Brain metastases are the most common malignancy found in the brain — more than 200,000 people are diagnosed with this form of tumor annually in the United States. These growths spread to the brain from other sites in the body, most often from lung, breast, colon, kidney and melanomas, and area sign of aggressive tumor behavior.
The Radiation One and Done Study (ROADS), a clinical trial now in Phase 3, is a randomized control trial comparing an FDA-cleared device called GammaTile with stereotactic radiotherapy, after the removal of a brain metastasis tumor. The clinical trial began in 2021.
Indiana University School of Medicine is one of 23 institutions in the clinical trial, and the university, in conjunction with its health partner Indiana University Health, enrolled the 100th patient in the study, according to the trial’s sponsor, GT Medical Technologies, Inc.
“Our dedication to the ROADS trial is fueled by our mission to furnish the highest caliber of clinical evidence through randomized trial research. The ROADS trial will help determine the most efficient and effective treatments after surgical resection,” said Angela Richardson, MD, PhD, assistant professor of neurological surgery and the principal investigator of the trial at IU School of Medicine.
Patients enrolled in the ROADS clinical trial are randomized to one of two treatment groups: those who receive internal radiation with GammaTile placement at the time of surgery to remove brain tumor, or those who receive standard of care external radiation.
For internal radiation patients, a neurosurgeon removes the tumor and implants small collagen tiles that contain radiation seeds to slowly deliver radiation into the cavity over the next 90 days. For external radiation patients, a neurosurgeon removes the tumor and sends the patient for external radiation within three to four weeks with a radiation oncologist.
External radiation, the current standard of care, requires daily visits to the radiation treatment center for radiation therapy for usually six weeks. The two groups will be monitored to assess the safety and efficacy of the two treatment approaches. The goal is to determine outcomes that allow for longer survival with delayed tumor recurrence and to evaluate the most efficient way to protect healthy brain tissue.
Na Tosha Gatson, MD, PhD, FAAN, professor of neurology and director of the Center for Neuro-Oncology in the IU School of Medicine-IU Health Neuroscience Institute, said while every single patient enrolled matters, the 100th patient milestone is of special significance as it is a testament to the team’s continued dedication to the delivery of leading-edge brain tumor care.
“All clinical trial enrollment is done with close patient assessment and is in line with strict institutional and trial guidelines. It is the best pathway toward drug development and innovations in cancer care,” Gatson said. “It speaks volumes about our excellent research staff and clinical providers who have earned the patient’s trust to move their treatment forward.”
The ROADS trial is targeted for completion in December 2024.
