Trial · NCT00967330
A Study of Avastin (Bevacizumab) and Irinotecan Versus Temozolomide Radiochemistry in Patients With Glioblastoma
NCT00967330, Phase 2, Completed, Hoffmann-La Roche; results first posted 2015-11-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Avastin (Bevacizumab) and Irinotecan Versus Temozolomide Radiochemistry in Patients With Glioblastoma. Trials, record NCT00967330. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00967330
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Avastin (Bevacizumab) and Irinotecan Versus Temozolomide Radiochemistry in Patients With Glioblastoma
- NCT number
- NCT00967330
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 182 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Glioblastoma Multiforme
- Interventions
- bevacizumab [Avastin], irinotecan, temozolomide
- First posted
- 2009-08-27
- Last updated
- 2015-11-20
- Results first posted
- 2015-11-20
- Limitations and caveats
- Data for time to treatment failure were not collected as this outcome was removed as per changes in planned analysis.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months | 6 months | Progression-free survival was defined as the time from randomization to objective tumor progression or death from any cause, whichever came first. Progression was defined as 25 percent (%) increase in size of enhancing tumor or any new tumor on gadolinium contrast agent magnetic resonance imaging (Gd-MRI) scans, or neurologically worse, and steroids stable or increased. Percentage of participants achieving PFS without disease progression or death was reported. |
| Secondary | Progression-Free Survival (PFS) | From baseline to the end of the study (up to 4.5 years) | Progression-free survival was defined as the time from randomization to objective tumor progression or death from any cause, whichever came first. Progression was defined as 25% increase in size of enhancing tumor or any new tumor on Gd-MRI scans, or neurologically worse, and steroids stable or increased. PFS was estimated using Kaplan-Meier method. |
| Secondary | Overall Survival (OS) | From baseline until death (up to 4.5 years) | Overall survival was defined as the time from randomization to death from any cause. OS was estimated using Kaplan-Meier method. |
| Secondary | Percentage of Participants Who Discontinued | From baseline until death (up to 4.5 years) | Discontinuation was defined as the percentage of participants who permanently discontinued treatment in either treatment arm. Percentage of participant with individual discontinuation reason are reported. CNS: central nervous system; CTCAE: Common Terminology Criteria for Adverse Events . Other reason refers to any other reason than the specified ones. |
| Secondary | Number of Participants With A Best Overall Response (BOR) of Complete Response (CR) and With A BOR of CR or Partial Response (PR) | 4 week after radiotherapy (RT) (up to Week 4), >4 Week after RT (up to Week 8) and Month 6 | BOR was defined as the best response observed for a participant during assessment. Number of participants who had BOR as CR and number of participants who had BOR as CR or PR were reported. Complete response was defined as disappearance of all enhancing tumor on consecutive Gd-MRI scans at least 1 month apart, off steroids, and neurologically stable or improved. Partial response was defined as 50% reduction in size of enhancing tumor on consecutive Gd-MRI scans at least 1 month apart, steroids stable or reduced, and neurologically stable or improved. |
| Secondary | Percentage of Participants With Response on FLAIR Imaging | At screening, Baseline, Month 6 and Therapy Discontinuation (Up to 4.5 years) | FLAIR lesions were determined as "stable", "progressive" or "decreased". FLAIR lesions was determined as "progressive" only if they were not be attributed to causes apart from tumor infiltration (sequelae of radiation therapy, demyelination, ischemia, infection, seizures, or other treatment effects). Percentage of participants are based on ITT population. Dis.=Discontinuation. |
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ - C30) at Baseline, Post-Baseline (up to Month 30) | Baseline, Post-Baseline (up to Month 30) | The EORTC QLQ-C30 incorporates: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; higher score for Global Qol/functional scales=better level of functioning or a higher score for symptom scale=greater degree of symptoms. The change in global health status was determined to be the difference in values at baseline and each specific visit. The term ''baseline'' refers to the time of randomization to the maintenance phase. |
| Secondary | Change From Baseline for EORTC QLQ Brain Neoplasm 20 (BN20) at Baseline, Post-Baseline (up to Month 30) | Baseline, Post-Baseline (up to Month 30) | EORTC QLQ-BN20 consisted of 20 items assessing visual disorders, motor dysfunction, communication deficit, various disease symptoms (e.g. headaches and seizures), treatment toxicities (e.g. hair loss) and future uncertainty. All of the 20 items are rated on a 4 point Likert scale from 1=not at all, 2=a little, 3=quite a bit and 4=very much, and were linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms. |
| Secondary | Change From Baseline for Mini-Mental Status Examination (MMSE) at Baseline, Post-Baseline (up to Month 30) | Baseline, Post-Baseline (up to Month 30) | The MMSE briefly measures orientation to time and place, immediate recall, short-term verbal memory, calculation, language and construct ability. Each area tested had a designated point value, the total score can range from 0 to 30, with a higher score indicating better function. |
