temporal lobectomy (ATL)Procedure or surgery
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.
Gross Total Resection (GTR)Procedure or surgery
Patients will be surgically treated with GTR in terms of removing 100% of the tumor tissue in gadolinium-enhanced MRI.

Study groups in NCT07021339
Study group	Role	What they receive
Gross total resection (GTR)	Active comparator	Complete resection of the contrast-enhancing tumor in Magnetic Resonance Imaging (MRI) Receives: Procedure: Gross Total Resection (GTR)
Anterior temporal lobectomy (ATL)	Experimental	Anterior temporal lobectomy Receives: Procedure: Anterior temporal lobectomy (ATL)

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall survival
OS in the modified intention to treat (mITT) population of patients with glioblastoma, Central Nervous System (CNS) World Health Organization (WHO) grade 4, Isocitrate Dehydrogenase wild-type (IDHwt)
Measured: From randomization until death or 36 months after recruitment of the last patient
Patient-reported Quality of Life
In case of significant OS differences, the patient-reported QoL domain "global health status" (EORTC QLQ-C30 questionnaire) in the modified intention to treat (mITT) population is the co-primary endpoint. Over-all superiority of ATL requires significantly prolonged OS and non-inferiority regarding the development of the global health status over time in the mITT population.
Measured: From randomization until death or 36 months after recruitment of the last patient

Secondary outcomes (6)

Progression-free survival
Progression is defined as the first documented evidence of progression of disease according to the Response Assessment in Neuro-Oncology 2.0 (RANO 2.0) criteria. Progression will be evaluated using the RANO (Response Assessment in Neuro-Oncology) 2.0. criteria.
Measured: PFS is measured from randomization at the day of surgery until progression or death. PFS will be assessed at the 12-week follow-up visit and at all subsequent visits scheduled at 12-week intervals up to three years.
Neurocognitive Outcome
All patients will undergo testing with the Brain Lesion Tracking Test (BLTT). The test covers all relevant domains of neurocognition-including episodic and semantic memory as well as executive functions-without excluding patients due to neurological impairments such as visual deficits or hemiparesis.
The BLTT includes interlocking word list learning with delayed free recall and recognition, semantic word generation and fluency, phonemic fluency, reverse digit span, and incidental memory, providing a rapid screening of neurocognitive function. Results are categorized into three performance domains: executive functions, episodic memory, and semantic memory. In addition, figural memory is assessed through a visual recognition task involving drawn objects presented on a series of cards.
Measured: Cognitive performance across all domains will be quantitatively assessed at baseline (preoperatively), and at follow-up visits on day 90 (visit 8) and one year after surgery (visit 11).
Karnofsky Performance Scale
Karnofsky Performance Scale (KPS) is an attempt to quantify cancer patients' general well-being and activities of daily life. The KPS ranking runs from 100 to 0, where 100 is "perfect" health and 0 is death.
Measured: KPS will be assessed at baseline, on postoperative day 1, and at follow-up visits on days 3, 14, 30, and 90, and subsequently at 12-week intervals.
Seizure outcome
Analysis of postoperative seizure outcome will be assessed referring to the ILAE classification system in the course of epilepsy surgical procedures: seizure freedom (ILAE class 1) will be de-fined as a favorable seizure outcome; ILAE classes 2-6 (i.e. pure auras, rare to no improvement and worsening of seizure frequency) will be referred to as unfavorable seizure outcome.
Measured: Seizure outcome will be assessed at the 12 weeks, the 6 months and all 12 week follow-up examination.
Modified Rankin Scale assessment (mRS)
The mRS will be used for measuring the degree of disability or dependence in the daily activities of patients. The mRS ranking runs from 0 to 6, where 0 is "perfect" health and 6 is death. Furthermore, 6 months after randomization of the 57th patient there will be carried out an interim safety analysis, which will evaluate differences in clinical performance (mRS) between the experimental and conventional intervention groups.
Measured: The mRS will be assessed at baseline, on postoperative day 1, and at follow-up visits on days 3, 14, 30, and 90, and subsequently at 12-week intervals.
Quality-of-life (QoL)
The EORTC quality of life (QoL) questionnaire modules QLQ-C30 and BN20 will be used to assess patients' QoL. These internationally recognized and well-validated instruments cover 26 QoL domains. Based on previous studies, particular emphasis will be placed on domains especially relevant to brain tumor patients, including global health status, physical functioning, social functioning, cognitive functioning, communication deficits, and motor dysfunction.
The questionnaires are designed for completion within approximately 10 minutes, both in the pretreatment phase and during ongoing treatment. Their validity has been demonstrated across various cancer populations and disease stages, including different treatment contexts. Test-retest reliability assessed over a four-day interval has shown good to excellent consistency across all functional domains, with Pearson's r values ranging from 0.72 to 0.91.
Measured: QoL will be assessed at baseline, at follow-up visits on days 14, 30, and 90, and subsequently at 24-week intervals.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Nov 202428 Feb 2031

