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Recurrent GBM With Maximal Neurosurgical Removal and Treatment With IORT

NCT04763031 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-11-09

No results posted yet for this study

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).

Conditions

Interventions

RADIATION

Intra-operative Radiation Therapy - IORT

Single dose of 20 Gy

Sponsors & Collaborators

  • Parkridge Medical Center

    lead OTHER

Principal Investigators

  • David A Wiles, MD · Parkridge Medical Center - Neurosurgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2023-11-03
Completion
2023-11-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04763031 on ClinicalTrials.gov