Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme

NCT01464177 | Completed Phase 2 DMC

• 1 other identifier: RT-01/2011
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. The treatment comprises maximal safe resection followed by radiotherapy and chemotherapy. Despite appropriate management, 90% of the patients will develop relapse or progression. After progression, the median survival is 5.2 months (Stupp, 2009). 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.

Conditions

Recurrent Glioblastoma Multiforme

Keywords

malignant glioma; glioblastoma; radiotherapy; randomized

Outcome Measures

Primary Outcomes (1)

• progression free survival

  progression free survival as defined by the "Response Assesment in Neuro Oncology Working Group"(Wen, 2010). Briefly progression is defined as: * increase in 25% of the product of perpendicular diameters of enhancing lesions * significant increase in T2/Flair non enhancing component * appearance of new lesions * clinical deterioration not attributable to other causes other than the tumor or reduction in corticosteroid dose

  from date of randomization until date of first documented progression or death from any cause, which ever comes first, assessed up to 48 months

Secondary Outcomes (4)

• overall survival

  from date of randomization until death from any cause, assessed up to 48 months

• local control

  from date of randomization until date of local progression, assessed up to 48 months

• toxicity

  from date of randomization until death, assessed up to 48 months

• quality of life

  from date of randomization until last follow-up, assessed up to a period of 48 months

Study Arms (2)

Stereotactic hypofractionated RT 5x5Gy

ACTIVE COMPARATOR

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.

Radiation: Stereotactic hypofractionated RT 5x5Gy

Stereotactic hypofractionated RT 5x7Gy

EXPERIMENTAL

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.

Radiation: Stereotactic hypofractionated RT 5x7Gy

Interventions

Stereotactic hypofractionated RT 5x5Gy RADIATION

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 RT 5x7Gy RADIATION

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• 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.

You may not qualify if:

• Important comorbidities
• Concomitant chemotherapy
• Contraindication to MRI
• Brainstem glioma

Sponsors & Collaborators

• Andre Tsin Chih Chen: lead

Study Sites (1)

Hospital das Clinicas da Faculdade de Medicina da USP

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (11)

• 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.

  PMID: 15758009 BACKGROUND

• 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.

  PMID: 19269895 BACKGROUND

• 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.

  PMID: 21159396 BACKGROUND

• 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.

  PMID: 9069312 BACKGROUND

• 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.

  PMID: 15924621 BACKGROUND

• 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.

  PMID: 17031558 BACKGROUND

• 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.

  PMID: 20479391 BACKGROUND

• 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.

  PMID: 19370426 BACKGROUND

• 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.

  PMID: 18628405 BACKGROUND

• 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.

  PMID: 19001097 BACKGROUND

• 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.

  PMID: 20231676 BACKGROUND

MeSH Terms

Conditions

Glioblastoma; Glioma

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Andre T Chen, M.D. / PhD

  Hospital das Clinicas da Faculdade de Medicina da USP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: November 3, 2011
• Study Start: October 1, 2011
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

BR (1)