low grade glioma, laaggradig glioom
Conditions
Interventions
Following complete resection patients will only be observed, as will be patients without symptoms or progression after incomplete resection or clinical diagnosis. Non-surgical therapy will be institut
Sponsors
International: SIOP
De voorzitter van de Trial Management Committee:
Dr. Astrid K. Gnekow
I. Klinik fuer Kinder und Jugendliche, Klinikum Augsburg
Stenglinstrasse.4
D-86156 Augsburg, Germany
National: Dutch Childhood Oncology Group (DCOG)
Eligibility
Inclusion criteria
Inclusion criteria: 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); 3. Primary tumor localization: Intracranial and spinal cord; 4. Dissemination: Children presenting with disseminated low grade glioma will be eligible for the study; 5. Associated conditions: Children are eligible for the trial regardless of the presence of associated genetic disease; 6. Primary tumor diagnosis: The tumor should not be pretreated with chemotherapy or radiotherapy; 7. Informed consent: The patient and/or his legal guardian ( parents ) have to have declared their written informed consent to the study. Within the randomized part of the study all histologies will be randomized, since up to now there are no data to exclude any of the subgroups, e.g. children with oligodendroglioma, from this study. Specific neuroradiological criteria may allow to diagnose a low grade chiasmatic-hypothalamic tumor without biopsy.
Exclusion criteria
Exclusion criteria: 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; 3. Pretreatment: Children treated with chemo- or radiotherapy prior to entering the study will be evaluated separately. Previous treatment with steroids is not considered a chemotherapeutic treatment; 4. Preexisting impairments of health status, making the conduct of the study impossible or ethically unwise; 5. Evidence of pregnancy or lactation period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival; 2. Assessment of integral dose to tumor and normal tissue and evaluation on the impact on long – term toxicity; 3. Assessment of tumor response to radiotherapy by imaging and clinical investigations; 4. Assessment of progression-free and overall survival, acute and long-term toxicity of crnio-spinal irradiation in metastatic disease. | — |
Contacts
Public ContactC.M. Damen-Korbijn
SKION Leyweg 299
Outcome results
None listed