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.
Parallel
Neoadjuvant Chemoradiotherapy
Drug5-FU is a fluoropyrimidine antimetabolite considered to act primarily as an inhibitor of thymidylate synthase. 5-FU is supplied as a colourless-to-faint yellow solution in 10-mL single use vials. Each 10 mL of solution contains 500 mg 5-FU, with pH adjusted to approximately 9.2 with sodium hydroxide. The CRT regimen consists of the standard algorithms: a total of 5400-5600 cGy of radiation (4500 cGy to the pelvis, with an integrated boost to the primary tumour and involved nodes of 500 cGy followed by an option boost to the primary tumour and involved nodes) delivered in 27-28 fractions, respectively, of 180-200 cGy each over a 5-6 week period.
Total Neoadjuvant Therapy
Drug5-FU is a fluoropyrimidine antimetabolite considered to act primarily as an inhibitor of thymidylate synthase. 5-FU is supplied as a colourless-to-faint yellow solution in 10-mL single use vials. Each 10 mL of solution contains 500 mg 5-FU, with pH adjusted to approximately 9.2 with sodium hydroxide. Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2- diaminocyclohexane with an oxalate ligand as a leaving group. Platinum content is 48.1% to 50.1%. All patients received the same chemotherapy (FOLFOX) and long-course chemoradiotherapy (50.4 Gy in 28 fractions) before surgery.
Overall survival
Alive
Clinical complete response
No residual tumour visible on imaging
Pathological complete response
Absence of residual invasive or in situ tumour on biopsy / resected specimen.
Disease-free survival
Measure of time after treatment where no evidence of disease is found.
Progression-free survival
Time from randomisation to occurrence of disease progression or death
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