Recurrent GBM With Maximal Neurosurgical Removal and Treatment With IORT (NCT04763031) | Clinical Trial Compass
TerminatedNot Applicable
Recurrent GBM With Maximal Neurosurgical Removal and Treatment With IORT
Stopped: No potential patients enrolled since first enrollment on 06/27/2022.
United States1 participantsStarted 2021-03-05
Plain-language summary
The purpose of this study is to assess the safety and efficacy of the Xoft Axxent eBx System when used for single-fraction IORT for recurrent Glioblastoma. IORT using the Xoft Axxent eBx System is no worse than (non-inferior) GliaSite radiation therapy when used as stand-alone radiation treatment immediately following maximal safe neurosurgical resection in patients with recurrent glioblastoma multiforme (GBM).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Subject must have a Karnofsky Performance Score ≥ 70%
✓. Subject must have had a T1 weighted 3D MRI with Gadolinium enhancement within fourteen (14) days prior to surgery
✓. Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment
✓. Subjects of child-bearing potential must agree to use adequate contraceptive precautions and not to breastfeed (if applicable)
Exclusion criteria
✕. More than three relapses
✕. Subject has multi-centric disease
✕. Subject has tumors in or near (less than 10mm from tumor margin) critical brain structures, that would exclude sufficient dose delivery to the tumor: such as:
✕
What they're measuring
1
The primary endpoint is Overall Survival (OS)
Timeframe: Overall Survival (OS) will be defined as the interval from enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to three years.
2
Patients treated with Xoft IORT device median overall survival (OS)
Timeframe: Overall Survival (OS) will be defined as the interval from enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to three years.
✕. Women who are pregnant or nursing. Women with child-bearing potential or sexually active men that are not willing/able to use medically acceptable forms of contraception
✕. Subject has contraindications for MRI with or without gadolinium injections
✕. Subject has contraindications for anesthesia or surgery