A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma
NCT ID: NCT00943826
Last Updated: 2017-09-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
921 participants
INTERVENTIONAL
2009-06-29
2015-09-09
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
QUADRUPLE
Study Groups
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Bevacizumab + RT + Temozolomide
In the Concurrent Phase participants will receive radiotherapy (RT) in daily fractions of 2 Gy to be given 5 days per week for 6 weeks and temozolomide 75 mg/m\^2 daily from the first day to the last day of radiotherapy (it may continue for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab 10 mg/kg IV every 2 weeks for 6 weeks. There will be a 4 week treatment break. Participants will then enter the Maintenance Phase where they receive six 28-day cycle of bevacizumab 10 mg/kg IV q2w and temozolomide 150 to 200 mg/m\^2 daily in the first 5 days of each cycle. The participants will then enter the Monotherapy Phase where they will receive bevacizumab 15 mg/kg IV q3w until disease progression/unacceptable toxicity.
Bevacizumab
10 mg/kg intravenously q2w in the Concurrent and Maintenance Phases. 15 mg/kg intravenously q3w in the Monotherapy Phase.
Temozolomide
75 mg/m\^2 once daily for 6 weeks, followed by 150-200 mg/m\^2 once daily on days 1-5 of six 4 week cycles.
Radiation therapy
30 fractions of 2 Gy delivered on days 1-5 per week for 6 weeks.
Placebo + RT + Temozolomide
In the Concurrent Phase participants will receive radiotherapy in daily fractions of 2 Gy to be given 5 days per week for 6 weeks and temozolomide 75 mg/m\^2 daily from the first day to the last day of radiotherapy (it may continue for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There will be a 4 week treatment break. Participants will then enter the Maintenance Phase where they will receive six 28-day cycle of placebo IV q2w and temozolomide 150 to 200 mg/m\^2 daily in the first 5 days of each cycle. The participants will then enter the Monotherapy Phase where they will receive placebo IV q3w until disease progression/unacceptable toxicity.
Temozolomide
75 mg/m\^2 once daily for 6 weeks, followed by 150-200 mg/m\^2 once daily on days 1-5 of six 4 week cycles.
Radiation therapy
30 fractions of 2 Gy delivered on days 1-5 per week for 6 weeks.
Placebo
Intravenously q2w in the Concurrent and Maintenance Phases and q3w in the Monotherapy Phase.
Interventions
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Bevacizumab
10 mg/kg intravenously q2w in the Concurrent and Maintenance Phases. 15 mg/kg intravenously q3w in the Monotherapy Phase.
Temozolomide
75 mg/m\^2 once daily for 6 weeks, followed by 150-200 mg/m\^2 once daily on days 1-5 of six 4 week cycles.
Radiation therapy
30 fractions of 2 Gy delivered on days 1-5 per week for 6 weeks.
Placebo
Intravenously q2w in the Concurrent and Maintenance Phases and q3w in the Monotherapy Phase.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* World Health Organization (WHO) performance status less than or equal to (\<=2)
* stable or decreasing corticosteroid dose within 5 days prior to randomization
Exclusion Criteria
* any prior chemotherapy or immunotherapy for glioblastomas and low grade astrocytomas
* any prior radiotherapy to brain
* clinically significant cardiovascular disease
* history of greater than or equal to (\>=) grade 2 hemoptysis within 1 month prior to randomization
* previous centralized screening for Methylguanine-DNA methyltransferase (MGMT) status for enrollment into a clinical trial
18 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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University of Alabama At Birmingham; Neuro-Oncology
Birmingham, Alabama, United States
UCLA
Los Angeles, California, United States
University of Colorado
Aurora, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
Oncology-Evanston Nthwest Healthcare Kellogg Cancer Care Ctr
Evanston, Illinois, United States
