Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma
NCT ID: NCT00025428
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2000-12-31
2013-11-30
Brief Summary
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PURPOSE: Phase III trial to determine the effectiveness of combination chemotherapy given before surgery in treating children who have localized neuroblastoma.
Detailed Description
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* 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
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Keywords
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Study Design
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TREATMENT
Interventions
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carboplatin
cyclophosphamide
doxorubicin hydrochloride
etoposide
vincristine sulfate
adjuvant therapy
conventional surgery
neoadjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of localized unresectable neuroblastoma
* Stage II or III
* No MYCN amplification
PATIENT CHARACTERISTICS:
Age:
* Over 1
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy
Surgery:
* Not specified
1 Year
18 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Societe Internationale d'Oncologie Pediatrique
OTHER
Principal Investigators
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Janice A. Kohler, MD, FRCP
Role: STUDY_CHAIR
University Hospital Southampton NHS Foundation Trust
Locations
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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.
Lisbon, , 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
Countries
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Other Identifiers
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SIOP-NB-2009
Identifier Type: -
Identifier Source: secondary_id
CCLG-NB-2000-09
Identifier Type: -
Identifier Source: secondary_id
EU-20107
Identifier Type: -
Identifier Source: secondary_id
CDR0000068960
Identifier Type: -
Identifier Source: org_study_id