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JOURNAL ONKOLOGIE – STUDIE
HR-NBL2

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

Rekrutierend

NCT-Nummer:
NCT04221035

Studienbeginn:
November 2019

Letztes Update:
13.02.2023

Wirkstoff:
Vincristine, Carboplatin, Etoposide, Cyclophosphamide, Vindesine, Dacarbazine, ifosfamide, Doxorubicin, Busulfan, Melphalan, Thiotepa, dinutuximab beta, Cisplatin, Temozolomide 100 MG, Irinotecan

Indikation (Clinical Trials):
Neuroblastoma

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 3

Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris

Collaborator:
-

Studienleiter

Dominique Valteau-Couanet, MD PhD
Study Chair
Gustave roussy, Paris, France

Kontakt

Dominique Valteau-Couanet, MD PhD
Kontakt:
Phone: +33 (0)1 42 11 42 11
E-Mail: dominique.valteau@gustaveroussy.fr» Kontaktdaten anzeigen

Studienlocations
(3 von 121)

Sydney children Hospital
NSW, 2031 Sydney
AustraliaNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Toby Nicholas Trahair, Phd, MD
Phone: 61 2 9382 2970
E-Mail: Toby.Trahair@health.nsw.gov.au» Ansprechpartner anzeigen
Children's Cancer Centre, Monash Children's Hospital
VIC 3168 Clayton
AustraliaNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Paul Wood, MD
Phone: 61 3 8572 3456
E-Mail: Paul.Wood@monashhealth.org» Ansprechpartner anzeigen
Oncology/Haematology Department, Perth Children's Hospital
WA, 6009 Nedlands
AustraliaNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Anne Ryan, MD
Phone: 61 8 6456 2222
E-Mail: Anne.Ryan@health.wa.gov.au» Ansprechpartner anzeigen
Children's Cancer & Haematology Services, John Hunter Children's Hospital
NSW, 2305 New Lambton Heights
AustraliaNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Janis chamberlin, MD
Phone: 61 2 4921 3080
E-Mail: Janis.Chamberlain@health.nsw.gov.au» Ansprechpartner anzeigen
Australian and New Zealand Children's Hematology/oncology Group
NSW, 2031 Sydney
AustraliaAktiv, nicht rekrutierend» Google-Maps
Cancer Centre for Children, The Children's Hospital
NSW, 2145, Westmead
AustraliaNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Bhavna Padhye, MD
Phone: 61 2 9845 2187
E-Mail: bhavna.padhye@health.nsw.gov.au» Ansprechpartner anzeigen
Hôpital Universitaire des Enfants Reine Fabiola (ULB)
1020 Brussels
BelgiumNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Safiato Diallo, MD
Phone: 0032 2 477 26 78
E-Mail: safiatou.diallo@huderf.be» Ansprechpartner anzeigen
Cliniques Universitaires Saint-Luc (UCL)
1200 Brussel
BelgiumNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Benedicte Brichard, MD
Phone: 0032 2 764 23 50
E-Mail: benedicte.brichard@saintluc.uclouvain.be» Ansprechpartner anzeigen
Department of Paediatrics and Adolescent Medicine, Rigshospitalet
DK-2100 Copenhagen
DenmarkRekrutierend» Google-Maps
Ansprechpartner:
jesper Sune Brok,, PhD
Phone: 0045 35458270
E-Mail: jesper.sune.brok@regionh.dk» Ansprechpartner anzeigen
The Hans Christian Andersen Children's Hospital, University of Southern Denmark
DK-5000 Odense
DenmarkNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Mathias Rathe, PhD
Phone: 0045 30296665
E-Mail: mathias.rathe@rsyd.dk» Ansprechpartner anzeigen
New Children's Hospital, Helsinki University Hospital, Helsinki and Uusimaa Hospital District
00029 Helsinki
FinlandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Minna Koskenvuo, MD
Phone: +358 50 427 0424
E-Mail: minna.koskenvuo@hus.fi» Ansprechpartner anzeigen
Gustave Roussy
94800 Villejuif
FranceRekrutierend» Google-Maps
Ansprechpartner:
Dominique Valteau-Couanet, MD PhD
Phone: +33 (0)1 42 11 42 11
E-Mail: dominique.valteau@gustaveroussy.fr