Henry Ford Health System
Detroit, Michigan, United States
Hatton Research Institutes
Cincinnati, Ohio, United States
Sarah Cannon Cancer Center and Research Institute
Nashville, Tennessee, United States
University of Virgina
Charlottesville, Virginia, United States
Prince of Wales Hospital; Department of Medical Oncology
Randwick, New South Wales, Australia
North Shore Private Hospital; Northern Specialist Centre
St Leonards, New South Wales, Australia
Royal North Shore Hospital; Department of Medical Oncology
St Leonards, New South Wales, Australia
Princess AleXandra Hospital; Department of Medical Oncology
Woolloongabba, Queensland, Australia
Calvary North Adelaide; North Adeliade Oncology Centre
North Adelaide, South Australia, Australia
Royal Melbourne Hospital; Hematology and Medical Oncology
Parkville, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Clin Univ de Bxl Hôpital Erasme
Brussels, , Belgium
Cliniques Universitaires St-Luc
Brussels, , Belgium
UZ Antwerpen
Edegem, , Belgium
AZ Sint Lucas (Sint Lucas)
Ghent, , Belgium
CHU Sart-Tilman
Liège, , Belgium
AZ Delta (Campus Wilgenstraat)
Roeselare, , Belgium
Tom Baker Cancer Centre-Calgary
Calgary, Alberta, Canada
Cross Cancer Institute ; Dept of Medical Oncology
Edmonton, Alberta, Canada
BC Cancer Agency, Vancouver Clinic; Dept. of Medical Oncology
Vancouver, British Columbia, Canada
CancerCare Manitoba; Neuro-Oncology
Winnipeg, Manitoba, Canada
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario; Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital Regional Cancer Centre; Neuro-Oncology
Ottawa, Ontario, Canada
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada
Princess Margaret Hospital; Pencer Brain Tumour Centre, 18-727
Toronto, Ontario, Canada
Hopital Notre-Dame
Montreal, Quebec, Canada
McGill University; Montreal Neurological Institute; Oncology
Montreal, Quebec, Canada
Chuq - Hopital Hotel Dieu de Quebec
Québec, Quebec, Canada
Saskatoon Cancer Centre; Uni of Saskatoon Campus
Saskatoon, Saskatchewan, Canada
Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.
Aalborg, , Denmark
Righospitalet, Hæmatologisk Klinik
København Ø, , Denmark
Odense Universitetshospital, Onkologisk Afdeling R
Odense, , Denmark
Hopital Avicenne; Rhumatologie
Bobigny, , France
Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale
Bordeaux, , France
Institut Bergonie; Gastro Enterologie Oncologie
Bordeaux, , France
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
Bron, , France
Centre Jean Perrin; Hopital De Jour
Clermont-Ferrand, , France
Hopital Beaujon; Oncologie
Clichy, , France
Centre Georges François Leclerc
Dijon, , France
Hopital de La Timone - CHU de Marseille; Service de neuro-oncologie - Hôpital Adultes - 12ème étage
Marseille, , France
Centre Val Aurelle Paul Lamarque; Medecine B3
Montpellier, , France
Hôpital Central; Departement de Neuro-Oncologie
Nancy, , France
Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin
Paris, , France
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Neurochirurgie
Dresden, , Germany
Justus-Liebig-Universität Giessen; Neurochirurgische Klinik
Giessen, , Germany
Universitatsklinikum Hamburg-Eppendorf; Klinik und Poliklinik fur Neurochirurgie
Hamburg, , Germany
Universitatsklinikum Heidelberg; Abteilung Neuroonkologie
Heidelberg, , Germany
Ärztehaus Velen
Ibbenbühren, , Germany
Klinikum der Johannes Gutenberg Uni Mainz; Studienz. Neurologie, Klinik und Poliklinik Neurologie
Mainz, , Germany
Uni Klinikum München - Großhardern; Med. Klinik U. Poliklinik III - Abt. Onkologie u. Hämatologie
München, , Germany
Univ General Hosp Heraklion; Medical Oncology
Heraklion, , Greece
University Hospital of Larissa; Oncology
Larissa, , Greece
Papageorgiou General Hospital; Medical Oncology
Thessaloniki, , Greece
Dr Stephen Yau; Clinical oncology
Hong Kong, , Hong Kong
Hong Kong Sanatorium & Hospital; Comprehensive Oncology Centre
Hong Kong, , Hong Kong
Queen Mary Hospital; Microbiology Dept.
