Prognostic Value of PARS Classification for Locally Recurrent Rectal Cancer

Completed

• Conditions: Local Recurrence of Malignant Tumor of Rectum

• Registration Number: NCT06808308
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

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.

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 Timeline

• Study Start: 2011-01-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Study First Submitted: 2025-01-23
• Study First Submitted QC: 2025-01-31
• Last Update Submitted: 2025-01-31
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PRS	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

Secondary Outcome Measures

Name	Time	Method
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.	Disease-free survival
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.	Local re-recurrent free survival