Clinical trial NCT01464177: Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme
Official title: Prospective Randomized Phase II Trial of Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Glioblastoma Multiforme
Keywords: malignant glioma
glioblastoma
radiotherapy
randomized
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-11-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 18 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.

Exclusion Criteria:

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

Primary outcomes:
measure: progression free survival
timeFrame: 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:
measure: overall survival
timeFrame: from date of randomization until death from any cause, assessed up to 48 months
measure: local control
timeFrame: from date of randomization until date of local progression, assessed up to 48 months
measure: toxicity
timeFrame: from date of randomization until death, assessed up to 48 months
measure: quality of life
timeFrame: from date of randomization until last follow-up, assessed up to a period of 48 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da USP
state: SP
Study officials:
affiliation: Hospital das Clinicas da Faculdade de Medicina da USP
name: Andre T Chen, M.D. / PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.