Radiological Markers in Locally Advanced Rectal Cancer

NCT06843655 | Not Yet Recruiting

• 1 other identifier: LARC Protocol
• Study Type: observational
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the prognostic significance of radiological markers, including the Likert Score derived from diffusion-weighted MRI (DWI), in patients with locally advanced rectal cancer (LARC) treated with total neoadjuvant therapy (TNT). Specifically, the study investigates the association between the Likert Score on restaging MRI and key clinical outcomes, such as overall survival (OS) and time to progression (TTP). Furthermore, it examines the impact of other MRI-derived markers-extramural venous invasion (EMVI), tumor deposits (TDs), and mesorectal fascia invasion (MFI)-on disease progression and patient prognosis. This study retrospectively analyzes 179 patients who underwent TNT followed by surgery between 2009 and 2022. Participants were required to have pre- and post-treatment MRI scans. MRI imaging data and patient outcomes, including overall survival (OS) and time to progression (TTP), will be analyzed over a follow-up period extending until July 31, 2024. Findings from this study may help refine MRI-based prognostic tools for personalized treatment strategies in rectal cancer.

Conditions

Locally Advanced Rectal Carcinoma

Keywords

Locally Advanced Rectal Cancer (LARC); Total Neoadjuvant Therapy (TNT); Diffusion-Weighted MRI (DWI); Likert Score; Radiological Prognostic Markers

Outcome Measures

Primary Outcomes (2)

• Time To Progression (TTP) Stratified by Likert Score

  TTP will be measured as the time from diagnosis to disease progression, as assessed through clinical, radiological, or pathological criteria. Patients will be stratified based on the Likert Score derived from diffusion-weighted MRI (DWI) at restaging. Kaplan-Meier survival curves will be used to estimate progression-free probabilities, with comparisons between groups performed using the log-rank test. Cox proportional hazards regression will be used to evaluate the prognostic significance of the Likert Score. TTP will be measured in months, defined as the time from diagnosis to documented disease progression based on clinical, radiological, or pathological criteria.

  5 years

• Overall Survival (OS) Stratified by Likert Score

  OS will be measured as the time from diagnosis to death from any cause in patients with locally advanced rectal cancer (LARC) treated with total neoadjuvant therapy (TNT). Patients will be stratified based on the Likert Score derived from diffusion-weighted MRI (DWI) at restaging. Kaplan-Meier survival curves will be used to estimate survival probabilities, and differences between groups will be compared using the log-rank test. Cox proportional hazards regression will be performed to assess the prognostic value of the Likert Score. OS will be measured in months, defined as the time from diagnosis to death. Patients alive at the end of the study period or lost to follow-up will be censored at their last recorded visit.

  5 years

Secondary Outcomes (6)

• Prognostic Value of EMVI Score on Time to Progression (TTP)

  5 years

• Prognostic Value of Tumor Deposits on Time to Progression (TTP)

  5 years

• Prognostic Value of Mesorectal Fascia Infiltration on Time to Progression (TTP)

  5 years

• Prognostic Value of EMVI Score on Overall Survival (OS)

  5 years

• Prognostic Value of Tumor Deposits on Overall Survival (OS)

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study includes patients with locally advanced rectal cancer (LARC) who underwent total neoadjuvant therapy (TNT) followed by surgery at our institution between 2009 and 2022. MRI imaging was performed both at initial staging and after TNT before surgery. The follow-up period extends until July 31, 2024, with survival outcomes being analyzed retrospectively.

You may qualify if:

• Risonanza Magnetica informed consent signed
• All patients that received total neoadjuvant therapy (TNT) (chemo/radiotherapy followed by surgery), between 2009 and 2022 at our institution
• Staging and re-staging MRI available

You may not qualify if:

• Staging and re-staging MRI not available

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Department of Radiology, IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 25, 2025
• Study Start: March 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: August 15, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)