Patients with High Risk Neuroblastoma
Conditions
Brief summary
R-I: 3-year EFS from the date of R-I randomisation R-HDC: 3-year EFS from the date of R-HDC randomisation R-RTx: 3-year EFS from the date of RTx randomization Chemoimmunotherapy arm: Metastatic response rate after 4 cycles of TEMIRI/DB. All analyses for randomized trials will be performed considering patients in the treatment group defined by randomization (intention to treat). The primary analysis will be controlled for stratification factors
Detailed description
For the whole population of high-risk neuroblastoma: - 3- and 5-year EFS, PFS and OS calculated from diagnosis, For each treatment phase of randomized trial : -5-year EFS, 3- and 5-year PFS and OS calculated from the date of each randomisation/ arm inclusion - Cumulative incidence of relapse/progression -Cumulative incidence of treatment related mortality and of disease related mortality - Overall response as per the new INRG response criteria (including primary tumour after induction), skeletal response on mIBG, bone marrow response, local control - Therapy-related toxicity, For patients in the chemoimmunotherapy arm: - Metastatic reponse rate after 2 cycles TEMIRI/DB and 3- and 5- year EFS/PFS/OS from the date of initial diagnosis
Interventions
DRUGMelphalan 50 mg concentrate and solvent for solution for injection/infusion
DRUGThiotepa 15 mg Powder for solution for injection
DRUGCisplatin 1 mg/ml concentrate for solution for infusion
DRUGsolution à diluer pour perfusion
DRUGIfosfamide Injection 2g
Sponsors
Institut Gustave Roussy
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R-I: 3-year EFS from the date of R-I randomisation R-HDC: 3-year EFS from the date of R-HDC randomisation R-RTx: 3-year EFS from the date of RTx randomization Chemoimmunotherapy arm: Metastatic response rate after 4 cycles of TEMIRI/DB. All analyses for randomized trials will be performed considering patients in the treatment group defined by randomization (intention to treat). The primary analysis will be controlled for stratification factors | — |
Secondary
| Measure | Time frame |
|---|---|
| For the whole population of high-risk neuroblastoma: - 3- and 5-year EFS, PFS and OS calculated from diagnosis, For each treatment phase of randomized trial : -5-year EFS, 3- and 5-year PFS and OS calculated from the date of each randomisation/ arm inclusion - Cumulative incidence of relapse/progression -Cumulative incidence of treatment related mortality and of disease related mortality - Overall response as per the new INRG response criteria (including primary tumour after induction), skeletal response on mIBG, bone marrow response, local control - Therapy-related toxicity, For patients in the chemoimmunotherapy arm: - Metastatic reponse rate after 2 cycles TEMIRI/DB and 3- and 5- year EFS/PFS/OS from the date of initial diagnosis | — |
Countries
Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Norway, Slovakia, Slovenia, Spain
Outcome results
None listed