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International Journal of Colorectal Disease
Published in: International Journal of Colorectal Disease 2/2018

01-02-2018 | Clinical Study Protocol

Non-inferiority multicenter prospective randomized controlled study of rectal cancer T2–T3s (superficial) N0, M0 undergoing neoadjuvant treatment and local excision (TEM) vs total mesorectal excision (TME)

Authors: X. Serra-Aracil, C. Pericay, T. Golda, L. Mora, E. Targarona, S. Delgado, A. Reina, F. Vallribera, J. M. Enriquez-Navascues, S. Serra-Pla, J. C. Garcia-Pacheco, On behalf of TAU-TEM study group

Published in: International Journal of Colorectal Disease | Issue 2/2018

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Abstract

Purpose

The standard treatment of rectal adenocarcinoma is total mesorectal excision (TME), in many cases requires a temporary or permanent stoma. TME is associated with high morbidity and genitourinary alterations. Transanal endoscopic microsurgery (TEM) allows access to tumors up to 20 cm from the anal verge, achieves minimal postoperative morbidity and mortality rates, and does not require an ostomy. The treatment of T2, N0, and M0 cancers remains controversial. Preoperative chemoradiotherapy (CRT) in association with TEM reduces local recurrence and increases survival. The TAU-TEM study aims to demonstrate the non-inferiority of the oncological outcomes and the improvement in morbidity and quality of life achieved with TEM compared with TME.

Methods

Prospective, multicenter, randomized controlled non-inferiority trial includes patients with rectal adenocarcinoma less than 10 cm from the anal verge and up to 4 cm in size, staged as T2 or T3-superficial N0-M0. Patients will be randomized to two areas: CRT plus TEM or radical surgery (TME). Postoperative morbidity and mortality will be recorded and patients will complete the quality of life questionnaires before the start of treatment, after CRT in the CRT/TEM arm, and 6 months after surgery in both arms. The estimated sample size for the study is 173 patients. Patients will attend follow-up controls for local and systemic relapse.

Conclusions

This study aims to demonstrate the preservation of the rectum after preoperative CRT and TEM in rectal cancer stages T2–3s, N0, M0 and to determine the ability of this strategy to avoid the need for radical surgery (TME).

Trial registration

ClinicalTrials.​gov identifier: NCT01308190. Número de registro del Comité de Etica e Investigación Clínica (CEIC) del Hospital universitario Parc Taulí: TAU-TEM-2009-01.
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Metadata
Title
Non-inferiority multicenter prospective randomized controlled study of rectal cancer T2–T3s (superficial) N0, M0 undergoing neoadjuvant treatment and local excision (TEM) vs total mesorectal excision (TME)
Authors
X. Serra-Aracil
C. Pericay
T. Golda
L. Mora
E. Targarona
S. Delgado
A. Reina
F. Vallribera
J. M. Enriquez-Navascues
S. Serra-Pla
J. C. Garcia-Pacheco
On behalf of TAU-TEM study group
Publication date
01-02-2018
Publisher
Springer Berlin Heidelberg
Published in
International Journal of Colorectal Disease / Issue 2/2018
Print ISSN: 0179-1958
Electronic ISSN: 1432-1262
DOI
https://doi.org/10.1007/s00384-017-2942-1

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