NCT00416559Unknown2 期
Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma
Children's Cancer and Leukaemia Group0 个研究点目标入组 140 人开始时间: 2004年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 140
- 主要终点
- Safety and efficacy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Supportive Care
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:
- •Histologically confirmed neuroblastoma or ganglioneuroblastoma
- •Meets 1 of the following International Neuroblastoma Staging System (INSS) criteria:
- •Stage 2A or 2B meeting 1 of the following criteria:
- •With or without N-myc amplification
- •No evaluation of NMA
- •Symptomatic spinal cord compression
- •Stage 3*
- •Dumbbell syndrome with clinical signs of spinal cord compression*
- •NOTE: *These patients are eligible for the study but do not undergo observation; instead they will undergo standard treatment
- •Has undergone complete or gross surgical resection OR diagnostic surgical or needle biopsy
- •No metastases within 1 month of diagnosis
- •No skin metastases by clinical examination and MIBG scan
- •Normal liver by CT scan or ultrasonography
- •Normal chest X-ray (in case of nonthoracic primary site)
- •PATIENT CHARACTERISTICS:
- •Not specified
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Prior steroids allowed
- •No prior chemotherapy
排除标准
- 未提供
结局指标
主要结局
Safety and efficacy
次要结局
- Predictive factors of relapse and survival
研究者
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