Clinical trial NCT06843655: Radiological Markers in Locally Advanced Rectal Cancer
Official title: Radiological Markers in Locally Advanced Rectal Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Locally Advanced Rectal Carcinoma
Keywords: Locally Advanced Rectal Cancer (LARC)
Total Neoadjuvant Therapy (TNT)
Diffusion-Weighted MRI (DWI)
Likert Score
Radiological Prognostic Markers
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

Detailed description: This study investigates the prognostic role of diffusion-weighted MRI (DWI), using the Likert Score and other radiological markers, in patients with locally advanced rectal cancer (LARC) undergoing total neoadjuvant therapy (TNT) followed by radical surgery. The study cohort consists of 179 patients who received TNT between 2009 and 2022 at our institution. Inclusion criteria required patients to have biopsy-confirmed stage II-III LARC, available MRI at both staging and restaging time points, and completion of the TNT protocol.

The TNT regimen included up to three cycles of modified XELOX chemotherapy (oxaliplatin and capecitabine), with the first cycle administered as induction chemotherapy and the remaining two cycles administered concurrently with radiotherapy (total dose: 46.2 Gy in 18 fractions). Surgical resection was performed at a median of 11 weeks post-radiotherapy, with adjuvant chemotherapy administered based on histopathology findings.

MRI acquisition was standardized using a 1.5-T scanner, with DWI sequences applied to assess key prognostic markers, including extramural venous invasion (EMVI), tumor deposits (TDs), and mesorectal fascia invasion (MFI). The Likert Score, a five-point grading system based on DWI findings, was applied to restaging MRI to stratify treatment response, with scores of 0-2 indicating a favorable response and 3-4 indicating a poor response.

The study's primary objective is to evaluate the impact of the Likert Score on overall survival (OS) and time to progression (TTP). Secondary objectives include assessing the prognostic significance of EMVI, TDs, and MFI in predicting OS and TTP. The statistical analysis will include Kaplan-Meier survival curves to estimate OS and TTP, stratified according to the presence/score of radiological markers, Cox proportional hazards regression to assess the impact of prognostic factors on survival outcomes, Fisher's exact test to evaluate associations between categorical variables, and Cohen's Kappa to measure interobserver agreement in MRI assessments..

This study aims to refine MRI-based prognostic assessment tools to enhance personalized treatment strategies for rectal cancer. Findings from this research may support the integration of DWI-based Likert Score evaluation into clinical practice to improve risk stratification and treatment decision-making in patients with LARC undergoing TNT. The follow-up period extends until July 31, 2024, ensuring a comprehensive analysis of long-term outcomes.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Staging and re-staging MRI not available

Primary outcomes:
measure: Time To Progression (TTP) Stratified by Likert Score
timeFrame: 5 years
measure: Overall Survival (OS) Stratified by Likert Score
timeFrame: 5 years
Secondary outcomes:
measure: Prognostic Value of EMVI Score on Time to Progression (TTP)
timeFrame: 5 years
measure: Prognostic Value of Tumor Deposits on Time to Progression (TTP)
timeFrame: 5 years
measure: Prognostic Value of Mesorectal Fascia Infiltration on Time to Progression (TTP)
timeFrame: 5 years
measure: Prognostic Value of EMVI Score on Overall Survival (OS)
timeFrame: 5 years
measure: Prognostic Value of Tumor Deposits on Overall Survival (OS)
timeFrame: 5 years
measure: Prognostic Value of Mesorectal Fascia Infiltration on Overall Survival (OS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Department of Radiology, IRCCS Ospedale San Raffaele
Study officials:
References: