GlioblastomaNCT04763031

Recurrent GBM With Maximal Neurosurgical Removal and Treatment With IORT

A study testing Intra-operative Radiation Therapy - IORT in people with Glioblastoma and GBM, run by Parkridge Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glioblastoma, GBM, Recurrent GBM
What is being tested?: Intra-operative Radiation Therapy - IORT
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteUnited States
Study dates: 5 Mar 2021to 3 Nov 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Potentially-resectable, histologically proven recurrent GBM
Subject must be ≥ 18 years of age
Subject must have a Karnofsky Performance Score ≥ 70%
Subject must have had a T1 weighted 3D MRI with Gadolinium enhancement within fourteen (14) days prior to surgery
Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment
Subjects of child-bearing potential must agree to use adequate contraceptive precautions and not to breastfeed (if applicable)

Who cannot join

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:
Optic Chiasm
Optic Nerve
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

Show all 16Show fewer

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:
Chiasm
Optic Nerve

Trial locations and contacts

1 site in 1 country.

United States1 site

Parkridge Medical Center - Neurosurgery
Chattanooga, Tennessee, 37404

Other trials in United States

About this study

Official title: A Pilot Study of Patients With Recurrent Glioblastoma Treated With Maximal Safe Neurosurgical Resection, Intra-Operative Radiation Therapy (IORT) Using the Xoft® Axxent® Electronic Brachytherapy System

Read the detailed description

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.

Conditions: Glioblastoma, GBM, Recurrent GBM
Being tested: Intra-operative Radiation Therapy - IORT
Keywords: Glioblastoma, GBM, Recurrent GBM, Recurrent Glioblastoma, IORT, Intra-Operative Radiation Therapy
Medical subject headings: Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intra-operative Radiation Therapy - IORTRadiation
Also called Electronic Brachytherapy
Single dose of 20 Gy

Study groups in NCT04763031
Study group	Role	What they receive
Intra-operative Radiation Therapy - IORT	Experimental	Intra-operative Radiation Therapy - IORT Receives: Radiation: Intra-operative Radiation Therapy - IORT

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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.

Secondary outcomes (5)

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.
Measured: LocPFS will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.
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"
Measured: 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.
Measured: 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.
Measured: 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:
- Device Related
- Procedure Related
- Radiation Related
Measured: UADEs will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Mar 20213 Nov 2023

First posted21 Feb 2021
Study start5 Mar 2021
Primary completion3 Nov 2023
Study completion3 Nov 2023

