Surgery and Tile-Based Radiation Therapy Versus Surgery and Stereotactic Radiation for Newly Diagnosed Brain Metastases: A Randomized, Open-Label, Phase III Trial

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Abstract
Purpose: Postoperative stereotactic radiation (SRT) is the standard-of-care for resected brain metastases. Implantation of cesium-131 collagen tiles (tile-based radiation therapy [TBRT]) initiates focal radiation immediately after resection, potentially offering therapeutic and logistical advantages. Radiation One and Done Study, a randomized, open-label, noninferiority, phase III trial (ClinicalTrials.gov identifier: NCT04365374 ), compared the safety and efficacy of resection with TBRT (R + TBRT) with resection with SRT (R + SRT) for patients with a newly diagnosed brain metastasis indicated for surgical resection. Methods: Across 32 US centers, patients were preoperatively randomly assigned 1:1 to R + TBRT or R + SRT. Any nonresected brain metastases received SRT postoperatively. Co-primary outcomes were time-to-surgical bed recurrence (SBR) and surgical bed recurrence-free survival (SB-RFS). Outcomes were analyzed using Cox proportional hazards models with stratification factors as covariates. Multiplicity was controlled by hierarchical testing. Analyses used the prespecified modified intention-to-treat (mITT) population (patients who underwent surgery, had pathologic confirmation of brain metastasis, and had follow-up information). Results: From April 2021 to August 2025, 230 patients were randomly assigned (115 per arm), 204 of whom (103 R + TBRT, 101 R + SRT) comprised the mITT population. The median follow-up was 12.9 months. The median time-to-SBR was not reached in R + TBRT versus 17.4 months in R + SRT (hazard ratio [HR]: 0.06 [95% CI, 0.01 to 0.46]; P = .0070). SB-RFS was improved with R + TBRT, with a median of not reached versus 10.9 months in R + SRT (HR, 0.48 [95% CI, 0.30 to 0.76]; P = .0021). Overall adverse events did not appear to differ: 83 patients (79.0% [95% CI, 70.0 to 86.4]) in R + TBRT versus 67 patients (80.7% [95% CI, 70.6 to 88.6]) in R + SRT. Conclusion: For patients with newly diagnosed brain metastases requiring resection, R + TBRT significantly improved SBR and SB-RFS, demonstrating both noninferiority and superiority.

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