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| Tracking Information | |||||||||
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| First Received Date ICMJE | October 11, 2001 | ||||||||
| Last Updated Date | February 6, 2009 | ||||||||
| Start Date ICMJE | December 2000 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Event-free survival at 3 years [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Event-free survival at 3 years | ||||||||
| Change History | Complete list of historical versions of study NCT00025428 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma | ||||||||
| Official Title ICMJE | Treatment Of Children Over The Age Of 1 Year With Unresectable Localized Neuroblastoma Without MYCN Amplification | ||||||||
| 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. |
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| Detailed Description | OBJECTIVES:
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. |
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| Study Phase | Phase III | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment | ||||||||
| Condition ICMJE | Neuroblastoma | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Gender | Both | ||||||||
| Ages | 1 Year to 18 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Austria, Belgium, Denmark, France, Germany, Italy, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00025428 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | CDR0000068960, SIOP-NB-2009, CCLG-NB-2000-09, EU-20107 | ||||||||
| Study Sponsor ICMJE | Societe Internationale d'Oncologie Pediatrique | ||||||||
| Collaborators ICMJE | Children's Cancer and Leukaemia Group | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | November 2006 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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