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

STATUS

Recruiting
End date

Nov 28, 2032
participants needed

800
sponsor

Gustave Roussy, Cancer Campus, Grand Paris

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Updated on 19 February 2024

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cancer

fever

bone disease

heart disease

renal function

carboplatin

bone lesions

x-rays

heart failure

dyspnea

ejection fraction

etoposide

chromosome abnormality

induction chemotherapy

primary tumor

oxygen saturation

phenytoin

myocardial infarction

arrhythmia

obstruction

infarct

oximetry

renal function tests

neuropathy

chest x-ray

hearing impairment

yellow fever

bone marrow procedure

renal function test

residual tumor

kidney function test

localized disease

fdg pet

st. john's wort

avid

shortening fraction

residual disease

peripheral neuropathy

inflammatory bowel disease

hyperhydration

fdg-pet

pulse oximetry

chromosomal abnormalities

dyspnea at rest

high-risk neuroblastoma

bone lesion

mycn

bacterial vaccines

bowel obstruction

mibg

intestinal obstruction

consolidation chemotherapies

bone marrow disease

yellow fever vaccine

prophylactic

neuroblastoma

renal toxicity

acute infarct

blood bilirubin

localized neuroblastoma

hypericum perforatum

numerical chromosomal alterations

charcot-marie-tooth syndrome

infarct, acute

Summary

Show definitions

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

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
Age	21years or below
Treatment	Cyclophosphamide, Carboplatin, Vincristine, Thiotepa, Etoposide, Vindesine, Dacarbazine, Ifosfamide, Doxorubicin, Busulfan, Melphalan, Radiotherapy, Dinutuximab Beta, Cisplatin
Clinical Study Identifier	NCT04221035
Sponsor	Gustave Roussy, Cancer Campus, Grand Paris
Last Modified on	19 February 2024

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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 (toxicity grade 2). If GFR < 60ml/min/1.73m, 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
	Concomittant 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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chromosome abnormality

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oxygen saturation

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myocardial infarction

bone marrow procedure

peripheral neuropathy

inflammatory bowel disease

hyperhydration

fdg-pet

pulse oximetry

chromosomal abnormalities

dyspnea at rest

high-risk neuroblastoma

intestinal obstruction

consolidation chemotherapies

localized neuroblastoma

hypericum perforatum

numerical chromosomal alterations

charcot-marie-tooth syndrome

infarct, acute

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