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

  • STATUS
    Recruiting
  • End date
    Nov 24, 2032
  • participants needed
    800
  • sponsor
    Gustave Roussy, Cancer Campus, Grand Paris
Updated on 24 September 2021

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.

Description

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.

The first randomization (R-I) will compare the efficacy of two induction chemotherapies (RAPID COJEC and GPOH regimens) in a phase III setting. The primary endpoint will be the 3-year EFS from date of randomization . The R-I randomization will be stratified on age, stage, MYCN status and countries.

The second randomization (R-HDC) will compare the efficacy of single HDC with Bu-Mel versus tandem HDC with Thiotepa followed by Bu-Mel. The primary endpoint is 3-year EFS calculated from the date of the R-HDC randomization. The R-HDC randomization will be stratified on the age, stage, MYCN status, induction chemotherapy regimen, response to induction phase and countries.

The impact of local treatment in this phase III setting will be assessed, according to the presence or not of a macroscopic residual disease after surgery and HDC.

In case of macroscopic residual disease, 21.6 Gy radiotherapy to the preoperative tumor bed will be randomized (R-RTx) versus the same treatment plus a sequential boost of additional 14.4 Gy to the residual tumor. The primary endpoint of R-RTx is 3-year EFS from the date of the R-RTx randomization. The R-RTx randomization will be stratified on age, stage, MYCN status, induction chemotherapy regimen, HDC regimen and countries.

In case of no macroscopic residual disease, 21.6 Gy radiotherapy will be delivered to the preoperative tumor bed.

Details
Condition High-Risk Neuroblastoma, High Risk Neuroblastoma
Treatment cyclophosphamide, cisplatin, etoposide, busulfan, ifosfamide, melphalan, carboplatin, Radiotherapy, vincristine, doxorubicin, Vindesine, thiotepa, dacarbazine, dinutuximab beta
Clinical Study IdentifierNCT04221035
SponsorGustave Roussy, Cancer Campus, Grand Paris
Last Modified on24 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Urinary outflow obstruction
severe arrhythmia, heart failure, previous cardiac infarct, acute inflammatory heart disease
severe peripheral neuropathy
demyelinating form of Charcot-Marie-Tooth syndrome
hearing impairment
Concurrent prophylactic use of phenytoin
cardiorespiratory disease that contraindicates hyperhydration
Non-inclusion criteria common to all randomizations (R-I, R-HDC and R-RTx)
Any negative answer concerning the inclusion criteria of R-I or R-HDC or R-RTx will render the patient ineligible for the corresponding therapy phase randomization. However, these patients may remain on study and be considered to receive standard treatment of the respective therapy phase, and may be potentially eligible for subsequent randomizations
Liver function: Alanine aminotransferase (ALT) > 3.0 x ULN and blood bilirubin > 1.5 x ULN (toxicity grade 2). In case of toxicity grade 2, call national principal investigator study coordinator to discuss the feasibility
Renal function: Creatinine clearance and/or GFR < 60 ml/min/1.73m^2 (toxicity grade 2). If GFR < 60 ml/min/1.73m^2, call national principal investigator to discuss.the feasibility
Dyspnea at rest and/or pulse oximetry < 95% in air
Any uncontrolled intercurrent illness or infection that in the investigator opinion would impair study participation
Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving his consent
Participating in another clinical study with an IMP while on study treatment
Concomitant use with yellow fever vaccine and with live virus or bacterial vaccines
Patient allergic to peanut or soya
Chronic inflammatory bowel disease and/or bowel obstruction
Pregnant or breastfeeding women
Known hypersensitivity to the active substance or to any of the excipients of study drugs known
Concomitant use with St John's Wort (Hypericum Perforatum)
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