NRG-BNO12
This study compares the addition of stereotactic radiosurgery before or after surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation only t...
About
NRG-BN012 is an unblinded, randomized phase III trial to determine if pre-resection stereotactic radiosurgery (SRS) to the intact lesion will significantly prolong time to composite adverse endpoint (CAE) compared to post-resection SRS in patients with resectable brain metastases. Randomization is a 1:1 ratio.
Arm 1: Surgery followed by post-resection SRS
Arm 2: Pre-resection SRS followed by surgery
NRG-BN012
Eligibility Criteria
Inclusion Criteria
- Patients ≥ 18 years of age
- Radiographic confirmation of 1-4 brain metastases, one of which requires resection, as defined by MRI with contrast obtained within 14 days prior to registration
- The maximum diameter of the lesion to be resected on the post-contrast MRI, as measured on any orthogonal plane (axial, sagittal, coronal), must measure ≥ 2.0 cm and ≤ 5.0 cm
- The maximum diameter of any lesion which will not be resected must be ≤ 4.0 cm in maximum diameter
- Known active or history of invasive non-CNS primary cancer based on documented pathologic diagnosis within the past 3 years
- All brain metastases must be located ≥ 5 mm from the optic chiasm and outside the brainstem
- Patient is able to medically tolerate surgery and SRS
Exclusion Criteria
- Prior cranial radiotherapy, including whole brain radiotherapy, or SRS to the resection site
- Evidence of leptomeningeal disease (LMD)
- Any medical conditions which would make this protocol unreasonably hazardous, including, but not limited to, contraindications to general endotracheal anesthesia, intracranial surgery and stereotactic radiosurgery
- Primary histology of germ cell tumor, small cell carcinoma or lymphoma
- More than one brain metastasis planned for resection
- Inability to undergo MRI with contrast
Primary Investigator
Cara Rogers, DO, is a board-certified neurosurgical oncologist. She completed her neurosurgical residency at Virginia Tech Carilion and a neurosurgical oncology fellowship at MD Anderson Cancer Center in Houston, Texas. Dr. Rogers joined the faculty of the Department of Neurosurgery in 2020 and is an assistant professor at the Virginia Tech Carilion School of Medicine.
Contact Information
Bailey Steele, MPH
Clinical Research Coordinator
