June 09 2023
NRG Oncology recently reactivated the phase III NRG-BN009 clinical trial following a major amendment that made changes to the study design to address insurance barriers with a goal of increasing enthusiasm among patients and physicians for engagement on this study.
NRG-BN009 will accrue patients with distant brain relapse with brain metastasis velocity of greater than or equal to four brain metastases a year since their last treatment with stereotactic radiosurgery (SRS). Trial participants will receive either the study experimental treatment of hippocampal-avoidant whole brain radiotherapy (HA-WBRT) or the standard of care treatment of SRS. Changes to the study approach did not impact the overall primary objective of the study to determine if HA-WBRT can improve freedom from neurologic death for these high-risk brain metastasis patients.
Additional changes to the protocol now allow patients that have undergone multiple SRS treatments for different brain metastases to be eligible for enrollment as long as prior brain metastasis velocity has been less than four brain metastases a year. Eligibility also now includes patients with small cell cancer.
“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 and continue to be treated with radiosurgery, 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 Warrenville, 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.”
“We are hoping that the changes made to NRG-BN009 address the barriers that we were made aware of from our sites. Our goal is to enable more patients and physicians to confidently accrue to this incredibly important study so we can address an important, unmet need for this patient population,” stated Michael Chan, MD, of the Wake Forest University Health Sciences Department of Radiation Oncology and the Co-Principal Investigator of NRG-BN009.
In addition to time to neurologic death, NRG-BN009 will also assess overall survival, intracranial progression-free survival, subsequent relapse, perceived difficulties in cognitive abilities, symptoms burden, and health status, cognitive function, adverse events, and recurrent intracranial disease as secondary objectives.
More Study Information
Learn more about this trial at ClinicalTrials.gov
Protocol documents and materials are located on the CTSU website
NRG-BN009 has a patient-facing study webpage available as well on the NRG website at http://www.nrgoncology.org/BN009.