Response-based Treatment of High-risk Neuroblastoma

  • STATUS
    Recruiting
  • End date
    Mar 21, 2023
  • participants needed
    54
  • sponsor
    Samsung Medical Center
Updated on 21 January 2021

Summary

The purpose of this study is to improve outcome of high risk neuroblastoma by tailoring the treatment intensity of tandem high dose chemotherapy according to the treatment response to induction chemotherapy.

Description

Although the outcome of high-risk neuroblastoma improved after the introduction of high-dose chemotherapy and autologous stem cell transplantation (HDCT/autoSCT), the outcome still needs to be unsatisfactory.

In the investigator's previous study, good responders who had greater reduction of tumor volume after induction chemotherapy showed lower relapse-free survival compared to poor responders.Simultaneously, the reduction in tumor volume also was greater in patients who died of treatment related mortality than patients who had relapsed tumors. These findings suggest that tailoring treatment intensity according to the early tumor response to induction chemotherapy may improve patient outcomes. So, in this study investigators tailored the treatment intensity of high dose chemotherapy according to the treatment response to induction chemotherapy.

Details
Condition Newly Diagnosed High Risk Neuroblastoma
Treatment cyclophosphamide, cisplatin, etoposide, ifosfamide, carboplatin, isotretinoin, Radiotherapy, doxorubicin, Interleukin-2, Tandem HDCT/auto-SCT, MIBG, MIBG
Clinical Study IdentifierNCT02771743
SponsorSamsung Medical Center
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with newly diagnosed high risk neuroblastoma
Patients with informed consent

Exclusion Criteria

Patients with progressive disease or relapse
Patients who underwent high dose chemotherapy before
Patients with organ dysfunction as follows (creatinine elevation > 3 x upper limit of normal, Total bilirubin > 3 x upper limit of normal, aspartate transaminase/alanine transaminase > 5 x upper limit of normal), ejection fraction <40%
Pregnant or nursing women
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