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

Primary Purpose

Glioblastoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bevacizumab
Temozolomide
Radiation therapy
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama At Birmingham; Neuro-Oncology
  • UCLA
  • University of Colorado
  • Moffitt Cancer Center
  • Oncology-Evanston Nthwest Healthcare Kellogg Cancer Care Ctr
  • Henry Ford Health System
  • Hatton Research Institutes
  • Sarah Cannon Cancer Center and Research Institute
  • University of Virgina
  • Prince of Wales Hospital; Department of Medical Oncology
  • North Shore Private Hospital; Northern Specialist Centre
  • Royal North Shore Hospital; Department of Medical Oncology
  • Princess AleXandra Hospital; Department of Medical Oncology
  • Calvary North Adelaide; North Adeliade Oncology Centre
  • Royal Melbourne Hospital; Hematology and Medical Oncology
  • Sir Charles Gairdner Hospital
  • Clin Univ de Bxl Hôpital Erasme
  • Cliniques Universitaires St-Luc
  • UZ Antwerpen
  • AZ Sint Lucas (Sint Lucas)
  • CHU Sart-Tilman
  • AZ Delta (Campus Wilgenstraat)
  • Tom Baker Cancer Centre-Calgary
  • Cross Cancer Institute ; Dept of Medical Oncology
  • BC Cancer Agency, Vancouver Clinic; Dept. of Medical Oncology
  • CancerCare Manitoba; Neuro-Oncology
  • Hamilton Health Sciences - Juravinski Cancer Centre
  • Cancer Centre of Southeastern Ontario; Kingston General Hospital
  • London Health Sciences Centre
  • Ottawa Hospital Regional Cancer Centre; Neuro-Oncology
  • Sunnybrook Odette Cancer Centre
  • Princess Margaret Hospital; Pencer Brain Tumour Centre, 18-727
  • Hopital Notre-Dame
  • McGill University; Montreal Neurological Institute; Oncology
  • Chuq - Hopital Hotel Dieu de Quebec
  • Saskatoon Cancer Centre; Uni of Saskatoon Campus
  • Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.
  • Righospitalet, Hæmatologisk Klinik
  • Odense Universitetshospital, Onkologisk Afdeling R
  • Hopital Avicenne; Rhumatologie
  • Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale
  • Institut Bergonie; Gastro Enterologie Oncologie
  • Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
  • Centre Jean Perrin; Hopital De Jour
  • Hopital Beaujon; Oncologie
  • Centre Georges François Leclerc
  • Hopital de La Timone - CHU de Marseille; Service de neuro-oncologie - Hôpital Adultes - 12ème étage
  • Centre Val Aurelle Paul Lamarque; Medecine B3
  • Hôpital Central; Departement de Neuro-Oncologie
  • Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin
  • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Neurochirurgie
  • Justus-Liebig-Universität Giessen; Neurochirurgische Klinik
  • Universitatsklinikum Hamburg-Eppendorf; Klinik und Poliklinik fur Neurochirurgie
  • Universitatsklinikum Heidelberg; Abteilung Neuroonkologie
  • Ärztehaus Velen
  • Klinikum der Johannes Gutenberg Uni Mainz; Studienz. Neurologie, Klinik und Poliklinik Neurologie
  • Uni Klinikum München - Großhardern; Med. Klinik U. Poliklinik III - Abt. Onkologie u. Hämatologie
  • Univ General Hosp Heraklion; Medical Oncology
  • University Hospital of Larissa; Oncology
  • Papageorgiou General Hospital; Medical Oncology
  • Dr Stephen Yau; Clinical oncology
  • Hong Kong Sanatorium & Hospital; Comprehensive Oncology Centre
  • Queen Mary Hospital; Microbiology Dept.
  • Magyar Honvedseg Egeszsegugyi Kozpont
  • Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház; Neurosurgery
  • Pécsi Tudományegyetem Áok; Onkoterapias Intezet
  • Rambam Medical Center; Oncology
  • Hadassah Hebrew University Hospital; Leslie and Michael Gaffin Center for Neuro-Oncology
  • Rabin MC; Davidof Center - Oncology Institute
  • Chaim Sheba MC; Pediatric Hematology Oncology
  • Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica
  • Ospedale Bufalini
  • Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica
  • Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia
  • Az. Osp. S. Maria; Dept. Di Oncologia Medica
  • Ospedale di Treviso, Universita di Padova; Neurosurgery Dept
  • Hiroshima University Hospital; Neurosurgery
  • Tsukuba University Hospital; Neurology
  • Kumamoto University Hospital; Neurosurgery
  • Kitano Hospital; Neurosurgery
  • Saitama Medical University International Medical Center; Clinical and Medical Oncology
  • National Cancer Center Hospital; Neurosurgery
  • Komagome Hospital; Neurosurgery
  • Kyorin University Hospital; Neurosurgery
  • Pusan National University Hospital; Neuro Sugery
  • Kyungpook National University Hosital; Neuro Sugery
  • National Cancer Centre; Neurosurgery Dept
  • Chonnam National University Hwasun Hospital
  • Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
  • Asan Medical Center; Medical Oncology
  • Yonsei University Severance Hospital; Medical Oncology
  • Samsung Medical Center; Neurosurgery Department
  • VU MEDISCH CENTRUM; Dept. of Medical Oncology
  • Catharina Ziekenhuis; Dept of Internal Medicin
  • Utrecht University Medical Centre; Dept of Medical Oncology and UPC
  • Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
  • Christchurch Hospital; Dept of Oncology
  • Waikato Hospital; Regional Cancer Center
  • Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
  • Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie; Klinika Neurochirurgii i Neurochirurgii Dzi
  • IPO de Coimbra; Servico de Oncologia Medica
  • IPO de Lisboa; Servico de Neurologia
  • Hospital de Santa Maria; Servico de Oncologia Medica
  • Hospital de Sao Joao; Servico de Oncologia
  • Institut Oncologic Prof. Dr. Alexandru Trestioreanu; Departament Radioterapie
  • Institut Oncologic Ion Chiricuta; Departament Radioterapie
  • Spital Clinic Judetean Mures; Oncologie
  • N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
  • Russian Research Oncology Center n.a. N.N. Blokhin of the RAMS; Department of Neurosurgery
  • Scientific Research Neurosurgery Institute; Dept. of Neurooncology
  • Institution of Higher Professional Learning Military; Neurooncology
  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
  • Institut Catala d Oncologia Hospital Duran i Reynals
  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
  • Hospital Ramon y Cajal; Servicio de Oncologia
  • Hospital Universitario La Paz; Servicio de Oncologia
  • Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
  • Sahlgrenska Universitetssjukhuset; Jubileumskliniken
  • Skånes University Hospital, Skånes Department of Onclology
  • Norrlands Universitetssjukhus; Cancer Centrum
  • Akademiska sjukhuset, Onkologkliniken
  • HUG; Oncologie
  • Queen Elizabeth Medical Centre; Neurosurgery
  • Bristol Haematology and Oncology Centre
  • The Royal Marsden NHS Foundation Trust; Oncology
  • Northern Centre for Cancer Care;Oncology
  • Nottingham City Hospital; Dept of Haematology
  • Queen's Hospital; Oncology
  • Weston Park Hospital; Cancer Clinical Trials Centre
  • Royal Marsden Hospital; Dept of Medical Oncology
  • The Clatterbridge Cancer Ctr For Oncolgy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bevacizumab + RT + Temozolomide

