Predicting Pathological Complete Response of Rectal Cancer to Neoadjuvant Chemoradiotherapy With MR Radiomics Method
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 538
- 试验地点
- 1
- 主要终点
- Pathological complete response(pCR)
研究概览
简要总结
This study plans to construct a MR radiomics model for predicting pathological complete response(pCR) to neoadjuvant chemoradiotherapy(CRT) in locally advanced rectal cancer(LARC) patients.
详细描述
We propose to develop and validate a radiomics model for individualized pCR evaluation after CRT in patients with LARC. We plan to use both pre- and post-CRT MRI data to construct the predictive radiomics model for evaluating if LARC patients achieve pCR after CRT. The ultimate aim is to select appropriate LARC patients for omission of surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologically proved rectal cancer
- •locally advanced rectal cancer (≥T3 or N+)
- •a distance less than 12cm between the lower edge of tumor and the anal margin
- •no evidence of distant metastases
- •no prior anti-cancer therapy before treatment
- •scheduled to receive preoperative CRT
排除标准
- •history or concurrent of other malignancy
- •incomplete preoperative CRT
- •failed to receive surgery or unavailable pCR assessment
- •poor quality of MR images for measurement
- •patient quit
结局指标
主要结局
Pathological complete response(pCR)
时间窗: within one week after surgery
Pathological complete response was defined as the absence of viable tumor cells in the primary tumor and lymph nodes.
次要结局
未报告次要终点
研究者
Sun Ying-Shi
Director
Peking University Cancer Hospital & Institute