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High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)

Study acronym: HR-NBL2
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Study sites: 137 to 142v13
  2. Study sites: 121 to 137
    • Interventions: Busulfan (Drug), Carboplatin (Drug), Cisplatin (Drug), Cyclophosphamide (Drug), Dacarbazine (Drug), Dinutuximab Beta (Drug), Doxorubicin… to Busulfan (Drug), Carboplatin (Drug), Cisplatin (Drug), Cyclophosphamid (Drug), Dacarbazine (Drug), Dinutuximab Beta (Drug), Doxorubicin…
    • Eligibility criteria expanded, about 326 words
    v12
  3. Study sites: 106 to 121v11
  4. Site details revised at 2 of 106 sitesv10
  5. Study sites: 95 to 106v9
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  1. Study sites: 36 to 95
    • Interventions: Busulfan (Drug), Carboplatin (Drug), Cisplatin (Drug), Cyclophosphamide (Drug), Dacarbazine (Drug), Dinutuximab Beta (Drug), Doxorubicin… to Busulfan (Drug), Carboplatin (Drug), Cisplatin (Drug), Cyclophosphamide (Drug), Dacarbazine (Drug), Dinutuximab Beta (Drug), Doxorubicin…
    v8
  2. Study sites: 28 to 36
    • Eligibility criteria expanded, about 67 words
    v7
  3. Study sites: 20 to 28v6
  4. Study sites: 16 to 20v5
  5. Study sites: 3 to 16v4
  6. Study sites: 1 to 3
    • Eligibility criteria expanded, about 5 words
    v3
  7. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04221035
Lead Sponsor Gustave Roussy, Cancer Campus, Grand Paris
Conditions
(from sponsor)		 High-Risk Neuroblastoma, Patient With Insufficient Response Chemoimmunotherapy
Enrollment 800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov