Last updated on August 2013

Surgery in Treating Patients With Neuroblastoma


Brief description of study

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 Study Description

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.

Clinical Study Identifier: NCT00003122

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Aberdeen Royal Infirmary

Aberdeen, United Kingdom
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LKH Leoben

Leoben, Austria
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Hospital Universitario de Canarias

San Cristobal de La Laguna, Spain
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Hospital General de Galicia

Santiago de Compostela, Spain
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Addenbrooke's Hospital

Cambridge, United Kingdom
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Leicester Royal Infirmary

Leicester, United Kingdom
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Christie Hospital

Manchester, United Kingdom
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Queen's Medical Centre

Nottingham, United Kingdom
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Southampton General Hospital

Southampton, United Kingdom
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Royal Marsden - Surrey

Sutton, United Kingdom
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Llandough Hospital

Llandough, United Kingdom
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Recruitment Status: Open


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