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Radiological Markers in Locally Advanced Rectal Cancer

Study acronym: LARC
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Not Yet Recruiting → Active, Not Recruiting Primary completion date changed from estimate of Jul 31, 2025 to Dec 31, 2025 · Completion pushed from Aug 15, 2025 to Dec 15, 2026 · Start date changed from estimate of Mar 1, 2025 to Mar 21, 2025 · 3 more Show 6 more changesShow less
    • Primary completion date changed from estimate of Jul 31, 2025 to Dec 31, 2025
    • Completion pushed from Aug 15, 2025 to Dec 15, 2026
    • Start date changed from estimate of Mar 1, 2025 to Mar 21, 2025
    • Secondary endpoints: details revised at 6 of 6 entries
    • Site contact updated
    • Eligibility criteria expanded, about 4 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06843655
Lead Sponsor IRCCS San Raffaele
Conditions Locally Advanced Rectal Carcinoma
Enrollment 179 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov