AzTrials
AzTrials

GlioblastomaPhase 3NCT00943826

A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma

A Phase 3 study testing Bevacizumab, Temozolomide and Radiation therapy in people with Glioblastoma, run by Hoffmann-La Roche at 133 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma
What is being tested?
Bevacizumab, Temozolomide and Radiation therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
921 participants
Where
133 sitesin 24 countries
Study dates
29 Jun 2009to 9 Sep 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • newly diagnosed glioblastoma
  • World Health Organization (WHO) performance status less than or equal to (<=2)
  • stable or decreasing corticosteroid dose within 5 days prior to randomization

Who cannot join

  • evidence of recent hemorrhage on postoperative magnetic resonance imaging (MRI) of brain
  • 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

Trial locations and contacts

133 sites in 24 countries.

133 sites in 24 countries

Canada14 sites

  • Tom Baker Cancer Centre-Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute ; Dept of Medical Oncology

    Edmonton, Alberta, T6G 1Z2

  • Hamilton Health Sciences - Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Cancer Centre of Southeastern Ontario; Kingston General Hospital

    Kingston, Ontario, K7L 5P9

  • London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • McGill University; Montreal Neurological Institute; Oncology

    Montreal, Quebec, H3A 2B4

  • Ottawa Hospital Regional Cancer Centre; Neuro-Oncology

    Ottawa, Ontario, K1H 1C4

  • Chuq - Hopital Hotel Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • Saskatoon Cancer Centre; Uni of Saskatoon Campus

    Saskatoon, Saskatchewan, S7N 4H4

  • Sunnybrook Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital; Pencer Brain Tumour Centre, 18-727

    Toronto, Ontario, M5G 2M9

  • BC Cancer Agency, Vancouver Clinic; Dept. of Medical Oncology

    Vancouver, British Columbia, V5Z 4E6

  • CancerCare Manitoba; Neuro-Oncology

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

France11 sites

  • Hopital Avicenne; Rhumatologie

    Bobigny, 93009

  • Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale

    Bordeaux, 33075

  • Institut Bergonie; Gastro Enterologie Oncologie

    Bordeaux, 33076

  • Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

    Bron, 69677

  • Centre Jean Perrin; Hopital De Jour

    Clermont-Ferrand, 63011

  • Hopital Beaujon; Oncologie

    Clichy, 92118

  • Centre Georges François Leclerc

    Dijon, 21000

  • Hopital de La Timone - CHU de Marseille; Service de neuro-oncologie - Hôpital Adultes - 12ème étage

    Marseille, 13385

  • Centre Val Aurelle Paul Lamarque; Medecine B3

    Montpellier, 34298

  • Hôpital Central; Departement de Neuro-Oncologie

    Nancy, 54000

  • Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin

    Paris, 75651

Other trials in France

United States9 sites

  • University of Colorado

    Aurora, Colorado, 80045

  • University of Alabama At Birmingham; Neuro-Oncology

    Birmingham, Alabama, 35294

  • University of Virgina

    Charlottesville, Virginia, 22908

  • Hatton Research Institutes

    Cincinnati, Ohio, 45220

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Oncology-Evanston Nthwest Healthcare Kellogg Cancer Care Ctr

