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
Written informed consent must be given according to ICH/GCP and national/local regulations and be obtained prior to any study-related procedures.
Histologically or cytologically confirmed surgically resectable adenocarcinoma of the rectum.
Clinical stage II (T3, N-) \
Absence of metastatic disease
Received prior chemotherapy for local or metastatic disease.
Locally advanced rectal cancer; >T3, Nodal disease
Primary unresectable rectal cancer. A tumour is considered unresectable when invading adjacent organs and an en bloc resection will not achieve negative margins.
Received prior pelvic radiotherapy.