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No potential patients enrolled since first enrollment on 06/27/2022.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-operative Radiation Therapy - IORT | Experimental | Intra-operative Radiation Therapy - IORT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-operative Radiation Therapy - IORT | Radiation | Single dose of 20 Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Local Progression-free Survival (PFS) | Local PFS will be assessed at following intra-operative treatment with the Xoft Axxent Electronic Brachytherapy System following maximal safe neurosurgical resection. | LocPFS will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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:
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
Intra-Operative Exclusion Criteria
Frozen section does not show any sign of malignant tissue
Dose at any organ at risk will exceed 10 Gy including:
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| Name | Affiliation | Role |
|---|---|---|
| David A Wiles, MD | Parkridge Medical Center - Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkridge Medical Center - Neurosurgery | Chattanooga | Tennessee | 37404 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2542195 | Background | Wallner KE, Galicich JH, Krol G, Arbit E, Malkin MG. Patterns of failure following treatment for glioblastoma multiforme and anaplastic astrocytoma. Int J Radiat Oncol Biol Phys. 1989 Jun;16(6):1405-9. doi: 10.1016/0360-3016(89)90941-3. | |
| 1512163 | Background | Gaspar LE, Fisher BJ, Macdonald DR, LeBer DV, Halperin EC, Schold SC Jr, Cairncross JG. Supratentorial malignant glioma: patterns of recurrence and implications for external beam local treatment. Int J Radiat Oncol Biol Phys. 1992;24(1):55-7. doi: 10.1016/0360-3016(92)91021-e. |
| Label | URL |
|---|---|
| Patterns of failure following treatment for glioblastoma multiforme and anaplastic astrocytoma | View source |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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Single 20 Gy (gray) dose of electronic brachytherapy (IORT)
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| Quality of Life Assessment (Fact-Br) |
To assess Quality of Life Status at baseline and following intra-operative treatment with the Xoft Axxent Electronic Brachytherapy System following maximal safe neurosurgical resection. The FACT-Br questionnaire assesses subjects on a scale of 0 (minimum) to 4 (maximum), 0 equal to "Not at all" and 4 equal to "Very Much" |
| QOL will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up. |
| Karnofsky Performance Status (KPS) | To assess Karnofsky Performance Status at baseline and following intra-operative treatment with the Xoft Axxent Electronic Brachytherapy System following maximal safe neurosurgical resection. The KPS grades from 100 to 0. 0, the lower score the worst the survival for the most serious illness. 100, the higher score, survival close to normal limits, no complaints. | KPS will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up. |
| Radiation-related Neurotoxicity | Assess the rate of radiation-related neurotoxicity in subjects treated with the Xoft Axxent electronic Brachytherapy System when used for single-fraction, intra-operative radiation therapy treatment following maximal safe neurosurgical resection. | 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) | The rate and severity of Adverse Events (AEs), Adverse Device Effects (ADEs), and Unanticipated Adverse Device Effects (UADEs) will be assessed at the time of treatment and at all follow-up visits. All Grade 3 or higher adverse events will be followed until resolution. Each event will be classified according to:
| UADEs will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up. |
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| 22582564 | Background | Zamzuri I, Rahman GI, Muzaimi M, Jafri AM, Nik Ruzman NI, Lutfi YA, Biswal BM, Nazaruddin HW, Mar W. Polymodal therapy for high grade gliomas: a case report of favourable outcomes following intraoperative radiation therapy. Med J Malaysia. 2012 Feb;67(1):121-2. |
| Supratentorial malignant glioma: patterns of recurrence and implications for external beam local treatment. | View source |
| Management of glioblastoma after recurrence: A changing paradigm. | View source |
| The Phenomenon of Long-Term Survival in Glioblastoma Patients. Part I: The Role of Clinical and Demographic Factors and an IDH1 Mutation | View source |
| The Value of Glioma Extent of Resection in the Modern Neurosurgical Era | View source |
| The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary | View source |
| European Association for Neuro-Oncology (EANO) guideline on the diagnosis and treatment of adult astrocytic and oligodendroglial gliomas. | View source |
| Treatment outcome of patients with recurrent glioblastoma multiforme: a retrospective multicenter analysis | View source |
| Retreatment of intracranial gliomas | View source |
| Reoperation in the treatment of recurrent intracranial malignant gliomas. | View source |
| Reoperation for recurrent glioblastoma and anaplastic astrocytoma. | View source |
| Novel Use of the Contura for High Dose Rate Cranial Brachytherapy | View source |
| Polymodal therapy for high grade gliomas: a case report of favourable outcomes following intraoperative radiation therapy. | View source |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |