CClinicalTrials.gg
CompletedNCT06808308Updated Feb 5, 2025

Prognostic Value of PARS Classification for Locally Recurrent Rectal Cancer

An observational study in Local Recurrence of Malignant Tumor of Rectum, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Completed. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-02-05.

Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
199
Ages
20 Years to 90 Years
Sex
All
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Study summary

The aim of this retrospective study was to explore the predictors of post-recurrent survival in locally recurrent rectal cancer patients undergoing salvage radical surgery. Based on the identified risk factors, investigators propose a new risk stratification to facilitate the development of strategies for surgical treatment and follow-up care.

Read the detailed description

With the introduction of total mesorectal excision (TME) and neoadjuvant chemoradiotherapy, the local recurrence rate of rectal cancer after surgery has markedly decreased; however, 5-18% of patients still experience recurrence in the pelvic field, significantly affecting their quality of life and contributing to high mortality rates. Several clinical and histologic features have been associated with the development of locally recurrent rectal cancer (LRRC), including higher primary T/N stage, positive margins, distal tumors, and histopathologic risk features such as tumor deposits (TD), lymphovascular invasion (LVI), and perineural invasion (PNI). Managing these recurrences is challenging, making risk stratification for re-recurrence through multidisciplinary evaluation essential for achieving personalized treatment in LRRC patients. Current imaging examinations typically stratify LRRC patients based on tumor recurrence patterns to guide clinical interventions. Due to primary treatment and varying local recurrence patterns, the pelvic fascial planes of LRRC patients are often altered or even absent, complicating surgery due to increased involvement of nearby organs or structures. Previous studies have indicated that surgical margin is the most crucial prognostic factor, with LRRC patients achieving R0 resections having a more favorable prognosis compared to those undergoing R1 or R2 resections or conservative treatments. Other potential features, such as gender, prior abdominoperineal resection, and advanced primary tumor stage, have been suggested to lead to poor post-recurrence prognoses; however, the prognostic impact of primary histologic risk features (TD, LVI, PNI) has rarely been addressed. Currently, there is no agreed-upon standardized treatment algorithm for LRRC, and nearly half of patients undergoing salvage radical surgery still experience re-recurrence within 12 months post-operation. The survival stratification of LRRC patients receiving salvage radical surgery remains underexplored.

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Conditions studied

  • Local Recurrence of Malignant Tumor of Rectum
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In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's enrollment of 199 is above the median of 160 across 413 observational studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 211 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

A total of 865 LRRC patients were found in our hospital between January 2011 and December 2022. Finally, 199 patients diagnosed with LRRC who underwent salvage radical surgery were included in the study.

Inclusion criteria

  • (1) the primary tumor was located in the sigmoid colon or rectum, following prior radical tumor resection;
  • (2) local recurrence was confirmed through CT, MRI, and serum cancer biomarker test, or endoscopic biopsy;
  • (3) the recurrent site was confined to the pelvis;
  • (4) the recurrent tumor underwent R0 or R1 surgical resection;
  • (5) the absence of uncontrollable distant metastases at the time of salvage radical surgery.

Exclusion criteria

Exclusion Criteria:

  • (1) patients with unresectable tumors identified before salvage radical surgery, leading to palliative therapy;
  • (2) a recurrence interval of less than three months;
  • (3) incomplete baseline characteristics, including pathologic data from the initial treatment;
  • (4) loss to follow-up.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
199 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • PARS Type I

    Patients with central recurrence who had zero or one PHF were classified as PARS Type I.

  • PARS Type II

    Patients with central recurrence who had two and more PHFs were classified as PARS Type II. Central recurrences with two and more PHFs and non-central recurrences with no PHF were also classified as PARS Type II.

  • PARS Type III

    Patients with non-central recurrence who had one and more PHF were classified as PARS Type III

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What researchers measure

Primary outcomes

  1. PRS

    Post-recurrent survival

    Time frame: PRS 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 140 months.

Secondary outcomes

  1. DFS

    Disease-free survival

    Time frame: DFS was calculated from the date of salvage radical surgery until the date when recurrence or metastasis was detected, assessed up to 140 months.

  2. LrRFS

    Local re-recurrent 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 140 months.

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No — Please contact us by Email

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06808308
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Responsible party
Cai Zerong (Deputy Director of the Department, Sixth Affiliated Hospital, Sun Yat-sen University) — Principal investigator
First posted
Feb 5, 2025
Start date
Jan 1, 2011
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
Feb 5, 2025

Study contacts

Zerong Cai, MD
study director · Sixth Affiliated Hospital, Sun Yat-sen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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