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

NCT04681677 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-04-26

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

Radiation: Intra-operative Radiation Therapy - IORT

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

DRUG

Bevacizumab

Bevacizumab

Sponsors & Collaborators

  • Icad, Inc.

    collaborator INDUSTRY

  • Xoft, Inc.

    lead INDUSTRY

Principal Investigators

  • Santosh Kesari, MD · Saint John's Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2024-04-24
Completion
2024-04-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT04681677 on ClinicalTrials.gov