Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Treatment | Closed | Over 1 | Other | SIOP-NB-2009 CCLG-NB-2000-09, EU-20107, NCT00025428 |
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.
Entry Criteria
Disease Characteristics:
Prior/Concurrent Therapy:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- Not specified
Patient Characteristics:
Age:
- Over 1
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Expected Enrollment
100A total of 100 patients will be accrued for this study within 4 years.
Outcomes
Primary Outcome(s)Event-free survival at 3 years
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.
Trial Lead Organizations
Societe Internationale d'Oncologie Pediatrique
 | | | |
| Janice Kohler, MD, FRCP, Protocol chair | |
| |
| |||
Children's Cancer and Leukaemia Group
| | | |
| Janice Kohler, MD, FRCP, Protocol chair | |
| |
| |||
| Registry Information | ||
| ||
| Official Title | Treatment Of Children Over The Age Of 1 Year With Unresectable Localized Neuroblastoma Without MYCN Amplification | |
| ||
| Trial Start Date | 2000-12-01 | |
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| Registered in ClinicalTrials.gov | NCT00025428 | |
| ||
| Date Submitted to PDQ | 2001-07-17 | |
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| Information Last Verified | 2006-11-26 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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