Trial Information

Randomized Study of Radiotherapy in Patients With Stage 2B/3 (INSS) Neuroblastoma in Children Over 1 Year of Age

OBJECTIVES:

- Compare the local control and event-free and overall survival of young patients with
stage IIB and III neuroblastoma treated with neoadjuvant combination chemotherapy
followed by surgery with vs without radiotherapy.

- Determine the toxic effects of these regimen in these patients.

OUTLINE: This is a multicenter, randomized study.

- Induction combination chemotherapy: Patients receive vincristine IV and
cyclophosphamide IV on day 1. Patients also receive cisplatin IV continuously over 24
hours on day 1 and etoposide IV over 4 hours on day 2 during courses 1, 3, and 5 and
carboplatin IV over 1 hour and etoposide IV over 4 hours on day 1 during courses 2 and
4. Treatment repeats every 21 days for 5 courses in the absence of disease progression
or unacceptable toxicity. Patients then proceed to surgery unless complete resection
was done during initial staging and complete response was maintained.

- Surgery: Patients undergo biopsy or surgical resection of the tumor 2-3 weeks after
completion of induction combination chemotherapy.

- Post-surgical treatment: Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive two additional courses of combination chemotherapy
comprising vincristine, cisplatin, etoposide, and cyclophosphamide in course 6 and
vincristine, carboplatin, etoposide, and cyclophosphamide in course 7.

- Arm II: Patients undergo radiotherapy 2-4 weeks after surgery. Beginning 3 weeks
after completion of radiotherapy, patients receive chemotherapy as in arm I After
completion of study treatment, patients are evaluated periodically.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.