TEMPE, Ariz., May 30, 2026
GT Medical Technologies announced positive Phase 3 results from the randomized multicenter ROADS clinical trial at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrating that GammaTile® tile-based radiation therapy (TBRT) significantly improved outcomes for patients with newly diagnosed operable brain metastases. The study compared GammaTile plus surgery against the current standard of care consisting of surgery followed by stereotactic radiation therapy (SRT). Results showed a dramatic reduction in tumor recurrence within the surgical cavity, with only 1.0% recurrence at 12 months for GammaTile-treated patients compared with 11.9% for SRT, highlighting the potential of GammaTile to become a new treatment standard in this patient population.
Superior Survival Outcomes Achieved Without Additional Toxicity
The Phase 3 ROADS study enrolled 230 patients across 32 centers and met its co-primary endpoints. Patients treated with GammaTile experienced a greater than 50% reduction in the risk of tumor recurrence or death compared with those receiving standard postoperative radiation therapy. Surgical bed recurrence-free survival was significantly improved, with the median not yet reached in the GammaTile arm versus 10.9 months for SRT. Importantly, the treatment also demonstrated a significant overall survival advantage, with an estimated 24-month overall survival rate of 61.7% compared to 35.7% for patients receiving SRT. Researchers reported that these improvements were achieved without increased toxicity, with quality of life, neurological function, adverse events, radiation necrosis, and distant brain failure rates remaining comparable between treatment groups.
Immediate Radiation Delivery Addresses Critical Treatment Gap
GammaTile is an FDA-cleared bioabsorbable collagen implant embedded with cesium-131 radioactive seeds that is placed directly into the surgical cavity immediately after tumor removal. Unlike conventional treatment approaches that require patients to wait several weeks before beginning radiation therapy, GammaTile starts delivering targeted radiation immediately following surgery. This approach eliminates a critical treatment gap during which residual cancer cells can regrow. In the ROADS trial, patients receiving GammaTile completed management of their operable brain metastasis in a median of one day, compared with approximately 30 days for those receiving surgery followed by SRT. The localized radiation emitted by GammaTile travels only a short distance, maximizing tumor control while minimizing exposure to healthy brain tissue.
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ASCO Data Support New Standard of Care for Operable Brain Metastases
Investigators from The University of Texas MD Anderson Cancer Center emphasized that the magnitude of benefit observed in the ROADS study exceeded expectations typically seen with stereotactic radiation therapy. Brain metastases affect up to 40% of cancer patients and remain a major cause of morbidity and mortality. The strong efficacy results, combined with comparable safety and quality-of-life outcomes, provide compelling evidence supporting broader adoption of GammaTile in clinical practice. GT Medical Technologies noted that GammaTile has already been adopted by more than 150 medical centers across the United States, and the company believes the Phase 3 data will further accelerate its use as a frontline treatment option for newly diagnosed operable brain metastases and other malignant brain tumors. The findings represent one of the most significant advances in postoperative brain tumor management presented at ASCO 2026 and may reshape future treatment standards in neuro-oncology.
Source: GT Medical Technologies press release
