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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07557316

Enrollment

100

Registered

2026-04-29

Start date

2026-05-10

Completion date

2027-05-10

Last updated

2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer Patients, Total Neoadjuvant Therapy

Keywords

ypN, TNT, ypT

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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).

Secondary

Measure	Time frame	Description
overall survival (OS)	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

Countries

Egypt

Contacts

CONTACTManar Abd El-Mawla Mohamed, master

Manar.Abdelmola@med.sohag.edu.eg01114314946

Outcome results