Radiation Tiles Improve Surgical Bed Control in Brain Metastases in ROADS Trial

Implanting cesium-131 collagen tiles during resection improved surgical bed control compared with postoperative stereotactic radiation therapy (SRT) in patients with newly diagnosed brain metastases, according to results of the phase 3 ROADS trial accepted for publication in the Journal of Clinical Oncology.

The randomized, open-label, noninferiority trial (NCT04365374) compared resection plus tile-based radiation therapy (TBRT) with resection plus SRT, which investigators described as the standard of care. TBRT used the GammaTile device (GT Medical Technologies), an FDA-cleared low-dose rate brachytherapy device implanted after intraoperative pathology confirms metastasis.

Across 32 US centers, 230 patients were randomized before surgery, and 204 formed the modified intent-to-treat population. Eligible patients had 1 surgical metastasis of 2.0 to 7.0 cm and up to 5 additional metastases. At a median follow-up of 12.9 months, time to surgical bed recurrence favored TBRT (1 vs 12 events; median not reached vs 17.4 months; hazard ratio [HR], 0.06; 95% CI, 0.01-0.46). Surgical bed recurrence-free survival, the second co-primary endpoint, also favored TBRT (median not reached vs 10.9 months; HR, 0.48; 95% CI, 0.30-0.76). TBRT met criteria for both noninferiority and superiority.

Median overall survival was 42.5 vs 17.6 months (HR, 0.59; 95% CI, 0.37-0.96), but the difference did not persist in the per-protocol population, and the authors said the finding requires validation. Rates of any adverse event (79.0% vs 80.7%), 12-month radiation necrosis (5.3% vs 5.7%), quality of life, and neurocognitive outcomes did not differ.

The co-primary endpoints were adopted in a June 2025 protocol amendment, before outcome data were reviewed. The authors noted the open-label design and limited systemic therapy data as limitations, and 17.8% of patients in the SRT arm did not complete SRT. The authors concluded that TBRT should be considered a standard-of-care option for newly diagnosed brain metastases.

Source: Weinberg JS, Imber BS, DiNapoli V, et al. 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. Published online September 28, 2026. doi:10.1200/JCO-26-01894