A Study of Avastin (Bevacizumab) and Irinotecan Versus Temozolomide Radiochemistry in Patients With Glioblastoma
NCT ID: NCT00967330
Last Updated: 2015-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
182 participants
INTERVENTIONAL
2010-06-30
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
bevacizumab [Avastin]
10mg/kg iv every 2 weeks
irinotecan
125mg/m2 iv every 2 weeks
2
temozolomide
75mg/m2 po daily during radiotherapy, followed by 150-200mg/m2/day po on days 1-5 of each 6x4 week cycle of adjuvant therapy
Interventions
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bevacizumab [Avastin]
10mg/kg iv every 2 weeks
irinotecan
125mg/m2 iv every 2 weeks
temozolomide
75mg/m2 po daily during radiotherapy, followed by 150-200mg/m2/day po on days 1-5 of each 6x4 week cycle of adjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* glioblastoma, confirmed histologically;
* no previous chemotherapy or radiotherapy for glioblastoma;
* non-methylated MGMT promoter in the tumor.
Exclusion Criteria
* prior treatment with Avastin;
* significant cardiovascular disease;
* other active malignant disease.
18 Years
70 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Aachen, , Germany
Berlin, , Germany
Bochum, , Germany
Bonn, , Germany
Chemnitz, , Germany
Cologne, , Germany
Dresden, , Germany
Düsseldorf, , Germany
Erfurt, , Germany
Erlangen, , Germany
Frankfurt am Main, , Germany
Freiburg im Breisgau, , Germany
Göttingen, , Germany
Idar-Oberstein, , Germany
Kiel, , Germany
Leipzig, , Germany
Mannheim, , Germany
Marburg, , Germany
München, , Germany
München, , Germany
Münster, , Germany
Regensburg, , Germany
Tübingen, , Germany
Ulm, , Germany
Countries
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References
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Schafer N, Proescholdt M, Steinbach JP, Weyerbrock A, Hau P, Grauer O, Goldbrunner R, Friedrich F, Rohde V, Ringel F, Schlegel U, Sabel M, Ronellenfitsch MW, Uhl M, Grau S, Hanel M, Schnell O, Krex D, Vajkoczy P, Tabatabai G, Mack F, Schaub C, Tzaridis T, Niessen M, Kebir S, Leutgeb B, Urbach H, Belka C, Stummer W, Glas M, Herrlinger U. Quality of life in the GLARIUS trial randomizing bevacizumab/irinotecan versus temozolomide in newly diagnosed, MGMT-nonmethylated glioblastoma. Neuro Oncol. 2018 Jun 18;20(7):975-985. doi: 10.1093/neuonc/nox204.
Herrlinger U, Schafer N, Steinbach JP, Weyerbrock A, Hau P, Goldbrunner R, Friedrich F, Rohde V, Ringel F, Schlegel U, Sabel M, Ronellenfitsch MW, Uhl M, Maciaczyk J, Grau S, Schnell O, Hanel M, Krex D, Vajkoczy P, Gerlach R, Kortmann RD, Mehdorn M, Tuttenberg J, Mayer-Steinacker R, Fietkau R, Brehmer S, Mack F, Stuplich M, Kebir S, Kohnen R, Dunkl E, Leutgeb B, Proescholdt M, Pietsch T, Urbach H, Belka C, Stummer W, Glas M. Bevacizumab Plus Irinotecan Versus Temozolomide in Newly Diagnosed O6-Methylguanine-DNA Methyltransferase Nonmethylated Glioblastoma: The Randomized GLARIUS Trial. J Clin Oncol. 2016 May 10;34(14):1611-9. doi: 10.1200/JCO.2015.63.4691. Epub 2016 Mar 14.
Other Identifiers
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2009-010390-21
Identifier Type: -
Identifier Source: secondary_id
ML21965
Identifier Type: -
Identifier Source: org_study_id