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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04221035


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT04221035
Ethics application status
Date submitted
6/01/2020
Date registered
9/01/2020
Date last updated
16/05/2024

Titles & IDs
Public title
High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)
Scientific title
High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)
Secondary ID [1] 0 0
2019/2894
Secondary ID [2] 0 0
2019-001068-31
Universal Trial Number (UTN)
Trial acronym
HR-NBL2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High-Risk Neuroblastoma 0 0
Patient With Insufficient Response Chemoimmunotherapy 0 0
Condition category
Condition code
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Children's - Other

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vincristine
Treatment: Drugs - Carboplatin
Treatment: Drugs - Etoposide
Treatment: Drugs - Vindesine
Treatment: Drugs - Dacarbazine
Treatment: Drugs - Ifosfamide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Busulfan
Treatment: Drugs - Melphalan
Treatment: Drugs - Thiotepa
Treatment: Other - Radiotherapy
Treatment: Drugs - Dinutuximab Beta
Treatment: Drugs - Cisplatin
Treatment: Drugs - Temozolomide 100 MG
Treatment: Drugs - Irinotecan
Treatment: Drugs - Cyclophosphamid

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.
Patients with insufficient metastatic response at the end of induction chemotherapy, defined as 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), have a poorer prognosis.
Chemoimmunotherapy arm Metastatic response rate after 4 courses of irinotecan-temozolomide (TEMIRI) combined with dinutuximab beta (DB) in patients with insufficient metastatic response at the end of induction chemotherapy (TEMIRI/DB).

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 a=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


Treatment: Drugs: Vincristine
1.5 mg/m2 (max dose 2 mg)

Treatment: Drugs: Carboplatin
750 mg/m2

Treatment: Drugs: Etoposide
175 mg/m2

Treatment: Drugs: Vindesine
3 mg/m2/day (max dose 6 mg)

Treatment: Drugs: Dacarbazine
200 mg/m2/day

Treatment: Drugs: Ifosfamide
1500 mg/m2/day

Treatment: Drugs: Doxorubicin
30 mg/m2/dose

Treatment: Drugs: 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

Treatment: Drugs: Melphalan
140 mg/m2/dose IV short infusion (15'), at least 24 h after the last busulfan dose

Treatment: Drugs: Thiotepa
300 mg/m2/day over 2 hours

Treatment: Other: Radiotherapy
21.6 Gy 21.6 Gy + boost de 14.4 Gy

Treatment: Drugs: 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

Treatment: Drugs: Cisplatin
80 mg/m2/24h

Treatment: Drugs: Temozolomide 100 MG
100 mg/m²/Day

Treatment: Drugs: Irinotecan
50 mg/m²/jour de J0 à J4

Treatment: Drugs: Cyclophosphamid
Cyclophosphamide has been demonstrated to have a cytostatic effect in many tumour types. The active metabolites of cyclophosphamide are alkylating agents which transfer alkyl groups to DNA during the process of cell division, thus preventing normal synthesis of DNA.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event free survival (EFS)
Timepoint [1] 0 0
Assessed at each end of randomization sequences up to one year

Eligibility
Key inclusion criteria
Enrollment in HR-NBL2 will be performed:

- 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

HR-NBL2 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 21 days after one cycle of Carboplatin-Etoposide
chemotherapy 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
low/intermediate risk neuroblastoma in Germany/Netherlands for patients with localized
neuroblastoma or infants with metastatic neuroblastoma with MYCN amplification

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 HR-NBL2 study 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"
(Appendix 11). Female patients who are lactating must agree to stop breast-feeding.

4. Written informed consent to enter the HR-NBL2 protocol 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

R-I eligibility criteria:

- Written informed consent to enter the R-I randomisation from patient or parents/legal
representative, patient, and age- appropriate assent.

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
before or within 3 weeks from the beginning of chemotherapy

R-HDC randomisation (Single HDC Bu-Mel/ Tandem HDC Thiotepa+Bu-Mel) Etoposide or one course
of the current protocol for low/intermediate risk neuroblastoma in Germany/Netherlands).
Patients will be treated with the standard induction regimen per country (Rapid COJEC or
GPOH) and will be potentially eligible for subsequent randomisations.

Randomisation for HDC strategy will be performed at the end of induction after the disease
evaluation and after surgery of the primary tumour 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 and no further treatment.