Hong Kong, , Hong Kong
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, , Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház; Neurosurgery
Miskolc, , Hungary
Pécsi Tudományegyetem Áok; Onkoterapias Intezet
Pécs, , Hungary
Rambam Medical Center; Oncology
Haifa, , Israel
Hadassah Hebrew University Hospital; Leslie and Michael Gaffin Center for Neuro-Oncology
Jerusalem, , Israel
Rabin MC; Davidof Center - Oncology Institute
Petah Tikva, , Israel
Chaim Sheba MC; Pediatric Hematology Oncology
Tel Litwinsky, , Israel
Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica
Bologna, Emilia-Romagna, Italy
Ospedale Bufalini
Forlì, Emilia-Romagna, Italy
Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica
Milan, Lombardy, Italy
Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia
Turin, Piedmont, Italy
Az. Osp. S. Maria; Dept. Di Oncologia Medica
Terni, Umbria, Italy
Ospedale di Treviso, Universita di Padova; Neurosurgery Dept
Treviso, Veneto, Italy
Hiroshima University Hospital; Neurosurgery
Hiroshima, , Japan
Tsukuba University Hospital; Neurology
Ibaraki, , Japan
Kumamoto University Hospital; Neurosurgery
Kumamoto, , Japan
Kitano Hospital; Neurosurgery
Osaka, , Japan
Saitama Medical University International Medical Center; Clinical and Medical Oncology
Saitama, , Japan
National Cancer Center Hospital; Neurosurgery
Tokyo, , Japan
Komagome Hospital; Neurosurgery
Tokyo, , Japan
Kyorin University Hospital; Neurosurgery
Tokyo, , Japan
VU MEDISCH CENTRUM; Dept. of Medical Oncology
Amsterdam, , Netherlands
Catharina Ziekenhuis; Dept of Internal Medicin
Eindhoven, , Netherlands
Utrecht University Medical Centre; Dept of Medical Oncology and UPC
Utrecht, , Netherlands
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
Auckland, , New Zealand
Christchurch Hospital; Dept of Oncology
Christchurch, , New Zealand
Waikato Hospital; Regional Cancer Center
Hamilton, , New Zealand
Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
Bialystok, , Poland
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
Bydgoszcz, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie; Klinika Neurochirurgii i Neurochirurgii Dzi
Lublin, , Poland
IPO de Coimbra; Servico de Oncologia Medica
Coimbra, , Portugal
IPO de Lisboa; Servico de Neurologia
Lisbon, , Portugal
Hospital de Santa Maria; Servico de Oncologia Medica
Lisbon, , Portugal
Hospital de Sao Joao; Servico de Oncologia
Porto, , Portugal
Institut Oncologic Prof. Dr. Alexandru Trestioreanu; Departament Radioterapie
Bucharest, , Romania
Institut Oncologic Ion Chiricuta; Departament Radioterapie
Cluj-Napoca, , Romania
Spital Clinic Judetean Mures; Oncologie
Târgu Mureş, , Romania
N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
Moscow, , Russia
Russian Research Oncology Center n.a. N.N. Blokhin of the RAMS; Department of Neurosurgery
Moscow, , Russia
Scientific Research Neurosurgery Institute; Dept. of Neurooncology
Moscow, , Russia
Institution of Higher Professional Learning Military; Neurooncology
Saint Petersburg, , Russia
Pusan National University Hospital; Neuro Sugery
Busan, , South Korea
Kyungpook National University Hosital; Neuro Sugery
Daegu, , South Korea
National Cancer Centre; Neurosurgery Dept
Goyang-si, , South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, , South Korea
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
Seoul, , South Korea
Asan Medical Center; Medical Oncology
Seoul, , South Korea
Yonsei University Severance Hospital; Medical Oncology
Seoul, , South Korea
Samsung Medical Center; Neurosurgery Department
Seoul, , South Korea
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, , Spain
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, , Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Barcelona, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, , Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Málaga, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, , Spain
Sahlgrenska Universitetssjukhuset; Jubileumskliniken
Gothenburg, , Sweden
Skånes University Hospital, Skånes Department of Onclology
Lund, , Sweden
Norrlands Universitetssjukhus; Cancer Centrum
Umeå, , Sweden
Akademiska sjukhuset, Onkologkliniken
Uppsala, , Sweden
HUG; Oncologie
Geneva, , Switzerland
Queen Elizabeth Medical Centre; Neurosurgery
Birmingham, , United Kingdom
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
The Royal Marsden NHS Foundation Trust; Oncology
London, , United Kingdom
The Clatterbridge Cancer Ctr For Oncolgy
Metropolitan Borough of Wirral, , United Kingdom
Northern Centre for Cancer Care;Oncology
Newcastle upon Tyne, , United Kingdom
Nottingham City Hospital; Dept of Haematology
Nottingham, , United Kingdom
Queen's Hospital; Oncology
Romford, , United Kingdom
Weston Park Hospital; Cancer Clinical Trials Centre
Sheffield, , United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology
Sutton, , United Kingdom
Countries
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References
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Seliger C, Oppong FB, Lefranc F, Chinot O, Stupp R, Nabors B, Gorlia T, Weller M; EORTC Brain Tumor Group. Association of antidepressant drug use with outcome of patients with glioblastoma. Int J Cancer. 2023 Apr 1;152(7):1348-1359. doi: 10.1002/ijc.34344. Epub 2022 Nov 17.
