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

Rectal Cancer Clinical Trial

Official title:
A Phase III, Multi-institutional Randomised Trial Comparing Neoadjuvant Chemoradiotherapy (NARCT) and Total Neoadjuvant Therapy (TNT) in Patients With T3 (a/b/c) Rectal Cancer

Clinical Trial Summary

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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06097416
Study type Interventional
Source St. James's Hospital, Ireland
Contact Michael Kelly, PhD
Phone 00353876638956
Email kellym11@tcd.ie
Status Not yet recruiting
Phase Phase 3
Start date October 2024
Completion date October 2030
View Details
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