Clinical Relevance of the Major Pathologic Regression for Locally Advanced Rectal Cancer Following Neoadjuvant Chemoradiotherapy: A Multi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,187
- 主要终点
- PFS
研究概览
简要总结
We evaluated all related clinical and pathologic data of patients with Locally Advanced Rectal Cancer following Neoadjuvant Chemoradiotherapy, including the pathologic regression grading, and other histopathologic characteristics. Finally, the present study was aimed at (1) clarifying the clinical significance of the Major Pathologic Regression for Locally Advanced Rectal Cancer following Locally Advanced Rectal Cancer and (2) comparing different Neoadjuvant Chemoradiotherapy treatments of this uncommon disease through conducting a large, multi-center cohort study.
详细描述
This large-scale, multi-center cohort study aims to investigate the clinical and prognostic implications of histopathologic characteristics in patients with Locally Advanced Rectal Cancer (LARC) following Neoadjuvant Chemoradiotherapy (NCRT). The study will retrospectively and prospectively analyze data from consecutive LARC patients treated at participating institutions between 2016 and 2022.
Study Design and Objectives
Primary Objective:
To evaluate the clinical significance of Major Pathologic Regression (MPR) in LARC patients following NCRT. MPR is defined as ≤10% residual viable tumor within the tumor bed in the pathologic evaluation. The study will correlate MPR status with long-term survival outcomes, including Progression-Free Survival (PFS) and Overall Survival (OS), to determine its validity as a surrogate endpoint for treatment efficacy.
Secondary Objectives:
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years) diagnosed with locally advanced rectal adenocarcinoma (clinical stage II-III).
- •Completion of NCRT followed by curative-intent surgery. Availability of pre- and post-treatment histopathologic data, including standardized regression grading and digitized whole-slide images (WSIs).
排除标准
- •Metastatic disease at diagnosis. Incomplete clinical or pathologic records.
结局指标
主要结局
PFS
时间窗: 5 year
Progression free regression
OS
时间窗: 5 year
overall survival
次要结局
未报告次要终点
研究者
Yanhong Deng
M.D.
Sun Yat-sen University