Prospective multicenter clinical trial for risk estimation and treatment stratification in low and intermediate risk neuroblastoma patients (NB2015-LR)

Prospective multicenter clinical trial for risk estimation and treatment stratification in low and intermediate risk neuroblastoma patients (NB2015-LR) - NB2015-LR

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004883-37-DE

Enrollment

280

Registered

2020-09-09

Start date

2021-05-12

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroblastoma, low or intermediate risk MedDRA version: 20.0 Level: PT Classification code 10029260 Term: Neuroblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: BUSULFAN CAS Number: 55-98-1 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: CARBOPLATI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Neuroblastoma diagnosed according to the INSS criteria • MYCN not amplified • Localized neuroblastoma INRGSS stage L1 or L2 / INSS stage 1-3 and age =18 months –and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Participation in other trials, which might interfere with NB2015-LR • Pregnancy, lactation, or insufficient contraception for girls in childbearing age, • Any concomitant non-protocol anticancer therapy, • Incomplete initial staging

Design outcomes

Primary

Measure	Time frame
Main Objective: Improvement of event free survival (EFS) of patients with intensified treatment and no impairment of EFS of patients with reduced treatment after treatment allocation by gene expression based risk stratification.;Secondary Objective: Implementation of a RNA expression based classifiere for the risk prediction of low- and intermediate risk neuroblastoma patients.;Primary end point(s): •Event-free survival (EFS): Time from diagnosis to event or last follow-up for patients without event; event is defined as death for all reasons, progression and relapse following previous complete remission or secondary malignant disease.;Timepoint(s) of evaluation of this end point: 3 years after the inclusion of the last patient	—

Measure

Time frame

Main Objective: Improvement of event free survival (EFS) of patients with intensified treatment and no impairment of EFS of patients with reduced treatment after treatment allocation by gene expression based risk stratification.;Secondary Objective: Implementation of a RNA expression based classifiere for the risk prediction of low- and intermediate risk neuroblastoma patients.;Primary end point(s): •Event-free survival (EFS): Time from diagnosis to event or last follow-up for patients without event; event is defined as death for all reasons, progression and relapse following previous complete remission or secondary malignant disease.;Timepoint(s) of evaluation of this end point: 3 years after the inclusion of the last patient

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Secondary

Measure	Time frame
Secondary end point(s): • Overall survival (OS): time from diagnosis to death for all reasons, • Impact of clinical and molecular markers, such as copy number alterations, telomere maintenance mechanisms, and somatic mutations on EFS and OS, • Incidence rates of toxic events, • Assessment of safety. ;Timepoint(s) of evaluation of this end point: 3 years after the inclusion of the last patient	—

Measure

Time frame

Secondary end point(s): • Overall survival (OS): time from diagnosis to death for all reasons, • Impact of clinical and molecular markers, such as copy number alterations, telomere maintenance mechanisms, and somatic mutations on EFS and OS, • Incidence rates of toxic events, • Assessment of safety. ;Timepoint(s) of evaluation of this end point: 3 years after the inclusion of the last patient

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Countries

Germany

Contacts

Public ContactNeuroblastom-Studienbüro

Children's Hospital, University of Cologne

neuroblastomstudie@uk-koeln.de+492214786853

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026