18 and older, any sex, with Glioblastoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Co-Primary: Progression-free Survival (PFS) as Assessed by InvestigatorPrimary· 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 (n
Group
Value
95% CI
Bevacizumab + RT + Temozolomide
10.6
10.0 – 11.4
Placebo + RT + Temozolomide
6.2
6.0 – 7.5
Co-Primary: Overall Survival (OS)Primary· 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.
Group
Value
95% CI
Bevacizumab + RT + Temozolomide
16.8
15.5 – 18.5
Placebo + RT + Temozolomide
16.7
15.4 – 18.4
PFS as Assessed by an Independent Review FacilitySecondary· 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 (no
Group
Value
95% CI
Bevacizumab + RT +Temozolomide
8.4
7.9 – 9.7
Placebo + RT + Temozolomide
4.3
4.1 – 5.1
Kaplan-Meier (KM) Estimate of One Year Overall SurvivalSecondary· 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.
Group
Value
95% CI
Bevacizumab + RT + Temozolomide
0.72
0.68 – 0.77
Placebo + RT + Temozolomide
0.66
0.62 – 0.71
Kaplan-Meier (KM) Estimate of Two Year Overall SurvivalSecondary· 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.
Group
Value
95% CI
Bevacizumab + RT + Temozolomide
0.34
0.29 – 0.38
Placebo + RT + Temozolomide
0.30
0.26 – 0.34
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)Secondary· 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
Global health status (n=354, 309)
Group
Value
95% CI
Bevacizumab + RT + Temozolomide
8
0 – 26
Placebo + RT + Temozolomide
4
1 – 29
Physical functioning (n=353, 318)
Group
Value
95% CI
Bevacizumab + RT + Temozolomide
7
0 – 27
Placebo + RT + Temozolomide
5
1 – 29
Social functioning (n=352, 327)
Group
Value
95% CI
Bevacizumab + RT + Temozolomide
8
0 – 26
Placebo + RT + Temozolomide
4
0 – 27
Motor dysfunction (n=361, 314)
Group
Value
95% CI
Bevacizumab + RT + Temozolomide
7
1 – 27
Placebo + RT + Temozolomide
4
0 – 26
Communication deficit (n=365, 329)
Group
Value
95% CI
Bevacizumab + RT + Temozolomide
8
0 – 27
Placebo + RT + Temozolomide
4
1 – 24
Number of Participants With Non-Serious Adverse Events, Serious Adverse Events and DeathSecondary· 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
Non-SAEs
Group
Value
95% CI
Bevacizumab + RT + Temozolomide
437
Placebo + RT + Temozolomide
412
SAEs
Group
Value
95% CI
Bevacizumab + RT + Temozolomide
179
Placebo + RT + Temozolomide
115
Death
Group
Value
95% CI
Bevacizumab + RT + Temozolomide
335
Placebo + RT + Temozolomide
337
Adverse events — posted to ClinicalTrials.gov
Time frame: Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months]).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07504588 — Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and
· Phase 2
· not yet recruiting
NCT07500298 — Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable
· Phase 1
· not yet recruiting
NCT07271355 — Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colore
· Phase 3
· not yet recruiting
NCT07318389 — ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer
· EARLY_PHASE1
· not yet recruiting
NCT07535632 — SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cance
· Phase 2
· not yet recruiting
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 25 September 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00943826.