NRG-BN012: A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients With Resectable Brain Metastases
Objective
Primary Objective: To determine if the time to composite adverse endpoint (CAE) [defined as: 1) local tumor progression within the surgical bed; and/or 2) adverse radiation effect (ARE), the imaging correlate of post-SRS radiation necrosis; and/or 3) nodular meningeal disease (nMD)] is improved in patients treated with pre-resection SRS to the intact lesion versus those treated with post-resection SRS.
Secondary Objectives: To assess the trajectory of symptom burden in patients treated with pre-resection SRS to the intact lesion versus those treated to the post-resection surgical cavity as measured by MD Anderson Symptom Inventory for brain tumor (MDASI-BT)To determine whether there is improved overall survival (OS) in patients with resected brain metastases who undergo pre-resection SRS compared to patients who receive post-resection SRS.To compare rates of ARE, the imaging correlate of radiation necrosis, in patients who receive pre-resection SRS to patients who receive post-resection SRS.To determine whether there is increased time to whole brain radiotherapy (WBRT) in patients who receive pre-resection SRS compared to patients who receive post-resection SRS.To assess the trajectory of neuro-cognitive function in patients treated with pre-resection SRS to the intact lesion versus those treated to the post-resection surgical cavity as measured by the Montreal Cognitive Assessment (MoCA).To compare rates of nodular meningeal disease in patients who receive pre-resection SRS to patients who receive post-resection SRS. To compare rates of local recurrence in the resection cavity for patients who receive pre-resection SRS to patients who receive post-resection SRS. To compare rates of local recurrence of intact, non-index metastases treated with SRS. To compare rates of distant brain failure in patients who receive pre-resection SRS to patients who receive post-resection SRS. To assess toxicity in the two treatment arms.
