JPRN-jRCTs041180041已完成2 期
Targeted radiotherapy for chemotherapy resistant neuroblastoma with I-131 metaiodobenzylguanidine (MIBG) - Targeted radiotherapy for chemotherapy resistant neuroblastoma with I-131 metaiodobenzylguanidine (MIBG)
Kinuya Seigo0 个研究点目标入组 63 人开始时间: 2019年2月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
研究概览
简要总结
Sixty-three neuroblastoma patients received I-131 MIBG treatment (23 cases of newly diagnosed and 46 cases of recurrent neuroblastoma). In the study period, there were 20 deaths due to exacerbation of the disease and 6 deaths from continuous treatment complications. The 5-year estimated survival rate after the initial treatment of I-131 MIBG was 65% in the newly diagnosed patients and 45% in the recurrent patient. The safe administration of I-131 MIBG for neuroblastoma was possible.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- One years old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Patients with histologically proven neuroblastoma
- •2)Positive I-131 MIBG uptake
- •3)Age > 1 y.o.
- •4)Patients with written informed consent from parents
- •5)Patients with ADL adequate for treatment in an isolation room. Patients with limited ADL that can be compensated by the others under the approval of the ethical board.
- •6)In case that high-dose treatment is chosen, bone marrow support must be secured.
排除标准
- •1)Patients with disturbed consciousness
- •2)An expected life expectancy of less than 1 month
- •3)Limited bone marrow capacity (except patients with bone marrow support)
- •hemoglobin<9.0g/dl, white blood cell count<3,000, platelet count<10,000
- •4)Renal disorder
- •glomerular filtrated rate (GFR)<30ml/min/1.73m2
- •5)Risks for the central nerve compression syndrome that might be caused by lesion edema during the treatment
- •6)In case that medical practice and radiation management is difficult in an isolation room, In case of uncontrolled symptoms that require emergent medical cares, In case that urine management is difficult, In case that understanding and cooperation cannot be obtained from family members
- •7)When medical staffs determine that treatment cannot be properly carried out.
研究者
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