OCTS-04 TRIAL IN PROGRESS: PHASE II STUDY OF PRE-OPERATIVE HYPOFRACTIONATED STEREOTACTIC RADIOSURGERY FOR RESECTABLE BRAIN METASTASES

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Abstract BACKGROUND The current standard of care for limited resectable brain metastases is surgical resection followed by post-operative single-fraction stereotactic radiosurgery (sfSRS) to the resection cavity. Recent retrospective studies showed that pre-operative SRS improves tumor bed control and nodular leptomeningeal disease, but prospective data are lacking. We hypothesize that hypofractionated stereotactic radiosurgery (hfSRS) delivered pre-operatively to resectable brain metastases will result in improved durable local control. METHODS This is a single institution phase II study to assess time to local failure in patients with resectable brain metastases (BM) who elect for hfSRS followed by resection. The intervention is hfSRS delivered to a BM designated for resection. The planned target volume for hfSRS is the enhancing tumor + 1-2 mm margin expansion. The dose prescription is 9 Gy per fraction for a total of 3 consecutive daily fractions, to a total of 27 Gy. Surgical resection is planned within 7 days following completion of hfSRS. Other BMs, if present, are treated concurrently with either sfSRS or hfSRS. Key eligibility criteria include patients with at least 1 BM between 1 cm and 6 cm in maximal dimension not previously treated with SRS, deemed resectable by neurosurgery, and are asymptomatic from BM with or without steroids. The primary endpoint is time to local failure at the resection cavity. Other endpoints include time to leptomeningeal disease, changes in neurocognitive function, changes in quality of life (QoL), intracranial distant control, and overall survival. Time-to event outcomes will be analyzed with Kaplan-Meier curves. Changes in neurocognitive function and QoL metrics will be analyzed using descriptive statistics. This study is currently open with 34 patients enrolled at the time of submission. Clinical trial information: NCT05267587

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