Surgery and Tile-Based Radiation Therapy Versus Surgery and Stereotactic Radiation for Newly Diagnosed Brain Metastases: A Randomized, Open-Label, Phase III Trial
Recommended Citation
Weinberg JS, Imber BS, DiNapoli V, Moss NS, Hoang KB, Wang F, Mohiuddin I, Mistry AM, Garcia MA, Tawbi H, Patel NV, Pham H, Ryan R, Wanebo J, Smith K, Chen CC, Paul A, Sloan L, Shepard MJ, Tatebe K, Shen CJ, Brachman DG, Richardson AM, Evans LT, Biedermann GB, Robin A, Patel TR, Filippidis A, Lin H, Chambless LB, Dombrowski J, Patel AJ, Chowdhary S, Lee KS, Peach MS, Nowlan A, McCracken DJ, Floyd J, Xia F, Rudnick J, Li J, Yeboa DN, Lang FF, Kudchadker RJ, McAleer MF, Wefel J, Ferguson SD, Yuan Y, Hanft S, Beckham TH. Surgery and Tile-Based Radiation Therapy Versus Surgery and Stereotactic Radiation for Newly Diagnosed Brain Metastases (ROADS): A Randomized, Open-Label, Phase 3 Trial. J Clin Oncol. 2026;101200jco2601894.
Document Type
Article
Publication Date
11-10-2026
Publication Title
Journal of clinical oncology
Abstract
PURPOSE: Post-operative 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. ROADS: a randomized, open-label, non-inferiority, phase 3 trial (NCT04365374) compared the safety and efficacy of resection with TBRT (R+TBRT) to resection with SRT (R+SRT) for patients with a newly diagnosed brain metastasis indicated for surgical resection. PATIENTS AND METHODS: Across 32 United States centers, patients were pre-operatively randomized 1:1 to resection R+TBRT or R+SRT. Any non-resected brain metastases received SRT post-operatively. 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 pre-specified modified intent-to-treat (mITT) population (patients who underwent surgery, had pathologic confirmation of brain metastasis, and had follow-up information). RESULTS: From April 2021 through August 2025, 230 patients were randomized (115 per arm); 204 of whom (103 R+TBRT, 101 R+SRT) comprised the mITT population. Median follow-up was 12.9 months. Median time-to-SBR was not reached (R+TBRT) versus 17.4 months (R+SRT) (hazard ratio [HR]: 0.06; 95% confidence interval [CI]: 0.01-0.46; p=0.0070). SB-RFS was improved with R+TBRT, with a median of not reached versus 10.9 months (R+SRT) (HR: 0.48; 95% CI: 0.30-0.76; p=0.0021). Overall adverse events did not appear to differ: 83 patients (79.0%, 95% CI: 70.0-86.4) (R+TBRT) versus 67 patients (80.7%, 95% CI:70.6-88.6) (R+SRT). CONCLUSION: For patients with newly diagnosed brain metastases requiring resection, R+TBRT significantly improved SBR and SB-RFS, demonstrating both non-inferiority and superiority.
PubMed ID
42804720
First Page
2601894
Last Page
2601894
