We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Trial
Coordinator
HighRisk-NBL2@trials.bham.ac.uk
Dr
Martin
Elliiott
martin.elliott1@nhs.net
Malignant neoplasms of thyroid and other endocrine glands
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
High-risk neuroblastoma (HR-NBL). remains one of the areas of unmet need in childhood cancer, as despite improvements in survival, current treatment strategies only cure 40% of patients.
The SIOPEN High-Risk Neuroblastoma 2 (HR-NBL2) trial is a pan-European phase 3 randomised clinical trial that aims to improve the outcome of children with HR-NBL It will seek to improve the upfront treatment of this population of children by comparing i) 2 different induction chemotherapy regimens ii) intensifying high dose chemotherapy iii) increasing radiotherapy dose in children with residual disease following surgery.
The HR-NBL2 trial has 3 primary aims:
• Induction chemotherapy : The trial is looking to compare 2 well established induction chemotherapy regimens to find out if either provides better outcomes, including survival and to compare the side effect profile of the regimens.
• Consolidation chemotherapy : The trial is looking to find out if two courses of high dose chemotherapy (HDC) each followed by a separate stem cell transplant results in better outcomes than the standard single course of high dose chemotherapy and single stem cell transplant, as consolidation therapy.
• Radiotherapy: The trial will compare the standard dose of radiation to the standard dose plus an additional boost dose targeted to the residual tumour. Outcomes including survival will be compared.
The study will recruit 800 patients with high-risk neuroblastoma internationally over
a 5-year period with an estimated 206 from the UK. All eligible HR-NBL patients will be able to enter the trial and the will be offered to participate in the three randomised aspects of treatment. The primary endpoint will be 3-year event free survival (EFS) from the time of each randomisation. Secondary end points will include Overall Survival and treatment related toxicity and morbidity.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;Radiotherapy;Imaging;Management of Care;Active Monitoring;
You can take part if:
You may not be able to take part if:
Induction chemotherapy: 1) Urinary outflow obstruction 2) Severe arrhythmia, heart failure, previous cardiac infarct, acute inflammatory heart disease 3) Severe peripheral neuropathy 4) Demyelinating form of Charcot-Marie-Tooth syndrome 5) Hearing impairment 6) Concurrent prophylactic use of phenytoin 7) Cardiorespiratory disease that contraindicates hyperhydration All randomisations: 1) Any negative answer concerning the inclusion criteria of the randomisation will render the patient ineligible for the corresponding therapy phase randomisation. However, these patients may remain on study for data collection 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). 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 to discuss feasibility. 4) Dyspnea at rest and/or pulse oximetry < 95% in the air 5) Any uncontrolled intercurrent illness or infection that in the investigator opinion would impair study participation 6) Participating in another clinical study with an IMP while on study treatment 7) Concomitant use with yellow fever vaccine and with live virus or bacterial vaccines 8) Patient allergic to peanut or soya 9) Chronic inflammatory bowel disease and/or bowel obstruction 10) Pregnant or breastfeeding women 11) Known hypersensitivity to the active substance or to any of the excipients of study drugs known 12) Concomitant use with St John’s Wort (Hypericum Perforatum)
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by INSTITUT GUSTAVE ROUSSY (France) and funded by Solving Kids' Cancer UK .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 46671
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
