JPRN-jRCTs041180040已完成2 期
Targeted radiotherapy for malignant neuroendocrine tumors with I-131 metaiodobenzylguanidine (MIBG) - Targeted radiotherapy for malignant neuroendocrine tumors with I-131 metaiodobenzylguanidine (MIBG)
Kinuya Seigo0 个研究点目标入组 61 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
- 61
研究概览
简要总结
Sixty-one patients with malignant neuroendocrine tumors received 100 doses of I-131 MIBG. There were 18 deaths from the primary disease within the study period for the overall survival after treatment. The 5-year estimated survival rate after the first treatment with I-131MIBG was 72%, and the 10-year survival rate was 54%. The predicted survival rate is better than the past reports of standard-dose I-131 MIBG treatment in Japan.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients with histologically proven malignant neuroendocrine tumors
- •2) Patients with metastases, recurrent lesions or unresectable lesions
- •3) Positive I131-MIBg uptake
- •4) Patients with written informed consent
- •5) Patients with ADL adequate for treatment in an isolation room. Patients with limited ADL which can be compensated by the others under the approval of the ethical board.
排除标准
- •1)Pregnant female and feeding female
- •2)Patients with disturbed consciousness
- •3)An expected life expectancy of less than 1 month4)Limited bone marrow capacity
- •Hb<9.0, WBC count<3,000, platelet count <100,000
- •5)Renal disorder
- •GFR<30 ml/min/1.73 m2
- •6)Risks for the central nerve compression syndrome that might be caused by lesion edema during the treatment
- •7) 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
- •8) When medical staffs determine that treatment cannot be properly carried out.
研究者
相似试验
已完成
2 期
Targeted radiotherapy for malignant neuroendocrine tumors with MIBGeuroendocrine tumorsneuroendocrine tumors, I-131 MIBG therapyD018358JPRN-jRCTs041190085Seigo Kinuya18
已完成
不适用
Targeted radiotherapy for malignant neuroendocrine tumors with I-131 metaiodobenzylguanidine (MIBG)malignant neuroendocrine tumorsJPRN-UMIN000002529Kanazawa University Hospital100
已完成
2 期
Targeted radiotherapy for chemotherapy resistant neuroblastoma with I-131 metaiodobenzylguanidine (MIBG)euroblastomaNeuroblastoma, I-131 MIBG therapyJPRN-jRCTs041180041Kinuya Seigo63
进行中（未招募）
不适用
Targeted radionuclide therapy of neuroendocrine tumours using 177Lu-DOTATATE combined with induced local tumour up-regulation of somatostatin receptor expression for increased tumour dosage and tumour to background ratio - NET Therapy 177Lu-DOTATATEEUCTR2012-000266-38-DKDepartment of Nuclear Medicine, Odense University Hospital50
已完成
不适用
Combination Targeted Radiotherapy in Neuroendocrine TumorsNeuroendocrine TumorsNCT01099228David Bushnell2