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

NCT07353567 | Completed

• 1 other identifier: 2025ZSLYEC-595
• Study Type: observational
• Target: 298
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Local re-recurrence free survival

  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

  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.

Study Arms (2)

patients without local re-recurrence

patients with local re-recurrence

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 298 patients who underwent radical salvage surgery for LRRC were included in the study, from January 1st, 2010 to March 1st, 2025.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Department

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 20, 2026
• Study Start: January 1, 2010
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share