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).
- Conditions
- ewly diagnosed high-grade gliomaMedDRA version: 19.1Level: LLTClassification code 10002226Term: Anaplastic ependymomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: LLTClassification code 10030288Term: Oligodendroglioma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: PTClassification code 10030286Term: OligodendrogliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: LLTClassification code 10027744Term: Mixed astrocytoma-oligodendrogliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: PTClassification code 10065443Term: Malignant gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: PTClassification code 10018338Term: GliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: PTClassification code 10026659Term: Malignant oligodendrogliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-022189-28-CZ
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 124
- Written informed consent obtained from the patient/parents or legally acceptable representative
- Paediatric patients, age >/=3 years and <18 years
- Newly diagnosed localized, supratentorial- or infratentorial cerebellar or peduncular, WHO Grade III or IV gliomas
- Local histological diagnosis confirmed by a designated central reference neuropathologist
- Availability of a baseline MRI performed according to imaging guidelines
- Able to commence trial treatment not before 4 weeks after cranial surgery and no later than 6 weeks following the last major surgery
- Adequate bone marrow, coagulation, liver, renal function
Are the trial subjects under 18? yes
Number of subjects for this age range: 130
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method