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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Long-term Effects Secondary to Cancer Therapy in Children, Neuroblastoma

Intervention / Treatment
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* Other: clinical observation


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed neuroblastoma or ganglioneuroblastoma Meets 1 of the following International Neuroblastoma Staging System (INSS) criteria: Stage 1 Stage 2A or 2B meeting 1 of the following criteria: With or without N-myc amplification No evaluation of NMA Symptomatic spinal cord compression Stage 3* Dumbbell syndrome with clinical signs of spinal cord compression* NOTE: *These patients are eligible for the study but do not undergo observation; instead they will undergo standard treatment Has undergone complete or gross surgical resection OR diagnostic surgical or needle biopsy No metastases within 1 month of diagnosis No skin metastases by clinical examination and MIBG scan Normal liver by CT scan or ultrasonography Normal chest X-ray (in case of nonthoracic primary site) PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics Prior steroids allowed No prior chemotherapy

Ages Eligible for Study
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Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: clinical observation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive factors of relapse and survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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long-term effects secondary to cancer therapy in children, localized resectable neuroblastoma, localized unresectable neuroblastoma, regional neuroblastoma