The Physical Dosimetry Study and Preliminary Clinical Results of 3D-printing Non Co-planar Template Assisted With CT-guidance for Iodine-125 Seed Brachytherapy in Pelvic Recurrent Rectum Carcinoma After Surgery and External Beam Radiotherapy, a Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 主要终点
- Local control time
研究概览
简要总结
This study observes the efficacy and side effects of 3D-printing non co-planar template(3D-PNCT) assisted with CT-guidance for radioactive Iodine-125 seed(RIS) brachytherapy in pelvic recurrent rectum carcinoma retrospectively, and analyzes the influence of clinical and dosimetric factors on the outcomes.
详细描述
3D-PNCT assisted with CT-guidance for radioactive Iodine-125 seed brachytherapy is a conventional treatment in Peking University Third Hospital. Radioactive Iodine-125 seed brachytherapy is the implantation of Iodine-125 seed into tumors.The radioactive Iodine-125 seed can release low dose of irradiation persistently which kills tumors cell and causes less damage to normal tissue at the same time. 3D-printing non co-planar template is made individually which guides the implantation of Iodine-125 seed into the tumor and ensures the accuracy of the position.This study collects the data of patients with pelvic recurrent rectal carcinoma who underwent 3D-PNCT assisted with CT-guidance for radioactive Iodine-125 seed implantation from 2015 to 2018. We evaluate the dose that covers 90% target volume(D90),the volume that 100% prescription dose covers(V100) and other dosimetric parameters after the implantation. The efficacy and adverse effects were observed. Local control(LC) time and overall survival(OS) time are evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •treated with 3D-printing non co-planar template assisted with CT-guidance for Iodine-125 seed brachytherapy in Peking University Third Hospital
- •histological proven recurrent rectal cancer
- •inoperable local recurrent cases
- •previous external beam radiotherapy, incapable of re-irradiation
- •expected life span>3 months
排除标准
- •serious medical illness
- •unable to tolerate anesthesia
- •blood coagulation dysfunction
结局指标
主要结局
Local control time
时间窗: From date of implantation to the date of recurrence of the implanted tumor or the date of last observation. The last follow-up timepoint is February 2019.
The time from the date of implantation to the date of recurrence of the implanted tumor or the date of last observation. Outcomes were followed up every 3 months after enrollment.
Overall survival time
时间窗: From date of implantation to the date of death from any cause or the date of last observation. The last follow-up timepoint is February 2019.
The time from the date of implantation to the date of death from any cause or the date of last observation. Outcomes were followed up every 3 months after enrollment.
次要结局
- Pain relief rate(3 months after the implantation. The last follow-up point is February 2019.)
- Incidence of adverse events(From date of implantation to the date of death from any cause or the date of last observation. The last follow-up timepoint is February 2019.)