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Neoadjuvant Radiotherapy vs Upfront Surgery in Locally Advanced Proximal Rectal Cancer

Sponsor: Istanbul University • ClinicalTrials.gov ID: NCT07802197

Registry updated: 2026-09-03

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Description

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.

Interventions

radiotherapy (Radiation)
Neoadjuvant Radiotherapy
surgery (Procedure)
Upfront Surgery

Eligibility criteria

Inclusion Criteria: * Locally Advanced Proximally Rectal Cancer Exclusion Criteria: * Distant metastasis

Conditions

Rectal Adenocarcinoma

Locations

İstanbul Univercity Faculty of Medicine — Istanbul, Turkey (Türkiye)

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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