European Infant Neuroblastoma Study Final Protocol
试验速览
- 阶段
- 3 期
- 发起方
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known which combination chemotherapy regimen given together with surgery, with or without autologous bone marrow or peripheral stem cell transplant, is more effective in treating newly diagnosed neuroblastoma.
PURPOSE: This phase III trial is studying combination chemotherapy to see which regimen given together with surgery, with or without autologous bone marrow or peripheral stem cell transplant, works in treating infants with newly diagnosed neuroblastoma.
详细描述
OBJECTIVES:
Primary
- Determine the outcome, in terms of survival and morbidity, in infants with localized, unresectable, non-MYCN-amplified neuroblastoma treated with reduced-intensity chemotherapy.
- Determine the survival of infants with stage 4S neuroblastoma, no MYCN amplification, and no bone, CNS, or pleural/lung metastases treated with short-course intensive chemotherapy.
- Determine the survival of infants with stage 4S neuroblastoma, no MYCN amplification, and bone, CNS, or pleural/lung metastases not treated with intensive high-dose chemotherapy consolidation.
- Determine the survival of infants with any stage (except stage 1) neuroblastoma and MYCN amplification treated with intensive consolidation high-dose chemotherapy followed by autologous bone marrow or stem cell support.
Secondary
- Correlate outcome with factors other than stage and MYCN status in infants with neuroblastoma.
- Define the behavior of neuroblastoma in infants treated with these regimens.
- Determine prognostic criteria in infants treated with these regimens.
- Determine whether deletion of chromosome 1p or diploidy/tetraploidy are prognostic factors in infants who do not have other adverse features, such as MYCN amplification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed neuroblastoma or ganglioblastoma
- •Newly diagnosed disease
- •MYCN status known
- •Patients are assigned to different study treatment regimens* according to the following disease criteria:
- •Regimen NB 99.1
- •Localized unresectable tumor
- •If open surgery is considered too hazardous due to the site of the tumor or condition of the infant, then cytological confirmation is allowed, provided adequate material is obtained for study procedures
- •No MYCN amplification (i.e., < 10 copies)
- •No metastatic deposits in the bone marrow
- •No MIBG or technetium uptake or radiological bone lesions in the skeleton
- •No liver disease by ultrasound
- •Regimen NB 99.2
- •Stage 4 or 4S with metastases confined to the skin, marrow, nodes, or liver
- •No bone involvement by radiographs
- •No pleural or lung involvement
- •No CNS involvement
- •No MYCN amplification (i.e., < 10 copies)
- •Regimen NB 99.3
- •Stage 4 disease, metastases must meet ≥ 1 of the following criteria:
- •Skeletal bone metastases by plain x-ray or CT scan
- •Pleural or lung metastases
- •CNS involvement
- •No MYCN amplification (i.e., < 10 copies)
- •Regimen NB 99.4
- •Stage 2-4 disease
- •MYCN amplification (i.e., ≥ 10 copies) NOTE: *Patients with stage 1 or resectable stage 2 disease with no MYCN amplification ( i.e., < 10 copies) are not eligible for a study treatment regimen but may be enrolled on the study for observation only
- •PATIENT CHARACTERISTICS:
- •Not specified
- •PRIOR CONCURRENT THERAPY:
- •No prior therapy
排除标准
- 未提供