Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma

Last updated: December 3, 2013
Sponsor: Societe Internationale d'Oncologie Pediatrique
Overall Status: Completed

Phase

3

Condition

Neuroblastoma

Treatment

N/A

Clinical Study ID

NCT00025428
CDR0000068960
CCLG-NB-2000-09
EU-20107
SIOP-NB-2009
  • Ages 1-18
  • All Genders

Study Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase III trial to determine the effectiveness of combination chemotherapy given before surgery in treating children who have localized neuroblastoma.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:

  • Diagnosis of localized unresectable neuroblastoma

  • Stage II or III

  • No MYCN amplification

PATIENT CHARACTERISTICS:

Age:

  • Over 1

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • Not specified

Study Design

Total Participants: 100
Study Start date:
December 01, 2000
Estimated Completion Date:
November 30, 2013

Study Description

OBJECTIVES:

  • Determine the outcome, in terms of local control, event-free survival, and overall survival, of children with localized unresectable neuroblastoma without MYCN amplification treated with carboplatin, etoposide, cyclophosphamide, doxorubicin, and vincristine followed by surgery.

OUTLINE: This is a multicenter study.

Patients receive carboplatin IV over 1 hour and etoposide IV over 2 hours on days 1-3 (courses 1 and 3). Patients receive cyclophosphamide IV over 1 hour on days 1-5 (or orally on days 2 and 3), doxorubicin IV over 6 hours on days 4-5, and vincristine IV on days 1 and 5 (courses 2 and 4). Treatment repeats every 21 days for 4 courses. Patients then undergo surgical resection followed by 2 additional courses of chemotherapy.

Patients are followed at months 8, 10, 12, 16, 20, 24, 30, 36, 42, 48, and 60.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 4 years.

Connect with a study center

  • St. Anna Children's Hospital

    Vienna, A-1090
    Austria

    Site Not Available

  • Universitair Ziekenhuis Gent

    Ghent, B-9000
    Belgium

    Site Not Available

  • Odense University Hospital

    Odense, DK-5000
    Denmark

    Site Not Available

  • Centre Hospitalier Regional de Purpan

    Toulouse, 31026
    France

    Site Not Available

  • Children's Hospital

    Cologne, D-50924
    Germany

    Site Not Available

  • Istituto Giannina Gaslini

    Genoa, 16148
    Italy

    Site Not Available

  • Rikshospitalet University Hospital

    Oslo, 0027
    Norway

    Site Not Available

  • Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.

    Lisboa, 1099-023 Codex
    Portugal

    Site Not Available

  • Hospital Universitario LA FE

    Valencia, 46009
    Spain

    Site Not Available

  • Ostra Sjukhuset

    Gothenburg, 41685
    Sweden

    Site Not Available

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011
    Switzerland

    Site Not Available

  • Southampton University Hospital NHS Trust

    Southampton, England SO16 6YD
    United Kingdom

    Site Not Available

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