Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma
- Evaluate the safety and efficacy of surgical treatment alone for stage II neuroblastoma
without N-myc amplification (NMA).
- Describe predictive factors of relapse and survival for stages I and II neuroblastoma
without NMA treated by surgery alone.
OUTLINE: Patients with localized resectable tumors undergo surgery. Postoperative
evaluations are performed 30 days following surgery. Study patients with stage I (without
N-myc amplification) tumors and trial patients with stage II tumors receive no further
Study patients (except stage I patients) receive surgery and/or chemotherapy according to
other protocols as necessary for disease progression or relapse.
Patients are followed every 3 months for the first year, then every 4 and 6 months for the
second and third year respectively, then yearly for 5 years.
PROJECTED ACCRUAL: This study will accrue 140 stage II patients for the trial portion at a
rate of 40 per year over 3.5 years. At least 70 more patients will be accrued for the study
Primary Purpose: Treatment
Safety and efficacy
Jean Marie Michon, MD