Spots Global Cancer Trial Database for Recurrent GBM Treated With Neurosurgical Resection and IORT Using the Xoft Axxent eBx System and Bevacizumab

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Trial Identification

Brief Title: Recurrent GBM Treated With Neurosurgical Resection and IORT Using the Xoft Axxent eBx System and Bevacizumab

Official Title: Phase II Study of Patients With Recurrent Glioblastoma Multiforme Treated With Maximal Safe Neurosurgical Resection and Intra-Operative Radiation Therapy (IORT) Using the Xoft Axxent Electronic Brachytherapy System and Bevacizumab

Study ID: NCT04681677

Conditions

Glioblastoma

Recurrent Glioblastoma

GBM

Recurrent GBM

Interventions

Radiation: Intra-operative Radiation Therapy - IORT

Bevacizumab

Study Description

Brief Summary: The purpose of this trial is to assess the overall survival of patients treated with the Xoft Axxent eBx System and post-radiation adjuvant Bevacizumab for single-fraction IORT following maximal neurosurgical resection of recurrent glioblastoma. A historical comparison will be made to the results of the EBRT + Bevacizumab arm of RTOG 1205.

Detailed 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 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.