Recurrent GBM With Maximal Neurosurgical Removal and Treatment With IORT
NCT ID: NCT04763031
Last Updated: 2023-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
1 participants
INTERVENTIONAL
2021-03-05
2023-11-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intra-operative Radiation Therapy - IORT
Intra-operative Radiation Therapy - IORT
Intra-operative Radiation Therapy - IORT
Single dose of 20 Gy
Interventions
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Intra-operative Radiation Therapy - IORT
Single dose of 20 Gy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
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
18 Years
ALL
No
Sponsors
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Parkridge Medical Center
OTHER
Responsible Party
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Principal Investigators
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David A Wiles, MD
Role: PRINCIPAL_INVESTIGATOR
Parkridge Medical Center - Neurosurgery
Locations
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Parkridge Medical Center - Neurosurgery
Chattanooga, Tennessee, United States
Countries
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References
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Weller M, van den Bent M, Tonn JC, Stupp R, Preusser M, Cohen-Jonathan-Moyal E, Henriksson R, Le Rhun E, Balana C, Chinot O, Bendszus M, Reijneveld JC, Dhermain F, French P, Marosi C, Watts C, Oberg I, Pilkington G, Baumert BG, Taphoorn MJB, Hegi M, Westphal M, Reifenberger G, Soffietti R, Wick W; European Association for Neuro-Oncology (EANO) Task Force on Gliomas. European Association for Neuro-Oncology (EANO) guideline on the diagnosis and treatment of adult astrocytic and oligodendroglial gliomas. Lancet Oncol. 2017 Jun;18(6):e315-e329. doi: 10.1016/S1470-2045(17)30194-8. Epub 2017 May 5.
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Related Links
Access external resources that provide additional context or updates about the study.
Patterns of failure following treatment for glioblastoma multiforme and anaplastic astrocytoma
Supratentorial malignant glioma: patterns of recurrence and implications for external beam local treatment.
Development of multiple lesions during radiation therapy and chemotherapy in patients with gliomas
Management of glioblastoma after recurrence: A changing paradigm.
The Phenomenon of Long-Term Survival in Glioblastoma Patients. Part I: The Role of Clinical and Demographic Factors and an IDH1 Mutation
The Value of Glioma Extent of Resection in the Modern Neurosurgical Era
The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary
European Association for Neuro-Oncology (EANO) guideline on the diagnosis and treatment of adult astrocytic and oligodendroglial gliomas.
Treatment outcome of patients with recurrent glioblastoma multiforme: a retrospective multicenter analysis
Retreatment of intracranial gliomas
Reoperation in the treatment of recurrent intracranial malignant gliomas.
Reoperation for recurrent glioblastoma and anaplastic astrocytoma.
Novel Use of the Contura for High Dose Rate Cranial Brachytherapy
Polymodal therapy for high grade gliomas: a case report of favourable outcomes following intraoperative radiation therapy.
Other Identifiers
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PMC-3422401
Identifier Type: -
Identifier Source: org_study_id
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