Risk Criteria Based on MRI Features Outperform Radiographic TNM Staging in Neoadjuvant Treatment Decisions for Patients With Rectal Cancer:A Single-Center, Open-Label, Retrospective, Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- 3-year event-free survival rate
研究概览
简要总结
This study investigates whether risk criteria based on MRI features could identify a cohort of patients with a good prognosis among those recommended for preoperative treatment by NCCN guidelines to avoid preoperative treatment with the likely good survival outcomes by primary surgery and more accurately indicate the response to the treatment and predict prognosis after neoadjuvant treatmen than radiographic TNM staging in the patients who received neoadjuvant therapy.
详细描述
There is a lack of international consensus on the choice of preoperative treatment for patients with rectal cancer. Existing guidelines decide whether to administer preoperative therapy to patients with rectal cancer mainly based on the TNM system developed by AJCC/UICC, however, radiographic TNM staging is unsatisfactory in predicting the prognosis of patients with rectal cancer, due to inflammatory and fibrotic responses TNM re-staging is less accurate than pre-treatment. Studies have shown that high-resolution magnetic resonance imaging(MRI) accurately predicted pathologic findings such as CRM involvement, EMVI and TD and patients with MRI-detected CRM involvement, EMVI and TD are at risk for local and distant recurrence as well as poor overall survival. This retrospective study is designed to was to evaluate whether risk criteria based on MRI features can be used as a basis for neoadjuvant treatment decisions and more accurately indicate the response to the treatment and predict prognosis after neoadjuvant treatment than radiographic TNM staging. Patients with MRI-detected circumferential resection margin (CRM) involvement, extramural venous invasion (EMVI), or tumor deposits (TD) were defined as MRI high-risk.
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
- •Underwent primary rectal adenocarcinoma resection
- •Received MRI scan before surgery
- •Willing and able to provide written informed consent for participation in this study.
- •Treatment-naive patients with histological or cytological documentation of rectal adenocarcinoma (<12 cm from the anal verge).
- •Clinical stage of T3Nx or T1-3N+ at initial diagnosis
- •Non-complicated primary tumor (complete obstruction, perforation, bleeding).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
排除标准
- •Treated with transanal local excision
- •with distant metastases at the time of initial diagnosis
- •Subjects with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer.
- •Subjects with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), myocardial infarction (MI), Transient Ischemic Attacks (TIA), or cerebralvascular accident (CVA).
结局指标
主要结局
3-year event-free survival rate
时间窗: 3 years after the surgery
次要结局
- Local recurrence(3 years after the surgery)
- 3-year overall survival rate(3 years after the surgery)
研究者
Yanhong Deng
Professor
Sun Yat-sen University
