Introduction
STaRT registry | ROADS | Memorial Sloan kettering cancer center phase II | GESTALT | PATHWAYS | |
---|---|---|---|---|---|
NCT # | NCT04427384 | NCT04365374 | NCT04690348 | NCT05342883 | NCT05900908 |
Tumor types | Brain metastases, GBM, meningioma, and all other brain tumor types | Newly diagnosed brain metastases requiring resection (2–5 cm). | Recurrent, previously irradiated metastases planned for resection | Newly diagnosed GBM | Recurrent GBM (1st recurrence) |
Design | Basket, observational | RCT Surgery + GT vs. Surgery + SRS. | RCT Surgery + GT vs. surgery alone | Single arm feasibility trial. Combining GT with IMRT + TMZ | RCT (1:2 randomization) Surgery vs. surgery + GT. Both arms get Lomustine or Bevacizumab. |
Planned enrollment | 600 | 180 | 76 | 61 | 267 |
Outcomes | LC, OS, Functional Status, AEs, QOL | LC, OS, AEs KPS, Neurocognitive Status, and QOL | LC, OS, AEs, and Neurocognitive Status | Starting IMRT + TMZ ≤ 35 days post-surgery, consent and attrition rate, AEs, OS, LC | Overall Survival, LC, Neurocognitive Status, QOL, AEs |
Follow up | 5 years | 2 years | 2 years | Up to 3 years | Up to 24 months |
Opened | 2020 | 2021 | 2020 | 2022 | Anticipated late 2023 |
Technical factors
Preoperative, intraoperative, and postoperative workflow
Brain metastases
Recurrent brain metastases
Newly diagnosed brain metastases
Glioblastoma
Recurrent glioblastoma
Newly diagnosed glioblastoma
Meningioma
Harms
Discussion & conclusion
Study | Study design | Cs-131 form factor | Patients | Tumor type(s) | Efficacy outcome | Toxicity |
---|---|---|---|---|---|---|
Kutuk 2023 PMID: 37,722,990 | Retrospective | GammaTile | 10 | Brain mets* | 100% LC at 6, 12, and 18 months | 1 case of symptomatic radiation necrosis |
Bander 2023 PMID: 37,249,824 | Retrospective | Stranded seeds | 119 | Brain mets*§ Meningiomas*§ Gliomas*§ | 1 year LC 84.7% for brain mets 83.3% for meningiomas 34.1% for gliomas | 8.4% radiographic necrosis 11.8% wound complication |
Dharnipragada 2023 PMID: 37,324,216 | Retrospective | GammaTile | 10 | Rapidly growing brain mets | 100% LC at median follow up of 6.2 months | No radiation necrosis No surgical complications |
Chen 2022 PMID: 35,061,986 | Retrospective | Stranded seeds | 36 | Brain mets* Meningiomas* Gliomas* | 1 year LC 88% for brain mets 100% for meningiomas NR for gliomas | 9.5% symptomatic adverse radiation effect 16.7% surgical complications |
Gessler 2021 PMID: 35,088,050 | Prospective | GammaTile | 22 | IDH wild-type Glioblastoma* | 86% LC at 6 months, 81% LC at 12 months | No radiation necrosis Two surgical complications |
Imber 2022 PMID: 35,896,906 | Prospective | GammaTile | 20 | Brain mets* | 8.4% 1 year progression incidence | 16% symptomatic radiation necrosis |
Smith 2022 PMID: 36,322,102 | Prospective | GammaTile | 28 | Glioblastoma* | Median time to local failure was 12.1 months | 7% rate of symptomatic radiation necrosis |
Nakaji 2020 PMID: 33,224,684 | Prospective | GammaTile | 11 | Brain mets*§ | 83% LC at 12 months | 12.5% radiation brain changes |
Xia 2018 PMID: 30,280,070 | Retrospective | Stranded seeds | 9 | Brain mets* | LC 100% at a median follow-up of 9.4 months | No radiation necrosis |
Brachman 2018 PMID: 30,579,269 | Prospective | GammaTile | 19 | Meningioma* | PFS 89% at 18 months | 10% radiation necrosis 10% patients with surgical complications |