high grade glioma
Conditions
Brief summary
The primary safety endpoint of rapamycin will be the assessment of the incidence of 3 and 4 grade adverse reactions (according to the CTCAE classification) during the treatment phase and follow-up.
Detailed description
OS (overall survival) after 15 months, 24 months, 3 years, 5 years, EFS (event free survival) after 15 months, 24 months, 3 years, 5 years, PFS (progression free survival) after 15 months, 24 months, 3 years, 5 years, ORR ( overall response rate) according RAPNO (CR, PR, SD, PD) criteria, Evaluation of adverse event seriousness according CTCAE, Evaluation of the number of patients who experience adverse events that effects with premature termination of tratment during the therapeutic dose period. OS, EFS and PFS will be counted from the start of cancer treatment (the day of surgery).
Interventions
Sponsors
Instytut Pomnik Centrum Zdrowia Dziecka
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint of rapamycin will be the assessment of the incidence of 3 and 4 grade adverse reactions (according to the CTCAE classification) during the treatment phase and follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| OS (overall survival) after 15 months, 24 months, 3 years, 5 years, EFS (event free survival) after 15 months, 24 months, 3 years, 5 years, PFS (progression free survival) after 15 months, 24 months, 3 years, 5 years, ORR ( overall response rate) according RAPNO (CR, PR, SD, PD) criteria, Evaluation of adverse event seriousness according CTCAE, Evaluation of the number of patients who experience adverse events that effects with premature termination of tratment during the therapeutic dose period. OS, EFS and PFS will be counted from the start of cancer treatment (the day of surgery). | — |
Countries
Poland
Outcome results
None listed