Long-term Outcomes and Risk Factors of Local Re-Recurrence in Patients

Sun Yat-sen University

Status: Completed

Conditions: Local Recurrence of Malignant Tumor of Rectum; Local Re-Recurrence of Malignant Tumor of Rectum

Study type: Observational

Funder types: Other

Identifiers

NCT07353567

2025ZSLYEC-595

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 284 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• (1). Patients had undergone curative-intent resection for a histologically confirmed primary rectal or rectosigmoid adenocarcinoma. A disease-free interval ≥3 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 3 months after salvage surgery.
• (4). Availability of complete clinicopathological and treatment-related data.

Exclusion criteria

• (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.

Trial design

284 participants in 2 patient groups

patients without local re-recurrence

patients with local re-recurrence