Why it stopped: No potential patients enrolled since first enrollment on 06/27/2022.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (31)Papers the sponsor has linked to this study.
Other trials for GlioblastomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Single 20 Gy (gray) dose of electronic brachytherapy (IORT)
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04763031
Sponsor's protocol ID: PMC-3422401
Status last verified: Nov 2023
First submitted: 4 Feb 2021
Last updated: 9 Nov 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 2542195
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.
PubMed 1512163
Choucair AK, Levin VA, Gutin PH, Davis RL, Silver P, Edwards MS, Wilson CB. Development of multiple lesions during radiation therapy and chemotherapy in patients with gliomas. J Neurosurg. 1986 Nov;65(5):654-8. doi: 10.3171/jns.1986.65.5.0654.
PubMed 3021931
Mallick S, Benson R, Hakim A, Rath GK. Management of glioblastoma after recurrence: A changing paradigm. J Egypt Natl Canc Inst. 2016 Dec;28(4):199-210. doi: 10.1016/j.jnci.2016.07.001. Epub 2016 Jul 28.
PubMed 27476474
Goryaynov SA, Gol'dberg MF, Golanov AV, Zolotova SV, Shishkina LV, Ryzhova MV, Pitskhelauri DI, Zhukov VY, Usachev DY, Belyaev AY, Kondrashov AV, Shurkhay VA, Potapov AA. [The phenomenon of long-term survival in glioblastoma patients. Part I: the role of clinical and demographic factors and an IDH1 mutation (R 132 H)]. Zh Vopr Neirokhir Im N N Burdenko. 2017;81(3):5-16. doi: 10.17116/neiro20178135-16. Russian.
PubMed 28665384
Haj A, Doenitz C, Schebesch KM, Ehrensberger D, Hau P, Putnik K, Riemenschneider MJ, Wendl C, Gerken M, Pukrop T, Brawanski A, Proescholdt MA. Extent of Resection in Newly Diagnosed Glioblastoma: Impact of a Specialized Neuro-Oncology Care Center. Brain Sci. 2017 Dec 25;8(1):5. doi: 10.3390/brainsci8010005.
PubMed 29295569
Hardesty DA, Sanai N. The value of glioma extent of resection in the modern neurosurgical era. Front Neurol. 2012 Oct 18;3:140. doi: 10.3389/fneur.2012.00140. eCollection 2012.
PubMed 23087667
Krivoshapkin A, Sergeev G, Gaytan A, Kurbatov V, Kiselev R, Kalneus L. Effect of pre- and postoperative tumor volumetric parameters on the life expectancy of patients with brain glioblastomas. Bull Neurol Psychiatry Neurosurg. 2016;6:59-67.
Krivoshapkin AL, Sergeev GS, Gaytan AS, Kurbatov VP, Kalneus LE, Tarantsev EG. New software for objective evaluation of brain glioblastoma resection degree. Zh Vopr Neirokhir Im N N Burdenko. 2014;78(5):33-9; discussion 40. English, Russian.
PubMed 25406906
Louis DN, Perry A, Reifenberger G, von Deimling A, Figarella-Branger D, Cavenee WK, Ohgaki H, Wiestler OD, Kleihues P, Ellison DW. The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary. Acta Neuropathol. 2016 Jun;131(6):803-20. doi: 10.1007/s00401-016-1545-1. Epub 2016 May 9.
PubMed 27157931
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.
PubMed 28483413
van Linde ME, Brahm CG, de Witt Hamer PC, Reijneveld JC, Bruynzeel AME, Vandertop WP, van de Ven PM, Wagemakers M, van der Weide HL, Enting RH, Walenkamp AME, Verheul HMW. Treatment outcome of patients with recurrent glioblastoma multiforme: a retrospective multicenter analysis. J Neurooncol. 2017 Oct;135(1):183-192. doi: 10.1007/s11060-017-2564-z. Epub 2017 Jul 20.
PubMed 28730289
Ringel F, Pape H, Sabel M, Krex D, Bock HC, Misch M, Weyerbrock A, Westermaier T, Senft C, Schucht P, Meyer B, Simon M; SN1 study group. Clinical benefit from resection of recurrent glioblastomas: results of a multicenter study including 503 patients with recurrent glioblastomas undergoing surgical resection. Neuro Oncol. 2016 Jan;18(1):96-104. doi: 10.1093/neuonc/nov145. Epub 2015 Aug 4.
PubMed 26243790
Landy HJ, Feun L, Schwade JG, Snodgrass S, Lu Y, Gutman F. Retreatment of intracranial gliomas. South Med J. 1994 Feb;87(2):211-4. doi: 10.1097/00007611-199402000-00013.
PubMed 8115886
Ammirati M, Galicich JH, Arbit E, Liao Y. Reoperation in the treatment of recurrent intracranial malignant gliomas. Neurosurgery. 1987 Nov;21(5):607-14. doi: 10.1227/00006123-198711000-00001.
PubMed 2827051

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of Patients With Recurrent Glioblastoma Treated With Maximal Safe Neurosurgical Resection, Intra-Operative Radiation Therapy (IORT) Using the Xoft® Axxent® Electronic Brachytherapy System
ClinicalTrials.gov ID: NCT04763031
Acronym / sponsor ID: PMC-3422401
Conditions: Glioblastoma, GBM, Recurrent GBM
Keywords: Glioblastoma, GBM, Recurrent GBM, Recurrent Glioblastoma, IORT, Intra-Operative Radiation Therapy
Study type: Interventional
Recruitment status: TerminatedReason stopped: No potential patients enrolled since first enrollment on 06/27/2022.
Enrolment: 1 participants (actual)
Lead sponsor: Parkridge Medical CenterUniversity, hospital or other
Study start: 5 Mar 2021 (actual)
Primary completion: 3 Nov 2023 (actual)
Study completion: 3 Nov 2023 (actual)
First posted: 21 Feb 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single 20 Gy (gray) dose of electronic brachytherapy (IORT)

Arm	Type	Receives
Intra-operative Radiation Therapy - IORT	Experimental	Radiation: Intra-operative Radiation Therapy - IORTIntra-operative Radiation Therapy - IORT

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Potentially-resectable, histologically proven recurrent GBM
Subject must be ≥ 18 years of age
Subject must have a Karnofsky Performance Score ≥ 70%
Subject must have had a T1 weighted 3D MRI with Gadolinium enhancement within fourteen (14) days prior to surgery
Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intra-operative Radiation Therapy - IORTAlso: Electronic BrachytherapySingle dose of 20 Gy	Radiation	Intra-operative Radiation Therapy - IORT

Primary outcome

The primary endpoint is Overall Survival (OS)
Time frame: 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.
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.
Patients treated with Xoft IORT device median overall survival (OS)
Time frame: 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.
The median and mean OS with Xoft will be calculated

5 secondary outcomes

Local Progression-free Survival (PFS)
Time frame: LocPFS will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.
Quality of Life Assessment (Fact-Br)
Time frame: QOL will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.
Karnofsky Performance Status (KPS)
Time frame: KPS will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.
Radiation-related Neurotoxicity
Time frame: 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)
Time frame: UADEs will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.

