High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)
Gustave Roussy, Cancer Campus, Grand Paris
800 participants
Nov 5, 2019
INTERVENTIONAL
Conditions
Summary
This is an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
1.5 mg/m2 (max dose 2 mg)
750 mg/m2
175 mg/m2
3 mg/m2/day (max dose 6 mg)
200 mg/m2/day
1500 mg/m2/day
30 mg/m2/dose
\< 9kg: 1.0 mg/kg/dose 9 kg to \< 16 kg : 1.2 mg/kg/dose 16 kg to 23 kg : 1.1 mg/kg/dose \>23 kg to 34 kg: 0.95 mg/kg/dose \>34 kg: 0.8 mg/kg/dose Infusion IV over 2 hours Administration every 6 hours for a total of 16 doses
140 mg/m2/dose IV short infusion (15'), at least 24 h after the last busulfan dose
300 mg/m2/day over 2 hours
21.6 Gy 21.6 Gy + boost de 14.4 Gy
Patients \>12 kg are dosed based on the BSA: 10 mg/m\^2/day Patients ≤ 12 kg are dosed according to their body weight: 0.33 mg/kg/day
80 mg/m2/24h
100 mg/m²/Day
50 mg/m²/jour de J0 à J4
Cyclophosphamide has been demonstrated to have a cytostatic effect in many tumour types. The active metabolites of cyclophosphamide are alkylating agents which transfer alkyl groups to DNA during the process of cell division, thus preventing normal synthesis of DNA.
Locations(142)
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NCT04221035