Non-inferiority multicenter prospective randomized controlled study of rectal cancer T<inf>2</inf>–T<inf>3s</inf> (superficial) N<inf>0</inf>, M<inf>0</inf> undergoing neoadjuvant treatment and local excision (TEM) vs total mesorectal excision (TME)

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, Eugeni Saigi, Emma Dotor, Aleidis Pisa, Ismael Macias, Anna Pallisera, Salvador Navarro, Antonio Lacy, Anna Otero, Sebastiano BiondoT. Golda, Eduardo Tarragona, Pilar Hernández, Mª Carmen Martínez, Juan Carlos Pernas, Marta Martín, Dolores González, David Paez, Xavier Cussó, C. Balagué, Mª José García Coret, Francisco Villalba Ferrer, Beatriz Díaz San Andrés, Álvarez Gallego, Higuera Prieto, Jose Luis Ramos, Javier Jiménez Miramó, Javier García Septiem, Francisco Angulo, Julio Castillo, Joaquín Alonso Martín, Isabel Seco, Carlos Manuel Palazuelo, Ángel Reina, Francisco A. Rubio Gil, Carmen Caro, Rubén Varela, Manuel Ramos, Ana Fernández, Ricardo Belda, Ramon Solbes, Begoña Medina, Piedad Reche, Eloy Espín, Francesc Vallribera, Stefania Landolfini, Jaume Capdevila, Marta Pascual, Silvia Salvans, Miguel Pera, César Díaz, Jose Gomez Barbadillo, Amalia Palacios, Carlos Villar Pastor, María Pleguezuelo, Francisco Triviño, José L. Martínez de Dueñas, Auxiliadora Gómez España, Elena Navarro Rodriguez, Roberto Lozoya Trujillo, Andrés Frangi, Mª Dolores Ruiz Carmona, Rodolfo Rodríguez Carrillo, Mireia Gil, Vicente Miranda, Carlos Álvarez Laso, Paola Lora, José Mª Enriquez Navascues, Carlos Placer, Nerea Borda, Adelaida La Casta, Jl Elosegui, Yolanda Saralegui, Elena Guimón, Ja Múgica, Javier Gallego Plazas, Antonio Arroyo, Aleidis Caro, Monica Millan

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9 Citations (Scopus)

Abstract

© 2017, Springer-Verlag GmbH Germany, part of Springer Nature. 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.
Original languageEnglish
Pages (from-to)241-249
JournalInternational Journal of Colorectal Disease
Volume33
Issue number2
DOIs
Publication statusPublished - 1 Feb 2018

Keywords

  • Local excision and rectal cancer
  • Neoadjuvant treatment and rectal cancer
  • Rectal cancer
  • Total mesorectal excision (TME)
  • Transanal endoscopic microsurgery (TEM)

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