Neoadjuvant Radiotherapy vs Upfront Surgery in Locally Advanced Proximal Rectal Cancer
ConditionRectal Adenocarcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstanbul University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Locally Advanced Proximally Rectal Cancer
Disqualifiers
Distant metastasis
Trial design
Design model
Single group
Treatments tested in this trial
radiotherapy
RadiationNeoadjuvant Radiotherapy
surgery
Procedure/SurgeryUpfront Surgery
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Upfront SurgeryActive comparator 1 intervention
Group B: Neoadjuvant Radiotherapy Followed by SurgeryExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Locally Recurrance
Time frame
The first five years after enrollment.Sponsors and contacts
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Source ClinicalTrials.gov