Back to resultsRecurrent GBM With Maximal Neurosurgical Removal and Treatment With IORT
Primary Purpose
Glioblastoma, GBM, Recurrent GBM
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intra-operative Radiation Therapy - IORT
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma focused on measuring Glioblastoma, GBM, Recurrent GBM, Recurrent Glioblastoma, IORT, Intra-Operative Radiation Therapy
Eligibility Criteria
Inclusion Criteria:
- 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)
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:
- 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
- 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
Sites / Locations
- Parkridge Medical Center - NeurosurgeryRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intra-operative Radiation Therapy - IORT
Arm Description
Intra-operative Radiation Therapy - IORT
Outcomes
Primary Outcome Measures
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.
Patients treated with Xoft IORT device median overall survival (OS)
The median and mean OS with Xoft will be calculated
Secondary Outcome Measures
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.
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"
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.
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.
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
Full Information
NCT ID
NCT04763031
First Posted
February 4, 2021
Last Updated
March 29, 2023
Sponsor
Parkridge Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04763031
Brief Title
Recurrent GBM With Maximal Neurosurgical Removal and Treatment With IORT
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
February 22, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Parkridge Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief 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 maximal safe neurosurgical resection in patients with recurrent glioblastoma multiforme (GBM).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, GBM, Recurrent GBM
Keywords
Glioblastoma, GBM, Recurrent GBM, Recurrent Glioblastoma, IORT, Intra-Operative Radiation Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single 20 Gy (gray) dose of electronic brachytherapy (IORT)
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intra-operative Radiation Therapy - IORT
Arm Type
Experimental
Arm Description
Intra-operative Radiation Therapy - IORT
Intervention Type
Radiation
Intervention Name(s)
Intra-operative Radiation Therapy - IORT
Other Intervention Name(s)
Electronic Brachytherapy
Intervention Description
Single dose of 20 Gy
Primary Outcome Measure Information:
Title
The primary endpoint is Overall Survival (OS)
Description
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.
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.
Title
Patients treated with Xoft IORT device median overall survival (OS)
Description
The median and mean OS with Xoft will be calculated
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.
Secondary Outcome Measure Information:
Title
Local Progression-free Survival (PFS)
Description
Local PFS will be assessed at following intra-operative treatment with the Xoft Axxent Electronic Brachytherapy System following maximal safe neurosurgical resection.
Time Frame
LocPFS will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.
Title
Quality of Life Assessment (Fact-Br)
Description
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"
Time Frame
QOL will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.
Title
Karnofsky Performance Status (KPS)
Description
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.
Time Frame
KPS will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.
Title
Radiation-related Neurotoxicity
Description
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.
Time Frame
Radiation-related Neurotoxicity will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.
Title
The rate and severity of Adverse Events (AEs), Adverse Device Effects (ADEs), and Unanticipated Adverse Device Effects (UADEs)
Description
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
Time Frame
UADEs will be assessed at baseline, Month 2, Month 6, then every 6 months until Year 3 follow-up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
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:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donna O. Howard, CCRC
Phone
423-493-1667
Email
donna.howard@hcahealthcare.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Wiles, MD
Organizational Affiliation
Parkridge Medical Center - Neurosurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkridge Medical Center - Neurosurgery
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David A. Wiles, MD
Phone
423-693-2175
Email
david.wiles@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Donna O. Howard, CCRC
Phone
423-493-1667
Email
donna.howard@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
David A Wiles, MD
First Name & Middle Initial & Last Name & Degree
Nitesh Rana, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
2542195
Citation
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.
Results Reference
background
PubMed Identifier
1512163
Citation
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.
Results Reference
background
PubMed Identifier
3021931
Citation
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.
Results Reference
background
PubMed Identifier
27476474
Citation
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.
Results Reference
background
PubMed Identifier
28665384
Citation
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.
Results Reference
background
PubMed Identifier
29295569
Citation
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.
Results Reference
background
PubMed Identifier
23087667
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
25406906
Citation
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.
Results Reference
background
PubMed Identifier
27157931
Citation
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.
Results Reference
background
PubMed Identifier
28483413
Citation
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. Erratum In: Lancet Oncol. 2017 Nov;18(11):e642.
Results Reference
background
PubMed Identifier
28730289
Citation
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.
Results Reference
background
PubMed Identifier
26243790
Citation
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.
Results Reference
background
PubMed Identifier
8115886
Citation
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.
