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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSohag University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Group 1

Trial outcomes

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).

Time frame
1 year

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

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