Results and safety

The study was stopped early (reason given: No potential patients enrolled since first enrollment on 06/27/2022.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
Background: PubMed 2542195Wallner 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.
Background: PubMed 1512163Gaspar 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.
Background: PubMed 3021931Choucair AK, Levin VA, Gutin PH, Davis RL, Silver P, Edwards MS, Wilson CB. Development of multiple lesions during radiation therapy and chemotherapy in patients with gliomas. J Neurosurg. 1986 Nov;65(5):654-8. doi: 10.3171/jns.1986.65.5.0654.
Background: PubMed 27476474Mallick S, Benson R, Hakim A, Rath GK. Management of glioblastoma after recurrence: A changing paradigm. J Egypt Natl Canc Inst. 2016 Dec;28(4):199-210. doi: 10.1016/j.jnci.2016.07.001. Epub 2016 Jul 28.
Background: PubMed 28665384Goryaynov SA, Gol'dberg MF, Golanov AV, Zolotova SV, Shishkina LV, Ryzhova MV, Pitskhelauri DI, Zhukov VY, Usachev DY, Belyaev AY, Kondrashov AV, Shurkhay VA, Potapov AA. [The phenomenon of long-term survival in glioblastoma patients. Part I: the role of clinical and demographic factors and an IDH1 mutation (R 132 H)]. Zh Vopr Neirokhir Im N N Burdenko. 2017;81(3):5-16. doi: 10.17116/neiro20178135-16. Russian.
Background: PubMed 29295569Haj A, Doenitz C, Schebesch KM, Ehrensberger D, Hau P, Putnik K, Riemenschneider MJ, Wendl C, Gerken M, Pukrop T, Brawanski A, Proescholdt MA. Extent of Resection in Newly Diagnosed Glioblastoma: Impact of a Specialized Neuro-Oncology Care Center. Brain Sci. 2017 Dec 25;8(1):5. doi: 10.3390/brainsci8010005.
Background: PubMed 23087667Hardesty DA, Sanai N. The value of glioma extent of resection in the modern neurosurgical era. Front Neurol. 2012 Oct 18;3:140. doi: 10.3389/fneur.2012.00140. eCollection 2012.
BackgroundKrivoshapkin A, Sergeev G, Gaytan A, Kurbatov V, Kiselev R, Kalneus L. Effect of pre- and postoperative tumor volumetric parameters on the life expectancy of patients with brain glioblastomas. Bull Neurol Psychiatry Neurosurg. 2016;6:59-67.
Background: PubMed 25406906Krivoshapkin AL, Sergeev GS, Gaytan AS, Kurbatov VP, Kalneus LE, Tarantsev EG. New software for objective evaluation of brain glioblastoma resection degree. Zh Vopr Neirokhir Im N N Burdenko. 2014;78(5):33-9; discussion 40. English, Russian.
Background: PubMed 27157931Louis DN, Perry A, Reifenberger G, von Deimling A, Figarella-Branger D, Cavenee WK, Ohgaki H, Wiestler OD, Kleihues P, Ellison DW. The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary. Acta Neuropathol. 2016 Jun;131(6):803-20. doi: 10.1007/s00401-016-1545-1. Epub 2016 May 9.
Background: PubMed 28483413Weller 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.
Background: PubMed 28730289van Linde ME, Brahm CG, de Witt Hamer PC, Reijneveld JC, Bruynzeel AME, Vandertop WP, van de Ven PM, Wagemakers M, van der Weide HL, Enting RH, Walenkamp AME, Verheul HMW. Treatment outcome of patients with recurrent glioblastoma multiforme: a retrospective multicenter analysis. J Neurooncol. 2017 Oct;135(1):183-192. doi: 10.1007/s11060-017-2564-z. Epub 2017 Jul 20.
Patterns of failure following treatment for glioblastoma multiforme and anaplastic astrocytomaLink provided by the sponsor.
Supratentorial malignant glioma: patterns of recurrence and implications for external beam local treatment.Link provided by the sponsor.
Management of glioblastoma after recurrence: A changing paradigm.Link provided by the sponsor.
The Phenomenon of Long-Term Survival in Glioblastoma Patients. Part I: The Role of Clinical and Demographic Factors and an IDH1 MutationLink provided by the sponsor.
The Value of Glioma Extent of Resection in the Modern Neurosurgical EraLink provided by the sponsor.
The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summaryLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David A Wiles, MD principal investigator

Parkridge Medical Center - Neurosurgery

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intra-operative Radiation Therapy - IORT in people with Glioblastoma and GBM, run by Parkridge Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: No potential patients enrolled since first enrollment on 06/27/2022.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary endpoint is Overall Survival (OS) (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04763031, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.