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Brachytherapy

IORT for Glioblastoma Recurrence

N/A

Waitlist Available

Led By David A Wiles, MD

Research Sponsored by Parkridge Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Medical Devices

The primary endpoint is Overall Survival (OS)

Secondary outcome measures

Karnofsky Performance Status (KPS)

Local Progression-free Survival (PFS)

Quality of Life Assessment (Fact-Br)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intra-operative Radiation Therapy - IORTExperimental Treatment1 Intervention

Intra-operative Radiation Therapy - IORT

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Parkridge Medical CenterLead Sponsor

David A Wiles, MDPrincipal InvestigatorParkridge Medical Center - Neurosurgery

Media Library

Xoft Axxent eBx System (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04763031 — N/A

Glioblastoma Research Study Groups: Intra-operative Radiation Therapy - IORT

Glioblastoma Clinical Trial 2023: Xoft Axxent eBx System Highlights & Side Effects. Trial Name: NCT04763031 — N/A

Xoft Axxent eBx System (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04763031 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being recruited for this research?

"Affirmative. According to clinicaltrials.gov, the trial that was initially posted on March 5th 2021 is currently accepting participants; a total of five patients are required across one site."

Answered by AI

What goals does this medical experiment aim to accomplish?

"The primary endpoint assessed by this study is Overall Survival (OS), which encompasses the time between enrolment and date of first documented progression or death, measured up to three years. Secondary endpoints include Quality of Life Assessment (Fact-Br) scored on a 0 to 4 scale where higher numbers reflect greater wellbeing; Radiation-Related Neurotoxicity observed during treatment with Xoft Axxent Electronic Brachytherapy System after maximal safe neurosurgical resection; and The rate and severity of Adverse Events (AEs), Adverse Device Effects (ADEs), and Unanticipated Adverse Device Effects (UADEs)."

Answered by AI

Is this clinical experiment currently accepting participants?

"Affirmative. Information hosted on clinicaltrials.gov confirms that this research, which was initially posted on March 5th 2021, is actively enrolling participants. Currently, the study needs to find five individuals at one specific centre."

Answered by AI

Recent research and studies

Journal of NeurosurgeryJournal

Development of Multiple Lesions During Radiation Therapy and Chemotherapy in Patients with Gliomas

Choucair, Ali K., Victor A. Levin, Philip H. Gutin, Richard L. Davis, Pamela Silver, Michael S. B. Edwards, and Charles B. Wilson. 1986. “Development of Multiple Lesions During Radiation Therapy and Chemotherapy in Patients with Gliomas”. Journal of Neurosurgery. Journal of Neurosurgery Publishing Group (JNSPG). doi:10.3171/jns.1986.65.5.0654.

Journal of Neuro-OncologyJournal

Treatment Outcome of Patients with Recurrent Glioblastoma Multiforme: A Retrospective Multicenter Analysis

van Linde, Myra E., Cyrillo G. Brahm, Philip C. de Witt Hamer, Jaap C. Reijneveld, Anna M. E. Bruynzeel, W. Peter Vandertop, Peter M. van de Ven, et al.. 2017. “Treatment Outcome of Patients with Recurrent Glioblastoma Multiforme: A Retrospective Multicenter Analysis”. Journal of Neuro-oncology. Springer Science and Business Media LLC. doi:10.1007/s11060-017-2564-z.

Clinical and Translational OncologyJournal

SEOM Clinical Guidelines for Diagnosis and Treatment of Glioblastoma (2017)

Martínez-Garcia, M., J. Álvarez-Linera, C. Carrato, L. Ley, R. Luque, X. Maldonado, M. Martínez-Aguillo, L. M. Navarro, M. A. Vaz-Salgado, and M. Gil-Gil. 2017. “SEOM Clinical Guidelines for Diagnosis and Treatment of Glioblastoma (2017)”. Clinical and Translational Oncology. Springer Science and Business Media LLC. doi:10.1007/s12094-017-1763-6.

International Journal of Radiation Oncology*Biology*PhysicsJournal