Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma

This study has been completed.
Sponsor:
Collaborator:
Children's Cancer and Leukaemia Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00025428
First received: October 11, 2001
Last updated: December 3, 2013
Last verified: November 2006
  Purpose

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.


Condition Intervention Phase
Neuroblastoma
Drug: carboplatin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: vincristine sulfate
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Treatment Of Children Over The Age Of 1 Year With Unresectable Localized Neuroblastoma Without MYCN Amplification

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival at 3 years [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2000
Study Completion Date: November 2013
Detailed 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.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025428

Locations
Austria
St. Anna Children's Hospital
Vienna, Austria, A-1090
Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium, B-9000
Denmark
Odense University Hospital
Odense, Denmark, DK-5000
France
Centre Hospitalier Regional de Purpan
Toulouse, France, 31026
Germany
Children's Hospital
Cologne, Germany, D-50924
Italy
Istituto Giannina Gaslini
Genoa, Italy, 16148
Norway
Rikshospitalet University Hospital
Oslo, Norway, 0027
Portugal
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.
Lisboa, Portugal, 1099-023 Codex
Spain
Hospital Universitario LA FE
Valencia, Spain, 46009
Sweden
Ostra Sjukhuset
Gothenburg, Sweden, 41685
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
United Kingdom
Southampton University Hospital NHS Trust
Southampton, England, United Kingdom, SO16 6YD
Sponsors and Collaborators
Societe Internationale d'Oncologie Pediatrique
Children's Cancer and Leukaemia Group
Investigators
Study Chair: Janice A. Kohler, MD, FRCP University Hospital Southampton NHS Foundation Trust.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00025428     History of Changes
Other Study ID Numbers: CDR0000068960, SIOP-NB-2009, CCLG-NB-2000-09, EU-20107
Study First Received: October 11, 2001
Last Updated: December 3, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized unresectable neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Cyclophosphamide
Doxorubicin
Etoposide
Vincristine
Carboplatin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on April 23, 2014