Surgery in Treating Patients With Neuroblastoma

Study Overview
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Brief Summary
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RATIONALE: Surgery may be an effective treatment for neuroblastoma. PURPOSE: This phase II trial is studying how well surgery works in treating patients with neuroblastoma.

Detailed Description
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OBJECTIVES: 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 therapy. 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 portion.

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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Neuroblastoma

Intervention / Treatment
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* Procedure: surgical procedure


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Trial: Histologically proven International Neuroblastoma Staging System (INSS) stage IIA and IIB neuroblastoma without amplification of the N-myc oncogene Study: Histologically proven neuroblastoma Stage I Stage II with amplified N-myc Stage II without evaluation of N-myc Stage II with symptomatic spinal cord compression Stage III No metastases diagnosed within 1 month of study PATIENT CHARACTERISTICS: Age: 20 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No adjuvant chemotherapy planned Endocrine therapy: Prior use of steroids allowed Radiotherapy: Not specified Surgery: Not specified

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: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: surgical procedure|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy |  |  | 
| 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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localized resectable neuroblastoma, localized unresectable neuroblastoma