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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07802197
Acronym
PRELUDE
Enrollment
100
Registered
2026-09-03
Start date
2026-04-06
Completion date
2031-12-01
Last updated
2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Adenocarcinoma

Keywords

Rectal Cancer, Neoadjuvant Radiotherapy, Upfront Surgery

Brief 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.

Interventions

RADIATIONradiotherapy

Neoadjuvant Radiotherapy

PROCEDUREsurgery

Upfront Surgery

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Locally Advanced Proximally Rectal Cancer

Exclusion criteria

* Distant metastasis

Design outcomes

Primary

MeasureTime frame
Locally RecurranceThe first five years after enrollment.

Countries

Turkey (Türkiye)

Contacts

CONTACTBaki Aydınlı
drbakiaydinli@gmail.com+9002124142000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026