Clinical Relevance of the Major Pathologic Regression for Locally Advanced Rectal Cancer Following Neoadjuvant Chemoradiotherapy: A Multi-center Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,187
- Primary Endpoint
- PFS
Study Overview
Brief Summary
We evaluated all related clinical and pathologic data of patients with Locally Advanced Rectal Cancer following Neoadjuvant Chemoradiotherapy, including the pathologic regression grading, and other histopathologic characteristics. Finally, the present study was aimed at (1) clarifying the clinical significance of the Major Pathologic Regression for Locally Advanced Rectal Cancer following Locally Advanced Rectal Cancer and (2) comparing different Neoadjuvant Chemoradiotherapy treatments of this uncommon disease through conducting a large, multi-center cohort study.
Detailed Description
This large-scale, multi-center cohort study aims to investigate the clinical and prognostic implications of histopathologic characteristics in patients with Locally Advanced Rectal Cancer (LARC) following Neoadjuvant Chemoradiotherapy (NCRT). The study will retrospectively and prospectively analyze data from consecutive LARC patients treated at participating institutions between 2016 and 2022.
Study Design and Objectives
Primary Objective:
To evaluate the clinical significance of Major Pathologic Regression (MPR) in LARC patients following NCRT. MPR is defined as ≤10% residual viable tumor within the tumor bed in the pathologic evaluation. The study will correlate MPR status with long-term survival outcomes, including Progression-Free Survival (PFS) and Overall Survival (OS), to determine its validity as a surrogate endpoint for treatment efficacy.
Secondary Objectives:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults (≥18 years) diagnosed with locally advanced rectal adenocarcinoma (clinical stage II-III).
- •Completion of NCRT followed by curative-intent surgery. Availability of pre- and post-treatment histopathologic data, including standardized regression grading and digitized whole-slide images (WSIs).
Exclusion Criteria
- •Metastatic disease at diagnosis. Incomplete clinical or pathologic records.
Outcomes
Primary Outcomes
PFS
Time Frame: 5 year
Progression free regression
OS
Time Frame: 5 year
overall survival
Secondary Outcomes
No secondary outcomes reported
Investigators
Yanhong Deng
M.D.
Sun Yat-sen University