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

NCT07557316 | Not Yet Recruiting DMC

• 1 other identifier: Soh-Med-26-4-9MS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rectal Cancer Patients; Total Neoadjuvant Therapy

Keywords

ypN; TNT; ypT

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  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 Outcomes (1)

• overall survival (OS)

  1 year

Study Arms (1)

Group 1

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, Egypt

Location

Central Study Contacts

Manar Abd El-Mawla Mohamed, master

CONTACT

01114314946; Manar.Abdelmola@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at Department of Clinical Oncology and Nuclear Medicine, Sohag Faculty of Medicine

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): May 10, 2026
• Primary Completion (Estimated): March 10, 2027
• Study Completion (Estimated): May 10, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

EG (1)