NCT00410631Unknown3 期
NB2004 Trial Protocol for Risk Adapted Treatment of Children With Neuroblastoma
German Society for Pediatric Oncology and Hematology GPOH gGmbH157 个研究点 分布在 1 个国家目标入组 642 人开始时间: 2004年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 642
- 试验地点
- 157
- 主要终点
- Event-free survival (EFS)
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 combination chemotherapy may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. This may allow more chemotherapy to be given so that more tumor cells are killed. 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 whether observation is more effective than combination chemotherapy, radiation therapy, and/or autologous stem cell transplant in treating neuroblastoma.
PURPOSE: This randomized phase III and phase IV trial is studying observation, combination chemotherapy, radiation therapy, and/or autologous stem cell transplant to compare how well they work in treating young patients with neuroblastoma.
详细描述
OBJECTIVES:
Primary
- Determine the event-free survival (EFS) of younger patients with newly diagnosed neuroblastoma categorized in the low-risk group (LRG) who undergo observation only or receive combination chemotherapy.
- Compare the EFS rate in patients with neuroblastoma categorized in the medium-risk group (MRG) treated with combination induction therapy, maintenance therapy, and consolidation therapy with that of a historical control group.
- Compare the EFS in patients with neuroblastoma categorized in the high-risk group (HRG) treated with standard vs experimental induction therapy followed by autologous stem cell transplantation and consolidation therapy.
Secondary
- Determine the locoregional EFS of patients in the LRG, MRG, or HRG.
- Determine the overall survival of these patients.
- Determine the extent of initial surgery, the extent or impact of best surgery, and surgery-related complications in these patients.
- Determine the time to transition to stage 4 disease in patients in the LRG or MRG.
- Determine the time to a locoregional event in patients in the LRG or HRG.
- Determine the time from diagnosis to an event in patients in the LRG.
- Determine the time from the beginning of regression to an adverse event in patients in the LRG.
- Determine the time to the beginning of primary tumor regression in patients in the LRG.
- Determine the time to the normalization of tumor markers in patients in the LRG.
- Determine the time to no evidence of disease in patients in the LRG with stage 4S disease.
- Assess the status of the primary tumor at 12 months and the best status of the primary tumor within 12 months in patients in the LRG.
- Determine the need for chemotherapy to control progression and the intensity of therapy required in patients in the LRG.
- Determine the acute and late side effects of external-beam radiotherapy in patients in the MRG or HRG.
- Determine the response to induction therapy in patients in the HRG.
- Assess early response after 2 courses of induction therapy in patients in the HRG.
- Determine the toxicity during induction courses 1 and 2 and the frequency of grade 3 or 4 toxicity during induction therapy in patients in the HRG.
- Assess the efficacy of iodine I 131 metaiodobenzylguanidine (MIBG) therapy, in terms of activity and whole body dose, in patients in the HRG.
- Assess molecular markers (e.g., chromosome 1p, chromosome 11q, neuroblastoma gene chip) in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of neuroblastoma by histology using tumor tissue or as evidenced by the presence of distinct neuroblastoma cells in the bone marrow AND elevated catecholamine metabolites (i.e., homovanillic acid [HVA] and vanillylmandelic acid [VMA]) in blood or urine
- •Newly diagnosed disease (for patients in the low-risk group)
- •Diagnosis from tumor tissue (for patients in the medium-risk group)
- •Meets criteria for 1 of the following risk groups:
- •Low-risk group
- •No MYCN amplification AND meets 1 of the following criteria:
- •Stage 1 disease
- •Stage 2 disease with no chromosome 1p deletion or imbalance
- •Stage 3 disease with no chromosome 1p deletion or imbalance (for patients < 2 years of age)
- •Stage 4S disease (for patients < 1 year of age)
- •Medium-risk group
- •No MYCN amplification AND meets 1 of the following criteria:
- •Stage 2 disease with chromosome 1p deletion or imbalance
- •Stage 3 disease with chromosome 1p deletion or imbalance
- •Any chromosome 1p status (for patients ≥ 2 years of age)
- •Stage 4 disease (for patients < 1 year of age)
- •High-risk group, meeting 1 of the following criteria:
- •Any stage disease with MYCN amplification
- •Any MYCN status (for patients ≥ 1 year of age)
- •PATIENT CHARACTERISTICS:
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •No prior nephrectomy or other mutilating surgery as initial surgery (for patients in the low-risk group)
- •No other concurrent anticancer therapy
排除标准
- 未提供
结局指标
主要结局
Event-free survival (EFS)
Locoregional EFS
次要结局
- Time from diagnosis to transition to stage 4 disease, to death from disease, or to the last follow-up (if no transition to stage 4 disease is observed)
- Overall survival
- Time to the beginning of primary tumor regression (in patients in the low-risk group [LRG])
- Time to the normalization of tumor markers HVA and VMA in urine
- Time to no evidence of disease (in patients in the LRG with stage 4S disease)
- Status of the primary tumor 12 months after diagnosis (LRG)
- Best status of the primary tumor within the first 12 months (LRG)
- Status of chromosome 1p (unblinded) and status of chromosome 11q (blinded)
- Comparison of the extent of initial surgery (incomplete resection vs macroscopic complete resection) (LRG)
- Comparison of the extent of best surgery during protocol treatment (incomplete resection vs macroscopic complete resection)
- Surgery-related complications (i.e., bleeding, infection, intestinal obstruction, or other)
- Disease progression and symptoms controlled after the first, second, third, and fourth N4 course (LRG)
- Disease progression and symptoms not controlled after four N4 courses (LRG)
- Transition to stage 4 disease at any time (LRG)
- Acute and late side effects of external-beam radiotherapy (medium-risk group [MRG] and high-risk group [HRG])
- Early response after 2 courses of induction therapy (N5 and N6 or two courses of N8) (HRG)
- Response to induction therapy prior to conditioning therapy or after 280 days (HRG)
- Grade of toxicity observed during induction therapy course 1 (N5 or N8) (HRG)
- Grade of toxicity observed during induction therapy course 2 (N6 or N8) (HRG)
- Frequency of grade 3 or 4 toxicity observed during the last 6 courses of induction therapy (3 courses of N5 and N6) (HRG)
- Activity and whole body dose of radiotherapy
研究者
研究点 (157)
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