Hagiwara A, Schlossman J, Shabani S, Raymond C, Tatekawa H, Abrey LE, Garcia J, Chinot O, Saran F, Nishikawa R, Henriksson R, Mason WP, Wick W, Cloughesy TF, Ellingson BM. Incidence, molecular characteristics, and imaging features of "clinically-defined pseudoprogression" in newly diagnosed glioblastoma treated with chemoradiation. J Neurooncol. 2022 Sep;159(3):509-518. doi: 10.1007/s11060-022-04088-3. Epub 2022 Jul 17.
Jiguet-Jiglaire C, Boissonneau S, Denicolai E, Hein V, Lasseur R, Garcia J, Romain S, Appay R, Graillon T, Mason W, Carpentier AF, Brandes AA, Ouafik L', Wick W, Baaziz A, Gigan JP, Arguello RJ, Figarella-Branger D, Chinot O, Tabouret E. Plasmatic MMP9 released from tumor-infiltrating neutrophils is predictive for bevacizumab efficacy in glioblastoma patients: an AVAglio ancillary study. Acta Neuropathol Commun. 2022 Jan 3;10(1):1. doi: 10.1186/s40478-021-01305-4.
Chinot OL, Nishikawa R, Mason W, Henriksson R, Saran F, Cloughesy T, Garcia J, Revil C, Abrey L, Wick W. Upfront bevacizumab may extend survival for glioblastoma patients who do not receive second-line therapy: an exploratory analysis of AVAglio. Neuro Oncol. 2016 Sep;18(9):1313-8. doi: 10.1093/neuonc/now046. Epub 2016 Mar 22.
Saran F, Chinot OL, Henriksson R, Mason W, Wick W, Cloughesy T, Dhar S, Pozzi E, Garcia J, Nishikawa R. Bevacizumab, temozolomide, and radiotherapy for newly diagnosed glioblastoma: comprehensive safety results during and after first-line therapy. Neuro Oncol. 2016 Jul;18(7):991-1001. doi: 10.1093/neuonc/nov300. Epub 2016 Jan 24.
Taphoorn MJ, Henriksson R, Bottomley A, Cloughesy T, Wick W, Mason WP, Saran F, Nishikawa R, Hilton M, Theodore-Oklota C, Ravelo A, Chinot OL. Health-Related Quality of Life in a Randomized Phase III Study of Bevacizumab, Temozolomide, and Radiotherapy in Newly Diagnosed Glioblastoma. J Clin Oncol. 2015 Jul 1;33(19):2166-75. doi: 10.1200/JCO.2014.60.3217. Epub 2015 May 26.
Chinot OL, Wick W, Mason W, Henriksson R, Saran F, Nishikawa R, Carpentier AF, Hoang-Xuan K, Kavan P, Cernea D, Brandes AA, Hilton M, Abrey L, Cloughesy T. Bevacizumab plus radiotherapy-temozolomide for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):709-22. doi: 10.1056/NEJMoa1308345.
Chinot OL, Macdonald DR, Abrey LE, Zahlmann G, Kerloeguen Y, Cloughesy TF. Response assessment criteria for glioblastoma: practical adaptation and implementation in clinical trials of antiangiogenic therapy. Curr Neurol Neurosci Rep. 2013 May;13(5):347. doi: 10.1007/s11910-013-0347-2.
Other Identifiers
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2008-006146-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BO21990
Identifier Type: -
Identifier Source: org_study_id