Trial · NCT01390948
A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma
NCT01390948, Phase 2, Completed, Hoffmann-La Roche; results first posted 2017-08-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma. Trials, record NCT01390948. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01390948
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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 (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma
- NCT number
- NCT01390948
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 124 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- High Grade Glioma
- Interventions
- Bevacizumab, Radiotherapy, Temozolomide (TMZ)
- First posted
- 2011-07-11
- Last updated
- 2020-08-06
- Other registries' IDs
- eudract:2010-022189-28
- Results first posted
- 2017-08-04
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-Free Survival (EFS) as Assessed by the Central Radiology Review Committee (CRRC) | From the time of randomization to the date of any defined event (up to 12 months) | EFS was defined as the time from randomisation to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non- HGG malignancy or death attributable to any cause. Tumor assessments were conducted using magnetic resonance imaging (MRI) and reviewed by the site-independent CRRC using Response Assessment in Neuro-Oncology (RANO) criteria. Tumor progression was defined as clear clinical progression or \>/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the subject on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method. |
| Secondary | Overall Survival | From the time of randomization to the date of death (up to approximately 60 months) | Overall Survival was defined as the time of diagnosis to the date of death due to any cause. Overall Survival was estimated using the Kaplan-Meier method. |
| Secondary | Percentage of Participants With 1-Year Survival | 1 year after end of treatment | 1-year survival was estimated using the Kaplan-Meier method. |
| Secondary | Percentage of Participants With EFS as Determined by the CRRC at 6 Months | 6 months | EFS was defined as the time from randomisation to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non- HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. Tumor progression was defined as clear clinical progression or \>/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the subject on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method. |
| Secondary | Percentage of Participants With EFS as Determined by the CRRC at 1 Year | 1 year | EFS was defined as the time from randomisation to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non- HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. Tumor progression was defined as clear clinical progression or \>/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the subject on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method. |
| Secondary | EFS as Assessed by the Investigator | From the time of randomization to the date of any defined event (up to 12 months) | EFS was defined as the time from randomisation to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non-HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the investigator using RANO criteria. Tumor progression was defined as clear clinical progression or \>/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the participant on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method. |
| Secondary | Objective Response Rate (ORR) | From the time of randomization to the date of any defined event (up to 12 months) | ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) determined on two consecutive occasions \>/= 4 weeks apart. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. The following were needed to qualify as CR: complete disappearance of all measurable enhancing lesions sustained for at least 4 weeks by MRI, no steroids above physiological levels, clinical status stable or improved compared to baseline. The following were needed to qualify as PR: ≥ 50% decrease from baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks by MRI, steroid dose not increased compared to baseline, clinical status stable or improved compared to baseline. |
| Secondary | Concordance Between Structural Versus Multimodal Imaging for CRRC-Assessed Event-Free Survival | Up to 12 months | Concordance is presented as the percentage of participants with concordance between assessments. EFS concordance was defined as event Structural assessment and Diffusion Perfusion assessment occurs within 28 days or no event Structural and no Diffusion Perfusion. |
| Secondary | Health Status as Measured by the Health Utility Index (HUI) | Baseline, Cycle 6 of the adjuvant phase, end of treatment (approximately 58 weeks post-baseline), and yearly during the follow-up period (maximum 5 years in follow-up) | HUI is a preference-based, multi-attitude, health-related instrument specifically developed for use with children. HUI consists of eight attributes of health status: vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain. Each attribute had 5 or 6 levels varying from highly impaired to normal. Each of the eight health dimensions was tested separately and a composite score ranging between 1 (perfect health) and 0 (death) was obtained for participants aged 5 years or older. |
| Secondary | Neurological Psychological Function as Measured by the Wechsler Scale | End of treatment (approximately 58 weeks post-baseline) | The Wechsler Intelligence Scale for Children version IV (WISC-IV) was used to generate a full scale intelligence quotient (IQ) which represents a child's general intellectual ability. The average IQ score is 100, with lower scores representing lower intellectual ability. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-Free Survival (EFS) as Assessed by the Central Radiology Review Committee (CRRC) | From the time of randomization to the date of any defined event (up to 12 months) | Randomized participant population included all randomized participants regardless of whether they received study treatment. | months | MEDIAN |
| SECONDARY | Overall Survival | From the time of randomization to the date of death (up to approximately 60 months) | Randomized participant population included all randomized participants regardless of whether they received study treatment. | months | MEDIAN |
