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Recurrent GBM With Maximal Neurosurgical Removal and Treatment With IORT

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04763031
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Parkridge Medical Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	David A Wiles, MD
Principal Investigator Affiliation	Parkridge Medical Center - Neurosurgery
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Terminated
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma, GBM, Recurrent GBM
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Experimental: Intra-operative Radiation Therapy - IORT

Intra-operative Radiation Therapy - IORT

Interventions

Radiation: - Intra-operative Radiation Therapy - IORT

Single dose of 20 Gy

Contact a Trial Team

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Parkridge Medical Center - Neurosurgery, Chattanooga, Tennessee

Status

Address

Parkridge Medical Center - Neurosurgery

Chattanooga, Tennessee, 37404

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