NCT00025428

Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma

Treatment Of Children Over The Age Of 1 Year With Unresectable Localized Neuroblastoma Without MYCN Amplification

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Societe Internationale d'Oncologie Pediatrique · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuroblastoma

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	cyclophosphamide
DRUG	doxorubicin hydrochloride
DRUG	etoposide
DRUG	vincristine sulfate
PROCEDURE	adjuvant therapy
PROCEDURE	conventional surgery
PROCEDURE	neoadjuvant therapy

Timeline

• Start date: 2000-12-01
• Completion: 2013-11-01
• First posted: 2003-01-27
• Last updated: 2013-12-04

Locations

12 sites across 12 countries: Austria, Belgium, Denmark, France, Germany, Italy, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom