Clinical Study on Pelvic Recurrence of Gynecologic Tumors After External Irradiation by Three Dimensional Printing Personalized Template Assisted With 192Ir High Dose Rate Interstitial Brachytherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Tumor Response Rate
研究概览
简要总结
This is a single-center study.Eligible patients will have histologically proven pelvic recurrence of cervical cancer after radiotherapy .
详细描述
The results of treatment, examination and follow-up of patients with recurrent cervical cancer after radiotherapy who recieved imaging guided three dimensional printing personalized template assisted with 192Ir high dose rate interorganizational braided therapy were statistically analyzed .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed pelvic recurrence of cervical cancer.
- •Age ≥ 18 years and ≤ 75 years.
- •Previous accept pelvic radiotherapy;
- •Karnofsky ≥60；
- •Patients reject or cannot tolerate surgery;
- •Received 192Ir high dose rate intertissue salvage therapy;
- •Ultrasound guidance or computed tomography guidance;
- •Regular review and follow-up.
排除标准
- •Patients participated in clinical trials of other drugs within four weeks;
- •The patient had a previous history of bleeding, and any bleeding event with severity rating of CTCAE5.0 or above occurred within 4 weeks prior to screening;
- •There are any puncture taboos.
- •Patients with severe cardiovascular and cerebrovascular diseases.
- •Unable to treat as planned.
- •Patients lack major indicators and cannot participate in post-treatment review and follow-up.
结局指标
主要结局
Tumor Response Rate
时间窗: three months
Tumor size changes were monitored using CT. According to the solid tumor treatment efficacy evaluation standard RECIST, evaluation results including complete response, partial response, stable disease, and progression disease.Tumor response rate was complete response rate plus partial response rate.
Local Progression Free Survival
时间窗: 2 years
Local progression free survival was defined as the time from the implantation of the treatment to the treatment of local tumor progression.
次要结局
- Overall survival(2 years)
- Safety and Tolerability(2 years)