Local excision in mid-to-low rectal cancer patients who revealed clinically total or near-total regression after preoperative chemoradiotherapy; a proposed trial.

Abstract

BACKGROUND:

Preoperative 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.

METHODS:

A 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.

DISCUSSION:

We 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 REGISTRATION:

KCT0002579 ( https://cris.nih.go.kr ) Dec-2017.

• Authors: Jong Lyul Lee, Seok-Byung Lim, Chang Sik Yu, In Ja Park, Yong Sik Yoon, Chan Wook Kim, Seong Ho Park, Jong Seok Lee, Yong Sang Hong, Sun Young Kim, Jeong Eun Kim, Jong Hoon Kim, Jin-Hong Park, Jihun Kim, Minkyu Han
• Journal: BMC cancer (BMC Cancer) Vol. 19 Issue 1 Pg. 404 (Apr 29 2019) ISSN: 1471-2407 [Electronic] England
• PMID: 31035949 (Publication Type: Journal Article, Randomized Controlled Trial)

Topics

• Adenocarcinoma (diagnostic imaging, therapy)
• Adult
• Aged
• Aged, 80 and over
• Chemoradiotherapy
• Female
• Humans
• Magnetic Resonance Imaging (methods)
• Male
• Middle Aged
• Outcome Assessment, Health Care (methods, statistics & numerical data)
• Postoperative Complications (diagnostic imaging)
• Preoperative Period
• Prospective Studies
• Rectal Neoplasms (diagnostic imaging, therapy)