    Evanston, Illinois, 60201

  • UCLA

    Los Angeles, California, 90095

  • Sarah Cannon Cancer Center and Research Institute

    Nashville, Tennessee, 37203

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

United Kingdom9 sites

  • Queen Elizabeth Medical Centre; Neurosurgery

    Birmingham, B15 2TT

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

  • The Royal Marsden NHS Foundation Trust; Oncology

    London, SW3 6JJ

  • The Clatterbridge Cancer Ctr For Oncolgy

    Metropolitan Borough of Wirral, CH63 4JY

  • Northern Centre for Cancer Care;Oncology

    Newcastle upon Tyne, NE7 7DN

  • Nottingham City Hospital; Dept of Haematology

    Nottingham, NG5 1PB

  • Queen's Hospital; Oncology

    Romford, RM7 0AG

  • Weston Park Hospital; Cancer Clinical Trials Centre

    Sheffield, S10 2SJ

  • Royal Marsden Hospital; Dept of Medical Oncology

    Sutton, SM2 5PT

Other trials in United Kingdom

Japan8 sites

  • Hiroshima University Hospital; Neurosurgery

    Hiroshima, 734-8551

  • Tsukuba University Hospital; Neurology

    Ibaraki, 305-8576

  • Kumamoto University Hospital; Neurosurgery

    Kumamoto, 860-8556

  • Kitano Hospital; Neurosurgery

    Osaka, 530-8480

  • Saitama Medical University International Medical Center; Clinical and Medical Oncology

    Saitama, 350-1298

  • National Cancer Center Hospital; Neurosurgery

    Tokyo, 104-0045

  • Komagome Hospital; Neurosurgery

    Tokyo, 113-8677

  • Kyorin University Hospital; Neurosurgery

    Tokyo, 181-8611

Other trials in Japan

South Korea8 sites

  • Pusan National University Hospital; Neuro Sugery

    Busan, 602-739

  • Kyungpook National University Hosital; Neuro Sugery

    Daegu, 700-721

  • National Cancer Centre; Neurosurgery Dept

    Goyang-si, 410-769

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

    Seoul, 03080

  • Asan Medical Center; Medical Oncology

    Seoul, 05505

  • Yonsei University Severance Hospital; Medical Oncology

    Seoul, 120-752

  • Samsung Medical Center; Neurosurgery Department

    Seoul, 135-170

Other trials in South Korea

Australia7 sites

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Calvary North Adelaide; North Adeliade Oncology Centre

    North Adelaide, South Australia, 5006

  • Royal Melbourne Hospital; Hematology and Medical Oncology

    Parkville, Victoria, 3052

  • Prince of Wales Hospital; Department of Medical Oncology

    Randwick, New South Wales, 2031

  • North Shore Private Hospital; Northern Specialist Centre

    St Leonards, New South Wales, 2065

  • Royal North Shore Hospital; Department of Medical Oncology

    St Leonards, New South Wales, 2065

  • Princess AleXandra Hospital; Department of Medical Oncology

    Woolloongabba, Queensland, 4102

Other trials in Australia

Germany7 sites

  • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Neurochirurgie

    Dresden, 01307

  • Justus-Liebig-Universität Giessen; Neurochirurgische Klinik

    Giessen, 35392

  • Universitatsklinikum Hamburg-Eppendorf; Klinik und Poliklinik fur Neurochirurgie

    Hamburg, 20246

  • Universitatsklinikum Heidelberg; Abteilung Neuroonkologie

    Heidelberg, 69120

  • Ärztehaus Velen

    Ibbenbühren, 49479

  • Klinikum der Johannes Gutenberg Uni Mainz; Studienz. Neurologie, Klinik und Poliklinik Neurologie

    Mainz, 55131

  • Uni Klinikum München - Großhardern; Med. Klinik U. Poliklinik III - Abt. Onkologie u. Hämatologie

    München, 81377

Other trials in Germany

Spain7 sites

  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología

    Barcelona, 08036

  • Institut Catala d Oncologia Hospital Duran i Reynals

    Barcelona, 08908

  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

    Barcelona, 08916

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034

  • Hospital Universitario La Paz; Servicio de Oncologia

    Madrid, 28046

  • Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

    Málaga, 29010

  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

    Valencia, 46010

Other trials in Spain

Belgium6 sites

  • Clin Univ de Bxl Hôpital Erasme

    Brussels, 1070

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • UZ Antwerpen

    Edegem, 2650

  • AZ Sint Lucas (Sint Lucas)

