Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma

Phase 3

Completed

• Conditions: Neuroblastoma

• Registration Number: NCT00025428
• Lead Sponsor: Societe Internationale d'Oncologie Pediatrique

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.

Study Timeline

• Study Start: 2000-12
• Study First Submitted: 2001-10-11
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2006-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event-free survival at 3 years

Trial Locations

Locations (12)

Odense University Hospital; 🇩🇰 Odense, Denmark

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

St. Anna Children's Hospital; 🇦🇹 Vienna, Austria

Universitair Ziekenhuis Gent; 🇧🇪 Ghent, Belgium

Centre Hospitalier Regional de Purpan; 🇫🇷 Toulouse, France

Children's Hospital; 🇩🇪 Cologne, Germany

Hospital Universitario LA FE; 🇪🇸 Valencia, Spain

Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.; 🇵🇹 Lisboa, Portugal

Istituto Giannina Gaslini; 🇮🇹 Genoa, Italy

Rikshospitalet University Hospital; 🇳🇴 Oslo, Norway

Ostra Sjukhuset; 🇸🇪 Gothenburg, Sweden

Southampton University Hospital NHS Trust; 🇬🇧 Southampton, England, United Kingdom