Surgery and tile-based radiation therapy versus surgery and stereotactic radiation for newly diagnosed brain metastases (ROADS): a randomized, open-label, phase 3 trial
Jeffrey S. Weinberg, Brandon S. Imber, Vincent DiNapoli, Nelson S. Moss, Kimberly B. Hoang, Fen Wang, Imran Mohiuddin, Akshitkumar M. Mistry, Michael A. Garcia, Hussein Tawbi, Nitesh V. Patel, Huong Pham, Robert Ryan, John Wanebo, Kris Smith, Clark C. Chen, Alexandra Paul, Lindsey Sloan, Matthew J. Shepard, Ken Tatebe, Colette J. Shen, David G. Brachman, Angela M. Richardson, Linton T. Evans, Gregory B. Biedermann, Adam Robin, Toral R. Patel, Aristotelis Filippidis, Heather Lin, Lola B. Chambless, John Dombrowski, Akash J. Patel, Sajeel Chowdhary, K. Stuart Lee, M. Sean Peach, Adam Nowlan, David J. McCracken, John Floyd, Fen Xia, Jeremy Rudnick, Jing Li, Debra Nana Yeboa, Frederick F. Lang, Rajat J. Kudchadker, Mary Frances McAleer, Jeffrey Wefel, Sherise Desiree Ferguson, Ying Yuan, Simon Hanft, Thomas H. BeckhamPURPOSE
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 (
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.