OR

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

2. Age < 21 years at the time of randomization

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

- 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

- Other metastatic sites: CR. (after induction chemotherapy +/- surgery), except
for distant lymph nodes for which PR is accepted with a possible secondary
surgery

4. Acceptable organ function and performance status:

- Performance status = 50%.

- Hematological status: ANC>0.5x109/L, platelets > 20x 109/L

- Cardiac function: (< grade 2)

- Normal chest X-Ray and oxygen saturation.

- Absence of any toxicity = grade 3. 4) Sufficient collected stem cells available;
a total harvest of at least 6 x 106/kg CD34+ cells, to be stored in at least 4
separate bags to administer at least 3 x 106/kg CD34+ cells per rescue.

5. Written informed consent, including agreement of patient or parents/legal guardian for
minors, to enter the R-HDC randomisation.

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, or insufficient stem cells, collection for tandem
HDC but with a minimum of 3 x 106 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 patients
will be eligible for the subsequent randomisation.

R-RTx randomisation (Local Radiotherapy) Chemoimmunotherapy arm

R-RTx eligibility criteria:

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 21,6-Gy
radiotherapy to the pre-operative tumour 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 >0.5x109/L, platelets > 20x109/L.

5. Written informed consent, including agreement of patient or parents/legal
guardian for minors, to enter the R-RTx randomisation.

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 randomisation, the patient will receive 21.6
Gy radiotherapy to the pre-operative tumour bed.

Chemoimmunotherapy arm eligibility criteria:

1. Insufficient metastatic response at the end of induction chemotherapy, defined as:

- 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) OR

- Bone marrow disease: SD according to International Neuroblastoma Response
Criteria OR

- Other metastatic sites: PR or SD. For distant lymph nodes: PR and not resectable
or SD.

2. Performance status = 50%.

3. Hematological status: ANC>0.75x109/L without G-CSF for at least 48 hours (or ANC =
0.50 x 109 /L in case of bone marrow involvement), platelets > 50x 109/L and rising,
without platelets transfusion for 72 hours.

4. AST or ALT =7.5 ULN and total bilirubin =1.5 ULN. In patients with liver metastases,
total bilirubin =2.5 ULN is allowed.

5. No active infection;

6. No grade >2 gastrointestinal toxicity.

7. No grade = 3 toxicity related to previous treatment.

8. Oxygen saturation > 94%

Non-inclusion criteria for HR-NBL2:

1. Any negative answer concerning the HR-NLB2 inclusion criteria

2. Patient under guardianship or deprived of his liberty by a judicial or administrative
decision or incapable of giving his consent.

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

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

5. Pregnant or breastfeeding women.

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

7. Concomitant self-medication medicine that in the investigator opinion could interact
with study treatments, including herbal medicine (e.g. St John's Wort (Hypericum
Perforatum).

Non-inclusion criteria specific to the R-I randomisation (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 randomisations (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 randomisation.
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 randomisations.

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/1.73m² (toxicity = grade
2). If GFR < 60ml/min/1.73m², call national principal investigator study coordinator
to discuss about the treatment.

4. Dyspnea at rest and/or pulse oximetry <95% in air (only for R-HDC, and R-RTx)

5. Any uncontrolled intercurrent illness or infection that in the investigator opinion
would impair study participation.

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

7. Patient allergic to peanut or soya.

Non-inclusion criteria to R-HDC:

- Any negative answer concerning the R-HDC inclusion criteria

Non-inclusion criteria to chemoimmunotherapy arm:

