Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 210
- 试验地点
- 190
- 主要终点
- Predictive factors of relapse and survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 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:
- •20 and under
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •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
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Predictive factors of relapse and survival
Safety and efficacy
次要结局
未报告次要终点