Results Reference
background
PubMed Identifier
2827051
Citation
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.
Results Reference
background
PubMed Identifier
2827052
Citation
Harsh GR 4th, Levin VA, Gutin PH, Seager M, Silver P, Wilson CB. Reoperation for recurrent glioblastoma and anaplastic astrocytoma. Neurosurgery. 1987 Nov;21(5):615-21. doi: 10.1227/00006123-198711000-00002.
Results Reference
background
PubMed Identifier
28593859
Citation
Pace A, Dirven L, Koekkoek JAF, Golla H, Fleming J, Ruda R, Marosi C, Le Rhun E, Grant R, Oliver K, Oberg I, Bulbeck HJ, Rooney AG, Henriksson R, Pasman HRW, Oberndorfer S, Weller M, Taphoorn MJB; European Association of Neuro-Oncology palliative care task force. European Association for Neuro-Oncology (EANO) guidelines for palliative care in adults with glioma. Lancet Oncol. 2017 Jun;18(6):e330-e340. doi: 10.1016/S1470-2045(17)30345-5.
Results Reference
background
PubMed Identifier
10776976
Citation
Lederman G, Wronski M, Arbit E, Odaimi M, Wertheim S, Lombardi E, Wrzolek M. Treatment of recurrent glioblastoma multiforme using fractionated stereotactic radiosurgery and concurrent paclitaxel. Am J Clin Oncol. 2000 Apr;23(2):155-9. doi: 10.1097/00000421-200004000-00010.
Results Reference
background
PubMed Identifier
6271933
Citation
Young B, Oldfield EH, Markesbery WR, Haack D, Tibbs PA, McCombs P, Chin HW, Maruyama Y, Meacham WF. Reoperation for glioblastoma. J Neurosurg. 1981 Dec;55(6):917-21. doi: 10.3171/jns.1981.55.6.0917.
Results Reference
background
PubMed Identifier
23039151
Citation
Bloch O, Han SJ, Cha S, Sun MZ, Aghi MK, McDermott MW, Berger MS, Parsa AT. Impact of extent of resection for recurrent glioblastoma on overall survival: clinical article. J Neurosurg. 2012 Dec;117(6):1032-8. doi: 10.3171/2012.9.JNS12504. Epub 2012 Oct 5.
Results Reference
background
PubMed Identifier
16517093
Citation
Ruben JD, Dally M, Bailey M, Smith R, McLean CA, Fedele P. Cerebral radiation necrosis: incidence, outcomes, and risk factors with emphasis on radiation parameters and chemotherapy. Int J Radiat Oncol Biol Phys. 2006 Jun 1;65(2):499-508. doi: 10.1016/j.ijrobp.2005.12.002. Epub 2006 Mar 6.
Results Reference
background
PubMed Identifier
25744350
Citation
Miyatake S, Nonoguchi N, Furuse M, Yoritsune E, Miyata T, Kawabata S, Kuroiwa T. Pathophysiology, diagnosis, and treatment of radiation necrosis in the brain. Neurol Med Chir (Tokyo). 2015;55(1):50-9. doi: 10.2176/nmc.ra.2014-0188. Epub 2014 Dec 20.
Results Reference
background
PubMed Identifier
25377756
Citation
Nguyen D, Rwigema JC, Yu VY, Kaprealian T, Kupelian P, Selch M, Lee P, Low DA, Sheng K. Feasibility of extreme dose escalation for glioblastoma multiforme using 4pi radiotherapy. Radiat Oncol. 2014 Nov 7;9:239. doi: 10.1186/s13014-014-0239-x.
Results Reference
background
PubMed Identifier
24465461
Citation
Veldwijk MR, Zhang B, Wenz F, Herskind C. The biological effect of large single doses: a possible role for non-targeted effects in cell inactivation. PLoS One. 2014 Jan 22;9(1):e84991. doi: 10.1371/journal.pone.0084991. eCollection 2014.
Results Reference
background
Citation
Herskind C, Wenz F. Radiobiological aspects of intraoperative tumour-bed irradiation with low-energy X-rays (LEX-IORT). Transl Cancer Res. 2014;3(1):3-17. doi:10.3978/j.issn.2218-676X.2014.01.06.
