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Clinical Trials in Egypt / NCT07557316
Starting soon Observational

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

NCT07557316 · tracked via the Priya Life Science Egypt tracker
Sponsor
Sohag University
Phase
Observational
Started
2026-05-10
Last updated
2026-04-29

Condition(s) studied

Rectal Cancer PatientsTotal Neoadjuvant Therapy

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Disease-free survival (DFS) — 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).

Trial sites (1)

FacilityCityRegionStatus
Sohag University Sohag Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07557316 on ClinicalTrials.gov ↗ ← All trials in Egypt