diffuse intrinsic pontine glioma
Conditions
Brief summary
Overall survival (OS) from the time of diagnosis until last visit or death, Safety assessment of sirolimus administered during radiotherapy and in combination with trametinib as adjunctive treatment after irradiation
Detailed description
Progression free survival from diagnosis to progression, Response rate assessed at time points specified in the protocol (MRI every 2 months from commnecement of systemic treatment), Quality of life assessment (using PedQoL- pediatric quality of life inventory) at time points specified in the protocol, Comparison of safety in 2 groups of patients; treated with sirolimus alone or in combination with trametinib
Interventions
Sponsors
Instytut Pomnik Centrum Zdrowia Dziecka
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) from the time of diagnosis until last visit or death, Safety assessment of sirolimus administered during radiotherapy and in combination with trametinib as adjunctive treatment after irradiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival from diagnosis to progression, Response rate assessed at time points specified in the protocol (MRI every 2 months from commnecement of systemic treatment), Quality of life assessment (using PedQoL- pediatric quality of life inventory) at time points specified in the protocol, Comparison of safety in 2 groups of patients; treated with sirolimus alone or in combination with trametinib | — |
Countries
Poland
Outcome results
None listed