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

Part of paid clinical trials in Santa Monica, California.

Sponsor
Xoft, Inc.
Study ID
NCT04681677
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiation: Intra-operative Radiation Therapy - IORT — RADIATION
    Single fraction, Intra-operative Radiation Therapy at the time of surgical resection of recurrent GBM followed by Bevacizumab 28-56 days after surgery.
  • Bevacizumab — DRUG
    Bevacizumab

Study Details

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.

Key Dates

First listed
Dec 23, 2020
Start date
Nov 2, 2021
Status verified
Apr 2024
Primary completion
Apr 24, 2024
Completion
Apr 24, 2024

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Intra-operative Radiation Therapy - IORT
    Radiation: Intra-operative Radiation Therapy - IORT

Primary Outcome Measure

median overall survival (mOS) [ Time Frame: 3 Years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Providence Saint John's Health CenterSanta MonicaCalifornia90404-

Find similar trials in Santa Monica, CA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Providence Saint John's Health Center· Santa Monica, CA

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