Neuroblastoma Clinical Trial
Official title:
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.
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.
;
Primary Purpose: Treatment
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