NCT07802197

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
63mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Apr 2026Dec 2031

Study Start

First participant enrolled

April 6, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2031

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2031

Last Updated

September 3, 2026

Status Verified

August 1, 2026

Enrollment Period

5.2 years

First QC Date

June 17, 2026

Last Update Submit

September 2, 2026

Conditions

Rectal Adenocarcinoma

Keywords

Rectal Cancer, Neoadjuvant Radiotherapy, Upfront Surgery

Outcome Measures

Primary Outcomes (1)

  • Locally Recurrance

    The first five years after enrollment.

Study Arms (2)

Upfront Surgery

ACTIVE COMPARATOR
Procedure: surgery

Neoadjuvant Radiotherapy Followed by Surgery

EXPERIMENTAL
Radiation: radiotherapyProcedure: surgery

Interventions

radiotherapyRADIATION

Neoadjuvant Radiotherapy

Neoadjuvant Radiotherapy Followed by Surgery
surgeryPROCEDURE

Upfront Surgery

Neoadjuvant Radiotherapy Followed by SurgeryUpfront Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Locally Advanced Proximally Rectal Cancer

You may not qualify if:

  • Distant metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Univercity Faculty of Medicine

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

RadiotherapySurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Baki Aydınlı

CONTACT

+9002124142000drbakiaydinli@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

June 17, 2026

First Posted

September 3, 2026

Study Start

April 6, 2026

Primary Completion (Estimated)

June 1, 2031

Study Completion (Estimated)

December 1, 2031

Last Updated

September 3, 2026

Record last verified: 2026-08

Locations

TU(1)