Observation of Young Patients With Localized Neuroblastoma Who Have Undergone Surgery Only

Overview

RATIONALE: Observation is closely monitoring a patient's condition and not giving treatment until symptoms appear or change. Observation may help doctors see how effective surgery is in treating neuroblastoma. PURPOSE: This phase II trial is studying how well surgery alone works in treating young patients with localized neuroblastoma.

OBJECTIVES: Primary * Evaluate the safety and efficacy of surgical treatment alone in young patients with stage 2 neuroblastoma without N-myc amplification (NMA). Secondary * 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.

Conditions

Interventions

Eligibility

Outcomes