September 12 2024
The NRG-BN013 phase III clinical trial was recently activated as a part of the NRG Oncology brain tumor portfolio. NRG-BN013 will compare two schedules of stereotactic radiosurgery (SRS) for patients with intact (i.e., unresected) brain metastases. The primary objective of the study is to determine if fractionated SRS (FSRS) with three treatments of radiotherapy over the course of a week improves the time to local failure over the usual treatment of one radiotherapy treatment in a single day for this population.
“At this time, single fraction SRS is the most commonly used focal approach but is associated with modest tumor control rates; as patients are living longer with intracranial metastatic disease, it is important to understand the best fractionation schedule. If the trial is able to prove that FSRS can improve tumor control over SRS, it has the potential to change clinical practice and establish a new standard of care. This is especially important to evaluate in the modern era in which patients receive systemic therapies with central nervous system (CNS) activity,” stated Rupesh Kotecha, MD, in the Department of Radiation Oncology at Miami Cancer Institute, Baptist Health South Florida and the Principal Investigator of the NRG-BN013 study.
Patients enrolled onto NRG-BN013 will be stratified by the presence of symptomatic brain metastasis, the use of targeted, immunotherapy, or antibody drug conjugates approximately 4 weeks prior to registration or planned within 4 weeks after completion of the SRS/FSRS, and the number of intracranial metastases. Following stratification, patients will be randomly assigned to receive either SRS in 22-24 Gy for 1 fraction (1-2cm) / 18-20 Gy in 1 fraction for (>2-3cm) or, FSRS for 30 Gy in 3 fractions (1-2cm) / 27 Gy in 3 fractions (>2-3cm).
Secondary objectives of this trial include comparing time to intracranial progression-free survival, overall survival, rates of radiation necrosis, time to salvage whole-brain radiotherapy, and rates of post-treatment adverse events between patients on the FSRS and SRS study arms. Additional secondary objectives include determining if the time to local failure is improved with FSRS compared to SRS as evaluated by central imaging and evaluating any differences in CNS failure patterns between the treatment arms.
Study documents for the NRG-BN013 study are available on CTSU.org
More information is available on ClinicalTrials.gov