Primary Surgical Therapy for Biologically Defined Low-Risk Neuroblastoma: A Pediatric Oncology Group/Children's Cancer Group Intergroup Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 968
- 试验地点
- 234
- 主要终点
- Estimate the 3 year survival rate for low risk asymptomatic stage 2A/2B patients who are treated with surgery alone
研究概览
简要总结
RATIONALE: Surgery alone may be effective in treating children with neuroblastoma.
PURPOSE: Phase III trial to study the effectiveness of surgery alone in treating children who have neuroblastoma.
详细描述
OBJECTIVES:
- To determine if asymptomatic patients with low-risk neuroblastoma treated with surgery alone will have a 3-year survival rate of 95%.
- Estimate the response and 3-year event-free survival rates of symptomatic patients treated with chemotherapy.
- Estimate the event-free survival and overall survival rates in patients who relapse or progress after initial treatment with surgery alone.
- Determine the acute and chronic toxic effects associated with treating low-risk neuroblastoma with surgery alone or surgery and chemotherapy.
OUTLINE: This is a multicenter study. Patients are stratified according to disease stage, MYCN status, age, and histology.
Patients undergo primary tumor resection and biopsy of regional nodes. Patients with at least 50% of the tumor resected are followed monthly for 3 months, every 3 months for 9 months, every 6 months for one year, and then annually thereafter.
Regimen I
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment 1 - Asymptomatic - no immediate chemotherapy
干预措施: conventional surgery (Procedure)
Symptomatic - immediate chemotherapy
干预措施: adjuvant therapy (Procedure)
Treatment 1 - Asymptomatic - no immediate chemotherapy
干预措施: radiation therapy (Radiation)
Symptomatic - immediate chemotherapy
干预措施: filgrastim (Biological)
Symptomatic - immediate chemotherapy
干预措施: sargramostim (Biological)
Symptomatic - immediate chemotherapy
干预措施: carboplatin (Drug)
Symptomatic - immediate chemotherapy
干预措施: cyclophosphamide (Drug)
Symptomatic - immediate chemotherapy
干预措施: doxorubicin hydrochloride (Drug)
Symptomatic - immediate chemotherapy
干预措施: etoposide (Drug)
Symptomatic - immediate chemotherapy
干预措施: conventional surgery (Procedure)
Symptomatic - immediate chemotherapy
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Estimate the 3 year survival rate for low risk asymptomatic stage 2A/2B patients who are treated with surgery alone
The primary objective is to estimate the 3 year survival rate for low risk asymptomatic stage 2A/2B patients who are treated with surgery alone. Under the assumption that about 90% of the low risk 2A/2B patients will be asymptomatic, and 10% of these will be lost to follow up, the projected sample size will enable estimation of the survival rate with a standard error less than .03. This sample size will also provide sufficient power for the sequential monitoring plan (see below) for this subgroup of patients.
次要结局
未报告次要终点