Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma

Societe Internationale d'Oncologie Pediatrique

Status and phase: Completed; Phase 3

Conditions: Neuroblastoma

Treatments: Procedure: conventional surgery; Procedure: adjuvant therapy; Drug: etoposide; Drug: doxorubicin hydrochloride; Drug: vincristine sulfate; Drug: cyclophosphamide; Drug: carboplatin; Procedure: neoadjuvant therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00025428

SIOP-NB-2009

EU-20107

CCLG-NB-2000-09

CDR0000068960

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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