    Ghent, 9000

  • CHU Sart-Tilman

    Liège, 4000

  • AZ Delta (Campus Wilgenstraat)

    Roeselare, 8800

Other trials in Belgium

Italy6 sites

  • Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica

    Bologna, Emilia-Romagna, 40139

  • Ospedale Bufalini

    Forlì, Emilia-Romagna, 47023

  • Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica

    Milan, Lombardy, 20133

  • Az. Osp. S. Maria; Dept. Di Oncologia Medica

    Terni, Umbria, 05100

  • Ospedale di Treviso, Universita di Padova; Neurosurgery Dept

    Treviso, Veneto, 31100

  • Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia

    Turin, Piedmont, 10126

Other trials in Italy

Israel4 sites

  • Rambam Medical Center; Oncology

    Haifa, 3525408

  • Hadassah Hebrew University Hospital; Leslie and Michael Gaffin Center for Neuro-Oncology

    Jerusalem, 91120

  • Rabin MC; Davidof Center - Oncology Institute

    Petah Tikva, 4941492

  • Chaim Sheba MC; Pediatric Hematology Oncology

    Tel HaShomer, 52621

Other trials in Israel

Portugal4 sites

  • IPO de Coimbra; Servico de Oncologia Medica

    Coimbra, 3000-075

  • IPO de Lisboa; Servico de Neurologia

    Lisbon, 1099-023

  • Hospital de Santa Maria; Servico de Oncologia Medica

    Lisbon, 1649-035

  • Hospital de Sao Joao; Servico de Oncologia

    Porto, 4200-319

Other trials in Portugal

Russia4 sites

  • N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

    Moscow, 105229

  • Russian Research Oncology Center n.a. N.N. Blokhin of the RAMS; Department of Neurosurgery

    Moscow, 115478

  • Scientific Research Neurosurgery Institute; Dept. of Neurooncology

    Moscow, 125047

  • Institution of Higher Professional Learning Military; Neurooncology

    Saint Petersburg, 194175

Other trials in Russia

Sweden4 sites

  • Sahlgrenska Universitetssjukhuset; Jubileumskliniken

    Gothenburg, 413 45

  • Skånes University Hospital, Skånes Department of Onclology

    Lund, 22185

  • Norrlands Universitetssjukhus; Cancer Centrum

    Umeå, 901 85

  • Akademiska sjukhuset, Onkologkliniken

    Uppsala, 75185

Other trials in Sweden

Denmark3 sites

  • Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.

    Aalborg, 9000

  • Righospitalet, Hæmatologisk Klinik

    København Ø, 2100

  • Odense Universitetshospital, Onkologisk Afdeling R

    Odense, 5000

Other trials in Denmark

Greece3 sites

  • Univ General Hosp Heraklion; Medical Oncology

    Heraklion, 711 10

  • University Hospital of Larissa; Oncology

    Larissa, 41 110

  • Papageorgiou General Hospital; Medical Oncology

    Thessaloniki, 546 29

Other trials in Greece

Hong Kong3 sites

  • Dr Stephen Yau; Clinical oncology

    Hong Kong

  • Hong Kong Sanatorium & Hospital; Comprehensive Oncology Centre

    Hong Kong

  • Queen Mary Hospital; Microbiology Dept.

    Hong Kong

Other trials in Hong Kong

Hungary3 sites

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, H-1134

  • Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház; Neurosurgery

    Miskolc, 3526

  • Pécsi Tudományegyetem Áok; Onkoterapias Intezet

    Pécs, 7623

Other trials in Hungary

Netherlands3 sites

  • VU MEDISCH CENTRUM; Dept. of Medical Oncology

    Amsterdam, 1081 HV

  • Catharina Ziekenhuis; Dept of Internal Medicin

    Eindhoven, 5623 EJ

  • Utrecht University Medical Centre; Dept of Medical Oncology and UPC

    Utrecht, 3584 CW

Other trials in Netherlands

New Zealand3 sites

  • Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

    Auckland, 1023

  • Christchurch Hospital; Dept of Oncology

    Christchurch

  • Waikato Hospital; Regional Cancer Center

    Hamilton

Other trials in New Zealand

Poland3 sites

  • Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

    Bialystok, 15-027

  • Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

    Bydgoszcz, 85-796

  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie; Klinika Neurochirurgii i Neurochirurgii Dzi

