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Combination Chemotherapy Followed by Stem Cell Transplant in High-risk Neuroblastoma Patients

NCT03042429 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2017-02-06

No results posted yet for this study

Summary

Improvement of event free survival of high-risk neuroblastoma patients by introduction of two additional topotecan containing chemotherapy cycles into the multimodal standard treatment (induction chemotherapy, myeloablative therapy, radiation, surgery as indicated, and consolidation therapy).

Conditions

Interventions

DRUG

Cycles N8, N5 and N6

two chemotherapy cycles N8 followed by standard arm therapy

DRUG

Cycles N5 and N6

Standard arm six chemotherapy cycles (3xN5 and 3x N6) followed by myeloablative therapy with stem cell support and isotretinoin

Sponsors & Collaborators

  • University of Cologne

    lead OTHER

Principal Investigators

  • Frank Berthold, Prof. · University of Cologne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
6 Months
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-01
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT03042429 on ClinicalTrials.gov