- Any negative answer concerning the inclusion criteria of chemoimmunotherapy arm.
Minimum age
No limit
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2032
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Randwic
Recruitment hospital [1] 0 0
Sydney children Hospital - Sydney
Recruitment hospital [2] 0 0
Children's Cancer Centre, Monash Children's Hospital - Clayton
Recruitment hospital [3] 0 0
Oncology/Haematology Department, Perth Children's Hospital - Nedlands
Recruitment hospital [4] 0 0
Children's Cancer & Haematology Services, John Hunter Children's Hospital - New Lambton Heights
Recruitment hospital [5] 0 0
Australian and New Zealand Children's Hematology/oncology Group - Sydney
Recruitment hospital [6] 0 0
sydney children Hospital - Sydney
Recruitment hospital [7] 0 0
Cancer Centre for Children, The Children's Hospital - Westmead
Recruitment postcode(s) [1] 0 0
NSW, 2031 - Sydney
Recruitment postcode(s) [2] 0 0
VIC 3168 - Clayton
Recruitment postcode(s) [3] 0 0
WA, 6009 - Nedlands
Recruitment postcode(s) [4] 0 0
NSW, 2305 - New Lambton Heights
Recruitment postcode(s) [5] 0 0
NSW, 2145, - Westmead
Recruitment outside Australia
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Belgium
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Brussels
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Belgium
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Brussel
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Leuven
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Odense
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Finland
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Kuopio
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Oulu
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Tampere
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Turku
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Clermont-Ferrand
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Dijon
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Grenoble
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Rennes
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Rouen
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Tours
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Berlin
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Köln
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Greece
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Athens
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Heraklion
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Greece
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Thessaloniki
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Israel
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Haifa
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Italy
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Bari
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Italy
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Brescia
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Catania
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Firenze
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Rimini
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Trieste
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Verona
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Lithuania
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Vilnius
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Netherlands
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Groningen
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Utrecht
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Haukeland
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Uppsala
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Aarau
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Basel
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Bellinzona
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Bern
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Switzerland
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Geneva
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Switzerland
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Lausanne
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Switzerland
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Lucerne
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Switzerland
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Saint Gallen
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Switzerland
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Zürich
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United Kingdom
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Aberdeen
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United Kingdom
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Belfast
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United Kingdom
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Birmingham
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United Kingdom
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Bristol
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United Kingdom
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Cambridge
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United Kingdom
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Cardiff
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United Kingdom
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Edinburgh
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United Kingdom
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Glasgow
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United Kingdom
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Leeds
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Newcastle
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United Kingdom
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Nottingham
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United Kingdom
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Sheffield
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United Kingdom
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Southampton
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United Kingdom
State/province [112] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Other
Name
Gustave Roussy, Cancer Campus, Grand Paris
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04221035
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Claudia Pasqualini, MD PhD
Address 0 0
Gustave roussy, Paris, France
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Claudia Pasqualini, MD PhD
Address 0 0
Country 0 0
Phone 0 0
+33 (0)1 42 11 42 11
Fax 0 0
Email 0 0
claudia.pasqualini@gustaveroussy.fr
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04221035

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
NSW,WA,VIC
Recruitment hospital [1] 76
Perth Children's Hospital
Recruitment hospital [2] 77
Monash Children’s Hospital
Recruitment hospital [3] 78
The Children's Hospital at Westmead
Recruitment hospital [4] 79
John Hunter Children's Hospital
Recruitment hospital [5] 80
Sydney Children's Hospital
Recruitment postcode(s) [1] 80
6009
Recruitment postcode(s) [2] 81
3168
Recruitment postcode(s) [3] 82
2145
Recruitment postcode(s) [4] 83
2305
Recruitment postcode(s) [5] 84
2031
Funding & Sponsors
Primary sponsor
Hospital
Primary sponsor name
Gustave Roussy
Primary sponsor address
114 Rue Edouard Vaillant
94 805 Villejuif
France
Primary sponsor country
France
Secondary sponsor category [1] 70
Other Collaborative groups
Name [1] 70
ANZCHOG
Address [1] 70
27-31 Wright Street Clayton, VIC, 3168
Country [1] 70
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 45
Hunter New England Human Research Ethics Committee
Address [1] 45
Research Ethics and Governance Unit Hunter New England Local Health District Lookout Road, New Lambton Heights, NSW, 2305
Country [1] 45
Australia
Date submitted for ethics approval [1] 45
16/12/2020
Approval date [1] 45
06/07/2021
Ethics approval number [1] 45
2020/ETH01048
 
Public notes

Contacts
Principal investigator
Title 321 0
Dr
Name 321 0
Toby Trahair
Address 321 0
Kids Cancer Centre, Sydney Children's Hospital, Level 1, High Street Randwick, NSW, 2031
Country 321 0
Australia
Phone 321 0
0293822970
Fax 321 0
Email 321 0
Contact person for public queries
Title 322 0
Dr
Name 322 0
Toby Trahair
Address 322 0
Kids Cancer Centre, Sydney Children's Hospital, Level 1, High Street Randwick, NSW, 2031
Country 322 0
Australia
Phone 322 0
0293822970
Fax 322 0
Email 322 0
Contact person for scientific queries
Title 323 0
Dr
Name 323 0
Toby Trahair
Address 323 0
Kids Cancer Centre, Sydney Children's Hospital, Level 1, High Street Randwick, NSW, 2031
Country 323 0
Australia
Phone 323 0
0293822970
Fax 323 0
Email 323 0