Recurrent GBM With Maximal Neurosurgical Removal and Treatment With IORT

November 7, 2023 updated by: Parkridge Medical Center

A Pilot Study of Patients With Recurrent Glioblastoma Treated With Maximal Safe Neurosurgical Resection, Intra-Operative Radiation Therapy (IORT) Using the Xoft® Axxent® Electronic Brachytherapy System

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Device Description: The Xoft Axxent Electronic Brachytherapy System is a device that delivers radiation at a high dose rate. It is designed for use with Axxent applicators to treat lesions, tumors, and conditions in or on the body where radiation is indicated. The Axxent System and Applicators are FDA cleared under 510(k)s K050843, K072683, K090914 and K122951.

The purpose of this trial is to assess the overall survival of patients treated with the Xoft Axxent eBx System for single-fraction IORT following maximal neurosurgical resection of recurrent glioblastoma. A historical comparison will be made for surgical excision and GliaSite radiation therapy (Chan 2005), which resulted in a median OS of 9.1 months.

Radiation is delivered to the target tissue (adjacent to the resection margins). It avoids treatment delays and eliminates weeks of post-surgical radiation therapy during which residual cancer cells might proliferate.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Parkridge Medical Center - Neurosurgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Potentially-resectable, histologically proven recurrent GBM
  2. Subject must be ≥ 18 years of age
  3. Subject must have a Karnofsky Performance Score ≥ 70%
  4. Subject must have had a T1 weighted 3D MRI with Gadolinium enhancement within fourteen (14) days prior to surgery
  5. Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment
  6. Subjects of child-bearing potential must agree to use adequate contraceptive precautions and not to breastfeed (if applicable)

Exclusion Criteria:

  1. More than three relapses
  2. Subject has multi-centric disease

  3. Subject has tumors in or near (less than 10mm from tumor margin) critical brain structures, that would exclude sufficient dose delivery to the tumor: such as:

    1. Optic Chiasm
    2. Optic Nerve
  4. Women who are pregnant or nursing. Women with child-bearing potential or sexually active men that are not willing/able to use medically acceptable forms of contraception
  5. Subject has contraindications for MRI with or without gadolinium injections
  6. Subject has contraindications for anesthesia or surgery
  7. Subject is on another therapeutic clinical trial concurrently
  8. Subject had previous radiation for GBM less than 3 month earlier
  9. Prior history of standard dose of Central Nervous System (CNS) of more than 60 Gy

Intra-Operative Exclusion Criteria

  1. Frozen section does not show any sign of malignant tissue

  2. Dose at any organ at risk will exceed 10 Gy including:

    1. Chiasm
    2. Optic Nerve

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intra-operative Radiation Therapy - IORT
Radiation: Intra-operative Radiation Therapy - IORT
Single dose of 20 Gy
Other Names:
  • Electronic Brachytherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary endpoint is Overall Survival (OS)
Time Frame: Overall Survival (OS) will be defined as the interval from enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to three years.
The primary study goal is to assess Overall Survival (OS) of subjects treated with the Xoft Axxent Electronic Brachytherapy (eBx)® System when used for single-fraction, intra-operative radiation therapy (IORT) following maximal safe neurosurgical resection of recurrent glioblastoma for patients.
Overall Survival (OS) will be defined as the interval from enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to three years.
Patients treated with Xoft IORT device median overall survival (OS)
Time Frame: Overall Survival (OS) will be defined as the interval from enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to three years.
The median and mean OS with Xoft will be calculated
Overall Survival (OS) will be defined as the interval from enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to three years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Progression-free Survival (PFS)
Time Frame: LocPFS will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.
Local PFS will be assessed at following intra-operative treatment with the Xoft Axxent Electronic Brachytherapy System following maximal safe neurosurgical resection.
LocPFS will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.
Quality of Life Assessment (Fact-Br)
Time Frame: QOL will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.
To assess Quality of Life Status at baseline and following intra-operative treatment with the Xoft Axxent Electronic Brachytherapy System following maximal safe neurosurgical resection. The FACT-Br questionnaire assesses subjects on a scale of 0 (minimum) to 4 (maximum), 0 equal to "Not at all" and 4 equal to "Very Much"
QOL will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.
Karnofsky Performance Status (KPS)
Time Frame: KPS will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.
To assess Karnofsky Performance Status at baseline and following intra-operative treatment with the Xoft Axxent Electronic Brachytherapy System following maximal safe neurosurgical resection. The KPS grades from 100 to 0. 0, the lower score the worst the survival for the most serious illness. 100, the higher score, survival close to normal limits, no complaints.
KPS will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.
Radiation-related Neurotoxicity
Time Frame: Radiation-related Neurotoxicity will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.
Assess the rate of radiation-related neurotoxicity in subjects treated with the Xoft Axxent electronic Brachytherapy System when used for single-fraction, intra-operative radiation therapy treatment following maximal safe neurosurgical resection.
Radiation-related Neurotoxicity will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.
The rate and severity of Adverse Events (AEs), Adverse Device Effects (ADEs), and Unanticipated Adverse Device Effects (UADEs)
Time Frame: UADEs will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.

The rate and severity of Adverse Events (AEs), Adverse Device Effects (ADEs), and Unanticipated Adverse Device Effects (UADEs) will be assessed at the time of treatment and at all follow-up visits. All Grade 3 or higher adverse events will be followed until resolution. Each event will be classified according to:

  • Device Related
  • Procedure Related
  • Radiation Related
UADEs will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parkridge Medical Center

Investigators

  • Principal Investigator: David A Wiles, MD, Parkridge Medical Center - Neurosurgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2021

Primary Completion (Actual)

November 3, 2023

Study Completion (Actual)

November 3, 2023

Study Registration Dates

First Submitted

February 4, 2021

First Submitted That Met QC Criteria

February 17, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMC-3422401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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