Prognostic Value of PARS Classification for Locally Recurrent Rectal Cancer

January 31, 2025 updated by: Cai Zerong, Sixth Affiliated Hospital, Sun Yat-sen University

Prognostic Value of PARS Classification in Predicting Post-recurrent Survival for Locally Recurrent Rectal Cancer Patients Undergoing Salvage Radical Surgery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
199

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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:

  • (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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PRS
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.
Post-recurrent survival
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
DFS
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.
Disease-free survival
DFS was calculated from the date of salvage radical surgery until the date when recurrence or metastasis was detected, assessed up to 140 months.
LrRFS
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.
Local re-recurrent 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 140 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Zerong Cai, MD, Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025ZSLYEC-050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Please contact us by Email

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings