High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeUp to 21
SponsorGustave Roussy, Cancer Campus, Grand Paris
About this trial
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 criteria
Qualifiers
at diagnosis before the beginning of chemotherapy or
up to 21 days after one course of Carboplatin-Etoposide for patients with localized neuroblastoma or infants with metastatic neuroblastoma with MYCN amplification or patients with metastatic neuroblastoma treated in emergency or
up to 21 days after one course of the current protocol for R-I randomisation (RAPID COJEC/GPOH) low/intermediate risk neuroblastoma in Germany/Netherlands for patients with localized neuroblastoma or infants with metastatic neuroblastoma with MYCN amplification
Stage M neuroblastoma above 365 days of age at diagnosis (no upper age limit) and Ms neuroblastoma 12-18 months old, any MYCN status or
Disqualifiers
- Stage M neuroblastoma above 365 days of age at diagnosis, any MYCN status, EXCEPT patients with stage M or Ms 12-18 months old with numerical chromosomal alterations only, and in complete metastatic response at the end of induction: in this case, patients will have surgery and no further treatment.
Age < 21 years at the time of randomization
Bone disease: mIBG uptake completely resolved or SIOPEN score ≤ 3 and at least 50% reduction in mIBG score (or ≤ 3 bone lesions and at least 50% reduction in number of FDG- PET-avid bone lesions for mIBG-nonavid tumours).
Bone marrow disease: CR and/or minimal disease (MD) according to International Neuroblastoma Response Criteria
Trial design
Treatments tested in this trial
- Vincristine
- Carboplatin
- Etoposide
- Vindesine
- Dacarbazine
- Ifosfamide
- Doxorubicin
- Busulfan
- Melphalan
- Thiotepa
- Radiotherapy
- Dinutuximab Beta
- Cisplatin
- Temozolomide 100 MG
- Irinotecan
- Cyclophosphamid
Treatment groups
800 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov