Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Long-term Effects Secondary to Cancer Therapy in Children
- Sponsor
- Children's Cancer and Leukaemia Group
- Enrollment
- 140
- Primary Endpoint
- Safety and efficacy
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Safety and efficacy
Secondary Outcomes
- Predictive factors of relapse and survival