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RECRUITING
NCT07802197
NA

Neoadjuvant Radiotherapy vs Upfront Surgery in Locally Advanced Proximal Rectal Cancer

Sponsor: Istanbul University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-04-06

Completion Date

2031-12-01

Last Updated

2026-09-03

Healthy Volunteers

No

Interventions

RADIATION

radiotherapy

Neoadjuvant Radiotherapy

PROCEDURE

surgery

Upfront Surgery

Locations (1)

İstanbul Univercity Faculty of Medicine

Istanbul, Turkey (Türkiye)