Locally Advanced Rectal CarcinomaLARCNCT06843655
Radiological Markers in Locally Advanced Rectal Cancer
An observational study of Locally Advanced Rectal Carcinoma, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Rectal Carcinoma
- How many people
- 179 participants
- Where
- 1 siteItaly
- Study dates
- 21 Mar 2025to 15 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Staging and re-staging MRI not available
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Locally Advanced Rectal Carcinoma
- Keywords
- Locally Advanced Rectal Cancer (LARC), Total Neoadjuvant Therapy (TNT), Diffusion-Weighted MRI (DWI), Likert Score, Radiological Prognostic Markers
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 years
Secondary outcomes (6)
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
Prognostic Value of Tumor Deposits on Overall Survival (OS)
The study will evaluate the impact of tumor deposits (TDs) 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 based on the presence of TDs, identified 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 TDs will be analyzed using Cox proportional hazards regression.
Measured: 5 years
Prognostic Value of Mesorectal Fascia Infiltration on Overall Survival (OS)
The study will evaluate the impact of mesorectal fascia infiltration (MFI) 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 based on the presence of MFI, assesed 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 MFI will be analyzed using Cox proportional hazards regression.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start21 Mar 2025
- Primary completion31 Dec 2025
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal CarcinomaStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 179 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco De Cobelli, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843655
- Sponsor's protocol ID
- LARC Protocol
- Acronym
- LARC
- Status last verified
- Sep 2026
- First submitted
- 18 Feb 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological Markers in Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT06843655
- Acronym / sponsor ID
- LARC / LARC Protocol
- Conditions
- Locally Advanced Rectal Carcinoma
- Keywords
- Locally Advanced Rectal Cancer (LARC), Total Neoadjuvant Therapy (TNT), Diffusion-Weighted MRI (DWI), Likert Score, Radiological Prognostic Markers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 179 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Staging and re-staging MRI not available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time To Progression (TTP) Stratified by Likert Score
Time frame: 5 years
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.
Overall Survival (OS) Stratified by Likert Score
Time frame: 5 years
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.
6 secondary outcomes
Prognostic Value of EMVI Score on Time to Progression (TTP)
Time frame: 5 years
Prognostic Value of Tumor Deposits on Time to Progression (TTP)
Time frame: 5 years
Prognostic Value of Mesorectal Fascia Infiltration on Time to Progression (TTP)
Time frame: 5 years
Prognostic Value of EMVI Score on Overall Survival (OS)
Time frame: 5 years
Prognostic Value of Tumor Deposits on Overall Survival (OS)
Time frame: 5 years
Prognostic Value of Mesorectal Fascia Infiltration on Overall Survival (OS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Rectal Carcinoma, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time To Progression (TTP) Stratified by Likert Score (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.