Spots Global Cancer Trial Database for Observation of Young Patients With Localized Neuroblastoma Who Have Undergone Surgery Only

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Trial Identification

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

Official Title: Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma

Study ID: NCT00416559

Conditions

Long-term Effects Secondary to Cancer Therapy in Children

Neuroblastoma

Interventions

clinical observation

Study Description

Brief Summary: 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.

Detailed Description: 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.