Radiochemotherapy trial with radiotherapy and temozolomide chemotherapy for children and young adolescents 3 years and older to 18 years of age with primary high grade glioma, pontine glioma or gliomatosis cerebri
- Conditions
- Primary high grade glioma, pontine glioma or gliomatosis cerebriCancerMalignant neoplasm of brain
- Registration Number
- ISRCTN19852453
- Lead Sponsor
- Martin Luther University Halle-Wittenberg (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 135
1. Newly diagnosed, previously untreated high grade glioma with central neuropathological review including glioblastoma multiforme (WHO IV), anaplastic astrocytoma (WHO III), anaplastic oligodendroglioma (WHO III), anaplastic mixed glioma/anaplastic oligoastrocytoma (WHO III), anaplastic pilocytic astrocytoma (WHO III), anaplastic ganglioglioma (WHO III), anaplastic pleomorphic xanthoastrocytoma (WHO III), giant cell glioblastoma (WHO IV), and gliosarcoma (WHO IV)
2. Newly diagnosed, previously untreated diffuse intrinsic pontine glioma of all tumour grades with central neuroradiological review
3. Newly diagnosed, previously untreated gliomatosis cerebri of all tumour grades with central neuropathological review
4. Patient aged 3 years and older but under 18 years at time of diagnosis, either sex
5. Written informed consent of the patient and/or the patient's parents or legal guardian according to national laws
1. Pre-treatment of glioblastoma multiforme (WHO IV), anaplastic astrocytoma (WHO III), anaplastic oligodendroglioma (WHO III), anaplastic mixed glioma/anaplastic oligoastrocytoma (WHO III), anaplastic pilocytic astrocytoma (WHO III), anaplastic ganglioglioma (WHO III), anaplastic pleomorphic xanthoastrocytoma (WHO III), giant cell glioblastoma (WHO IV), gliosarcoma (WHO IV), diffuse intrinsic pontine glioma and gliomatosis cerebri differing from study protocol
2. Known hypersensitivity or contraindication to study drugs and/or dacarbazine
3. Prior chemotherapy or radiotherapy which prevents adequate performance of radiotherapy as outlined by the present protocol. This may mainly apply to patients with secondary malignant glioma after previous malignant brain tumour, e.g. medulloblastoma, supratentorial PNET. If previous treatment does not prevent the adequate performance of the outlined treatment protocol patients with secondary malignant glioma will be eligible for the present trial.
4. Other (simultaneous) malignancies
5. Pregnancy and/or lactation
6. Patients who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly or surgical sterile)
7. Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial
8. Very poor clinical condition as defined by demand of mechanical ventilation and/or demand for intravenous catecholamines and/or very severe neurological damage equivalent to a coma and/or tetraplegia with complete incapability for communication (deafness, blindness, mutism)
9. Severe concomitant diseases (e.g. immune deficiency syndrome)
10. Known human immunodeficiency virus (HIV) positivity
Country-specifically very young patients may be excluded to comply with national laws or formal insurance requirements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event-status 6 months after diagnosis: event/no event (i.e. by magnetic resonance imaging). An event is defined as:<br>1. Progression/relapse of disease<br>2. Diagnosis of a secondary malignancy<br>3. Death of any cause
- Secondary Outcome Measures
Name Time Method 1. Event-free survival defined as time from diagnosis until the first event, measured after 1 year and 2 years<br>2. Overall survival defined as time from diagnosis until death of any cause, measured after 6 months, 1 year, and 2 years<br>3. Common Toxicity Criteria (CTC) toxicity levels of treatment elements<br><br>A follow-up of 2 years after study entry is required, however, a long term follow-up is highly recommended. Thus, event-free survival and overall survival will possibly be evaulated after 5 years and longer.