Placebo + RT + Temozolomide

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Co-Primary: Overall Survival (OS)
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
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
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
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)
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
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.

Full Information

First Posted
July 17, 2009
Last Updated
August 25, 2017
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00943826
Brief Title
A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 29, 2009 (Actual)
Primary Completion Date
February 28, 2013 (Actual)
Study Completion Date
September 9, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
921 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab + RT + Temozolomide
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo + RT + Temozolomide
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
10 mg/kg intravenously q2w in the Concurrent and Maintenance Phases. 15 mg/kg intravenously q3w in the Monotherapy Phase.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
30 fractions of 2 Gy delivered on days 1-5 per week for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenously q2w in the Concurrent and Maintenance Phases and q3w in the Monotherapy Phase.
Primary Outcome Measure Information:
Title
Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator
Description
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.
Time Frame
Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)
Title
Co-Primary: Overall Survival (OS)
Description
Overall Survival was defined as the time from randomization to death due to any cause.
Time Frame
Randomization until OS Event (Until data cutoff= 28 February 2013 [up to 42.2 months])
Secondary Outcome Measure Information:
Title
PFS as Assessed by an Independent Review Facility
Description
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.
Time Frame
Randomization until PFS Event (Until data cutoff= 31 March 2012 [up to 29.5 months])
Title
Kaplan-Meier (KM) Estimate of One Year Overall Survival
Description
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.
Time Frame
Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months])
Title
Kaplan-Meier (KM) Estimate of Two Year Overall Survival
Description
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.
Time Frame
Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months])
Title
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)
Description
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.
Time Frame
Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)
Title
Number of Participants With Non-Serious Adverse Events, Serious Adverse Events and Death
Description
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.
Time Frame
Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
35842871
Citation
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.
Results Reference
derived
PubMed Identifier
34980260
Citation
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.
Results Reference
derived
PubMed Identifier
27006178
Citation
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.
Results Reference
derived
PubMed Identifier
26809751
Citation
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.
Results Reference
derived
PubMed Identifier
26014298
Citation
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.
Results Reference
derived
PubMed Identifier
24552318
Citation
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.
Results Reference
derived
PubMed Identifier
23529375
Citation
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.
Results Reference
derived

Learn more about this trial

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

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