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Brief Title: Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma
Official Title: Treatment Of Children Over The Age Of 1 Year With Unresectable Localized Neuroblastoma Without MYCN Amplification
Study ID: NCT00025428
Brief 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.
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.
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
St. Anna Children's Hospital, Vienna, , Austria
Universitair Ziekenhuis Gent, Ghent, , Belgium
Odense University Hospital, Odense, , Denmark
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., Lisboa, , Portugal
Hospital Universitario LA FE, Valencia, , Spain
Ostra Sjukhuset, Gothenburg, , Sweden
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Southampton University Hospital NHS Trust, Southampton, England, United Kingdom
Name: Janice A. Kohler, MD, FRCP
Affiliation: University Hospital Southampton NHS Foundation Trust
Role: STUDY_CHAIR