Surgery and tile-based radiation therapy versus surgery and stereotactic radiation for newly diagnosed brain metastases (ROADS): a randomized, open-label, phase 3 trial

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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Journal
Journal of Clinical Oncology
Published
2026-09-28
DOI
https://doi.org/10.1200/jco-26-01894
Primary Topic
Brain Metastases and Treatment
Type
article
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article

Surgery and tile-based radiation therapy versus surgery and stereotactic radiation for newly diagnosed brain metastases (ROADS): a randomized, open-label, phase 3 trial

Hussein A. Tawbi, Kris Smith, Gregory B. Biedermann, Matthew J. Shepard et al.
Journal of Clinical Oncology
Brain Metastases and Treatment
article

Surgery and tile-based radiation therapy versus surgery and stereotactic radiation for newly diagnosed brain metastases (ROADS): a randomized, open-label, phase 3 trial

Hussein A. Tawbi, Kris Smith, Gregory B. Biedermann, Matthew J. Shepard, Ying Yuan, Brandon S. Imber, Frederick F. Lang, Lindsey Sloan, Aristotelis Filippidis, David J. McCracken, Lola Chambless, Colette J. Shen, Kimberly Bojanowski Hoang, Jeffrey S. Weinberg, Sherise Desiree Ferguson, Linton T. Evans, Simon Hanft, Akshitkumar M. Mistry, H PHAM, Ken Tatebe, Heather Yan Lin, Matthew Sean Peach, Thomas Hendrix Beckham, Akash J. Patel, Angela Mae Richardson, Nelson S. Moss, Jeffrey S. Wefel, David G Brachman, Fen Xia, Rajat J. Kudchadker, Fen Wang, Robert Ryan, Jeremy Rudnick, John Wanebo, Adam Robin, Michael A. Garcia, Alexandra Paul, John Floyd, Vincent DiNapoli, Imran Mohiuddin, Toral R. Patel, K. Stuart Lee, Sajeel Chowdhary, Mary Frances McAleer, Nitesh V. Patel, Adam Nowlan, Debra Nana Yeboa, Jing Li, Clark C. Chen, John Dombrowski
article en

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.

Journal of Clinical Oncology
University of North Carolina at Chapel Hill (US), Cedars-Sinai Medical Center (US), Indiana University Health (US), Dartmouth–Hitchcock Medical Center (US), University of Minnesota (US), Allegheny Health Network (US), Virginia Mason Medical Center (US), Westchester Medical Center (US), Memorial Sloan Kettering Cancer Center (US), The University of Texas MD Anderson Cancer Center (US), University of Louisville (US), University of Kansas (US), Emory University (US), Henry Ford Health System (US), Baylor College of Medicine (US), East Carolina University (US), Vanderbilt University (US), Brown University (US), AdventHealth Orlando (US), Piedmont Atlanta Hospital (US), Tampa General Hospital (US), Phoenix Analysis and Design Technologies (United States) (US), Mayfield Brain & Spine (US), HonorHealth (US), Jersey Shore University Medical Center (US), St. Vincent's HealthCare (US), Banner MD Anderson Cancer Center, UNC Lineberger Comprehensive Cancer Center, University of Arizona College of Medicine- Phoenix (US), The University of Texas at San Antonio (US), Saint Louis University (US), Rush University (US), Drexel University (US), University of Missouri (US), Albany Medical Center Hospital (US), University of Arkansas for Medical Sciences (US), The University of Texas Southwestern Medical Center (US)
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Brain Metastases and Treatment
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