Abstract
BackgroundPreoperative chemoradiotherapy (pre-CRT) followed by total mesorectal excision (TME) is currently a standard therapy for locally advanced mid-to-low rectal cancer. Less aggressive, organ-preserving option such as local excision (LE) or watchful wait can alternatively be used for patients who respond well to pre-CRT. High-resolution rectal magnetic resonance imaging (MRI) is one of the most useful methods to assess pre-CRT response, and the MERCURY group has shown that the MR tumor regression grade (mrTRG) correlated with the pathologic TRG. The aim of this study is to compare postoperative complication and oncologic outcomes between LE and TME in mid-to-low rectal cancer patients whose tumors are mrTRG grade 1 (radiological complete remission) or 2 (predominant fibrosis; near-complete remission) after pre-CRT.MethodsA prospective, double-arm, randomized, open-labeled, single center, clinical trial will be conducted in patients with mid-to-low rectal cancer whose tumors are mrTRG 1/2 after pre-CRT at the Asan Medical Center, Seoul, Korea, after approval from the Institution Review Board. Patient medical records will be de-identified using a serial number to protect personal information. Inclusion criteria will include rectal adenocarcinoma with an inferior border < 8 cm from the anal verge, mrTRG 1/2, age > 20, and provision of informed consent. Postoperative complications will be assessed by Clavien-Dindo Classification Grade. Oncologic and functional outcomes will be collected and risk factors related to these outcomes will be investigated.DiscussionWe believed that the rate of postoperative complication of LE will be comparable to that of TME in mid-to-low advanced rectal cancer patients with a favorable response after pre-CRT.Trial registrationKCT0002579 (https://cris.nih.go.kr) Dec-2017.
Highlights
Preoperative chemoradiotherapy followed by total mesorectal excision (TME) is currently a standard therapy for locally advanced mid-to-low rectal cancer
Preoperative chemoradiotherapy (Pre-CRT) followed by TME is recommended for patients with locally advanced mid-to-low rectal cancer [5,6,7,8,9]
Discussion Preoperative chemoradiotherapy (pre-CRT) followed by TME has become the standard treatment for patients with locally advanced rectal cancer, recent evidences suggests that organ-preserving strategies such as local excision (LE) and watchful waiting can be used as an alternatively to TME in patients with a favorable response to pre-CRT without compromising oncologic outcomes and high rate of major low anterior resection syndrome (LARS) [14,15,16,17,18,19, 31]
Summary
Preoperative chemoradiotherapy (pre-CRT) followed by total mesorectal excision (TME) is currently a standard therapy for locally advanced mid-to-low rectal cancer. The aim of this study is to compare postoperative complication and oncologic outcomes between LE and TME in mid-to-low rectal cancer patients whose tumors are mrTRG grade 1 (radiological complete remission) or 2 (predominant fibrosis; near-complete remission) after pre-CRT. In the treatment of rectal cancer, total mesorectal excision (TME) improves oncologic outcomes and adding preoperative chemo-radiotherapy (pre-CRT) to TME has been shown to effectively improve local control [1,2,3,4]. For this reason, pre-CRT followed by TME is recommended for patients with locally advanced mid-to-low rectal cancer [5,6,7,8,9]. This results suggests that LE, compared with watchful wait, is more likely to result in pCR [25]
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