CompletedNot Applicable

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

298 participantsStarted 2010-01-01

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * (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. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Local re-recurrence free survival

Timeframe: 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

Timeframe: 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.

Trial details

NCT IDNCT07353567

SponsorSixth Affiliated Hospital, Sun Yat-sen University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-01

View on ClinicalTrials.gov More Local Re-Recurrence of Malignant Tumor of Rectum trials