We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00943826
First Posted: July 22, 2009
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention Phase
Glioblastoma Drug: Bevacizumab Drug: Temozolomide Radiation: Radiation therapy Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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) ]
    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.

  • Co-Primary: Overall Survival (OS) [ Time Frame: Randomization until OS Event (Until data cutoff= 28 February 2013 [up to 42.2 months]) ]
    Overall Survival was defined as the time from randomization to death due to any cause.


Secondary Outcome Measures:
  • PFS as Assessed by an Independent Review Facility [ Time Frame: Randomization until PFS Event (Until data cutoff= 31 March 2012 [up to 29.5 months]) ]
    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.

  • Kaplan-Meier (KM) Estimate of One Year Overall Survival [ Time Frame: Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months]) ]
    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.

  • Kaplan-Meier (KM) Estimate of Two Year Overall Survival [ Time Frame: Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months]) ]
    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.

  • 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) [ Time Frame: Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months) ]
    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.

  • Number of Participants With Non-Serious Adverse Events, Serious Adverse Events and Death [ Time Frame: Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months]) ]
    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.


Enrollment: 921
Actual Study Start Date: June 29, 2009
Study Completion Date: September 9, 2015
Primary Completion Date: February 28, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Bevacizumab
10 mg/kg intravenously q2w in the Concurrent and Maintenance Phases. 15 mg/kg intravenously q3w in the Monotherapy Phase.
Other Name: Avastin
Drug: 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: Radiation therapy
30 fractions of 2 Gy delivered on days 1-5 per week for 6 weeks.
Placebo Comparator: 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.
Drug: 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: Radiation therapy
30 fractions of 2 Gy delivered on days 1-5 per week for 6 weeks.
Drug: Placebo
Intravenously q2w in the Concurrent and Maintenance Phases and q3w in the Monotherapy Phase.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00943826