First posted13 Jun 2025
Study start28 Nov 2024
Primary completion28 Feb 2028 (estimated)
Study completion28 Feb 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Newly-diagnosed GlioblastomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 178 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07021339
Sponsor's protocol ID: 70114652
Other IDs: 290/23
Acronym: ATLAS/NOA-29
Status last verified: Jun 2025
First submitted: 26 Mar 2025
Last updated: 13 Jun 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Schneider M, Potthoff AL, Karpel-Massler G, Schuss P, Siegelin MD, Debatin KM, Duffau H, Vatter H, Herrlinger U, Westhoff MA. The Alcatraz-Strategy: a roadmap to break the connectivity barrier in malignant brain tumours. Mol Oncol. 2024 Dec;18(12):2890-2905. doi: 10.1002/1878-0261.13642. Epub 2024 Apr 3.
PubMed 38567664
Schneider M, Potthoff AL, Ahmadipour Y, Borger V, Clusmann H, Combs SE, Czabanka M, Duhrsen L, Etminan N, Freiman TM, Gerlach R, Gessler F, Giordano FA, Gkika E, Goldbrunner R, Guresir E, Hamou H, Hau P, Ille S, Jagersberg M, Keric N, Khaleghi-Ghadiri M, Konig R, Konczalla J, Krenzlin H, Krieg S, McLean AL, Layer JP, Lehmberg J, Malinova V, Meyer B, Meyer HS, Miller D, Muller O, Musahl C, Pregler BEF, Rashidi A, Ringel F, Roder C, Rossler K, Rohde V, Sandalcioglu IE, Schafer N, Schaub C, Schmidt NO, Schubert GA, Seidel C, Seliger C, Senft C, Shawarba J, Steinbach J, Stocklein V, Stummer W, Sure U, Tabatabai G, Tatagiba M, Thon N, Timmer M, Wach J, Wagner A, Wirtz CR, Zeiler K, Zeyen T, Schuss P, Surges R, Fuhrmann C, Paech D, Schmid M, Borck Y, Pietsch T, Struck R, Radbruch A, Helmstaedter C, Nemeth R, Herrlinger U, Vatter H. 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. 2025 Feb 20;25(1):306. doi: 10.1186/s12885-025-13682-3.
PubMed 39979825
Borger V, Hamed M, Ilic I, Potthoff AL, Racz A, Schafer N, Guresir E, Surges R, Herrlinger U, Vatter H, Schneider M, Schuss P. Seizure outcome in temporal glioblastoma surgery: lobectomy as a supratotal resection regime outclasses conventional gross-total resection. J Neurooncol. 2021 Apr;152(2):339-346. doi: 10.1007/s11060-021-03705-x. Epub 2021 Feb 7.
PubMed 33554293
Schneider M, Potthoff AL, Keil VC, Guresir A, Weller J, Borger V, Hamed M, Waha A, Vatter H, Guresir E, Herrlinger U, Schuss P. Surgery for temporal glioblastoma: lobectomy outranks oncosurgical-based gross-total resection. J Neurooncol. 2019 Oct;145(1):143-150. doi: 10.1007/s11060-019-03281-1. Epub 2019 Sep 4.
PubMed 31485921
Karschnia P, Young JS, Dono A, Hani L, Sciortino T, Bruno F, Juenger ST, Teske N, Morshed RA, Haddad AF, Zhang Y, Stoecklein S, Weller M, Vogelbaum MA, Beck J, Tandon N, Hervey-Jumper S, Molinaro AM, Ruda R, Bello L, Schnell O, Esquenazi Y, Ruge MI, Grau SJ, Berger MS, Chang SM, van den Bent M, Tonn JC. Prognostic validation of a new classification system for extent of resection in glioblastoma: A report of the RANO resect group. Neuro Oncol. 2023 May 4;25(5):940-954. doi: 10.1093/neuonc/noac193.
PubMed 35961053
Roh TH, Kang SG, Moon JH, Sung KS, Park HH, Kim SH, Kim EH, Hong CK, Suh CO, Chang JH. Survival benefit of lobectomy over gross-total resection without lobectomy in cases of glioblastoma in the noneloquent area: a retrospective study. J Neurosurg. 2019 Mar 1;132(3):895-901. doi: 10.3171/2018.12.JNS182558. Print 2020 Mar 1.
PubMed 30835701
Schneider M, Ilic I, Potthoff AL, Hamed M, Schafer N, Velten M, Guresir E, Herrlinger U, Borger V, Vatter H, Schuss P. Safety metric profiling in surgery for temporal glioblastoma: lobectomy as a supra-total resection regime preserves perioperative standard quality rates. J Neurooncol. 2020 Sep;149(3):455-461. doi: 10.1007/s11060-020-03629-y. Epub 2020 Sep 29.
PubMed 32990861

