Nodal Downstaging Versus Primary Tumor Regression as Predictors of Survival After Total Neoadjuvant Therapy for Rectal Cancer: A Retrospective Study

April 22, 2026 updated by: Manar Abdelmola Mohamed, Sohag University
To evaluate the prognostic impact of post-TNT pathological nodal status (ypN) on LRFS, DMFS, and OS, and compare it with that of primary tumor response

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Disease-free survival (DFS), measured from surgery to recurrence (local or distant) or death. DFS will be evaluated in correlation with the pathological response after TNT, comparing the prognostic impact of nodal status (ypN0 vs ypN+) and primary tumor response (ypT stage and/or tumor regression grade).

  • overall survival (OS), defined as the time from the date of diagnosis to death from any cause, and will be analyzed in the same manner as DFS in correlation with the pathological nodal status and primary tumor response.
  • Identification of Independent Prognostic Factors: To identify which clinical and pathological factors independently affect disease-free and overall survival after adjusting for other variables.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with locally advanced rectal adenocarcinoma received total neoadjuvant therapy then underwent total mesorectal excision.

Description

Inclusion Criteria:

patients who were more than18 years old at time of diagnosis. Pathological confirmation of rectal adenocarcinoma. Locally advanced stage II&III rectal carcinoma (≥T3 and or N+) at initial diagnosis.

Patients treated with Total Neoadjuvant Therapy (TNT), including either chemoradiotherapy (CRT) followed by consolidation chemotherapy, induction chemotherapy followed by CRT, or short-course radiotherapy (SCRT) followed by chemotherapy, and subsequently undergoing TME.

Available pathological assessment of surgical specimens.

Exclusion Criteria:

Patients with distant metastasis at presentation or other comorbid diseases. Patients with incomplete clinical and pathological staging information. Missing key clinical or pathological data. Patients who did not receive TNT or undergo TME surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1
patients with locally advanced rectal adenocarcinoma received total neoadjuvant therapy then underwent total mesorectal excision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS)
Time Frame: 1 year
Disease-free survival (DFS), measured from surgery to recurrence (local or distant) or death. DFS will be evaluated in correlation with the pathological response after TNT, comparing the prognostic impact of nodal status (ypN0 vs ypN+) and primary tumor response (ypT stage and/or tumor regression grade).
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival (OS)
Time Frame: 1 year
  • overall survival (OS), defined as the time from the date of diagnosis to death from any cause, and will be analyzed in the same manner as DFS in correlation with the pathological nodal status and primary tumor response.
  • Identification of Independent Prognostic Factors: To identify which clinical and pathological factors independently affect disease-free and overall survival after adjusting for other variables
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 10, 2026

Primary Completion (Estimated)

March 10, 2027

Study Completion (Estimated)

May 10, 2027

Study Registration Dates

First Submitted

April 22, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Soh-Med-26-4-9MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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