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

N/ANot Yet RecruitingNCT07557316

Sohag University100 enrolled

Overview

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

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

100

Conditions

Rectal Cancer Patients Total Neoadjuvant Therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sohag University

Sohag, Egypt

Outcomes

Primary Outcomes

Disease-free survival (DFS)

Time frame: 1 year

Secondary Outcomes

overall survival (OS)

* 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

Time frame: 1 year

Central Contacts

Manar Abd El-Mawla Mohamed, master

CONTACT

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

Data from ClinicalTrials.gov

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