Childeren with newly diagnosed brain-tumor
Conditions
Interventions
Newly diagnosed patients:
Arm A: Chemoradiation with TMZ followed, after a TMZ treatment break of
approximately 4 weeks, by up to 12 cycles of TMZ
Arm B: Bevacizumab delivered concomitantly with Ch
Sponsors
Hoffmann-La Roche
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: Newly diagnosed patients: 1. Written informed consent obtained from the patient/parents or legally acceptable representative; 2. Age at randomization: 3 to 18 years; 3. Newly diagnosed localized, supratentorial or infratentorial cerebelar or peduncular, non-brain stem WHO Grade III or IV glioma; 4. Local histological diagnosis confirmed by a designated central reference neuropathologist; 5. Availability of a baseline MRI performed according to imaging guidelines 6. Able to commence trial treatment not before 4 weeks after the neurosurgical intervention and no later than 6 weeks following the last major surgery; 7-15: Adequate bone marrow, coagulation, liver, renal function.;Patients with progressive or relapsed disease: 1. Written informed consent obtained from parents or legal representative 2. Age at enrolment: from >= 6 months to
Exclusion criteria
Exclusion criteria: Newly diagnosed patients: 1. Metastatic (HGG) defined as evidence of neuraxis dessimination by MRI or positive CSF cytology; Diagnostic CSF cytology is not required. If, however, CSF is obtained and the cytology proves positive, the patient would be considered to have metastatic disease and would, therefore, be ineligible 2. WHO-defined Gliomatosis cerebri (multifocal HGG); 3. 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; 4. Low probability of protocol compliance (and any specific contraindication to MRI [e.g., cardiac pacemaker, cochlear implant]) 5. Radiological evidence of surgically related intracranial bleeding; 6. Prior diagnosis of a malignancy and disease-free for 5 years; 7. Prior systemic anti-cancer therapy; 8. Previous cranial irradiation.;Patients with progressive or relapsed disease: 1. WHO-defined Gliomatosis cerebri (multifocal HGG) 2. Newly diagnosed HGG below the age of 3 years 3. Relapsed HGG below the age of 6 months or above the age of 3 years regardless of the age at first onset 4. Indication for concomitant cranial irradiation, regardless of age 5. Any disease or condition that contraindicates the use of the study medication/treatment or places the child at an unacceptable risk of experiencing treatment-related complications 6. Low probability of protocol compliance (any specific contraindication to MRI [e.g., cardiac pacemaker, cochlear implant]) 7. Radiological evidence of surgically related intracranial bleeding (excluding asymptomatic, resolving haemorrhagic changes associated with recent surgery and the presence of punctuate haemorrhage in the tumour)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event (disease)-Free Survival (EFS) as assessed by the central radiology review committee | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall Survival (OS) and 1 year survival rate 2. 6 mongh and 1 year EFS rates 3. Event (disease)- Free Survival (EFS) as assessed by the investigates 4. Overall respoonse 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 Weschsler scale 8. Safety, feasibility and tolerability | — |
Countries
Netherlands
Outcome results
None listed