Results Reference
background
PubMed Identifier
19031175
Citation
Bensaleh S, Bezak E, Borg M. Review of MammoSite brachytherapy: advantages, disadvantages and clinical outcomes. Acta Oncol. 2009;48(4):487-94. doi: 10.1080/02841860802537916.
Results Reference
background
PubMed Identifier
27668386
Citation
Davis ME. Glioblastoma: Overview of Disease and Treatment. Clin J Oncol Nurs. 2016 Oct 1;20(5 Suppl):S2-8. doi: 10.1188/16.CJON.S1.2-8.
Results Reference
background
PubMed Identifier
29086250
Citation
Martinez-Garcia M, Alvarez-Linera J, Carrato C, Ley L, Luque R, Maldonado X, Martinez-Aguillo M, Navarro LM, Vaz-Salgado MA, Gil-Gil M. SEOM clinical guidelines for diagnosis and treatment of glioblastoma (2017). Clin Transl Oncol. 2018 Jan;20(1):22-28. doi: 10.1007/s12094-017-1763-6. Epub 2017 Oct 30.
Results Reference
background
PubMed Identifier
20555079
Citation
Stupp R, Tonn JC, Brada M, Pentheroudakis G; ESMO Guidelines Working Group. High-grade malignant glioma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010 May;21 Suppl 5:v190-3. doi: 10.1093/annonc/mdq187. No abstract available.
Results Reference
background
PubMed Identifier
21144735
Citation
Scanderbeg DJ, Alksne JF, Lawson JD, Murphy KT. Novel use of the Contura for high dose rate cranial brachytherapy. Med Dosim. 2011 Winter;36(4):344-6. doi: 10.1016/j.meddos.2010.08.001. Epub 2010 Dec 8.
Results Reference
background
PubMed Identifier
22582564
Citation
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.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/2542195
Description
Patterns of failure following treatment for glioblastoma multiforme and anaplastic astrocytoma
URL
http://www.ncbi.nlm.nih.gov/pubmed/1512163
Description
Supratentorial malignant glioma: patterns of recurrence and implications for external beam local treatment.
URL
https://doi.org/10.3171/jns.1986.65.5.0654
Description
Development of multiple lesions during radiation therapy and chemotherapy in patients with gliomas
URL
http://doi.org/10.1016/j.jnci.2016.07.001
Description
Management of glioblastoma after recurrence: A changing paradigm.
URL
http://doi.org/10.17116/neiro20178135-16
Description
The Phenomenon of Long-Term Survival in Glioblastoma Patients. Part I: The Role of Clinical and Demographic Factors and an IDH1 Mutation
URL
http://doi.org/10.3390/brainsci8010005
Description
Extent of resection in newly diagnosed glioblastoma: Impact of a specialized neuro-oncology care center.
URL
https://www.frontiersin.org/article/10.3389/fneur.2012.00140
Description
The Value of Glioma Extent of Resection in the Modern Neurosurgical Era
URL
http://doi.org/10.1007/s00401-016-1545-1
Description
The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary
URL
http://doi.org/10.1016/S1470-2045(17)30194-8
Description
European Association for Neuro-Oncology (EANO) guideline on the diagnosis and treatment of adult astrocytic and oligodendroglial gliomas.
URL
http://doi.org/10.1007/s11060-017-2564-z
Description
Treatment outcome of patients with recurrent glioblastoma multiforme: a retrospective multicenter analysis
URL
http://doi.org/10.1093/neuonc/nov145
Description
Clinical benefit from resection of recurrent glioblastomas: results of a multicenter study including 503 patients with recurrent glioblastomas undergoing surgical resection
URL
http://www.ncbi.nlm.nih.gov/pubmed/8115886
Description
Retreatment of intracranial gliomas
URL
http://www.ncbi.nlm.nih.gov/pubmed/2827051
Description
Reoperation in the treatment of recurrent intracranial malignant gliomas.
URL
http://www.ncbi.nlm.nih.gov/pubmed/2827052
Description
Reoperation for recurrent glioblastoma and anaplastic astrocytoma.
URL
http://doi.org/10.1016/j.meddos.2010.08.001
Description
Novel Use of the Contura for High Dose Rate Cranial Brachytherapy
URL
http://www.ncbi.nlm.nih.gov/pubmed/22582564.
Description
Polymodal therapy for high grade gliomas: a case report of favourable outcomes following intraoperative radiation therapy.
Learn more about this trial
Recurrent GBM With Maximal Neurosurgical Removal and Treatment With IORT
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