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RecruitingNCT07802197PRELUDEUpdated Sep 3, 2026

Neoadjuvant Radiotherapy vs Upfront Surgery in Locally Advanced Proximal Rectal Cancer

An interventional study of radiotherapy and surgery in Rectal Adenocarcinoma, sponsored by Istanbul University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Istanbul University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Rectal Adenocarcinoma

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Keywords

  • Rectal Cancer, Neoadjuvant Radiotherapy, Upfront Surgery
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Locally Advanced Proximally Rectal Cancer

Exclusion criteria

Exclusion Criteria:

  • Distant metastasis
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Upfront Surgery

    Procedure: surgery

  • Experimental
    Neoadjuvant Radiotherapy Followed by Surgery

    Radiation: radiotherapy · Procedure: surgery

Interventions

  • Radiationradiotherapy

    Neoadjuvant Radiotherapy

  • Proceduresurgery

    Upfront Surgery

05

What researchers measure

Primary outcomes

  1. Locally Recurrance

    Time frame: The first five years after enrollment.

06

Study locations

1 of 1 sites recruiting
  • İstanbul Univercity Faculty of Medicine
    Istanbul, Turkey (Türkiye)
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07802197
Lead sponsor
Istanbul University
Responsible party
Baki Aydinli (medical doctor, Istanbul University) — Principal investigator
First posted
Sep 3, 2026
Start date
Apr 6, 2026
Primary completion
Jun 1, 2031 (estimated)
Completion
Dec 1, 2031 (estimated)
Last update
Sep 3, 2026

Study contacts

Baki Aydınlı
Contact
drbakiaydinli@gmail.com
+9002124142000

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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