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
Active, not recruitingPhase 1/2
A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma
Glioblastoma
Active, not recruitingPhase 2
Chemoradiotherapy Versus Chemotherapy for Elderly and Frail GBM Patients
Glioblastoma Multiforme
Active, not recruitingPhase 2
Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma
Anaplastic Astrocytoma, Anaplastic Astrocytoma, Not Otherwise Specified

All Newly-diagnosed Glioblastoma trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Controlled Trial of Anterior Temporal Lobectomy Versus Gross Total Resection in Newly-diagnosed Temporal Glioblastoma (ATLAS/NOA-29)
ClinicalTrials.gov ID: NCT07021339
Acronym / sponsor ID: ATLAS/NOA-29 / 70114652
Conditions: Newly-diagnosed Glioblastoma, Temporal Lobe
Keywords: ATLAS/NOA-29, ATLAS, NOA-29, Anterior temporal lobectomy, gross total resection
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 178 participants (estimated)
Lead sponsor: University Hospital, BonnUniversity, hospital or other
Collaborators: University Hospital, Aachen, Kantonsspital Aarau, Department of Neurosurgery, Dortmund Hospital, Neurosurgical Department, HELIOS Hospital, Erfurt, Germany, University Hospital, Essen, University Hospital Frankfurt, Department of Neurosurgery, University Hospital Giessen, Department of Neurosurgery, University Medical Center Göttingen, Department of Neurosurgery, Universitätsklinikum Hamburg-Eppendorf, University Hospital Heidelberg, Jena University Hospital, University of Cologne, Center of Neurosurgery Department of General Neurosurgery, University Hospital Leipzig, Department of Neurosurgery, University Hopsital Schleswig Holstein Campus Lübeck, Medical Faculty University Hospital Magdeburg, University Clinic for Neurosurgery, University Medical Center Mainz, Department of Neurosurgery, University Hospital Mannheim, Medical Faculty Mannheim, Department of Neurosurgery, Technical University of Munich, LMU University Hospital, Department of Neurosurgery, University Hospital of Münster, Department of Neurosurgery, University Hospital Regensburg, University Medical Center Rostock, University Hospital Tübingen, Department of Neurosurgery, University Hospital Ulm/Günzburg, University of Ulm, Department of Neurosurgery, Medical University of Vienna
Study start: 28 Nov 2024 (actual)
Primary completion: 28 Feb 2028 (estimated)
Study completion: 28 Feb 2031 (estimated)
First posted: 13 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Gross total resection (GTR)	Active comparator	Procedure: Gross Total Resection (GTR)Complete resection of the contrast-enhancing tumor in Magnetic Resonance Imaging (MRI)
Anterior temporal lobectomy (ATL)	Experimental	Procedure: Anterior temporal lobectomy (ATL)Anterior temporal lobectomy

