Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma

Treatment Of Children Over The Age Of 1 Year With Unresectable Localized Neuroblastoma Without MYCN Amplification

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00025428

Enrollment

100

Registered

2003-01-27

Start date

2000-12-31

Completion date

2013-11-30

Last updated

2013-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroblastoma

Keywords

localized unresectable neuroblastoma

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.

Interventions

DRUGcarboplatin

DRUGcyclophosphamide

DRUGdoxorubicin hydrochloride

DRUGetoposide

DRUGvincristine sulfate

PROCEDUREadjuvant therapy

PROCEDUREconventional surgery

PROCEDUREneoadjuvant therapy

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * 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

Design outcomes

Primary

Measure	Time frame
Event-free survival at 3 years	—

Countries

Austria, Belgium, Denmark, France, Germany, Italy, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026