    Lublin, 20-954

Other trials in Poland

Romania3 sites

  • Institut Oncologic Prof. Dr. Alexandru Trestioreanu; Departament Radioterapie

    Bucharest, 022328

  • Institut Oncologic Ion Chiricuta; Departament Radioterapie

    Cluj-Napoca, 400015

  • Spital Clinic Judetean Mures; Oncologie

    Târgu Mureş, 540142

Other trials in Romania

Switzerland1 site

  • HUG; Oncologie

    Geneva, 1211

Other trials in Switzerland

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Bevacizumab, Temozolomide and Radiotherapy, Followed by Bevacizumab and Temozolomide Versus Placebo, Temozolomide and Radiotherapy Followed by Placebo and Temozolomide in Patients With Newly Diagnosed Glioblastoma

This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram (mg/kg) intravenously [IV] once every 2 week [q2w]) or the placebo arm, in combination with radiation therapy (total dose 60 Gray [Gy], administered as 2 Gy fractions, 5 days/week) plus temozolomide (75 milligrams per meter squared [mg/m^2] oral administration [po] daily) for 6 weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10 mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m^2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment or until disease progression or unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab (15 mg/kg iv every 3 weeks [q3w]) or placebo monotherapy continued. The time on study treatment was until disease progression.

Conditions
Glioblastoma
Being tested
Bevacizumab, Temozolomide, Radiation therapy, Placebo
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    Also called Avastin

    10 mg/kg intravenously q2w in the Concurrent and Maintenance Phases. 15 mg/kg intravenously q3w in the Monotherapy Phase.

  • TemozolomideDrug

    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 therapyRadiation

    30 fractions of 2 Gy delivered on days 1-5 per week for 6 weeks.

  • PlaceboDrug

    Intravenously q2w in the Concurrent and Maintenance Phases and q3w in the Monotherapy Phase.

Study groups in NCT00943826
Study groupRoleWhat they receive
Bevacizumab + RT + TemozolomideExperimentalIn 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.
Receives: Drug: Bevacizumab; Drug: Temozolomide; Radiation: Radiation therapy
Placebo + RT + TemozolomidePlacebo comparatorIn 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.
Receives: Drug: Temozolomide; Radiation: Radiation therapy; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator

    PFS is defined as time from randomization to disease progression (PD) or death. PD was assessed using adapted Macdonald response criteria (modified World Health Organization [WHO] criteria) based on 3 components: radiological tumor assessments using Magnetic Resonance Imaging [MRI] scans,neurological assessment and changes in corticosteroid use. PD is assessed as greater than or equal to(>=) 25% increase in sum of products of the longest diameters of all index lesions (enhancing,measurable) compared with the smallest recorded sum (nadir); or unequivocal PD of existing non-index lesions (non-enhancing and enhancing,non-measurable); or unequivocal appearance of new lesions); or neurological worsening (if corticosteroid dose is stable or increased) compared to neurological evaluation at previous disease assessment with no need for a confirmatory scan. Participants without a PFS event were censored at last disease assessment.

    Measured: Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)

  2. Co-Primary: Overall Survival (OS)

    Overall Survival was defined as the time from randomization to death due to any cause.

