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Evaluation of 2 Intensification Treatment Strategies for Neuroblastoma Patients With a Poor Response to Induction

NCT03165292 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-09-02

No results posted yet for this study

Summary

The main objective is to evaluate the efficacy of two intensified consolidation strategies in very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from randomisation date. This evaluation will follow a hierarchical testing procedure: each experimental treatment will be first evaluated as a single-arm phase 2 study, and in case of positive conclusion, the relative efficacy of both arms will then be evaluated comparatively.

Conditions

  • Very High Risk Neuroblastoma

Interventions

RADIATION

mIBG

Day 1 131I-mIBG course 1: about 444MBq/kg with in vivo whole-body dosimetry Day 15 131I-mIBG course 2: the target is to deliver a combined whole-body radiation dose of 4 Gy

DRUG

Topotecan

Day 1-5 Topotecan 0.7 mg/m2 daily Day 15-19 Topotecan 0.7 mg/m2 daily

DRUG

Thiotepa

Day 1-3 Thiotepa

PROCEDURE

Autologous stem cell transplant

ASCT as soon as radiation level allows it in ARM A

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Principal Investigators

  • Dominique Valteau-Couanet, MD, PhD · Gustave roussy Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2023-08-28
Completion
2024-03-28

Countries

  • Austria
  • France
  • Italy
  • Netherlands
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03165292 on ClinicalTrials.gov