  Hide Study Locations
Locations
United States, Alabama
University of Alabama At Birmingham; Neuro-Oncology
Birmingham, Alabama, United States, 35294
United States, California
UCLA
Los Angeles, California, United States, 90095
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Illinois
Oncology-Evanston Nthwest Healthcare Kellogg Cancer Care Ctr
Evanston, Illinois, United States, 60201
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Ohio
Hatton Research Institutes
Cincinnati, Ohio, United States, 45220
United States, Tennessee
Sarah Cannon Cancer Center and Research Institute
Nashville, Tennessee, United States, 37203
United States, Virginia
University of Virgina
Charlottesville, Virginia, United States, 22908
Australia, New South Wales
Prince of Wales Hospital; Department of Medical Oncology
Randwick, New South Wales, Australia, 2031
North Shore Private Hospital; Northern Specialist Centre
St Leonards, New South Wales, Australia, 2065
Royal North Shore Hospital; Department of Medical Oncology
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
Princess AleXandra Hospital; Department of Medical Oncology
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Calvary North Adelaide; North Adeliade Oncology Centre
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Royal Melbourne Hospital; Hematology and Medical Oncology
Parkville, Victoria, Australia, 3052
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Belgium
Clin Univ de Bxl Hôpital Erasme
Bruxelles, Belgium, 1070
Cliniques Universitaires St-Luc
Bruxelles, Belgium, 1200
UZ Antwerpen
Edegem, Belgium, 2650
AZ Sint Lucas (Sint Lucas)
Gent, Belgium, 9000
CHU Sart-Tilman
Liège, Belgium, 4000
AZ Delta (Campus Wilgenstraat)
Roeselare, Belgium, 8800
Canada, Alberta
Tom Baker Cancer Centre-Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute ; Dept of Medical Oncology
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BC Cancer Agency, Vancouver Clinic; Dept. of Medical Oncology
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
CancerCare Manitoba; Neuro-Oncology
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Cancer Centre of Southeastern Ontario; Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Ottawa Hospital Regional Cancer Centre; Neuro-Oncology
Ottawa, Ontario, Canada, K1H 1C4
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital; Pencer Brain Tumour Centre, 18-727
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
McGill University; Montreal Neurological Institute; Oncology
Montreal, Quebec, Canada, H3A 2B4
Chuq - Hopital Hotel Dieu de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Saskatoon Cancer Centre; Uni of Saskatoon Campus
Saskatoon, Saskatchewan, Canada, S7N 4H4
Denmark
Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.
Aalborg, Denmark, 9000
Righospitalet, Hæmatologisk Klinik
København Ø, Denmark, 2100
Odense Universitetshospital, Onkologisk Afdeling R
Odense, Denmark, 5000
France
Hopital Avicenne; Rhumatologie
Bobigny, France, 93009
Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale
Bordeaux, France, 33075
Institut Bergonie; Gastro Enterologie Oncologie
Bordeaux, France, 33076
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
Bron, France, 69677
Centre Jean Perrin; Hopital De Jour
Clermont Ferrand, France, 63011
Hopital Beaujon; Oncologie
Clichy, France, 92118
Centre Georges François Leclerc
Dijon, France, 21000
Hopital de La Timone - CHU de Marseille; Service de neuro-oncologie - Hôpital Adultes - 12ème étage
Marseille, France, 13385
Centre Val Aurelle Paul Lamarque; Medecine B3
Montpellier, France, 34298
Hôpital Central; Departement de Neuro-Oncologie
Nancy, France, 54000
Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin
Paris, France, 75651
Germany
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Neurochirurgie
Dresden, Germany, 01307
Justus-Liebig-Universität Giessen; Neurochirurgische Klinik
Gießen, Germany, 35392
Universitatsklinikum Hamburg-Eppendorf; Klinik und Poliklinik fur Neurochirurgie
Hamburg, Germany, 20246
Universitatsklinikum Heidelberg; Abteilung Neuroonkologie
Heidelberg, Germany, 69120
Ärztehaus Velen
Ibbenbühren, Germany, 49479
Klinikum der Johannes Gutenberg Uni Mainz; Studienz. Neurologie, Klinik und Poliklinik Neurologie
Mainz, Germany, 55131
Uni Klinikum München - Großhardern; Med. Klinik U. Poliklinik III - Abt. Onkologie u. Hämatologie
München, Germany, 81377
Greece
Univ General Hosp Heraklion; Medical Oncology
Heraklion, Greece, 711 10
University Hospital of Larissa; Oncology
Larissa, Greece, 41 110
Papageorgiou General Hospital; Medical Oncology
Thessaloniki, Greece, 546 29
Hong Kong
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
Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, Hungary, H-1134
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház; Neurosurgery
Miskolc, Hungary, 3526
Pécsi Tudományegyetem Áok; Onkoterapias Intezet
Pecs, Hungary, 7623
Israel
Rambam Medical Center; Oncology
Haifa, Israel, 3525408
Hadassah Hebrew University Hospital; Leslie and Michael Gaffin Center for Neuro-Oncology
Jerusalem, Israel, 91120
Rabin MC; Davidof Center - Oncology Institute
Petach Tikva, Israel, 4941492
Chaim Sheba MC; Pediatric Hematology Oncology
Tel Hashomer, Israel, 52621
Italy
Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica
Bologna, Emilia-Romagna, Italy, 40139
Ospedale Bufalini
Forli, Emilia-Romagna, Italy, 47023
Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica
Milano, Lombardia, Italy, 20133
Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia
Torino, Piemonte, Italy, 10126
Az. Osp. S. Maria; Dept. Di Oncologia Medica
Terni, Umbria, Italy, 05100
Ospedale di Treviso, Universita di Padova; Neurosurgery Dept
Treviso, Veneto, Italy, 31100
Japan
Hiroshima University Hospital; Neurosurgery
Hiroshima, Japan, 734-8551
Tsukuba University Hospital; Neurology
Ibaraki, Japan, 305-8576
Kumamoto University Hospital; Neurosurgery
Kumamoto, Japan, 860-8556
Kitano Hospital; Neurosurgery
Osaka, Japan, 530-8480
Saitama Medical University International Medical Center; Clinical and Medical Oncology
Saitama, Japan, 350-1298
National Cancer Center Hospital; Neurosurgery
Tokyo, Japan, 104-0045
Komagome Hospital; Neurosurgery
Tokyo, Japan, 113-8677
Kyorin University Hospital; Neurosurgery
Tokyo, Japan, 181-8611
Korea, Republic of
Pusan National University Hospital; Neuro Sugery
Busan, Korea, Republic of, 602-739
Kyungpook National University Hosital; Neuro Sugery
Daegu, Korea, Republic of, 700-721
National Cancer Centre; Neurosurgery Dept
Goyang-si, Korea, Republic of, 410-769
Chonnam National University Hwasun Hospital
Jeollanam-do, Korea, Republic of, 58128
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
Seoul, Korea, Republic of, 03080
Asan Medical Center; Medical Oncology
Seoul, Korea, Republic of, 05505
Yonsei University Severance Hospital; Medical Oncology
Seoul, Korea, Republic of, 120-752
Samsung Medical Center; Neurosurgery Department
Seoul, Korea, Republic of, 135-170
Netherlands
VU MEDISCH CENTRUM; Dept. of Medical Oncology
Amsterdam, Netherlands, 1081 HV
Catharina Ziekenhuis; Dept of Internal Medicin
Eindhoven, Netherlands, 5623 EJ
Utrecht University Medical Centre; Dept of Medical Oncology and UPC
Utrecht, Netherlands, 3584 CW
New Zealand
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
Auckland, New Zealand, 1023
Christchurch Hospital; Dept of Oncology
Christchurch, New Zealand
Waikato Hospital; Regional Cancer Center
Hamilton, New Zealand
Poland
Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
Bialystok, Poland, 15-027
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
Bydgoszcz, Poland, 85-796
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie; Klinika Neurochirurgii i Neurochirurgii Dzi
Lublin, Poland, 20-954
Portugal
IPO de Coimbra; Servico de Oncologia Medica
Coimbra, Portugal, 3000-075
IPO de Lisboa; Servico de Neurologia
Lisboa, Portugal, 1099-023
Hospital de Santa Maria; Servico de Oncologia Medica
Lisboa, Portugal, 1649-035
Hospital de Sao Joao; Servico de Oncologia
Porto, Portugal, 4200-319
Romania
Institut Oncologic Prof. Dr. Alexandru Trestioreanu; Departament Radioterapie
Bucharest, Romania, 022328
Institut Oncologic Ion Chiricuta; Departament Radioterapie
Cluj-napoca, Romania, 400015
Spital Clinic Judetean Mures; Oncologie
Targu Mures, Romania, 540142
Russian Federation
N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
Moscow, Russian Federation, 105229
Russian Research Oncology Center n.a. N.N. Blokhin of the RAMS; Department of Neurosurgery
Moscow, Russian Federation, 115478
Scientific Research Neurosurgery Institute; Dept. of Neurooncology
Moscow, Russian Federation, 125047
Institution of Higher Professional Learning Military; Neurooncology
St. Petersburg, Russian Federation, 194175
Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, Spain, 08036
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, Spain, 08908
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Barcelona, Spain, 08916
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, Spain, 28034
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, Spain, 28046
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Malaga, Spain, 29010
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, Spain, 46010
Sweden
Sahlgrenska Universitetssjukhuset; Jubileumskliniken
Göteborg, Sweden, 413 45
Skånes University Hospital, Skånes Department of Onclology
Lund, Sweden, 22185
Norrlands Universitetssjukhus; Cancer Centrum
Umea, Sweden, 901 85
Akademiska sjukhuset, Onkologkliniken
Uppsala, Sweden, 75185
Switzerland
HUG; Oncologie
Geneve, Switzerland, 1211
United Kingdom
Queen Elizabeth Medical Centre; Neurosurgery
Birmingham, United Kingdom, B15 2TT
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
The Royal Marsden NHS Foundation Trust; Oncology
London, United Kingdom, SW3 6JJ
Northern Centre for Cancer Care;Oncology
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Nottingham City Hospital; Dept of Haematology
Nottingham, United Kingdom, NG5 1PB
Queen's Hospital; Oncology
Romford, United Kingdom, RM7 0AG
Weston Park Hospital; Cancer Clinical Trials Centre
Sheffield, United Kingdom, S10 2SJ
Royal Marsden Hospital; Dept of Medical Oncology
Sutton, United Kingdom, SM2 5PT
The Clatterbridge Cancer Ctr For Oncolgy
Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00943826     History of Changes
Other Study ID Numbers: BO21990
2008-006146-26 ( EudraCT Number )
First Submitted: July 17, 2009
First Posted: July 22, 2009
Results First Submitted: March 29, 2013
Results First Posted: May 20, 2013
Last Update Posted: September 25, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Bevacizumab
Temozolomide
Dacarbazine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action