Study for the low and intermediate risk of Neuroblastoma

European Low and Intermediate Risk Neuroblastoma - LINES

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021396-81-AT

Enrollment

685

Registered

2012-05-09

Start date

2012-06-20

Completion date

Unknown

Last updated

2025-02-17

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

Conditions

INTERMEDIATE AND LOW RISK NEUROBLASTOMA

Interventions

Product Name: Carboplatin Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Carboplatin CAS Number: 41575-94-4 Other descriptive name: Carboplatin Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The inclusion criteria depend on the subgroup that the patient is assigned to and can be found in the protocol Are the trial subjects under 18? yes Number of subjects for this age range: 685 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: The exclusion criteria depend on the subgroup that the patient is assigned to and can be found in the protocol

Design outcomes

Primary

Measure	Time frame
Main Objective: - To demonstrate through a randomisation between observation and chemotherapy that you can safely reduce treatment in a subgroup of low riks patients by giving less treatment than has been given historically while maintaining an excellent overall survival of 100%. Randomisation was closed in 2017 following IDMC recommendations - To improve the event-free survival to 70% with an overall survival of 90% of intermediate risk neuroblastoma patients with poorly differentiated or uindifferentiated tumour histology by the addition of radiotherapy and 13-cis RA compared to historical conventional therapy (study registry) - To maintain a 3-year event free survival over 80%, with a non-operative therapeutic approach (serial monitoring, surgery if warranted) in infants with a localised suprarenal mass disconvered ante or neonatally (study register);Secondary Objective: The secondary objectives of this study registry depend on the risk group the patient has been assigned to and can be found in detail in the synopsis ;Primary end point(s): EFS event free survival. Time from the date of diagnosis to the date of the first event, that is Progression of disease, relapse or death.;Timepoint(s) of evaluation of this end point: 1 year EFS . 2 years EFS. 3 years EFS. Depending of the subgroup of study.	—

Measure

Time frame

Main Objective: - To demonstrate through a randomisation between observation and chemotherapy that you can safely reduce treatment in a subgroup of low riks patients by giving less treatment than has been given historically while maintaining an excellent overall survival of 100%. Randomisation was closed in 2017 following IDMC recommendations - To improve the event-free survival to 70% with an overall survival of 90% of intermediate risk neuroblastoma patients with poorly differentiated or uindifferentiated tumour histology by the addition of radiotherapy and 13-cis RA compared to historical conventional therapy (study registry) - To maintain a 3-year event free survival over 80%, with a non-operative therapeutic approach (serial monitoring, surgery if warranted) in infants with a localised suprarenal mass disconvered ante or neonatally (study register);Secondary Objective: The secondary objectives of this study registry depend on the risk group the patient has been assigned to and can be found in detail in the synopsis ;Primary end point(s): EFS event free survival. Time from the date of diagnosis to the date of the first event, that is Progression of disease, relapse or death.;Timepoint(s) of evaluation of this end point: 1 year EFS . 2 years EFS. 3 years EFS. Depending of the subgroup of study.

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Secondary

Measure	Time frame
Secondary end point(s): Evaluate the tumour genomic profile and its correlation with patient outcome.;Timepoint(s) of evaluation of this end point: 5 years.	—

Countries

Austria, Belgium, Denmark, France, Greece, Ireland, Italy, Lithuania, Norway, Portugal, Spain, Sweden

Contacts

Public ContactRuth Ladenstein

St. Anna Kinderkrebsforschung

ruth.ladenstein@ccri.at43140470 4750

Outcome results

None listed

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