Postoperative Complications After Neoadjuvant Chemoradiotherapy or Short-course Radiotherapy and Total Neoadjuvant Treatment: a Multicentric Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- 90 days postoperative complications
研究概览
简要总结
The primary objective of the study is to compare the rate of postoperative complications between rectal cancer patients undergoing standard neoadjuvant chemoradiotherapy or short- course radiotherapy and patients receiving TNT. The secondary objectives of the study include the evaluation of treatment-related adverse reactions and postoperative complications in elderly patients receiving the treatments and the comparison of treatment-related adverse reactions and postoperative complications in patients receiving induction versus consolidation TNT.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with locally advanced (T2N+, T3N+, T4N0, or T4N+) rectal adenocarcinoma who underwent neoadjuvant chemoradiotherapy or short-course radiotherapy or TNT and surgery between January 2016 and January 2025;
- •Patients who underwent restorative or non-restorative surgery;
- •Patients undergoing open, laparoscopic, or robotic intervention.
排除标准
- •Patients who underwent non-operative management after neoadjuvant treatment.
研究组 & 干预措施
Chemoradiotherapy
Patient received chemoradiotherapy or short course radiotherapy before surgery
干预措施: Chemoradiotherapy (Procedure)
TNT
TNT neoadjuvant treatment
干预措施: Chemoradiotherapy (Procedure)
结局指标
主要结局
90 days postoperative complications
时间窗: 12 months
The primary endpoint of the study is the rate of 90-day postoperative complications between the study cohorts.
The primary endpoint of the study is the rate of 90-day postoperative complications between the study cohorts.
时间窗: 3 months
The primary endpoint of the study is the rate of 90-day postoperative complications between the study cohorts.
次要结局
- 90 days severe postoperative complications between the cohorts(12 months)
- 90-day Comprehensive Complication Index(12 months)
- Treatment-related adverse reactions(12 months)
- Severe treatment-related adverse reactions(12 months)
- 90-day postoperative complications between patients receiving neoadjuvant chemoradiotherapy,short-course radiotherapy, induction TNT, and consolidation TNT.(12 months)
- Treatment-related adverse reactions between patients receiving neoadjuvant chemoradiotherapy,short-course radiotherapy, induction TNT, and consolidation TNT(12 months)
- The rate of 90-day postoperative complications between the two cohorts in a sub-population of elderly patients(12 months)
- The rate of treatment-related adverse reactions between the study cohorts in a sub-population of elderly patients(12 months)