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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 or surgery	Anterior temporal lobectomy (ATL)
Gross Total Resection (GTR)Patients will be surgically treated with GTR in terms of removing 100% of the tumor tissue in gadolinium-enhanced MRI.	Procedure or surgery	Gross total resection (GTR)

Primary outcome

Overall survival
Time frame: From randomization until death or 36 months after recruitment of the last patient
OS in the modified intention to treat (mITT) population of patients with glioblastoma, Central Nervous System (CNS) World Health Organization (WHO) grade 4, Isocitrate Dehydrogenase wild-type (IDHwt)
Patient-reported Quality of Life
Time frame: From randomization until death or 36 months after recruitment of the last patient
In case of significant OS differences, the patient-reported QoL domain "global health status" (EORTC QLQ-C30 questionnaire) in the modified intention to treat (mITT) population is the co-primary endpoint. Over-all superiority of ATL requires significantly prolonged OS and non-inferiority regarding the development of the global health status over time in the mITT population.

6 secondary outcomes

Progression-free survival
Time frame: PFS is measured from randomization at the day of surgery until progression or death. PFS will be assessed at the 12-week follow-up visit and at all subsequent visits scheduled at 12-week intervals up to three years.
Neurocognitive Outcome
Time frame: Cognitive performance across all domains will be quantitatively assessed at baseline (preoperatively), and at follow-up visits on day 90 (visit 8) and one year after surgery (visit 11).
Karnofsky Performance Scale
Time frame: KPS will be assessed at baseline, on postoperative day 1, and at follow-up visits on days 3, 14, 30, and 90, and subsequently at 12-week intervals.
Seizure outcome
Time frame: Seizure outcome will be assessed at the 12 weeks, the 6 months and all 12 week follow-up examination.
Modified Rankin Scale assessment (mRS)
Time frame: The mRS will be assessed at baseline, on postoperative day 1, and at follow-up visits on days 3, 14, 30, and 90, and subsequently at 12-week intervals.
Quality-of-life (QoL)
Time frame: QoL will be assessed at baseline, at follow-up visits on days 14, 30, and 90, and subsequently at 24-week intervals.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
Background: PubMed 38567664Schneider M, Potthoff AL, Karpel-Massler G, Schuss P, Siegelin MD, Debatin KM, Duffau H, Vatter H, Herrlinger U, Westhoff MA. The Alcatraz-Strategy: a roadmap to break the connectivity barrier in malignant brain tumours. Mol Oncol. 2024 Dec;18(12):2890-2905. doi: 10.1002/1878-0261.13642. Epub 2024 Apr 3.
Background: PubMed 39979825Schneider M, Potthoff AL, Ahmadipour Y, Borger V, Clusmann H, Combs SE, Czabanka M, Duhrsen L, Etminan N, Freiman TM, Gerlach R, Gessler F, Giordano FA, Gkika E, Goldbrunner R, Guresir E, Hamou H, Hau P, Ille S, Jagersberg M, Keric N, Khaleghi-Ghadiri M, Konig R, Konczalla J, Krenzlin H, Krieg S, McLean AL, Layer JP, Lehmberg J, Malinova V, Meyer B, Meyer HS, Miller D, Muller O, Musahl C, Pregler BEF, Rashidi A, Ringel F, Roder C, Rossler K, Rohde V, Sandalcioglu IE, Schafer N, Schaub C, Schmidt NO, Schubert GA, Seidel C, Seliger C, Senft C, Shawarba J, Steinbach J, Stocklein V, Stummer W, Sure U, Tabatabai G, Tatagiba M, Thon N, Timmer M, Wach J, Wagner A, Wirtz CR, Zeiler K, Zeyen T, Schuss P, Surges R, Fuhrmann C, Paech D, Schmid M, Borck Y, Pietsch T, Struck R, Radbruch A, Helmstaedter C, Nemeth R, Herrlinger U, Vatter H. 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. 2025 Feb 20;25(1):306. doi: 10.1186/s12885-025-13682-3.
