Combined Treatment of Patients With Newly Diagnosed Glioblastoma Using the Xoft® Axxent® E
Glioblastoma is the most aggressive primary brain tumor due to its highly infiltrative growth pattern, strong proliferative potential, and multiple mechanisms of resistance to treatment . Based on results from multicenter studies, English oncologist Roger Stupp proposed in 2005 a new treatment approach involving initia
| Condition(s) | Glioblastoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | Glioblastoma is the most aggressive primary brain tumor due to its highly infiltrative growth pattern, strong proliferative potential, and multiple mechanisms of resistance to treatment . Based on results from multicenter studies, English oncologist Roger Stupp proposed in 2005 a new treatment approach involving initial tumor resection followed by conformal external beam radiation therapy combined with temozolomide, plus subsequent cycles of monochemotherapy with this drug. This approach extended median survival by only 2 months, yet remains the standard of care due to lack of better alternatives. Consequently, recent protocols for malignant CNS tumors in Russia and internationally recommend prioritizing clinical trial enrollment over "standard" treatment. Numerous studies demonstrate that |
| Who can participate | Inclusion Criteria: * The subject's age must be ≥ 40 years but not older than 75 years. * The subject's Karnofsky Performance Status (KPS) must be ≥ 70%. * The subject is willing and able to independently provide informed consent for participation in the study. * The subject has been newly diagnosed with glioblastoma (GB) based on preoperative neuroimaging (contrast-enhanced brain MRI ± amino acid-based PET/CT) and confirmed by intraoperative histopathological examination of the tumor. * Total or near-total resection of the contrast-enhancing tumor portion is feasible. * The expected post-resection cavity size must allow placement of the Axxent Xoft eBx balloon applicator system. * Women of childbearing potential must have a negative pregnancy test within 7 days before treatment initiation |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Lead sponsor | Joint Stock Company European Medical Centre |
| Locations | Moscow, Moscow, Russia |
| Start date | 2025-09-01 |
| NCT ID | NCT07141732 |
| Official listing | https://clinicaltrials.gov/study/NCT07141732 |