Comparison of Two Surgical Procedures for Newly Diagnosed Glioblastoma in the Temporal Lobe (ATLAS/NOA-29)

A glioblastoma is the most common and most aggressive malignant brain tumor in adults (WHO Grade 4). The tumor cells grow rapidly and spread into the surrounding brain tissue. This makes it difficult to remove the tumor completely. If the tumor is located in the temporal lobe, two surgical procedures are available. In a gross total resection (GTR), surgeons completely remove the tumor as visible on magnetic resonance imaging (MRI). This refers to the portion of the tumor that becomes visible on MRI after the administration of a contrast agent. In an anterior temporal lobe resection (ATL), surgeons remove not only the tumor but also surrounding tissue of the temporal lobe. This procedure has been used in epilepsy surgery for many years and is considered an established practice in that field.

The goal of this Phase 3 study is to investigate whether the extended surgery (ATL) leads to better treatment outcomes compared to the standard surgery (GTR). Patients are randomly assigned to one of the two surgical procedures. The study is open-label (not blinded), as the type of surgery can be identified later through imaging. After surgery, all patients receive follow-up treatment in accordance with current guidelines. This typically involves radiation therapy in combination with the drug temozolomide. For older patients or those with certain tumor characteristics (such as MGMT promoter methylation), different treatment regimens are used. These include, for example, a shortened course of radiation therapy or a combination of radiation therapy and the drugs lomustine (CCNU) and temozolomide. The main objective (the primary endpoint) of the study is to assess overall survival. At the same time, patients’ quality of life is monitored. Participation lasts between 36 and 72 months, depending on the individual’s course of the disease.

Eligible participants are women and men between the ages of 18 and 75 with a newly diagnosed glioblastoma in the temporal lobe. The tumor must be completely resectable by surgery. Patients must be in sufficiently good general health. They must not have previously undergone chemotherapy or radiation therapy to the brain.