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Phase III Study of Carboplatin, Etoposide, Cyclophosphamide, Doxorubicin, and Vincristine Followed By Surgery in Children With Localized Unresectable Neuroblastoma Without MYCN Amplification

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma

Basic Trial Information

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:

Diagnosis of localized unresectable neuroblastoma
- Stage II or III
- No MYCN amplification

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

100

A 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 Contact Information

Trial Lead Organizations

Societe Internationale d'Oncologie Pediatrique

Janice Kohler, MD, FRCP, Protocol chair
Ph: 44-23-8079-6942

Children's Cancer and Leukaemia Group

Janice Kohler, MD, FRCP, Protocol chair
Ph: 44-23-8079-6942

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

Registered in ClinicalTrials.gov		NCT00025428

Date Submitted to PDQ		2001-07-17

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.