JPRN-jRCTs042210139招募中1 期
Clinical study of safety and efficacy of peritoneal catheter placement and saline injection as artificial ascites for space-making radiotherapy in patient with abdominal or pelvic malignant tumor
Onoe Tsuyoshi0 个研究点目标入组 18 人开始时间: 2022年2月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable(—)
- 性别
- All
入选标准
- •(1) Histologically or clinically confirmed primary or metastatic malignant tumors (carcinoma or sarcoma) located in the abdomen and pelvis.
- •(2) The presence of a bowel within a 10 mm distance from GTV
- •(3) ability to maintain a prone or supeine position during radiotherapy
- •(4) Age of 18 years or older
- •(5) Eastern Cooperative Oncology Group performance status 0, 1, and 2
- •(6) prognosis of > 6 months, based on New Katagiri score
- •(7) provision of written informed consent
排除标准
- •(1) Patients who potentially have severe tissue adhesion in the area where catheter will be placed
- •(2) Patients with disseminated metastasis of the peritoneum detected by cytology or radiography in the area of catheter insertion and/or placemen
- •(3) patients with radiation-sensitive tumors, including malignant lymphoma, myeloma, or germ cell tumor
- •(4) Platelet count<50,000 / mm3
- •1. Heart disease, hypertension, diabetes, psychiatric disease, seizure and seizure disease, intractable infectious disease whose medical treatment is difficult to control.
- •2. Patients who take antiplatelet drugs ,anticoagulants, and is difficult to discontinue them
- •(6)Woman who is pregnant , lactating or wishing to have children
- •(7)Patient who is deemed inappropriate by the doctor due to medical or psychological factors
研究者
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