| Secondary | Change From Baseline for Karnofsky Performance Status (KPS) Score at Baseline, Post-Baseline (up to Month 30) | Baseline, Post-Baseline (up to Month 30) | KPS is an 11-level score (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100) which ranges between 0 (death) to 100 (complete healthy status); a higher score represents a higher ability to perform daily tasks. Deterioration in KPS was defined as decrease of 20 or more points in KPS score. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months | 6 months | Intent-to-treat (ITT) population included participants randomized for whom it cannot be ruled out, that they took study medication at least once and where primary variable was measured at least once under study medication. Data were analyzed according to the treatment randomized (as randomized). | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | From baseline to the end of the study (up to 4.5 years) | ITT population. Data were analyzed according to the treatment randomized (as randomized). | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From baseline until death (up to 4.5 years) | ITT population. Data were analyzed according to the treatment randomized (as randomized). | Months | MEDIAN |
| SECONDARY | Percentage of Participants Who Discontinued | From baseline until death (up to 4.5 years) | ITT population | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With A Best Overall Response (BOR) of Complete Response (CR) and With A BOR of CR or Partial Response (PR) | 4 week after radiotherapy (RT) (up to Week 4), >4 Week after RT (up to Week 8) and Month 6 | ITT population. Data were analyzed according to the treatment randomized (as randomized). Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable of specified time-point. | participants | NUMBER |
| SECONDARY | Percentage of Participants With Response on FLAIR Imaging | At screening, Baseline, Month 6 and Therapy Discontinuation (Up to 4.5 years) | ITT population. Here, n = participants with at least 1 assessment during specified time-point. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ - C30) at Baseline, Post-Baseline (up to Month 30) | Baseline, Post-Baseline (up to Month 30) | ITT population. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline for EORTC QLQ Brain Neoplasm 20 (BN20) at Baseline, Post-Baseline (up to Month 30) | Baseline, Post-Baseline (up to Month 30) | ITT population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline for Mini-Mental Status Examination (MMSE) at Baseline, Post-Baseline (up to Month 30) | Baseline, Post-Baseline (up to Month 30) | ITT population. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline for Karnofsky Performance Status (KPS) Score at Baseline, Post-Baseline (up to Month 30) | Baseline, Post-Baseline (up to Month 30) | ITT population | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group134
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months | Bevacizumab + Irinotecan | 79.31 | 95% Confidence Interval 68.859 to 84.617 | percentage of participants | |
| Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months | Temozolomide | 42.59 | 95% Confidence Interval 26.680 to 53.050 | percentage of participants | |
| Progression-Free Survival (PFS) | Bevacizumab + Irinotecan | 9.74 | 95% Confidence Interval 8.72 to 10.76 | Months | |
| Progression-Free Survival (PFS) | Temozolomide | 5.99 | 95% Confidence Interval 2.73 to 6.15 | Months | |
| Overall Survival (OS) | Bevacizumab + Irinotecan | 16.64 | 95% Confidence Interval 15.43 to 18.36 | Months | |
| Overall Survival (OS) | Temozolomide | 17.30 | 95% Confidence Interval 14.77 to 20.36 | Months | |
| Percentage of Participants Who Discontinued | Bevacizumab + Irinotecan | Persisting non-hematological toxicity CTCAE Grade3 | 0 | percentage of participants | |
| Percentage of Participants Who Discontinued | Temozolomide | Persisting non-hematological toxicity CTCAE Grade3 | 1.9 | percentage of participants | |
| Percentage of Participants Who Discontinued | Bevacizumab + Irinotecan | CNS hemorrhagic event (CTCAE Grade >1) | 0.9 | percentage of participants | |
| Percentage of Participants Who Discontinued | Temozolomide | CNS hemorrhagic event (CTCAE Grade >1) | 0 | percentage of participants |
1 to 10 of 134Source ClinicalTrials.gov
See all 134 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bevacizumab + Irinotecan | 122 | |
| Overall Study | STARTED | Temozolomide | 60 | |
| Overall Study | COMPLETED | Bevacizumab + Irinotecan | 0 | |
| Overall Study | COMPLETED | Temozolomide | 0 | |
| Overall Study | NOT COMPLETED | Bevacizumab + Irinotecan | 122 | |
| Overall Study | NOT COMPLETED | Temozolomide | 60 |
Source ClinicalTrials.gov
Adverse events226
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 | Diarrhoea | Gastrointestinal disorders | Bevacizumab + Irinotecan | 54 | 119 | |
| other | Diarrhoea | Gastrointestinal disorders | Temozolomide | 8 | 55 | |
| other | Nausea | Gastrointestinal disorders | Bevacizumab + Irinotecan | 88 | 119 | |
| other | Nausea | Gastrointestinal disorders | Temozolomide | 28 | 55 | |
| other | Headache | Nervous system disorders | Bevacizumab + Irinotecan | 60 | 119 | |
| other | Headache | Nervous system disorders | Temozolomide | 22 | 55 | |
| serious | Leukopenia | Blood and lymphatic system disorders | Bevacizumab + Irinotecan | 2 | 119 | |
| serious | Leukopenia | Blood and lymphatic system disorders | Temozolomide | 0 | 55 | |
| serious | Neutropenia | Blood and lymphatic system disorders | Bevacizumab + Irinotecan | 0 | 119 | |
| serious | Neutropenia | Blood and lymphatic system disorders | Temozolomide | 1 | 55 |
1 to 10 of 226Source ClinicalTrials.gov
See all 226 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bevacizumab + Irinotecan | ||
| Total, all-cause mortality | Temozolomide | ||
| Total, other adverse events | Bevacizumab + Irinotecan | 107 | 119 |
| Total, other adverse events | Temozolomide | 37 | 55 |
| Total, serious adverse events | Bevacizumab + Irinotecan | 86 | 119 |
| Total, serious adverse events | Temozolomide | 46 | 55 |
Source ClinicalTrials.gov
Papers2
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 + Irinotecan vs 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.
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