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NCT Number: NCT07802197

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

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.

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Key information

Conditions

Rectal Adenocarcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İstanbul Univercity Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Locally Advanced Proximally Rectal Cancer

Exclusion criteria

  • Distant metastasis

Treatment and study plan

Radiotherapy

Radiation

Neoadjuvant Radiotherapy

Surgery

Procedure

Upfront Surgery

Primary outcomes

  1. Locally Recurrance

    Time frame: The first five years after enrollment.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study 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

Acronym: PRELUDE

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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