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	Treatment or Intervention	Phase
localized unresectable neuroblastoma	Drug: carboplatin  Drug: cyclophosphamide  Drug: doxorubicin  Drug: etoposide  Drug: vincristine  Procedure: adjuvant therapy  Procedure: chemotherapy  Procedure: conventional surgery  Procedure: neoadjuvant therapy  Procedure: surgery	Phase III

Further Study Details: 

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.

Ages Eligible for Study:  1 Year   -   18 Years,  Genders Eligible for Study:  Both

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

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

Study chairs or principal investigators

Janice A. Kohler, MD, FRCP,  Study Chair,  Southampton General Hospital   
Janice A. Kohler, MD, FRCP,  Study Chair,  Southampton General Hospital   

Study ID Numbers:  CDR0000068960; SIOP-NB-2009; UKCCSG-NB-2000-09; EU-20107; NCT00025428
Record last reviewed:  September 2003
Last Updated:  March 3, 2005
Record first received:  October 11, 2001
ClinicalTrials.gov Identifier:  NCT00025428
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08