Attalah Habiba, PhD
Phone: +33 (0)1 42 11 42 11
E-Mail: habiba.attalah@gustaveroussy.fr» Ansprechpartner anzeigen
Centre François Baclesse
Caen
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Georges-François Leclerc
Dijon
FranceAktiv, nicht rekrutierend» Google-Maps
Institut de cancérologie de Loraine
Nancy
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Antoine Lacassagne
Nice
FranceAktiv, nicht rekrutierend» Google-Maps
Institut de cancérologie de l'Ouest - Sité René Gauducheau
Saint-Herblain
FranceAktiv, nicht rekrutierend» Google-Maps
Institut de Cancérologie Strasbourg
Strasbourg
FranceAktiv, nicht rekrutierend» Google-Maps
"MITERA" Private, General, Obstetrics - Gynaecology, Paediatric Clinic S.A.
15123 Athens
GreeceRekrutierend» Google-Maps
Ansprechpartner:
DANA ELENI, MD
Phone: 0030 210 6869631
E-Mail: danaeleni@hotmail.gr» Ansprechpartner anzeigen
University General Hospital of Thessaloniki "AHEPA"
54621 Thessaloniki
GreeceRekrutierend» Google-Maps
Ansprechpartner:
EMMANOUEL HATZIPANTELIS, MD
Phone: 0030 2310994810
E-Mail: hatzip@auth.gr» Ansprechpartner anzeigen
General Hospital of Thessaloniki "IPPOKRATIO"
54642 Thessaloniki
GreeceRekrutierend» Google-Maps
Ansprechpartner:
EVGENIA PAPAKONSTANTINOU, MD
Phone: 0030 2313312430
E-Mail: eugepapa@yahoo.gr» Ansprechpartner anzeigen
Spedali civili Ospedale Dei Bambini Oncoematologia pediatrica e TMO
3995041 Brescia
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Fulvio porta
Phone: 0303995711
E-Mail: fulvio.porta@asst-spedalicivili.it» Ansprechpartner anzeigen
U.O Pediatria, SS Oncoematologia pediatrica
47900 Rimini
ItalyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Roberta Pericoli, MD
Phone: 0541/705034
E-Mail: roberta.pericoli@auslromagna.it» Ansprechpartner anzeigen
U.O.C oncoematologia pediatrica ospedale Donna Bambino
37126 Verona
ItalyRekrutierend» Google-Maps
Ansprechpartner:
simone cesaro, MD
Phone: 0458127874
E-Mail: simone.cesaro@ospedaleuniverona.it» Ansprechpartner anzeigen
Vilnius University Hospital Santaros Klinikos
08406 Vilnius
LithuaniaNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Jelena Rascon, Pr
Phone: +370 5 232 8703
E-Mail: jelena.rascon@santa.lt» Ansprechpartner anzeigen
Universitair Medisch Centrum Groningen
9700 Groningen
NetherlandsAktiv, nicht rekrutierend» Google-Maps
Princess Maxima center
3584CS Utrecht
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
Lieve TyTGAT, MD
Phone: +31 06-55234711
E-Mail: G.A.M.Tytgat@prinsesmaximacentrum.nl

