Radiation: Intra-operative Radiation Therapy - IORT for Glioblastoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Glioblastoma+4 More
Radiation: Intra-operative Radiation Therapy - IORT - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is to see if a new treatment for brain cancer is better than the current standard of care.

Eligible Conditions
  • Glioblastoma
  • GBM

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 3 Years

3 Years
Local and distant progression-free survival
Quality of Life and radiation-related neurotoxicity
Rate of adverse events/safety
imaging changes
median overall survival (mOS)
4 Weeks
tumor progression at four weeks
6 Month
6 Month rate progression-free survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Bevacizumab
22%vitreous hemorrhage
17%worsening of cataract
9%vitreous syneresis
9%posterior capsule opacification
4%pyelonephritis
4%pneumonia
4%colon cancer
4%cranial nerve VI palsy
4%bradycardia
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT02036424) in the Bevacizumab ARM group. Side effects include: vitreous hemorrhage with 22%, worsening of cataract with 17%, vitreous syneresis with 9%, posterior capsule opacification with 9%, pyelonephritis with 4%.

Trial Design

1 Treatment Group

Experimental: Intra-operative Radiation Therapy - IORT
1 of 1

Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: Radiation: Intra-operative Radiation Therapy - IORT · No Placebo Group · Phase 2

Experimental: Intra-operative Radiation Therapy - IORTExperimental Group · 3 Interventions: Bevacizumab, Avastin, Radiation: Intra-operative Radiation Therapy - IORT · Intervention Types: Drug, Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Bevacizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Xoft, Inc.Lead Sponsor
10 Previous Clinical Trials
2,300 Total Patients Enrolled
Icad, Inc.Industry Sponsor
4 Previous Clinical Trials
1,248 Total Patients Enrolled
Santosh Kesari, MDPrincipal InvestigatorSaint John's Cancer Institute
2 Previous Clinical Trials
58 Total Patients Enrolled
1 Trials studying Glioblastoma
18 Patients Enrolled for Glioblastoma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing to comply with all study procedures for the duration of the study.
Subjects must have shown unequivocal radiographic evidence for tumor progression by contrast-enhanced MRI within 21 days prior to enrollment.
The recurrent GBM must have the appropriate dimensions to allow a Xoft applicator balloon to fit into the tumor cavity.
You have undergone CNS related core or needle biopsies, a minimum of 7 days must have elapsed prior to registration.
You have a history of or are experiencing a neurologic condition that may affect your ability to participate in the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 28th, 2021

Last Reviewed: November 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References