Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme
NCT ID: NCT01464177
Last Updated: 2024-12-09
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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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2011-10-31
2024-08-31
Brief Summary
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The treatment of GBM relapse remains investigational. Reirradiation is an option in selected cases.
The objective of this study is to compare 2 schemes of stereotactic hypofractionated radiotherapy in the management of recurrent GBM.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Stereotactic hypofractionated RT 5x5Gy
Stereotactic hypofractionated radiation therapy delivered as follows:
* Gross tumor volume (GTV) equals enhancement area in T1 contrast enhanced MRI.
* Planning tumor volume (PTV) equals GTV plus 3mm margin.
* the dose of radiation will be 25Gy delivered in 5 fractions.1 fraction per day, non consecutive days in a maximum period of 10 working days.
* RT to begin in a maximum of 2 weeks after randomization.
Stereotactic hypofractionated RT 5x5Gy
Stereotactic hypofractionated radiation therapy delivered as follows:
* Gross tumor volume (GTV) equals enhancement area in T1 contrast enhanced MRI.
* Planning tumor volume (PTV) equals GTV plus 3mm margin.
* The dose of radiation will be 25Gy delivered in 5 fractions.1 fraction per day, non consecutive days in a maximum period of 10 working days.
* RT to begin in a maximum of 2 weeks after randomization
Stereotactic hypofractionated RT 5x7Gy
Stereotactic hypofractionated radiation therapy delivered as follows:
* Gross tumor volume (GTV) equals enhancement area in T1 contrast enhanced MRI.
* Planning tumor volume (PTV) equals GTV plus 3mm margin.
* the dose of radiation will be 35Gy delivered in 5 fractions.1 fraction per day, non consecutive days in a maximum period of 10 working days.
* RT to begin in a maximum of 2 weeks after randomization.
Stereotactic hypofractionated RT 5x7Gy
Stereotactic hypofractionated radiation therapy delivered as follows:
* Gross tumor volume (GTV) equals enhancement area in T1 contrast enhanced MRI.
* Planning tumor volume (PTV) equals GTV plus 3mm margin.
* The dose of radiation will be 35Gy delivered in 5 fractions.1 fraction per day, non consecutive days in a maximum period of 10 working days.
* RT to begin in a maximum of 2 weeks after randomization.
Interventions
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Stereotactic hypofractionated RT 5x5Gy
Stereotactic hypofractionated radiation therapy delivered as follows:
* Gross tumor volume (GTV) equals enhancement area in T1 contrast enhanced MRI.
* Planning tumor volume (PTV) equals GTV plus 3mm margin.
* The dose of radiation will be 25Gy delivered in 5 fractions.1 fraction per day, non consecutive days in a maximum period of 10 working days.
* RT to begin in a maximum of 2 weeks after randomization
Stereotactic hypofractionated RT 5x7Gy
Stereotactic hypofractionated radiation therapy delivered as follows:
* Gross tumor volume (GTV) equals enhancement area in T1 contrast enhanced MRI.
* Planning tumor volume (PTV) equals GTV plus 3mm margin.
* The dose of radiation will be 35Gy delivered in 5 fractions.1 fraction per day, non consecutive days in a maximum period of 10 working days.
* RT to begin in a maximum of 2 weeks after randomization.
Eligibility Criteria
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Inclusion Criteria
* KPS equal or greater than 60
* Anatomopathological confirmation of GBM
* Previous RT with therapeutic doses
* At least 5 months from the end of RT course
* Not a candidate to surgical resection
* Patients with partial resection after resection of recurrent GBM will be allowed
* Patients with local progression after resection of recurrent GBM will be allowed
* Lesion with a maximal 150cc volume, as defined by enhancing portion in contrast enhanced MRI
* Hemoglobin levels (Hb) equal or greater than 10ng/dl. Blood transfusions to correct the Hb will be allowed.
Exclusion Criteria
* Concomitant chemotherapy
* Contraindication to MRI
* Brainstem glioma
18 Years
ALL
No
Sponsors
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Andre Tsin Chih Chen
OTHER
Responsible Party
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Andre Tsin Chih Chen
Medical Doctor
Principal Investigators
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Andre T Chen, M.D. / PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital das Clinicas da Faculdade de Medicina da USP
Locations
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Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil
Countries
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References
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Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.
Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 May;10(5):459-66. doi: 10.1016/S1470-2045(09)70025-7. Epub 2009 Mar 9.
Niyazi M, Siefert A, Schwarz SB, Ganswindt U, Kreth FW, Tonn JC, Belka C. Therapeutic options for recurrent malignant glioma. Radiother Oncol. 2011 Jan;98(1):1-14. doi: 10.1016/j.radonc.2010.11.006. Epub 2010 Dec 13.
Shepherd SF, Laing RW, Cosgrove VP, Warrington AP, Hines F, Ashley SE, Brada M. Hypofractionated stereotactic radiotherapy in the management of recurrent glioma. Int J Radiat Oncol Biol Phys. 1997 Jan 15;37(2):393-8. doi: 10.1016/s0360-3016(96)00455-5.
Vordermark D, Kolbl O, Ruprecht K, Vince GH, Bratengeier K, Flentje M. Hypofractionated stereotactic re-irradiation: treatment option in recurrent malignant glioma. BMC Cancer. 2005 May 30;5:55. doi: 10.1186/1471-2407-5-55.
Ernst-Stecken A, Ganslandt O, Lambrecht U, Sauer R, Grabenbauer G. Survival and quality of life after hypofractionated stereotactic radiotherapy for recurrent malignant glioma. J Neurooncol. 2007 Feb;81(3):287-94. doi: 10.1007/s11060-006-9231-0. Epub 2006 Sep 20.
Fogh SE, Andrews DW, Glass J, Curran W, Glass C, Champ C, Evans JJ, Hyslop T, Pequignot E, Downes B, Comber E, Maltenfort M, Dicker AP, Werner-Wasik M. Hypofractionated stereotactic radiation therapy: an effective therapy for recurrent high-grade gliomas. J Clin Oncol. 2010 Jun 20;28(18):3048-53. doi: 10.1200/JCO.2009.25.6941. Epub 2010 May 17.
Fokas E, Wacker U, Gross MW, Henzel M, Encheva E, Engenhart-Cabillic R. Hypofractionated stereotactic reirradiation of recurrent glioblastomas : a beneficial treatment option after high-dose radiotherapy? Strahlenther Onkol. 2009 Apr;185(4):235-40. doi: 10.1007/s00066-009-1753-x. Epub 2009 Apr 16.
Cheng JX, Zhang X, Liu BL. Health-related quality of life in patients with high-grade glioma. Neuro Oncol. 2009 Feb;11(1):41-50. doi: 10.1215/15228517-2008-050. Epub 2008 Jul 15.
Liu R, Page M, Solheim K, Fox S, Chang SM. Quality of life in adults with brain tumors: current knowledge and future directions. Neuro Oncol. 2009 Jun;11(3):330-9. doi: 10.1215/15228517-2008-093. Epub 2008 Nov 10.
Wen PY, Macdonald DR, Reardon DA, Cloughesy TF, Sorensen AG, Galanis E, Degroot J, Wick W, Gilbert MR, Lassman AB, Tsien C, Mikkelsen T, Wong ET, Chamberlain MC, Stupp R, Lamborn KR, Vogelbaum MA, van den Bent MJ, Chang SM. Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group. J Clin Oncol. 2010 Apr 10;28(11):1963-72. doi: 10.1200/JCO.2009.26.3541. Epub 2010 Mar 15.
Other Identifiers
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RT-01/2011
Identifier Type: -
Identifier Source: org_study_id