Long-term Outcomes and Risk Factors of Local Re-Recurrence in Patients With Locally Recurrent Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 298
- 主要终点
- Local re-recurrence free survival
研究概览
简要总结
To analyze the long-term oncological outcome and identify independent risk factors for local re-recurrence in patients undergoing radical salvage surgery for locally recurrent rectal cancer.
详细描述
Locally recurrent rectal cancer (LRRC) occurs in 5-12% of rectal cancer patients following curative treatment and continues to pose a considerable clinical challenge1-6. At present, radical salvage surgery represents the only potentially curative approach, with 5-year overall survival (OS) rates of 40-55% reported in selected patient cohorts7-11. Despite advances in surgical techniques and systemic treatments, a significant proportion of patients still develops local re-recurrence (LrR) after salvage surgery for LRRC. In a cohort study with a 10 years of follow-up, 42% of LRRC patients undergoing radical surgery developed LrR, with a concomitant distant metastasis rate of 54.8%11, and another multicenter retrospective study reported a 33% rate of LrR12. Nevertheless, data regarding risk factors and the prognosis of LrR remains scarce.
Several clinical factors associated with LrR has been reported, including positive resection margin and the administration of systemic or local treatments13-15. Furthermore, it remains unclear whether clinicopathological characteristics-from the primary tumor through to local recurrence-can predict the risk of re-recurrence after salvage radical resection.
Therefore, this study aimed to investigate the incidence of LrR among LRRC patients who underwent radical salvage surgery at a high-volume tertiary center in China, and to identify independent prognostic factors associated with LrR. The results may contribute to improving postoperative surveillance and facilitating the development of individualized management strategies for LRRC patients.
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
- •(1). Patients had undergone curative-intent resection for a histologically confirmed primary rectal or rectosigmoid adenocarcinoma. A disease-free interval ≥1 months was required to distinguish subsequent local recurrence from persistent disease;
- •(2). LRRC located within the true pelvis or at the pelvic brim, confirmed by radiological imaging (e.g., MRI, CT, PET-CT) and/or pathological verification;
- •(3). Patients who underwent radical salvage surgery (R0/R1) for LRRC. No evidence of residual disease or early second recurrence was observed within 1 months after salvage surgery.
- •(4). Availability of complete clinicopathological and treatment-related data.
排除标准
- •(1). History of synchronous or metachronous other primary malignancies;
- •(2). R2 resection for LRRC;
- •(3). Presence of uncontrollable synchronous distant metastasis at the time of either primary tumor treatment or LRRC diagnosis;
- •(4). Patients lost to follow-up or lacking essential survival data.
研究组 & 干预措施
patients without local re-recurrence
patients with local re-recurrence
结局指标
主要结局
Local re-recurrence free survival
时间窗: LrRFS was calculated from the date of salvage radical surgery until the date when any local re-recurrence was detected by imaging or histology, or until censored at the last follow-up or death, assessed up to 180 months.]
post-recurrent overall survival
时间窗: PROS was calculated from the date of salvage radical surgery until the date of death or until censored at the last follow-up, assessed up to 180 months.
次要结局
未报告次要终点
研究者
Cai Zerong
Deputy Director of the Department
Sixth Affiliated Hospital, Sun Yat-sen University