Predicting Locally Advanced Rectal Cancer Response to NCT and NCRT With MRI, and Comparison of MR Imaging Evaluation Between NCT and NCRT
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- pTRG
研究概览
简要总结
This trial was designed to to study whether there is a difference in MRI image evaluation between NCRT and NCT, and try to build a model to predict the efficacy of neoadjuvant therapy by combining multiple imaging indexes.
详细描述
This study was designed as a retrospective case-control study. All 116 patients with locally advanced rectal cancer who started neoadjuvant chemoradiotherapy and underwent radical surgery in West of China Hospital and completed the required MR examination before and after neoadjuvant treatment were included from March 2016 to December 2019. MRI imaging indicators of patients before and after neoadjuvant therapy, including tumor location, longitudinal diameter, circumferential Angle, DWI signal, mrTRG and texture feature data, were retrospectively collected to analyze the changes before and after treatment, and compared with patients receiving NCT in PART1. At the same time, indicators with statistical differences will be included in the construction of models predicting different pathological outcomes after NCT and NCRT, and the efficacy of the models was evaluated through c-index values and ROC analysis of bootstrap resampling 500 times.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathological diagnosis of rectal cancer;
- •received neoadjuvant chemoradiotherapy before surgery;
- •before neoadjuvant therapy and before surgery, the patients received thin and high resolution MRI examination of the rectum.
- •before neoadjuvant therapy, colonoscopy, rectal contrast-enhanced ultrasound or MRI showed that the lower margin of the tumor was within 12cm from the anal margin;
- •pre-neoadjuvant clinical stage II/III (AJCC 7th edition);
排除标准
- •simultaneous distant metastatic tumor should be considered at the first diagnosis;
- •patients with distant metastasis were not considered at the initial diagnosis;
- •with other malignant tumors;
- •before neoadjuvant therapy, patients had received other relevant treatments;
- •to undergo palliative surgery or emergency surgery in the course of neoadjuvant therapy;
结局指标
主要结局
pTRG
时间窗: within 2 week after surgery
pathological tumour regression grading
次要结局
未报告次要终点
研究者
Ziqiang Wang,MD
physician
West China Hospital