January 12 2021
Phase III Trial of Salvage Stereotactic Radiosurgery (SRS) or SRS + Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for First or Second Distant Brain Relapse After Upfront SRS with Brain Metastasis Velocity ≥4 Brain Metastases/Year
The NRG Oncology clinical trial NRG-BN009 activated in December 2020. NRG-BN009 is a phase III trial that will be comparing salvage stereotactic radiosurgery (SRS) to SRS with the addition of hippocampal-avoidant whole brain radiotherapy (HA-WBRT) for patients with recurrent brain metastases and high brain metastases velocity (BMV) after upfront radiosurgery. Patients on this trial initially receive upfront SRS prior to the trial arm procedures.
“At this time, there is no standard of care for patients with recurrent brain metastases following upfront radiosurgery. However, there is emerging evidence that patients who present with high brain metastasis velocity at the time of recurrence are at higher risk of not only developing further metastases but also dying from neurologic causes,” stated Vinai Gondi, MD, Co-Director of the Brain & Spine Tumor Center at the Northwestern Medicine Cancer Center in Warrenville, the Director of Research and Education Northwestern Medicine Chicago Proton Center, and Co-Principal Investigator of NRG-BN009. “There was a need to develop NRG-BN009 to determine a standard of care treatment to help improve survival outcomes in this high-risk population of brain metastasis patients.”
NRG-BN009 will accrue patients at the time of their first or second distant brain relapse following upfront SRS with a BMV of greater to or equal to four brain metastases per year. Patients eligible to participate on NRG-BN009 will be stratified by the number of brain metastases, whether the patient has received immunotherapy prior to the trial or not, and the patient’s diagnosis-specific graded prognostic assessment. Following stratification, participants will be randomly assigned to receive either the control treatment of salvage SRS or salvage SRS with HA-WBRT and the medication memantine.
“Our goal is to determine if utilizing memantine and hippocampal-avoidance can help with neuroprotective strategies to safely prolong neurological survival for these high-risk patients when compare to stereotactic radiosurgery alone,” stated Michael Chan, MD, of the Wake Forest University Health Sciences Department of Radiation Oncology and the Co-Principal Investigator of NRG-BN009.
Study researchers will be primarily analyzing if the addition of HA-WBRT to upfront and salvage SRS helps to prolong the time until a patient’s neurological death. Additionally, the NRG-BN009 trial will assess if the SRS and HA-WBRT arm helps to prolong overall survival and intracranial progression-free survival as well as improve brain metastases velocity for subsequent relapses. Included in the trial will also be comparisons of cognitive and patient-reported outcomes and adverse events between treatments.
Learn more about this trial on ClinicalTrials.gov
Protocol documents and materials are located on the CTSU website.