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Spots Global Cancer Trial Database for Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma

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Trial Identification

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

Conditions

Neuroblastoma

Study Description

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.

Eligibility

Minimum Age: 1 Year

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Janice A. Kohler, MD, FRCP

Affiliation: University Hospital Southampton NHS Foundation Trust

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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