JAAP MUR
Phone: +31 06 5000 66 46
E-Mail: J.Mur@prinsesmaximacentrum.nl» Ansprechpartner anzeigen
University medical center Ljubljana, University Children's Hospital Ljubljana, Slovenia
1000 Ljubljana
SloveniaRekrutierend» Google-Maps
Ansprechpartner:
Cesen maja, MD
Phone: : 00 386 41 365 384
E-Mail: maja.cesenmazic@kclj.si» Ansprechpartner anzeigen
Hospital Universitario Vall D´Hebron
08035 Barcelona
SpainNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Lucas Moreno Martin, MD
Phone: +34934893093
E-Mail: lucas.moreno@vallhebron.cat» Ansprechpartner anzeigen
Hospital Universitario Cruces
48903 Cruces
SpainNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Ricardo Lopez Almaraz, MD
Phone: +34946006289
E-Mail: RICARDO.LOPEZALMARAZ@osakidetza.eus» Ansprechpartner anzeigen
Hospital Clínico Universitario Virgen de la Arrixaca
30120 El Palmar
SpainNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Maria Del Mar Bermudez, MD
Phone: +34968929461
E-Mail: mariam.bermudez2@carm.es» Ansprechpartner anzeigen
Hospital Universitario Infantil Niño Jesús
28009 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Alba Rubio San Simon, MD
Phone: +34915035900
E-Mail: alba.rubio@salud.madrid.org» Ansprechpartner anzeigen
Hospital Regional Universitario de Málaga
29010 Málaga
SpainNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Laura Garcia Hidalgo, MD
Phone: +34662244641
E-Mail: laura.garcia.hidalgo.sspa@juntadeandalucia.es» Ansprechpartner anzeigen
Hospital Universitario Donostia
20014 San Sebastián
SpainNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Miriam Abos Garcia, MD
Phone: +34943007176
E-Mail: miriam.garciaabos@osakidetza.eus» Ansprechpartner anzeigen
Hospital Clínico Universitario de Santiago
15706 Santiago De Compostela
SpainNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Manuel Fernández Sanmartín, MD
Phone: +34981951120
E-Mail: manuel.fernandez.sanmartin@sergas.es» Ansprechpartner anzeigen
Hospital Universitario Virgen del Rocío
41013 Sevilla
SpainNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
catalina Marquez Vega, MD
Phone: +34955012921
E-Mail: catalina.marquez.sspa@juntadeandalucia.es» Ansprechpartner anzeigen
Kantonsspital Aarau AG Klinik für Kinder und Jugendliche
CH-5001 Aarau
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Andreas Klein-Franke, MD
Phone: 41 62 838 92 45
E-Mail: Andreas.Klein-Franke@ksa.ch» Ansprechpartner anzeigen
Universitäts-Kinderspital beider Basel (UKBB)
CH-4031 Basel
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Nicolas von der Weid, Pr
Phone: 41 61 704 17 62
E-Mail: nicolas.vonderweid@ukbb.ch» Ansprechpartner anzeigen
Ospedale San Giovanni Pediatria, Emato-oncologia pediatrica
CH-6500 Bellinzona
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Pierluigi Brazzola, MD
Phone: 41 91 811 89 76
E-Mail: Pierluigi.Brazzola@eoc.ch» Ansprechpartner anzeigen
Inselspital, Universitätsklinik für Kinderheilkunde
CH-3010 Bern
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Jochen Rößler, MD
Phone: 41 31 632 94 95
E-Mail: jochen.roessler@insel.ch» Ansprechpartner anzeigen
HUG Hôpitaux Universitaires de Genève Unité d'Hémato-Oncologie Pédiatrique
CH-1205 Geneva
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Fabienne Gumy Pause, MD
Phone: 41 79 55 32 594
E-Mail: fabienne.gumypause@hcuge.ch» Ansprechpartner anzeigen
CHUV - Centre Hospitalier Universitaire Vaudois
CH-1011 Lausanne
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Maja Beck Popovic, Pr
Phone: 41 21 314 35 67
E-Mail: maja.beck-popovic@chuv.ch» Ansprechpartner anzeigen
Luzerner Kantonsspital, Kinderspital pädiatrische Hämatologie/Onkologie
CH-6000 Lucerne
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Freimut H. Schilling, MD
Phone: +41 41 205 32 10
E-Mail: freimut.schilling@luks.ch» Ansprechpartner anzeigen
Ostschweizer Kinderspital Hämatologie/Onkologie Claudiusstrasse 6
CH-9006 Saint Gallen
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Cornelia Vetter, MD
Phone: +41 71 243 13 48
E-Mail: cornelia.vetter@kispisg.ch» Ansprechpartner anzeigen
Division of Pediatric Oncology Universitäts-Kinderspital Zürich
CH-8032 Zürich
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Sabina Kroiss Benninger, MD
Phone: 41 44 266 70 57
E-Mail: sabine.kroiss@kispi.uzh.ch» Ansprechpartner anzeigen
University Hospitals Birmingham Queen Elisabeth Hospital(UHB)
B46NH Birmingham
United KingdomAktiv, nicht rekrutierend» Google-Maps
Royal Manchester Children's Hospital
Manchester
United KingdomRekrutierend» Google-Maps
Royal Victoria Infirmary, Newcastle
Newcastle
United KingdomAktiv, nicht rekrutierend» Google-Maps
Sheffield Children's Hospital
S102TH Sheffield
United KingdomAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed 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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

At diagnosis (or up to 21 days after one cycle of chemotherapy for patients with localized

neuroblastoma with MYCN amplification).

R-I eligibility criteria:

1. Established diagnosis of neuroblastoma according to the SIOPEN-modified International

Neuroblastoma Risk Group (INRG) criteria, High-risk neuroblastoma defined as:

- 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

- L2, M or Ms neuroblastoma any age with MYCN amplification or focal high level MYC

or MYCL amplification * In Germany, patients aged less than 18 months with stage

M and without MYCN amplification will not be enrolled in HR-NBL2 trial.

2. No previous chemotherapy or up to 21days one cycle of chemotherapy for patients with

localized neuroblastoma with MYCN amplification or patients with metastatic

neuroblastoma treated in emergency

3. Females of childbearing potential must have a negative serum or urine pregnancy test

within 7 days prior to initiation of treatment. Sexually active patients must agree to

use acceptable and appropriate contraception while on HRNBL2 study drug and for one

year after stopping the study . Acceptable contraception is defined in CTFG Guidelines

"Recommendations related to contraception and pregnancy testing in clinical trials".

Female patients who are lactating must agree to stop breast-feeding.

4. Written informed consent to enter the R-I randomization from patient or parents/legal

representative, patient, and age-appropriate assent.

5. Patient affiliated to a social security regimen or beneficiary of the same according

to local requirements.

6. Patients should be able and willing to comply with study visits and procedures as per

protocol.

In case of parents'/patient's refusal to R-I, or organ toxicity, exclusion criteria at

diagnosis, patients can still be enrolled in HR-NBL2 trial with parents'/patient's consent

within 3 weeks from the beginning of chemotherapy. Patients will be treated with the

standard induction regimen per country (rapid COJEC or GPOH) and will be potentially

eligible for subsequent randomizations.

Randomization for HDC strategy will be performed at the end of induction after the disease

evaluation and after surgery of the primary tumor for those patients who will receive

surgery before HDC.

R-HDC eligibility criteria:

1. - 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 but will not be eligible for R-HDC and will not be able to

pursue the trial.

OR

- L2, M or Ms neuroblastoma any age with MYCN amplification or focal high level MYC or

MYCL amplification

2. Age < 21 years

3. Complete response (CR) or partial response (PR) at metastatic sites:

- Bone disease: MIBG uptake (or FDG-PET uptake for MIBG-nonavid tumors) 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 tumors).

- Bone marrow disease: CR and/or minimal disease (MD) according to International

Neuroblastoma Response Criteria [Park JR, JCO 2017; Burchill S, Cancer 2017].

- Other metastatic sites: complete response after induction chemotherapy +/-

surgery.

4. Acceptable organ function and performance status

- Performance status ≥ 50%.

- Hematological status: ANC > 0.5x10^9/L, platelets > 20x 10^9/L

- Cardiac function (< grade 2)

- Normal chest X-ray and oxygen saturation.

- Absence of any toxicity ≥ grade 3.

5. Sufficient collected stem cells available; minimum required: 6 x 10^6 CD34+ cells/kg

body weight stored in 3 separate fractions.

6. Written informed consent, including agreement of patient or parents/legal guardian for

minors, to enter the R-HDC randomization.

7. Patient affiliated to a social security regimen or beneficiary of the same according

to local requirements.

8. Patients should be able and willing to comply with study visits and procedures as per

protocol.

In case of parents'/patient's refusal, or insufficient stem cells, collection for tandem

HDC but with a minimum of 3 x 10^6 CD34+ cells/kg body weight, or in case of patients older

than 21 years, or organ toxicity, HDC will consist on the standard HD Bu-Mel and will be

eligible for subsequent randomization.

An evaluation of the local disease will be performed after HDC/ASCR and surgery:

- In case of no local macroscopic disease, all patients will receive 21-Gy radiotherapy

to the pre-operative tumor bed

- In case of local macroscopic residual disease, patients will be eligible to R-RTx if

the following criteria are met:

1. No evidence of disease progression after HDC/ASCR.

2. Interval between the last ASCR and radiotherapy start between 60 and 90 days.

3. Performance status greater or equal 50%.

4. Hematological status: ANC > 0.5x10^9/L, platelets > 20x10^9/L.

5. Written informed consent, including agreement of patient or parents/legal

guardian for minors, to enter the R-RTx randomization.

6. Patient affiliated to a social security regimen or beneficiary of the same

according to local requirements.

7. Patients should be able and willing to comply with study visits and procedures as

per protocol.

