NCT04763031

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

March 5, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2023

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

2.7 years

First QC Date

February 4, 2021

Last Update Submit

November 7, 2023

Conditions

GlioblastomaGBMRecurrent GBM

Keywords

GlioblastomaGBMRecurrent GBMRecurrent GlioblastomaIORTIntra-Operative Radiation Therapy

Outcome Measures

Primary Outcomes (2)

  • The primary endpoint is Overall Survival (OS)

    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)

    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 Outcomes (5)

  • Local Progression-free Survival (PFS)

    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)

    QOL will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.

  • Karnofsky Performance Status (KPS)

    KPS will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.

  • Radiation-related Neurotoxicity

    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)

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

Study Arms (1)

Intra-operative Radiation Therapy - IORT

EXPERIMENTAL

Intra-operative Radiation Therapy - IORT

Radiation: Intra-operative Radiation Therapy - IORT

Interventions

Intra-operative Radiation Therapy - IORTRADIATION

Single dose of 20 Gy

Also known as: Electronic Brachytherapy
Intra-operative Radiation Therapy - IORT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • More than three relapses
  • Subject has multi-centric disease
  • 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:
  • Optic Chiasm
  • Optic Nerve
  • 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
  • Subject has contraindications for MRI with or without gadolinium injections
  • Subject has contraindications for anesthesia or surgery
  • Subject is on another therapeutic clinical trial concurrently
  • Subject had previous radiation for GBM less than 3 month earlier
  • Prior history of standard dose of Central Nervous System (CNS) of more than 60 Gy
  • Frozen section does not show any sign of malignant tissue
  • Dose at any organ at risk will exceed 10 Gy including:
  • Chiasm
  • Optic Nerve

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parkridge Medical Center - Neurosurgery

Chattanooga, Tennessee, 37404, United States

Location

Related Publications (31)

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Related Links

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • David A Wiles, MD

    Parkridge Medical Center - Neurosurgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single 20 Gy (gray) dose of electronic brachytherapy (IORT)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 21, 2021

Study Start

March 5, 2021

Primary Completion

November 3, 2023

Study Completion

November 3, 2023

Last Updated

November 9, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)