    Measured: Randomization until OS Event (Until data cutoff= 28 February 2013 [up to 42.2 months])

Secondary outcomes (5)

  1. PFS as Assessed by an Independent Review Facility

    An Independent Review Facility reviewed the MRI scans used by investigator to evaluate radiological tumor response. PFS is defined as time from randomization to PD or death. PD was assessed using adapted Macdonald response (modified WHO) criteria based on 3 components: radiological tumor assessments using MRI scans, neurological assessment and changes in corticosteroid use. PD is assessed as >=25% increase in sum of products of the longest diameters of all index lesions (enhancing, measurable) compared with the smallest recorded sum (nadir); or unequivocal PD of existing non-index lesions (non-enhancing and enhancing, non-measurable); or unequivocal appearance of new lesions); or neurological worsening (if corticosteroid dose is stable or increased) compared to neurological evaluation at previous disease assessment with no need for a confirmatory scan. Participants without a PFS event were censored at last disease assessment.

    Measured: Randomization until PFS Event (Until data cutoff= 31 March 2012 [up to 29.5 months])

  2. Kaplan-Meier (KM) Estimate of One Year Overall Survival

    KM estimate of one year overall survival (probability to survive for at least 1 year) was reported. Corresponding 95% confidence interval (CI) was calculated using Greenwood's formula.

    Measured: Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months])

  3. Kaplan-Meier (KM) Estimate of Two Year Overall Survival

    KM estimate of two year overall survival was reported (probability to survive for at least 2 years). Corresponding 95% CI was calculated using Greenwood's formula.

    Measured: Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months])

  4. PFS in Participants With Stable/Improved Health Related Quality of Life (HRQoL) Based on European Organization for Research & Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30)(EORTC QLQ-C30) & EORTC QLQ Brain Neoplasm 20 (BN20)

    EORTC QLQ-C30: 30 items; 5 functional scales; 9 symptom scales; \& global health status. Most questions used 4-point scale (1:Not at all, 4:Very much), 2 questions used 7-point scale (1:very poor, 7:Excellent). EORTC QLQ-BN20: 20 items rated on a 4 point scale (1:not at all, 4:very much). EORTC QLQ-C30 and BN20 scores were transformed to a 0-100 scale, higher score=better functioning/global health (C30) or more severe symptoms (BN20). Stable HRQoL: change from baseline (BL) within 10 points. Improved HRQoL: an increase from BL >/=10 points for functioning/global health status, \& decrease of >/=10 points for symptoms. PFS is reported for participants with Stable/Improved global health; physical, social functioning (C30); motor dysfunction \& communication deficit (BN20). PFS: randomization to PD or death. PD: >=25% increase in sum of products of longest diameters of index lesions; or progression of existing non-index lesions; or appearance of new lesions; or neurological worsening.

    Measured: Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)

  5. Number of Participants With Non-Serious Adverse Events, Serious Adverse Events and Death

    An adverse event (AE) was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as AE.A serious adverse event (SAE) is any experience that suggests a significant hazard,contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Non-serious adverse events (Non-SAEs) included all AEs except SAEs (non-SAEs = all AEs - SAEs). Nine participants randomized to the Placebo+RT+Temozolomide arm incorrectly received at least 1 dose of bevacizumab and were added to the Bevacizumab+RT+Temozolomide arm for Safety.

    Measured: Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2009 (estimated)
  2. Study start29 Jun 2009
  3. Primary completion28 Feb 2013
  4. Study completion9 Sep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
921 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00943826
Sponsor's protocol ID
BO21990
Other IDs
2008-006146-26, 2008
Status last verified
Aug 2017
First submitted
17 Jul 2009
Last updated
25 Sep 2017

Publications

  • 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.

    PubMed 36346112

  • 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.

    PubMed 35842871

  • 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.

    PubMed 34980260

  • 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.

    PubMed 27006178

  • 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.

    PubMed 26809751

  • 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.

    PubMed 26014298

  • 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.

    PubMed 24552318

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab, Temozolomide and Radiation therapy in people with Glioblastoma, run by Hoffmann-La Roche at 133 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 133 sites in Canada, France, United States, United Kingdom, Japan and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator (time frame: Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00943826, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.

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