Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma
- Evaluate the safety and efficacy of surgical treatment alone in young patients with
stage 2 neuroblastoma without N-myc amplification (NMA).
- Determine predictive factors of relapse and survival of patients with stage 1, 2A, or
2B neuroblastoma without NMA who have undergone surgery only.
OUTLINE: This is a nonrandomized, multicenter study.
Patients with stage 1 or 2 disease and no N-myc amplification (NMA) undergo observation
comprising clinical evaluation, ultrasound or CT scan of the abdomen, and chest x-ray
periodically for up to 5 years. All other patients undergo additional therapy and follow-up
according to national standards. Patients who develop recurrent disease or disease
progression may undergo surgical resection, preceded or followed by chemotherapy, according
to national standards.
PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.
Allocation: Non-Randomized, Primary Purpose: Supportive Care
Safety and efficacy
Bruno De Bernardi, MD
Istituto Giannina Gaslini
United States: Federal Government