Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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

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
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussel
Country [3] 0 0
Belgium
State/province [3] 0 0
Gent
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
Belgium
State/province [5] 0 0
Liège
Country [6] 0 0
Czechia
State/province [6] 0 0
Prague
Country [7] 0 0
Czechia
State/province [7] 0 0
Brno
Country [8] 0 0
Denmark
State/province [8] 0 0
Aarhus
Country [9] 0 0
Denmark
State/province [9] 0 0
Copenhagen
Country [10] 0 0
Denmark
State/province [10] 0 0
Odense
Country [11] 0 0
Finland
State/province [11] 0 0
Helsinki
Country [12] 0 0
Finland
State/province [12] 0 0
Kuopio
Country [13] 0 0
Finland
State/province [13] 0 0
Oulu
Country [14] 0 0
Finland
State/province [14] 0 0
Tampere
Country [15] 0 0
Finland
State/province [15] 0 0
Turku
Country [16] 0 0
France
State/province [16] 0 0
Val De Marne
Country [17] 0 0
France
State/province [17] 0 0
Amiens
Country [18] 0 0
France
State/province [18] 0 0
Angers
Country [19] 0 0
France
State/province [19] 0 0
Besançon
Country [20] 0 0
France
State/province [20] 0 0
Bordeaux
Country [21] 0 0
France
State/province [21] 0 0
Brest
Country [22] 0 0
France
State/province [22] 0 0
Caen
Country [23] 0 0
France
State/province [23] 0 0
Clermont-Ferrand
Country [24] 0 0
France
State/province [24] 0 0
Dijon
Country [25] 0 0
France
State/province [25] 0 0
Grenoble
Country [26] 0 0
France
State/province [26] 0 0
La Réunion
Country [27] 0 0
France
State/province [27] 0 0
Lille
Country [28] 0 0
France
State/province [28] 0 0
Limoges
Country [29] 0 0
France
State/province [29] 0 0
Lyon
Country [30] 0 0
France
State/province [30] 0 0
Marseille
Country [31] 0 0
France
State/province [31] 0 0
Nancy
Country [32] 0 0
France
State/province [32] 0 0
Nice
Country [33] 0 0
France
State/province [33] 0 0
Paris
Country [34] 0 0
France
State/province [34] 0 0
Poitiers
Country [35] 0 0
France
State/province [35] 0 0
Reims
Country [36] 0 0
France
State/province [36] 0 0
Rennes
Country [37] 0 0
France
State/province [37] 0 0
Rouen
Country [38] 0 0
France
State/province [38] 0 0
Saint-Herblain
Country [39] 0 0
France
State/province [39] 0 0
Saint-Étienne
Country [40] 0 0
France
State/province [40] 0 0
Strasbourg
Country [41] 0 0
France
State/province [41] 0 0
Toulouse
Country [42] 0 0
France
State/province [42] 0 0
Tours
Country [43] 0 0
Germany
State/province [43] 0 0
Berlin
Country [44] 0 0
Germany
State/province [44] 0 0
Köln
Country [45] 0 0
Greece
State/province [45] 0 0
Athens
Country [46] 0 0
Greece
State/province [46] 0 0
Heraklion
Country [47] 0 0
Greece
State/province [47] 0 0
Thessaloniki
Country [48] 0 0
Israel
State/province [48] 0 0
Haifa
Country [49] 0 0
Italy
State/province [49] 0 0
Bari
Country [50] 0 0
Italy
State/province [50] 0 0
Brescia
Country [51] 0 0
Italy
State/province [51] 0 0
Catania
Country [52] 0 0
Italy
State/province [52] 0 0
Firenze
Country [53] 0 0
Italy
State/province [53] 0 0
Genova
Country [54] 0 0
Italy
State/province [54] 0 0
Modena
Country [55] 0 0
Italy
State/province [55] 0 0
Parma
Country [56] 0 0
Italy
State/province [56] 0 0
Pavia
Country [57] 0 0
Italy
State/province [57] 0 0
Rimini
Country [58] 0 0
Italy
State/province [58] 0 0
Trieste
Country [59] 0 0
Italy
State/province [59] 0 0
Verona
Country [60] 0 0
Lithuania
State/province [60] 0 0
Vilnius
Country [61] 0 0
Netherlands
State/province [61] 0 0
Groningen
Country [62] 0 0
Netherlands
State/province [62] 0 0
Utrecht
Country [63] 0 0
Norway
State/province [63] 0 0
Haukeland
Country [64] 0 0
Norway
State/province [64] 0 0
Oslo
Country [65] 0 0
Norway
State/province [65] 0 0
Tromsø
Country [66] 0 0
Norway
State/province [66] 0 0
Trondheim
Country [67] 0 0
Slovakia
State/province [67] 0 0
Banská Bystrica
Country [68] 0 0
Slovakia
State/province [68] 0 0
Bratislava
Country [69] 0 0
Slovakia
State/province [69] 0 0
Košice
Country [70] 0 0
Slovenia
State/province [70] 0 0
Ljubljana
Country [71] 0 0
Spain
State/province [71] 0 0
Balea
Country [72] 0 0
Spain
State/province [72] 0 0
Barcelona
Country [73] 0 0
Spain
State/province [73] 0 0
Cruces
Country [74] 0 0
Spain
State/province [74] 0 0
El Palmar
Country [75] 0 0
Spain
State/province [75] 0 0
Madrid
Country [76] 0 0
Spain
State/province [76] 0 0
Málaga
Country [77] 0 0
Spain
State/province [77] 0 0
San Sebastián
Country [78] 0 0
Spain
State/province [78] 0 0
Santiago De Compostela
Country [79] 0 0
Spain
State/province [79] 0 0
Sevilla
Country [80] 0 0
Spain
State/province [80] 0 0
Valence
Country [81] 0 0
Sweden
State/province [81] 0 0
Gothenburg
Country [82] 0 0
Sweden
State/province [82] 0 0
Linköping
Country [83] 0 0
Sweden
State/province [83] 0 0
Lund
Country [84] 0 0
Sweden
State/province [84] 0 0
Stockholm
Country [85] 0 0
Sweden
State/province [85] 0 0
Umeå
Country [86] 0 0
Sweden
State/province [86] 0 0
Uppsala
Country [87] 0 0
Switzerland
State/province [87] 0 0
Aarau
Country [88] 0 0
Switzerland
State/province [88] 0 0
Basel
Country [89] 0 0
Switzerland
State/province [89] 0 0
Bellinzona
Country [90] 0 0
Switzerland
State/province [90] 0 0
Bern
Country [91] 0 0
Switzerland
State/province [91] 0 0
Geneva
Country [92] 0 0
Switzerland
State/province [92] 0 0
Lausanne
Country [93] 0 0
Switzerland
State/province [93] 0 0
Lucerne
Country [94] 0 0
Switzerland
State/province [94] 0 0
Saint Gallen
Country [95] 0 0
Switzerland
State/province [95] 0 0
Zürich
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Aberdeen
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Belfast
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Birmingham
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Bristol
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Cambridge
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Cardiff
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Edinburgh
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Glasgow
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Leeds
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Liverpool
Country [106] 0 0
United Kingdom
State/province [106] 0 0
London
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Manchester
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Newcastle
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Nottingham
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Sheffield
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Southampton
Country [112] 0 0
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
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?


Supporting document/s available: Study protocol, Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/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