Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma
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.
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Treatment Of Children Over The Age Of 1 Year With Unresectable Localized Neuroblastoma Without MYCN Amplification|
- Event-free survival at 3 years [ Designated as safety issue: No ]
|Study Start Date:||December 2000|
|Study Completion Date:||November 2013|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025428
|St. Anna Children's Hospital|
|Vienna, Austria, A-1090|
|Universitair Ziekenhuis Gent|
|Ghent, Belgium, B-9000|
|Odense University Hospital|
|Odense, Denmark, DK-5000|
|Centre Hospitalier Regional de Purpan|
|Toulouse, France, 31026|
|Cologne, Germany, D-50924|
|Istituto Giannina Gaslini|
|Genoa, Italy, 16148|
|Rikshospitalet University Hospital|
|Oslo, Norway, 0027|
|Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.|
|Lisboa, Portugal, 1099-023 Codex|
|Hospital Universitario LA FE|
|Valencia, Spain, 46009|
|Gothenburg, Sweden, 41685|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Southampton University Hospital NHS Trust|
|Southampton, England, United Kingdom, SO16 6YD|
|Study Chair:||Janice A. Kohler, MD, FRCP||University Hospital Southampton NHS Foundation Trust|