Radiological Markers in Locally Advanced Rectal Cancer
ConditionLocally Advanced Rectal Carcinoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Staging and re-staging MRI not available
Trial 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.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
5 years2
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.
Time frame
5 yearsSecondary outcomes
1
Prognostic Value of EMVI Score on Time to Progression (TTP)
The study will evaluate the impact of extramural venous invasion (EMVI) on time to progression (TTP) in patients with locally advanced rectal cancer (LARC) undergoing total neoadjuvant therapy (TNT). TTP, measured in months, will be defined as the time from diagnosis to documented disease progression based on clinical, radiological, or pathological criteria. Patients will be stratified by EMVI Score, assessed on staging MRI. Progression-free probabilities will be estimated using Kaplan-Meier survival curves, with group comparisons performed via the log-rank test. The prognostic value of the EMVI Score will be examined through Cox proportional hazards regression.
Time frame
5 years2
Prognostic Value of Tumor Deposits on Time to Progression (TTP)
The study will evaluate the impact of tumor deposits (TDs) on time to progression (TTP) in patients with locally advanced rectal cancer (LARC) undergoing total neoadjuvant therapy (TNT). TTP, measured in months, will be defined as the time from diagnosis to documented disease progression based on clinical, radiological, or pathological criteria. Patients will be stratified based on the presence of TDs, identified on staging MRI. Progression-free probabilities will be estimated using Kaplan-Meier survival curves, with group comparisons performed via the log-rank test. The prognostic significance of TDs will be analyzed using Cox proportional hazards regression.
Time frame
5 years3
Prognostic Value of Mesorectal Fascia Infiltration on Time to Progression (TTP)
The study will evaluate the impact of mesorectal fascia infiltration (MFI) on time to progression (TTP) in patients with locally advanced rectal cancer (LARC) undergoing total neoadjuvant therapy (TNT). TTP, measured in months, will be defined as the time from diagnosis to documented disease progression based on clinical, radiological, or pathological criteria. Patients will be stratified based on the presence of MFI, identified on staging MRI. Progression-free probabilities will be estimated using Kaplan-Meier survival curves, with group comparisons performed via the log-rank test. The prognostic significance of MFI will be analyzed using Cox proportional hazards regression.
Time frame
5 years4
Prognostic Value of EMVI Score on Overall Survival (OS)
The study will evaluate the impact of the EMVI Score on OS in patients with locally advanced rectal cancer (LARC) undergoing total neoadjuvant therapy (TNT). OS, measured in months, will be defined as the time from diagnosis to death. Patients will be stratified by EMVI Score, assessed on staging MRI. Survival probabilities will be estimated using Kaplan-Meier curves, with group comparisons performed via the log-rank test. The prognostic significance of the EMVI Score will be analyzed using Cox proportional hazards regression.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov
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