Neoadjuvant Chemoradiotherapy Versus Total Neoadjuvant Therapy in the Treatment of T3 Rectal Cancer

The gold standard treatment for locally advanced, non-metastatic rectal cancer includes neoadjuvant chemoradiotherapy (NACRT), total mesorectal excision (TME) and adjuvant chemotherapy (AC). The primary goal of treatment is to achieve local disease control, reduce tumour volume and minimise the risk of distant metastases. While this multimodal treatment approach has offered improvements in local control and sphincter preservation, it has had little effect on distant recurrence and overall survival. We aim to compare NACRT and TME using the following endpoints: Primary --\>To compare the effects neoadjuvant chemoradiotherapy versus total neoadjuvant therapy (TNT) for T3 rectal cancer on overall survival. Secondary --\> To compare the effects neoadjuvant chemoradiotherapy (NARCT) and total neoadjuvant therapy (TNT) for cT3 rectal cancer on clinical outcomes: * Clinical complete response (cCR) * Pathological complete response (pCR) * Disease-free survival (DFS) * Organ preservation * Overall morbidity / mortality * Treatment-related morbidity / mortality * Peri-operative outcomes

NCT Number	NCT06097416
Lead Sponsor	St. James's Hospital, Ireland
Conditions	Rectal Cancer
Enrollment	100 participants
Start Date	2024-10
Primary Completion	2025-10 (estimated)
Study Completion	2030-10 (estimated)
Updated on ClinicalTrials.gov	2023-10-25