A study for all children and adolescents with a low grade glioma.
- Conditions
- low grade glioma, laaggradig glioom
- Registration Number
- NL-OMON20306
- Lead Sponsor
- International: SIOPDe voorzitter van de Trial Management Committee:Dr. Astrid K. GnekowI. Klinik fuer Kinder und Jugendliche, Klinikum AugsburgStenglinstrasse.4D-86156 Augsburg, GermanyNational: Dutch Childhood Oncology Group (DCOG)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1. Age: Children and adolescents up to age 16 years;
2. Histology: Glioma of low grade malignancy ( ICD O-Codes: 9421/1, 9384/1, 9413/0, 9412/1, 9505/1, 9424/3, 9450/3, 9382/3, 9400/3, 9420/3, 9410/3, 9411/3);
1. Primary tumor localization: Diffuse intrinsic tumors of the pons, even if histologically an Astrocytoma II° is diagnosed. Exception: pontine glioma II° in NF I patients may be entered into the study;
2. Special diagnosis: Patients presenting with rare intracranial neoplasms of low grade malignancy, but non-glial origin. Their data may be registered however, to learn about those therapeutic interventions which may prove useful to these patients and to develop separate strategies in the future. Choroid plexus papilloma should be entered on the SIOP-CPT-study;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival.
- Secondary Outcome Measures
Name Time Method 1. Overall survival;<br /><br>2. Assessment of integral dose to tumor and normal tissue and evaluation on the impact on long – term toxicity;<br /><br>3. Assessment of tumor response to radiotherapy by imaging and clinical investigations;<br /><br>4. Assessment of progression-free and overall survival, acute and long-term toxicity of crnio-spinal irradiation in metastatic disease.