NCT00416559

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Children's Cancer and Leukaemia Group · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Long-term Effects Secondary to Cancer Therapy in Children
• Neuroblastoma

Interventions

Type	Name	Description
OTHER	clinical observation

Timeline

• Start date: 2004-12-01
• First posted: 2006-12-28
• Last updated: 2013-09-20