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 Biondo; T. 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

doi:10.1007/s00384-017-2942-1

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

Research output: Contribution to journal › Article › Research › peer-review

16 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 language	English
Pages (from-to)	241-249
Journal	International Journal of Colorectal Disease
Volume	33
Issue number	2
DOIs	https://doi.org/10.1007/s00384-017-2942-1
Publication status	Published - 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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This output contributes to the following UN Sustainable Development Goals (SDGs)

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Serra-Aracil, X., Pericay, C., Golda, T., Mora, L., Targarona, E., Delgado, S., Reina, A., Vallribera, F., Enriquez-Navascues, J. M., Serra-Pla, S., Garcia-Pacheco, J. C., Saigi, E., Dotor, E., Pisa, A., Macias, I., Pallisera, A., Navarro, S., Lacy, A., Otero, A., ... Millan, M. (2018). 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). International Journal of Colorectal Disease, 33(2), 241-249. https://doi.org/10.1007/s00384-017-2942-1

Serra-Aracil, X. ; Pericay, C. ; Golda, T. et al. / 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). In: International Journal of Colorectal Disease. 2018 ; Vol. 33, No. 2. pp. 241-249.

@article{5571f108fbd649e18397bffe8b945996,

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)",

abstract = "{\textcopyright} 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. N{\'u}mero de registro del Comit{\'e} de Etica e Investigaci{\'o}n Cl{\'i}nica (CEIC) del Hospital universitario Parc Taul{\'i}: TAU-TEM-2009-01.",

keywords = "Local excision and rectal cancer, Neoadjuvant treatment and rectal cancer, Rectal cancer, Total mesorectal excision (TME), Transanal endoscopic microsurgery (TEM)",

author = "X. Serra-Aracil and C. Pericay and T. Golda and L. Mora and E. Targarona and S. Delgado and A. Reina and F. Vallribera and Enriquez-Navascues, {J. M.} and S. Serra-Pla and Garcia-Pacheco, {J. C.} and Eugeni Saigi and Emma Dotor and Aleidis Pisa and Ismael Macias and Anna Pallisera and Salvador Navarro and Antonio Lacy and Anna Otero and Sebastiano Biondo and T. Golda and Eduardo Tarragona and Pilar Hern{\'a}ndez and Mart{\'i}nez, {Mª Carmen} and Pernas, {Juan Carlos} and Marta Mart{\'i}n and Dolores Gonz{\'a}lez and David Paez and Xavier Cuss{\'o} and C. Balagu{\'e} and Coret, {Mª Jos{\'e} Garc{\'i}a} and Ferrer, {Francisco Villalba} and Andr{\'e}s, {Beatriz D{\'i}az San} and {\'A}lvarez Gallego and Higuera Prieto and Ramos, {Jose Luis} and Miram{\'o}, {Javier Jim{\'e}nez} and Septiem, {Javier Garc{\'i}a} and Francisco Angulo and Julio Castillo and Mart{\'i}n, {Joaqu{\'i}n Alonso} and Isabel Seco and Palazuelo, {Carlos Manuel} and {\'A}ngel Reina and {Rubio Gil}, {Francisco A.} and Carmen Caro and Rub{\'e}n Varela and Manuel Ramos and Ana Fern{\'a}ndez and Ricardo Belda and Ramon Solbes and Bego{\~n}a Medina and Piedad Reche and Eloy Esp{\'i}n and Francesc Vallribera and Stefania Landolfini and Jaume Capdevila and Marta Pascual and Silvia Salvans and Miguel Pera and C{\'e}sar D{\'i}az and Barbadillo, {Jose Gomez} and Amalia Palacios and Pastor, {Carlos Villar} and Mar{\'i}a Pleguezuelo and Francisco Trivi{\~n}o and {Mart{\'i}nez de Due{\~n}as}, {Jos{\'e} L.} and Espa{\~n}a, {Auxiliadora G{\'o}mez} and Rodriguez, {Elena Navarro} and Trujillo, {Roberto Lozoya} and Andr{\'e}s Frangi and Carmona, {Mª Dolores Ruiz} and Carrillo, {Rodolfo Rodr{\'i}guez} and Mireia Gil and Vicente Miranda and Laso, {Carlos {\'A}lvarez} and Paola Lora and Navascues, {Jos{\'e} Mª Enriquez} and Carlos Placer and Nerea Borda and {La Casta}, Adelaida and Jl Elosegui and Yolanda Saralegui and Elena Guim{\'o}n and Ja M{\'u}gica and Plazas, {Javier Gallego} and Antonio Arroyo and Aleidis Caro and Monica Millan",

