Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma

Treatment Of Children Over The Age Of 1 Year With Unresectable Localized Neuroblastoma Without MYCN Amplification

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.

Study Overview

• Status: Completed
• Conditions: Neuroblastoma
• Intervention / Treatment: Drug: carboplatin; Drug: cyclophosphamide; Drug: etoposide; Drug: vincristine sulfate; Procedure: adjuvant therapy; Procedure: neoadjuvant therapy; Drug: doxorubicin hydrochloride; Procedure: conventional surgery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, A-1090
    • St. Anna Children's Hospital
• Belgium
  • Ghent, Belgium, B-9000
    • Universitair Ziekenhuis Gent
• Denmark
  • Odense, Denmark, DK-5000
    • Odense University Hospital
• France
  • Toulouse, France, 31026
    • Centre Hospitalier Regional de Purpan
• Germany
  • Cologne, Germany, D-50924
    • Children's Hospital
• Italy
  • Genoa, Italy, 16148
    • Istituto Giannina Gaslini
• Norway
  • Oslo, Norway, 0027
    • Rikshospitalet University Hospital
• Portugal
  • Lisboa, Portugal, 1099-023 Codex
    • Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.
• Spain
  • Valencia, Spain, 46009
    • Hospital Universitario La Fe
• Sweden
  • Gothenburg, Sweden, 41685
    • Östra Sjukhuset
• Switzerland
  • Lausanne, Switzerland, CH-1011
    • Centre Hospitalier Universitaire Vaudois
• United Kingdom
  • England
    • Southampton, England, United Kingdom, SO16 6YD
      • Southampton University Hospital NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Event-free survival at 3 years

Collaborators and Investigators

• Sponsor: Societe Internationale d'Oncologie Pediatrique
• Collaborators: Children's Cancer and Leukaemia Group
• Investigators: Study Chair: Janice A. Kohler, MD, FRCP, University Hospital Southampton NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: December 1, 2000
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: October 11, 2001
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): December 4, 2013
• Last Update Submitted That Met QC Criteria: December 3, 2013
• Last Verified: November 1, 2006

More Information

Terms related to this study

• Keywords: localized unresectable neuroblastoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive; Neuroectodermal Tumors, Primitive, Peripheral; Neuroblastoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Carboplatin; Etoposide; Doxorubicin; Liposomal doxorubicin; Vincristine
• Other Study ID Numbers: CDR0000068960; SIOP-NB-2009; CCLG-NB-2000-09; EU-20107