Medical Student, Neurosurgery Research Fellow Westchester Medical Center/New York Medical College New York, New York, United States
Introduction: In the United States, approximately 98,000 to 170,000 cases of brain metastases occur in patients each year. The current standard of care is surgical tumor removal followed by stereotactic radiotherapy three to four weeks later. This is a multicenter, phase III randomized controlled trial (RCT) to study the safety and efficacy of surgical tumor removal followed by intraoperative radiation therapy using FDA-cleared GammaTile-Surgically Targeted Radiation Therapy (GT) for newly-diagnosed brain metastases, compared to the current standard of care.
Methods: This multicenter, phase III RCT opened for enrollment in 2021. The enrollment goal is 180 patients. The target patient population is adult patients (≥18 years old) with one to six newly-diagnosed brain metastases from an extracranial primary tumor. The index lesion (2 to 7 cm) must be surgically removed. Non-index lesions must measure less than or equal to 4.0 cm. Previous and/or concurrent systemic therapy is permitted. The primary outcome measure is surgical bed recurrence-free survival. Secondary outcomes include local control, overall survival, adverse effects, Karnofsky Performance Score, neurocognitive status, and quality of life. The follow-up period is four years.
Results: Thus far, 139 patients across 30 sites in the United States have been consented. Of these, 131 patients have been randomized, and 110 have continued with their treatment allocation (i.e. GT or stereotactic radiosurgery). Histology of the primary brain cancers include lung (45.5%), breast (15.5%), melanoma (13.6%), other (23.6%), and unknown (1.8%).
Conclusion : This is the first randomized clinical trial for an adjunctive radiotherapy to target newly-diagnosed brain metastases in adult patients. Through optimization of radiation dosimetry and precision of radiation delivery, GT has the potential to become more routinely utilized in the treatment of upfront brain metastases.
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