Recurrent GBM Treated With Neurosurgical Resection and IORT Using the Xoft Axxent eBx System and Bevacizumab
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- GBM
- Glioblastoma
- Recurrent GBM
- Recurrent Glioblastoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Single arm, prospective, multi-center, non-randomized, historical control, non-inferiority study of subjects treated with single fraction, Intra-Operative Radiation Therapy at the time of maximal resection for recurrent GBM. Treatment with Bevacizumab will be initiated 28-56 days after surgery depending on surgical wound healing assessment at the discretion of the treating investigator.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The rationale for IORT, as the sole radiation therapy following surgical resection of recurrent GBM is to expand upon the favorable preliminary results in feasibility, safety and efficacy outcomes obtained at the European Medical Center Study Group (EMC Study Group). The rationale to add Bevacizumab...
The rationale for IORT, as the sole radiation therapy following surgical resection of recurrent GBM is to expand upon the favorable preliminary results in feasibility, safety and efficacy outcomes obtained at the European Medical Center Study Group (EMC Study Group). The rationale to add Bevacizumab as a systemic treatment is to target radio-resistant and highly tumorigenic cancer stem cells as well as to benefit from its radioprotective effects, i.e. reducing risk of radiation necrosis. Lastly, using Bevacizumab as a systemic therapy will enable the comparison of the results to the historic control arm, the EBRT arm of RTOG 1205.
Tracking Information
- NCT #
- NCT04681677
- Collaborators
- Icad, Inc.
- Investigators
- Principal Investigator: Santosh Kesari, MD John Wayne Cancer Institute
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