In case of parents'/patient's refusal of the randomization, the patient will receive 21.6

Gy radiotherapy to the pre-operative tumor bed

Exclusion Criteria:

Non-inclusion criteria specific to the R-I randomization (RAPID COJEC/GPOH) :

1. Urinary tract obstruction ≥ grade 3

2. Heart failure or myocarditis ≥ grade 2, any arrhythmia or myocardial infection

3. Peripheral motor or sensory neuropathy ≥ grade 3

4. demyelinating form of Charcot-Marie-Tooth syndrome

5. hearing impairment ≥ grade 2

6. Concurrent prophylactic use of phenytoin

7. cardiorespiratory disease that contraindicates hyperhydration

Non-inclusion criteria common to all randomizations (R-I, R-HDC and R-RTx) :

1. 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.

2. 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.

3. 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 about

the treatment

4. Dyspnea at rest and/or pulse oximetry < 95% in air.

5. Any uncontrolled intercurrent illness or infection that in the investigator opinion

would impair study participation.

6. Patient under guardianship or deprived of his liberty by a judicial or administrative

decision or incapable of giving his consent.

7. Participating in another clinical study with an IMP while on study treatment.

8. Concomitant use with yellow fever vaccine and with live virus or bacterial vaccines.

9. Patient allergic to peanut or soya.

10. Chronic inflammatory bowel disease and/or bowel obstruction.

11. Pregnant or breastfeeding women.

12. Known hypersensitivity to the active substance or to any of the excipients of study

drugs known

13. Concomitant use with St John's Wort (Hypericum Perforatum).

Non-inclusion criteria to R-HDC:

Patients with insufficient metastatic response at the end of induction SIOPEN score > 3 or

less than 50% reduction in mIBG score or > 3 bone lesions or less 50% reduction in number

of FDG-PET-avid bone lesions for mIBG-non avid tumours, will not be eligible for RHDC

Studien-Rationale

Primary outcome:

1. Event free survival (EFS) (Time Frame - Assessed at each end of randomization sequences up to one year):
Event free survival

Studien-Arme

  • Experimental: phase induction-R-I
    R-I: induction regimens RAPID COJEC vs GPOH Assuming a baseline 3-year EFS of 40%, with a sample size of 686 patients (343 in each arm) and a two-sided alpha=5% this trial will have 90% power to demonstrate an improvement of 12% in 3-year EFS, within a recruitment period of 3 years and a minimum follow up of 1.5 years.
  • Experimental: Phase high dose chemotherapy consolidation
    R-HDC: consolidation regimen Bu-Mel vs Thiotepa + Bu-Mel The 3-year EFS in the Bu-Mel arm (with immunotherapy) is estimated to be 55%. This study aims to show an improvement of 12% for the Thiotepa + Bu-Mel arm (3-year EFS of 67%). With a recruitment of 448 patients (224 in each arm) over a period of 3 years and a minimum follow-up of 2 years, the power to show a 12% difference is 80% (two-sided logrank test and α=5%).
  • Experimental: Phase of radiotherapy
    R-RTx: 21.6 Gy radiotherapy vs 21.6 Gy + 14.4 Gy boost in patients with macroscopic residual disease

Geprüfte Regime

  • Vincristine (L01CA02):
    1.5 mg/m^2 (max dose 2 mg)
  • Carboplatin (LO1XA02):
    750 mg/m^2
  • Etoposide (L01CB01):
    175 mg/m^2
  • Cyclophosphamide:
    1050 mg/m^2
  • Vindesine (L01CA03):
    3 mg/m^2/day (max dose 6 mg)
  • Dacarbazine (L01AX04):
    200 mg/m^2/day
  • Ifosfamide:
    1500 mg/m^2/day
  • Doxorubicin (L01DB01):
    30 mg/m^2/dose
  • Busulfan:
    < 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
  • Melphalan (L01AA03):
    140 mg/m^2/dose IV short infusion (15'), at least 24 h after the last busulfan dose
  • Thiotepa:
    300 mg/m^2/day over 2 hours
  • Radiotherapy:
    21.6 Gy 21.6 Gy + boost de 14.4 Gy
  • Dinutuximab Beta:
    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
  • Cisplatin:
    80 mg/m^2/24h
  • Temozolomide 100 MG (TEMIRI):
    100 mg/m²/Day from D0-D4
  • Irinotecan:
    50 mg/m²/jour de J0 à J4

Quelle: ClinicalTrials.gov


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

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