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
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.
Exclusion Criteria:
Procedure: surgery
Radiation: radiotherapy · Procedure: surgery
Neoadjuvant Radiotherapy
Upfront Surgery
Locally Recurrance
Time frame: The first five years after enrollment.
Plan to share: Undecided
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Istanbul University