Treatment of children with newly diagnosed brain tumour (known as supratentorial, infratentorial cerebellar, or peduncular high-grade glioma) using bevacizumab, an anti-angiogenic drug, added to conventional therapy (surgery, chemotherapy with temozolomide and radiation therapy).

A PHASE II OPEN-LABEL, RANDOMIZED, MULTI- CENTRE COMPARATIVE STUDY OF BEVACIZUMAB-BASED THERAPY IN PAEDIATRIC PATIENTS WITH NEWLY DIAGNOSED SUPRATENTORIAL, INFRATENTORIAL CEREBELLAR, OR PEDUNCULAR HIGH-GRADE GLIOMA - HERBY

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022189-28-AT

Enrollment

139

Registered

2011-05-17

Start date

2011-06-07

Completion date

Unknown

Last updated

2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly diagnosed high-grade glioma MedDRA version: 20.0 Level: LLT Classification code 10002226 Term: Anaplastic ependymoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1 Level: LLT Classification code 10030288 Term: Oligodendroglioma malignant System Organ Class:

Interventions

Trade Name: Avastin Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: BEVACIZUMAB CAS Number: 216974-75-3

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Written informed consent obtained from the patient/parents or legally acceptable representative - Paediatric patients, age >/=3 years and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Metastatic (HGG) defined as evidence of neuraxis dessimination by MRI or positive CSF cytology - WHO-defined Gliomatosis cerebri (multifocal HGG) - Any disease or condition that contraindicates the use of the study medication/treatment or places the patient at an unacceptable risk of experiencing treatment-related complications - Radiological evidence of surgically related intracranial bleeding - Prior diagnosis of a malignancy and disease-free for 5 years - Prior systemic anti-cancer therapy - Previous cranial irradiation

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the benefit in terms of EFS of the addition of bevacizumab to postoperative radiotherapy with concomitant and adjuvant TMZ.;Secondary Objective: To evaluate the efficacy, safety and tolerability of the addition of bevacizumab to postoperative radiotherapy with concomitant and adjuvant TMZ.;Primary end point(s): Event-free Survival (EFS) as assessed by the central radiology review committee;Timepoint(s) of evaluation of this end point: 12 months after last evaluable patients has been randomized	—

Measure

Time frame

Main Objective: To determine the benefit in terms of EFS of the addition of bevacizumab to postoperative radiotherapy with concomitant and adjuvant TMZ.;Secondary Objective: To evaluate the efficacy, safety and tolerability of the addition of bevacizumab to postoperative radiotherapy with concomitant and adjuvant TMZ.;Primary end point(s): Event-free Survival (EFS) as assessed by the central radiology review committee;Timepoint(s) of evaluation of this end point: 12 months after last evaluable patients has been randomized

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Secondary

Measure	Time frame
Secondary end point(s): 1. Overall Survival (OS) and 1 year survival rate 2. 6 month and 1 year EFS rates 3. EFS as assessed by the investigates 4. Overall Response Rate as assessed by central radiology committee 5. Functional changes in tumour on diffusion/perfusion MRI imaging 6. Health status as measured by the Health Utility Index (HUI) 7. Neuro-psychological function as measured by the Wechsler scale 8. Safety, feasibility and tolerability ; Timepoint(s) of evaluation of this end point: 1. at the time of primary endpoint analysis (interim OS) and 3 years after the last patient has been randomised (final OS) 2. at the time of primary endpoint analysis 3. at the time of primary endpoint analysis 4. at the time of primary endpoint analysis 5. at the time of primary endpoint analysis 6. at the time of primary endpoint analysis 7. at the time of primary endpoint analysis 8. Over time by the IDMC, at the time of primary endpoint analysis, and final OS analysis	—

Measure

Time frame

Secondary end point(s): 1. Overall Survival (OS) and 1 year survival rate 2. 6 month and 1 year EFS rates 3. EFS as assessed by the investigates 4. Overall Response Rate as assessed by central radiology committee 5. Functional changes in tumour on diffusion/perfusion MRI imaging 6. Health status as measured by the Health Utility Index (HUI) 7. Neuro-psychological function as measured by the Wechsler scale 8. Safety, feasibility and tolerability ; Timepoint(s) of evaluation of this end point: 1. at the time of primary endpoint analysis (interim OS) and 3 years after the last patient has been randomised (final OS) 2. at the time of primary endpoint analysis 3. at the time of primary endpoint analysis 4. at the time of primary endpoint analysis 5. at the time of primary endpoint analysis 6. at the time of primary endpoint analysis 7. at the time of primary endpoint analysis 8. Over time by the IDMC, at the time of primary endpoint analysis, and final OS analysis

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Countries

Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom

Contacts

Public ContactTrial Information Support Line-TISL

F.Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026