Background: PubMed 33554293Borger V, Hamed M, Ilic I, Potthoff AL, Racz A, Schafer N, Guresir E, Surges R, Herrlinger U, Vatter H, Schneider M, Schuss P. Seizure outcome in temporal glioblastoma surgery: lobectomy as a supratotal resection regime outclasses conventional gross-total resection. J Neurooncol. 2021 Apr;152(2):339-346. doi: 10.1007/s11060-021-03705-x. Epub 2021 Feb 7.
Background: PubMed 31485921Schneider M, Potthoff AL, Keil VC, Guresir A, Weller J, Borger V, Hamed M, Waha A, Vatter H, Guresir E, Herrlinger U, Schuss P. Surgery for temporal glioblastoma: lobectomy outranks oncosurgical-based gross-total resection. J Neurooncol. 2019 Oct;145(1):143-150. doi: 10.1007/s11060-019-03281-1. Epub 2019 Sep 4.
Background: PubMed 35961053Karschnia P, Young JS, Dono A, Hani L, Sciortino T, Bruno F, Juenger ST, Teske N, Morshed RA, Haddad AF, Zhang Y, Stoecklein S, Weller M, Vogelbaum MA, Beck J, Tandon N, Hervey-Jumper S, Molinaro AM, Ruda R, Bello L, Schnell O, Esquenazi Y, Ruge MI, Grau SJ, Berger MS, Chang SM, van den Bent M, Tonn JC. Prognostic validation of a new classification system for extent of resection in glioblastoma: A report of the RANO resect group. Neuro Oncol. 2023 May 4;25(5):940-954. doi: 10.1093/neuonc/noac193.
Background: PubMed 30835701Roh TH, Kang SG, Moon JH, Sung KS, Park HH, Kim SH, Kim EH, Hong CK, Suh CO, Chang JH. Survival benefit of lobectomy over gross-total resection without lobectomy in cases of glioblastoma in the noneloquent area: a retrospective study. J Neurosurg. 2019 Mar 1;132(3):895-901. doi: 10.3171/2018.12.JNS182558. Print 2020 Mar 1.
Background: PubMed 32990861Schneider M, Ilic I, Potthoff AL, Hamed M, Schafer N, Velten M, Guresir E, Herrlinger U, Borger V, Vatter H, Schuss P. Safety metric profiling in surgery for temporal glioblastoma: lobectomy as a supra-total resection regime preserves perioperative standard quality rates. J Neurooncol. 2020 Sep;149(3):455-461. doi: 10.1007/s11060-020-03629-y. Epub 2020 Sep 29.
ATLAS/NOA-29 WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

Related trials for Newly-diagnosed Glioblastoma

Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
Active, not recruitingPhase 1/2
A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma
Glioblastoma
Active, not recruitingPhase 2
Chemoradiotherapy Versus Chemotherapy for Elderly and Frail GBM Patients
Glioblastoma Multiforme
Active, not recruitingPhase 2
Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma
Anaplastic Astrocytoma, Anaplastic Astrocytoma, Not Otherwise Specified

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

University Hospital Bonn

Bonn, Germany

+49 228 287 10586

rafael.struck@ukbonn.de

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: From randomization until death or 36 months after recruitment of the last patient). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07021339, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.