TRIALS IN PROGRESS: REGISTRY OF SAFETY and EFFICACY IN ADULTS WITH PRIMARY and METASTATIC INTRACRANIAL TUMORS TREATED WITH START (GAMMATILES (CS-131 SOURCE BRACHY-THERAPY)): NCT04427384
Recommended Citation
Dunbar E, Lee S, Peach MS, Wanbo J, Smith C, Hansfit S, Mertitz K, Berkowitz A, Sloan L, Ferreira C, Neil E, Kotecha R, Nowlan A, McCracken D, Patel T, Wardak Z, Richardson A, Shah M, Chowdhary S, DiNapoli V, Floyd J, Nagib M, Wasilewski A, Patel A, Rao G, Pham H, Ryan R, Shen C, Robin AM, Lee IY, Leng L, Hoang K, Olson J. TRIALS IN PROGRESS: REGISTRY OF SAFETY and EFFICACY IN ADULTS WITH PRIMARY and METASTATIC INTRACRANIAL TUMORS TREATED WITH START (GAMMATILES (CS-131 SOURCE BRACHY-THERAPY)): NCT04427384. Neuro Oncol 2024; 26(Suppl 8):viii114-viii115.
Document Type
Conference Proceeding
Publication Date
11-11-2024
Publication Title
Neuro Oncol
Abstract
INTRO: This is the first observational registry study of R+STaRT, delivered by Cs-131 sources in permanently implanted resorbable collagen tile carriers, for patients with intracranial tumors. METHODS: Since October 2020, 37 sites to-date have enrolled 359 patients with primary and metastatic intracranial tumors into the R+STaRT registry to assess the safety and efficacy of the addition of Gamma Tile to medically needed resection. Local control, overall survival, QOL, neurocognition, functional decline, and surgical and radiation associated AE's are collected at 1, 3, 6, 9,12, 18 and 24 months, then every 6 months through 5 years. RESULTS: Demographics include 359 patients, avg. age 57 y.o. 162 malignant gliomas, 125 metastatic tumors, 38 meningiomas, and 34 rare other tumors. 197 Males (163 White, 23 Black, 5 Asian, and other races) and 157 Females (White 121, 28 Black, 0 Asian, and 8 other races). No unexpected outcomes reported in the hands of experienced providers have occurred, although close clinical-radiographic follow-up, to ensure early detection of possible treatment-effects, is paramount. Steroid-use, and above endpoints, continue to be collected. CONCLUSIONS: In this observational registry of Gamma Tiles (Cs-131 source brachy-therapy) added to medically needed resections for patients with primary and metastatic intracranial tumors continues. Data will be used to benchmark clinical outcomes of R+STaRT therapy and allow for comparisons to existing standard-of-care treatments. The outcome measures captured will allow for evaluation of the potential risks and benefits of this treatment approach for patients in a real-world setting.
Volume
26
Issue
Suppl 8
First Page
viii114
Last Page
viii115
