recurrent/progressive medulloblastoma, ependymoma and atypical teratoid rhabdoid tumor (ATRT), rare CNS tumors
Conditions
Brief summary
π: probability for response, lack of recurrence after gross total resection. Stratum II+III: H0: π≤15% study therapy is considered as ineffective (type I error rate α=0.05, two sided). H1: π≥35% study therapy is considered as effective (type II error rate β=0.10 in Stratum I, β=0.20 in Stratum II+III). Stratum IV: H0: π1≤ π2 study therapy is considered as equal or inferior (type I error rate α=0.025, one sided). H1: π1>π2 study therapy is consididered as superior (type II error rate β=0.20)
Detailed description
Kaplan Meier survival estimates of overall survival rates after 6, 12, 24, and 36 months with 95% confidence intervals will be evaluated and compared to historical samples, Kaplan Meier estimates of progression free survival after 6, 12, 24, and 36 months with 95% confidence intervals will be evaluated and compared to historical samples, The number and relative frequency of toxicities (CTCAE Version 5.0 grade 3, 4 and 5) will be evaluated every 12 weeks., Performance status will be compared from the start of therapy and every 12 weeks, Subscale-scores and total scores of the KINDL assessments at the start of therapy, after 6 months 12 months, 18 months and 24 months of therapy will be evaluated. PRO will be evaluated every two weeks., The aforementioned variables will be evaluated comparing their influence on response rate, overall survival rate, progression free survival rate, toxicity, quality of life and performance status by multivariate cox-regression, Examination of predictive and prognostic factors will be descriptive.
Interventions
DRUGEtoposid Ebewe 20 mg/ml - Konzentrat zur Herstellung einer Infusionslösung
DRUGLipcor 200 mg-Kapseln
DRUGThalidomide 50 mg capsules
DRUGhard
DRUGAvastin 25 mg/ml concentrate for solution for infusion.
DRUGIrinotecan 20 mg/ml Concentrate for Solution for Infusion
DRUGCELEBREX® 200 mg Hartkapseln
DRUGCytarabine 100 mg/ml Solution for Injection
Sponsors
Medical University Of Vienna
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| π: probability for response, lack of recurrence after gross total resection. Stratum II+III: H0: π≤15% study therapy is considered as ineffective (type I error rate α=0.05, two sided). H1: π≥35% study therapy is considered as effective (type II error rate β=0.10 in Stratum I, β=0.20 in Stratum II+III). Stratum IV: H0: π1≤ π2 study therapy is considered as equal or inferior (type I error rate α=0.025, one sided). H1: π1>π2 study therapy is consididered as superior (type II error rate β=0.20) | — |
Secondary
| Measure | Time frame |
|---|---|
| Kaplan Meier survival estimates of overall survival rates after 6, 12, 24, and 36 months with 95% confidence intervals will be evaluated and compared to historical samples, Kaplan Meier estimates of progression free survival after 6, 12, 24, and 36 months with 95% confidence intervals will be evaluated and compared to historical samples, The number and relative frequency of toxicities (CTCAE Version 5.0 grade 3, 4 and 5) will be evaluated every 12 weeks., Performance status will be compared from the start of therapy and every 12 weeks, Subscale-scores and total scores of the KINDL assessments at the start of therapy, after 6 months 12 months, 18 months and 24 months of therapy will be evaluated. PRO will be evaluated every two weeks., The aforementioned variables will be evaluated comparing their influence on response rate, overall survival rate, progression free survival rate, toxicity, quality of life and performance status by multivariate cox-regression, Examination of predictive an | — |
Countries
Austria, Czechia, Denmark, France, Norway, Spain, Sweden
Outcome results
None listed