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Intra-operative Radiation Therapy - IORT for Glioblastoma Multiforme (GBM)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Glioblastoma Multiforme (GBM)+2 MoreIntra-operative Radiation Therapy - IORT - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial assesses whether a new, single-fraction radiation treatment is as good as the standard radiation treatment for people with a type of brain cancer that has come back.

Eligible Conditions
  • Glioblastoma Multiforme (GBM)
  • Glioblastoma Multiforme
  • Glioblastoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
TheraSphere GBM
1
Combination Drug Therapy
1
Radiation Therapy

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: 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.

Year 3
Karnofsky Performance Status (KPS)
Year 3
Local Progression-free Survival (PFS)
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.
Medical Devices
The primary endpoint is Overall Survival (OS)
Year 3
Quality of Life Assessment (Fact-Br)
Year 3
Radiation-related Neurotoxicity
Year 3
The rate and severity of Adverse Events (AEs), Adverse Device Effects (ADEs), and Unanticipated Adverse Device Effects (UADEs)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
TheraSphere GBM
1
Combination Drug Therapy
1
Radiation Therapy

Trial Design

1 Treatment Group

Intra-operative Radiation Therapy - IORT
1 of 1

Experimental Treatment

5 Total Participants · 1 Treatment Group

Primary Treatment: Intra-operative Radiation Therapy - IORT · No Placebo Group · N/A

Intra-operative Radiation Therapy - IORT
Radiation
Experimental Group · 1 Intervention: Intra-operative Radiation Therapy - IORT · Intervention Types: Radiation

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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.

Who is running the clinical trial?

Parkridge Medical CenterLead Sponsor
David A Wiles, MDPrincipal InvestigatorSoutheastern Spine & Neurosurgery

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
during the study and for the duration of any follow-up period Potential subjects who could have children must agree to use contraception and not to breastfeeding for the duration of the study and any follow up period.
The subject must have had a T1 weighted 3D MRI with Gadolinium enhancement within 14 days prior to surgery.
and use effective contraception for the first three months following treatment Women of child-bearing potential must have a negative pregnancy test one week before treatment, and use effective contraception for the first three months following treatment.
A tumor that has recurred (come back) after treatment and is histologically ( microscopically ) proved to be a glioblastoma multiforme (GBM) is potentially resectable.
The subject must be at least eighteen years of age.
The subject must have a Karnofsky Performance Score of at least 70%.
References

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