| SECONDARY | Percentage of Participants With 1-Year Survival | 1 year after end of treatment | Randomized participant population included all randomized participants regardless of whether they received study treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With EFS as Determined by the CRRC at 6 Months | 6 months | Randomized participant population included all randomized participants regardless of whether they received study treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With EFS as Determined by the CRRC at 1 Year | 1 year | Randomized participant population included all randomized participants regardless of whether they received study treatment. | percentage of participants | NUMBER |
| SECONDARY | EFS as Assessed by the Investigator | From the time of randomization to the date of any defined event (up to 12 months) | Randomized participant population included all randomized participants regardless of whether they received study treatment. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | From the time of randomization to the date of any defined event (up to 12 months) | Randomized participant population with a measurable lesion at baseline. | percentage of participants | NUMBER |
| SECONDARY | Concordance Between Structural Versus Multimodal Imaging for CRRC-Assessed Event-Free Survival | Up to 12 months | Randomized participant population included all randomized participants regardless of whether they received study treatment. | percentage of participants | NUMBER |
| SECONDARY | Health Status as Measured by the Health Utility Index (HUI) | Baseline, Cycle 6 of the adjuvant phase, end of treatment (approximately 58 weeks post-baseline), and yearly during the follow-up period (maximum 5 years in follow-up) | Randomized participant population aged 5 years or older with a measure at the specified time point. Here, 'n' represents the number of participants with a measure at the specified time point. | units on a scale | MEAN |
| SECONDARY | Neurological Psychological Function as Measured by the Wechsler Scale | End of treatment (approximately 58 weeks post-baseline) | Randomized participant population included all randomized participants regardless of whether they received study treatment. | units on a scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group53
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-Free Survival (EFS) as Assessed by the Central Radiology Review Committee (CRRC) | Chemoradiation + TMZ | 11.79 | 95% Confidence Interval 7.85 to 16.39 | months | |
| Event-Free Survival (EFS) as Assessed by the Central Radiology Review Committee (CRRC) | Chemoradiation + Bevacizumab + TMZ | 8.21 | 95% Confidence Interval 7.75 to 12.68 | months | |
| Overall Survival | Chemoradiation + TMZ | 20.27 | 95% Confidence Interval 14.75 to 33.77 | months | |
| Overall Survival | Chemoradiation + Bevacizumab + TMZ | 18.30 | 95% Confidence Interval 16.20 to 25.69 | months | |
| Percentage of Participants With 1-Year Survival | Chemoradiation + TMZ | 67.69 | 95% Confidence Interval 55.39 to 79.99 | percentage of participants | |
| Percentage of Participants With 1-Year Survival | Chemoradiation + Bevacizumab + TMZ | 74.83 | 95% Confidence Interval 63.79 to 85.87 | percentage of participants | |
| Percentage of Participants With EFS as Determined by the CRRC at 6 Months | Chemoradiation + TMZ | 66.46 | 95% Confidence Interval 52.58 to 77.13 | percentage of participants | |
| Percentage of Participants With EFS as Determined by the CRRC at 6 Months | Chemoradiation + Bevacizumab + TMZ | 68.43 | 95% Confidence Interval 55.06 to 78.58 | percentage of participants | |
| Percentage of Participants With EFS as Determined by the CRRC at 1 Year | Chemoradiation + TMZ | 48.37 | 95% Confidence Interval 34.82 to 60.65 | percentage of participants | |
| Percentage of Participants With EFS as Determined by the CRRC at 1 Year | Chemoradiation + Bevacizumab + TMZ | 38.28 | 95% Confidence Interval 25.79 to 50.64 | percentage of participants |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemoradiation + TMZ | 59 | |
| Overall Study | STARTED | Chemoradiation + Bevacizumab + TMZ | 62 | |
| Overall Study | STARTED | Bevacizumab + TMZ Young Patient Cohort (YPC) | 3 | |
| Overall Study | Treated | Chemoradiation + TMZ | 56 | |
| Overall Study | Treated | Chemoradiation + Bevacizumab + TMZ | 60 | |
| Overall Study | Treated | Bevacizumab + TMZ Young Patient Cohort (YPC) | 3 | |
| Overall Study | COMPLETED | Chemoradiation + TMZ | 44 | |
| Overall Study | COMPLETED | Chemoradiation + Bevacizumab + TMZ | 44 | |
| Overall Study | COMPLETED | Bevacizumab + TMZ Young Patient Cohort (YPC) | 2 | |
| Overall Study | NOT COMPLETED | Chemoradiation + TMZ | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events411
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 | ANAEMIA | Blood and lymphatic system disorders | Chemoradiation + TMZ | 6 | 56 | 13 |
| other | ANAEMIA | Blood and lymphatic system disorders | Chemoradiation + Bevacizumab + TMZ | 5 | 60 | 9 |
| other | ANAEMIA | Blood and lymphatic system disorders | Bevacizumab + TMZ Young Patient Cohort (YPC) | 0 | 3 | 0 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Chemoradiation + TMZ | 6 | 56 | 11 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Chemoradiation + Bevacizumab + TMZ | 3 | 60 | 3 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Bevacizumab + TMZ Young Patient Cohort (YPC) | 0 | 3 | 0 |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Chemoradiation + TMZ | 3 | 56 | 4 |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Chemoradiation + Bevacizumab + TMZ | 0 | 60 | 0 |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Bevacizumab + TMZ Young Patient Cohort (YPC) | 0 | 3 | 0 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Chemoradiation + TMZ | 12 | 56 | 26 |
1 to 10 of 411Source ClinicalTrials.gov
See all 411 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemoradiation + TMZ | ||
| Total, all-cause mortality | Chemoradiation + Bevacizumab + TMZ | ||
| Total, all-cause mortality | Bevacizumab + TMZ Young Patient Cohort (YPC) | ||
| Total, other adverse events | Chemoradiation + TMZ | 56 | 56 |
| Total, other adverse events | Chemoradiation + Bevacizumab + TMZ | 60 | 60 |
| Total, other adverse events | Bevacizumab + TMZ Young Patient Cohort (YPC) | 3 | 3 |
| Total, serious adverse events | Chemoradiation + TMZ | 27 | 56 |
| Total, serious adverse events | Chemoradiation + Bevacizumab + TMZ | 35 | 60 |
| Total, serious adverse events | Bevacizumab + TMZ Young Patient Cohort (YPC) | 0 | 3 |
Source ClinicalTrials.gov
Papers5
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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