Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Neoadjuvant Radiotherapy Before Surgery for Locally Advanced Proximal 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

Run by Istanbul University · NCT07802197 · Data updated 2026-11-12

This study tests whether giving radiotherapy before surgery reduces cancer return in people with locally advanced proximal rectal cancer.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorIstanbul University
Academic / other
Locations1 site (Istanbul)
StatusRecruiting
StartedApril 6, 2026
Main results expectedJune 1, 2031
Study endsDecember 1, 2031
Registry record updatedSeptember 3, 2026
Trial IDNCT07802197 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with locally advanced proximal rectal cancer without distant metastasis who are candidates for either neoadjuvant radiotherapy plus TME or upfront surgery.

Probably not a fit

Patients with distant metastases or tumors not suitable for radiotherapy or TME may not benefit from this approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PRELUDE Study is a prospective cohort conducted at a single center to compare two treatment approaches for locally advanced proximal rectal cancer: neoadjuvant radiotherapy followed by total mesorectal excision (TME) versus upfront surgery. The primary outcome is local recurrence, with secondary measures including overall survival, disease-free survival, and functional bowel, urinary, and sexual outcomes. The study aims to determine if preoperative radiotherapy can lower local recurrence and improve long-term oncologic and functional results in this anatomically defined subgroup. Participants are adults with locally advanced proximal rectal cancer without distant metastasis, and the intervention involves radiotherapy and surgical resection. This is a non-randomized, observational comparison within a single center.

Why it matters

Potential benefit: If successful, patients may experience lower local recurrence and better long-term cancer control with preserved function.

How similar studies have gone: Prior studies in rectal cancer have explored neoadjuvant radiotherapy with varying success; this study adds prospective cohort data for a specific proximal subgroup.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Locally Advanced Proximally Rectal Cancer

Exclusion Criteria:

* Distant metastasis

Where it's running

  • İstanbul Univercity Faculty of Medicine
    Istanbul, Turkey (Türkiye)
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.