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. Weinberg B. Imber V. Dinapoli N. Moss K. Hoang Fen Wang I. Mohiuddin Akshitkumar M. Mistry Michael A. Garcia H. Tawbi Nitesh V. Patel H. Pham R. Ryan J. Wanebo Kris A. Smith Clark C. Chen Alexandra R. Paul Lindsey Sloan M. Shepard K. Tatebe Colette J. Shen D. Brachman Angela M. Richardson L. Evans G. Biedermann Adam M. Robin T. Patel Aristotelis S. Filippidis Heather Y. Lin L. Chambless J. Dombrowski Akash J. Patel Sajeel A. Chowdhary K. S. Lee M. Peach A. Nowlan D. McCracken J. Floyd F. Xia J. Rudnick Jing Li D. Yeboa Frederick F. Lang R. Kudchadker M. McAleer J. Wefel S. Ferguson Ying Yuan S. Hanft T. Beckham

Sep 2026 · Journal of Clinical Oncology · pp. 101200JCO2601894 · 0 citations

Medicine

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.

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