Neoadjuvant Chemoradiotherapy Versus Total Neoadjuvant Therapy in the Treatment of T3 Rectal Cancer
Status:
Not yet recruiting
Trial end date:
2030-10-01
Target enrollment:
Participant gender:
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