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.
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
Purpose
TREATMENT
Enrollment
100
St. Anna Children's Hospital
Vienna, Austria
Universitair Ziekenhuis Gent
Ghent, Belgium
Odense University Hospital
Odense, Denmark
Event-free survival at 3 years
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Centre Hospitalier Regional de Purpan
Toulouse, France
Children's Hospital
Cologne, Germany
Istituto Giannina Gaslini
Genoa, Italy
Rikshospitalet University Hospital
Oslo, Norway
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.
Lisbon, Portugal
Hospital Universitario LA FE
Valencia, Spain
Ostra Sjukhuset
Gothenburg, Sweden
...and 2 more locations