Local Re-Recurrence of Malignant Tumor of RectumNCT07353567
Long-term Outcomes and Risk Factors of Local Re-Recurrence in Patients
An observational study of Local Re-Recurrence of Malignant Tumor of Rectum and Local Recurrence of Malignant Tumor of Rectum, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Local Re-Recurrence of Malignant Tumor of Rectum, Local Recurrence of Malignant Tumor of Rectum
- How many people
- 298 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- (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.
Who cannot join
- (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.
About this study
Official title: Long-term Outcomes and Risk Factors of Local Re-Recurrence in Patients With Locally Recurrent Rectal Cancer
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.
Read the detailed 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients without local re-recurrence | Not described | |
| patients with local re-recurrence | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local re-recurrence free survival
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jan 2010
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Re-Recurrence of Malignant Tumor of RectumStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cai Zerong, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353567
- Sponsor's protocol ID
- 2025ZSLYEC-595
- Status last verified
- Feb 2026
- First submitted
- 9 Dec 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Please contact us by Email
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes and Risk Factors of Local Re-Recurrence in Patients With Locally Recurrent Rectal Cancer
- ClinicalTrials.gov ID
- NCT07353567
- Acronym / sponsor ID
- 2025ZSLYEC-595
- Conditions
- Local Re-Recurrence of Malignant Tumor of Rectum, Local Recurrence of Malignant Tumor of Rectum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients without local re-recurrence | – | – |
| patients with local re-recurrence | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- (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.
Key exclusion criteria (4 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Local re-recurrence free survival
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No. Please contact us by Email
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Local Re-Recurrence of Malignant Tumor of Rectum and Local Recurrence of Malignant Tumor of Rectum, run by Sixth Affiliated Hospital, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local re-recurrence free survival (time frame: 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.]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.