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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic hypofractionated RT 5x5Gy | Active Comparator | Stereotactic hypofractionated radiation therapy delivered as follows:
|
|
| Stereotactic hypofractionated RT 5x7Gy | Experimental | Stereotactic hypofractionated radiation therapy delivered as follows:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic hypofractionated RT 5x5Gy | Radiation | Stereotactic hypofractionated radiation therapy delivered as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | progression free survival as defined by the "Response Assesment in Neuro Oncology Working Group"(Wen, 2010). Briefly progression is defined as:
| from date of randomization until date of first documented progression or death from any cause, which ever comes first, assessed up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andre T Chen, M.D. / PhD | Hospital das Clinicas da Faculdade de Medicina da USP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clinicas da Faculdade de Medicina da USP | São Paulo | São Paulo | 05403-010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15758009 | Background | 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. | |
| 19269895 |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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|
| Stereotactic hypofractionated RT 5x7Gy | Radiation | Stereotactic hypofractionated radiation therapy delivered as follows:
|
|
| 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 |
| 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. |
| 21159396 | 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. |
| 9069312 | 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. |
| 15924621 | 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. |
| 17031558 | 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. |
| 20479391 | 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. |
| 19370426 | 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. |
| 18628405 | 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. |
| 19001097 | 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. |
| 20231676 | 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. |
| 38232937 | Derived | Chen ATC, Serante AR, Ayres AS, Tonaki JO, Moreno RA, Shih H, Gattas GS, Lopez RVM, Dos Santos de Jesus GR, de Carvalho IT, Marotta RC, Marta GN, Feher O, Neto HS, Ribeiro ISN, Vasconcelos KGMDC, Figueiredo EG, Weltman E. Prospective Randomized Phase 2 Trial of Hypofractionated Stereotactic Radiation Therapy of 25 Gy in 5 Fractions Compared With 35 Gy in 5 Fractions in the Reirradiation of Recurrent Glioblastoma. Int J Radiat Oncol Biol Phys. 2024 Jul 15;119(4):1122-1132. doi: 10.1016/j.ijrobp.2024.01.013. Epub 2024 Jan 15. |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |