Low grade glioma in children and adolescents up to the age of 25 (25th birthday) MedDRA version: 9.1 Level: LLT Classification code 10018338 Term: Glioma
Conditions
Interventions
Product Name: Etoposide
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ETOPOSIDE
CAS Number: 33419-42-0
Sponsors
University Hospitals of Leicester NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Age: children and adolescents up to the completion of the 25th year of life (25th birthday). •Histology: glioma of low grade malignancy according to ICD O Code. •Site: intracranial and/or spinal cord primary site. •Extent: localized or disseminated tumour. •Associated conditions: Children are eligible for the trial regardless of the presence of associated genetic disease. •Primary tumor diagnosis: The tumor should not be pretreated with chemotherapy or radiotherapy. •Written informed consent. •National and local ethical approval. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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
Exclusion criteria
Exclusion criteria: •Primary tumour localisation: Diffuse tumours of the pons, even if histologically an Astrocytoma Io or IIo is diagnosed. Exception: pontine glioma IIo in NFI patients may be entered into the study. •Special diagnosis: Patients presenting with rare intracranial neoplasms of low grade malignancy, but of non-glial origin may be treated according to this protocol but will not be included in the randomised trial. •Previous treatment: Patients who have had treatment with chemo- or radiotherapy prior to entering the study will be evaluated separately. •Pre-existing impairment of health status, making the conduct of the study impossible or ethically unwise. •Pregnancy or lactation period •NB: Concomitant medication for associated or other conditions (e.g. steroids, hormone replacement, anticonvulsants) should be recorded, but it is not an exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate in a randomised trial, if adding Etoposide to standard induction therapy will improve progression- free survival in patients with non-NF1 low grade glioma. To investigate by comparison with historical series, if prolonging treatment duration to 18months will improve progression-free survival. ; Secondary Objective: •Improve response and progression/ event free and overall survival •Reduced late effects and improvement of quality of life at short and long term •Evaluation of prognostic factors ; Primary end point(s): Assessment of progression-free survival Measurement of response at the end of induction. | — |
Countries
Ireland, Norway, United Kingdom
Outcome results
None listed