NCT04365374

Post-Surgical Stereotactic Radiotherapy (SRT) Versus GammaTile-ROADS (Radiation One and Done Study)

Active, enrolled Phase 3 Last updated 7 October 2025

What this trial tests

Phase 3 trial testing Gamma Tile-Surgically Targeted Radiation Therapy (STaRT) in Brain Metastases in 230 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

6 April 2021

Primary endpoint
30 August 2029

30 August 2029

Quick facts

Lead sponsor	GT Medical Technologies, Inc.
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	230
Start date	6 April 2021
Primary completion	30 August 2029
Estimated completion	30 August 2029
Sites	37 locations across United States

Drugs / interventions tested

• Gamma Tile-Surgically Targeted Radiation Therapy (STaRT)
• Stereotactic Radiation Therapy

Conditions studied

• Brain Metastases — all drugs for Brain Metastases →

Sponsor

GT Medical Technologies, Inc. — full company profile →

Who can join

18 and older, any sex, with Brain Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial will be a randomized controlled study comparing the efficacy and safety of intraoperative radiation therapy using GammaTilesTM (GT) versus SRT 3-4 weeks following metastatic tumor resection which is the current standard of care.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Update on the Management of Brain Metastasis.
   Singh K, Saxena S, Khosla AA, McDermott MW, et al · · 2022 · cited 38× · PMID 36422836 · DOI 10.1007/s13311-022-01312-w
2. Surgically targeted radiation therapy (STaRT) trials for brain neoplasms: A comprehensive review.
   Odia Y, Gutierrez AN, Kotecha R. · · 2022 · cited 18× · PMID 36322100 · DOI 10.1093/neuonc/noac130
3. The role of GammaTile in the treatment of brain tumors: a technical and clinical overview.
   Garcia MA, Turner A, Brachman DG. · · 2024 · cited 14× · PMID 38261141 · DOI 10.1007/s11060-023-04523-z
4. Dosimetric Impacts of Source Migration, Radioisotope Type, and Decay with Permanent Implantable Collagen Tile Brachytherapy for Brain Tumors.
   Pinnaduwage DS, Srivastava SP, Yan X, Jani S, et al · · 2022 · cited 8× · PMID 35712977 · DOI 10.1177/15330338221106852
5. Current status and perspectives of interventional clinical trials for brain metastases: analysis of ClinicalTrials.gov.
   Tini P, Marampon F, Giraffa M, Bucelli S, et al · · 2023 · cited 4× · PMID 37016421 · DOI 10.1186/s13014-023-02243-2
6. Clinical Trials in Progress: ROADS Trial.
   Weinberg J. · · 2021 · cited 3× · PMID 34398588 · DOI 10.46883/onc.2021.3508.0495
7. Understanding the Radiobiology of Central Nervous System Diseases in the Golden Age of Radiosurgery-Does It Matter?
   Lam FC, Byun J, Guru S, AbuReesh D, et al · · 2025 · cited 2× · PMID 40563819 · DOI 10.3390/brainsci15060649
8. A Novel Multimodal Approach to Refractory Brain Metastases: A Case Report.
   Katlowitz KA, Beckham TH, Kudchadker RJ, Wefel J, et al · · 2024 · cited 2× · PMID 38405307 · DOI 10.1016/j.adro.2023.101349