Trial · NCT00943826
A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma
NCT00943826, Phase 3, Completed, Hoffmann-La Roche; results first posted 2013-05-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma. Trials, record NCT00943826. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00943826
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma
- NCT number
- NCT00943826
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 921 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Glioblastoma
- Interventions
- Bevacizumab, Temozolomide, Radiation therapy, Placebo
- First posted
- 2009-07-22
- Last updated
- 2017-09-25
- Other registries' IDs
- eudract:2008-006146-26
- Results first posted
- 2013-05-20
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator | 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. |
| Primary | Co-Primary: Overall Survival (OS) | 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 | PFS as Assessed by an Independent Review Facility | 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. |
| Secondary | Kaplan-Meier (KM) Estimate of One Year Overall Survival | 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. |
| Secondary | Kaplan-Meier (KM) Estimate of Two Year Overall Survival | 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. |
| Secondary | 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) | 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. |
| Secondary | Number of Participants With Non-Serious Adverse Events, Serious Adverse Events and Death | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator | Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months) | Intent to treat population. | Months | MEDIAN |
| PRIMARY | Co-Primary: Overall Survival (OS) | Randomization until OS Event (Until data cutoff= 28 February 2013 [up to 42.2 months]) | Intent to treat population. | Months | MEDIAN |
| SECONDARY | PFS as Assessed by an Independent Review Facility | Randomization until PFS Event (Until data cutoff= 31 March 2012 [up to 29.5 months]) | Intent to treat population. | Months | MEDIAN |
| SECONDARY | Kaplan-Meier (KM) Estimate of One Year Overall Survival | Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months]) | Intent to treat population. | probability of being alive | NUMBER |
| SECONDARY | Kaplan-Meier (KM) Estimate of Two Year Overall Survival | Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months]) | Intent to treat population. | probability of being alive | NUMBER |
| SECONDARY | 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) | Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months) | Intent to treat population. Number of Participants Analyzed = overall participants evaluable for this outcome measure; n = participants evaluable for specified category. | Months | MEDIAN |
| SECONDARY | Number of Participants With Non-Serious Adverse Events, Serious Adverse Events and Death | Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months]) | Safety Population included all randomized participants who received study treatment during the treatment period (10 participants did not receive at least one dose of study treatment and were therefore excluded, 4 in Placebo and 6 in Bevacizumab. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator | Bevacizumab + RT + Temozolomide | 10.6 | 95% Confidence Interval 10.0 to 11.4 | Months | |
| Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator | Placebo + RT + Temozolomide | 6.2 | 95% Confidence Interval 6.0 to 7.5 | Months | |
| Co-Primary: Overall Survival (OS) | Bevacizumab + RT + Temozolomide | 16.8 | 95% Confidence Interval 15.5 to 18.5 | Months | |
| Co-Primary: Overall Survival (OS) | Placebo + RT + Temozolomide | 16.7 | 95% Confidence Interval 15.4 to 18.4 | Months | |
| PFS as Assessed by an Independent Review Facility | Bevacizumab + RT +Temozolomide | 8.4 | 95% Confidence Interval 7.9 to 9.7 | Months | |
| PFS as Assessed by an Independent Review Facility | Placebo + RT + Temozolomide | 4.3 | 95% Confidence Interval 4.1 to 5.1 | Months | |
| Kaplan-Meier (KM) Estimate of One Year Overall Survival | Bevacizumab + RT + Temozolomide | 0.72 | 95% Confidence Interval 0.68 to 0.77 | probability of being alive | |
| Kaplan-Meier (KM) Estimate of One Year Overall Survival | Placebo + RT + Temozolomide | 0.66 | 95% Confidence Interval 0.62 to 0.71 | probability of being alive | |
| Kaplan-Meier (KM) Estimate of Two Year Overall Survival | Bevacizumab + RT + Temozolomide | 0.34 | 95% Confidence Interval 0.29 to 0.38 | probability of being alive | |
| Kaplan-Meier (KM) Estimate of Two Year Overall Survival | Placebo + RT + Temozolomide | 0.30 | 95% Confidence Interval 0.26 to 0.34 | probability of being alive |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow26
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Concurrent Phase | STARTED | Bevacizumab + RT + Temozolomide | 458 | |
| Concurrent Phase | STARTED | Placebo + RT + Temozolomide | 463 | |
| Concurrent Phase | Treated | Bevacizumab + RT + Temozolomide | 452 | |
| Concurrent Phase | Treated | Placebo + RT + Temozolomide | 459 | |
| Concurrent Phase | COMPLETED | Bevacizumab + RT + Temozolomide | 397 | |
| Concurrent Phase | COMPLETED | Placebo + RT + Temozolomide | 421 | |
| Concurrent Phase | NOT COMPLETED | Bevacizumab + RT + Temozolomide | 61 | |
| Concurrent Phase | NOT COMPLETED | Placebo + RT + Temozolomide | 42 | |
| Maintenance Phase | STARTED | Bevacizumab + RT + Temozolomide | 396 | |
| Maintenance Phase | STARTED | Placebo + RT + Temozolomide | 370 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 participant flowAdverse events494
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Bevacizumab + RT+Temozolomide | 223 | 461 | |
| other | Nausea | Gastrointestinal disorders | Placebo + RT+Temozolomide | 191 | 450 | |
| other | Constipation | Gastrointestinal disorders | Bevacizumab + RT+Temozolomide | 178 | 461 | |
| other | Constipation | Gastrointestinal disorders | Placebo + RT+Temozolomide | 137 | 450 | |
| other | Vomiting | Gastrointestinal disorders | Bevacizumab + RT+Temozolomide | 145 | 461 | |
| other | Vomiting | Gastrointestinal disorders | Placebo + RT+Temozolomide | 100 | 450 | |
| other | Diarrhoea | Gastrointestinal disorders | Bevacizumab + RT+Temozolomide | 95 | 461 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo + RT+Temozolomide | 69 | 450 | |
| other | Abdominal pain | Gastrointestinal disorders | Bevacizumab + RT+Temozolomide | 33 | 461 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo + RT+Temozolomide | 17 | 450 |
1 to 10 of 494Source ClinicalTrials.gov
See all 494 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bevacizumab + RT+Temozolomide | ||
| Total, all-cause mortality | Placebo + RT+Temozolomide | ||
| Total, other adverse events | Bevacizumab + RT+Temozolomide | 437 | 461 |
| Total, other adverse events | Placebo + RT+Temozolomide | 412 | 450 |
| Total, serious adverse events | Bevacizumab + RT+Temozolomide | 179 | 461 |
| Total, serious adverse events | Placebo + RT+Temozolomide | 115 | 450 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Bevacizumab + RT+Temozolomide vs Placebo + RT+Temozolomide: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00943826
GET https://conductscience.org/api/trials/v1/NCT00943826/results?page=2