RecruitingNot ApplicableNCT07802197

Neoadjuvant Radiotherapy vs Upfront Surgery in Locally Advanced Proximal Rectal Cancer

The PRELUDE Study: A Prospective Cohort Study Comparing Neoadjuvant Radiotherapy Followed by Total Mesorectal Excision Versus Upfront Surgery in Patients With Locally Advanced Proximal Rectal Cancer


Sponsor

Istanbul University

Enrollment

100 participants

Start Date

Apr 6, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The PRELUDE Study: A Prospective Cohort Study Comparing Neoadjuvant Radiotherapy Followed by Total Mesorectal Excision Versus Upfront Surgery in Patients with Locally Advanced Proximal Rectal Cancer The PRELUDE Study is a single-center, prospective cohort study designed to compare neoadjuvant radiotherapy followed by total mesorectal excision (TME) with upfront surgery alone in patients with locally advanced proximal rectal cancer. The primary endpoint is the rate of local recurrence. Secondary endpoints include overall survival, disease-free survival, and functional outcomes related to bowel, urinary, and sexual function. The aim of this study is to determine whether neoadjuvant radiotherapy reduces the risk of local recurrence and improves long-term oncological and functional outcomes in this anatomically distinct subgroup of patients with rectal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying radiotherapy and a procedure called surgery for people with rectal adenocarcinoma. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONradiotherapy

Neoadjuvant Radiotherapy

PROCEDUREsurgery

Upfront Surgery


Locations(1)

İstanbul Univercity Faculty of Medicine

Istanbul, Turkey (Türkiye)

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NCT07802197


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