Prognostic Value of PARS Classification for Locally Recurrent Rectal Cancer

NCT06808308 | Completed

• 1 other identifier: 2025ZSLYEC-050
• Study Type: observational
• Target: 199
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Local Recurrence of Malignant Tumor of Rectum

Outcome Measures

Primary Outcomes (1)

• PRS

  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 Outcomes (2)

• DFS

  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

  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.

Study Arms (3)

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

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

The pathological specimens before operation and the specimens after operation

Study Officials

• Zerong Cai, MD

  Sixth Affiliated Hospital, Sun Yat-sen University

  STUDY DIRECTOR

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: January 23, 2025
• First Posted: February 5, 2025
• Study Start: January 1, 2011
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share