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Serra-Aracil, X, Pericay, C, Golda, T, Mora, L, Targarona, E, Delgado, S, Reina, A, Vallribera, F, Enriquez-Navascues, JM, Serra-Pla, S, Garcia-Pacheco, JC, Saigi, E, Dotor, E, Pisa, A, Macias, I, Pallisera, A, Navarro, S, Lacy, A, Otero, A, Biondo, S, Golda, T, Tarragona, E, Hernández, P, Martínez, MC, Pernas, JC, Martín, M, González, D, Paez, D, Cussó, X, Balagué, C, Coret, MJG, Ferrer, FV, Andrés, BDS, Gallego, Á, Prieto, H, Ramos, JL, Miramó, JJ, Septiem, JG, Angulo, F, Castillo, J, Martín, JA, Seco, I, Palazuelo, CM, Reina, Á, Rubio Gil, FA, Caro, C, Varela, R, Ramos, M, Fernández, A, Belda, R, Solbes, R, Medina, B, Reche, P, Espín, E, Vallribera, F, Landolfini, S, Capdevila, J, Pascual, M, Salvans, S, Pera, M, Díaz, C, Barbadillo, JG, Palacios, A, Pastor, CV, Pleguezuelo, M, Triviño, F, Martínez de Dueñas, JL, España, AG, Rodriguez, EN, Trujillo, RL, Frangi, A, Carmona, MDR, Carrillo, RR, Gil, M, Miranda, V, Laso, CÁ, Lora, P, Navascues, JME, Placer, C, Borda, N, La Casta, A, Elosegui, J, Saralegui, Y, Guimón, E, Múgica, J, Plazas, JG, Arroyo, A, Caro, A & Millan, M 2018, '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)', International Journal of Colorectal Disease, vol. 33, no. 2, pp. 241-249. https://doi.org/10.1007/s00384-017-2942-1

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). / Serra-Aracil, X.; Pericay, C.; Golda, T. et al.

In: International Journal of Colorectal Disease, Vol. 33, No. 2, 01.02.2018, p. 241-249.

Research output: Contribution to journal › Article › Research › peer-review

TY - JOUR

T1 - 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)

AU - Serra-Aracil, X.

AU - Pericay, C.

AU - Golda, T.

AU - Mora, L.

AU - Targarona, E.

AU - Delgado, S.

AU - Reina, A.

AU - Vallribera, F.

AU - Enriquez-Navascues, J. M.

AU - Serra-Pla, S.

AU - Garcia-Pacheco, J. C.

AU - Saigi, Eugeni

AU - Dotor, Emma

AU - Pisa, Aleidis

AU - Macias, Ismael

AU - Pallisera, Anna

AU - Navarro, Salvador

AU - Lacy, Antonio

AU - Otero, Anna

AU - Biondo, Sebastiano

AU - Golda, T.

AU - Tarragona, Eduardo

AU - Hernández, Pilar

AU - Martínez, Mª Carmen

AU - Pernas, Juan Carlos

AU - Martín, Marta

AU - González, Dolores

AU - Paez, David

AU - Cussó, Xavier

AU - Balagué, C.

AU - Coret, Mª José García

AU - Ferrer, Francisco Villalba

AU - Andrés, Beatriz Díaz San

AU - Gallego, Álvarez

AU - Prieto, Higuera

AU - Ramos, Jose Luis

AU - Miramó, Javier Jiménez

AU - Septiem, Javier García

AU - Angulo, Francisco

AU - Castillo, Julio

AU - Martín, Joaquín Alonso

AU - Seco, Isabel

AU - Palazuelo, Carlos Manuel

AU - Reina, Ángel

AU - Rubio Gil, Francisco A.

AU - Caro, Carmen

AU - Varela, Rubén

AU - Ramos, Manuel

AU - Fernández, Ana

AU - Belda, Ricardo

AU - Solbes, Ramon

AU - Medina, Begoña

AU - Reche, Piedad

AU - Espín, Eloy

AU - Vallribera, Francesc

AU - Landolfini, Stefania

AU - Capdevila, Jaume

AU - Pascual, Marta

AU - Salvans, Silvia

AU - Pera, Miguel

AU - Díaz, César

AU - Barbadillo, Jose Gomez

AU - Palacios, Amalia

AU - Pastor, Carlos Villar

AU - Pleguezuelo, María

AU - Triviño, Francisco

AU - Martínez de Dueñas, José L.

AU - España, Auxiliadora Gómez

AU - Rodriguez, Elena Navarro

AU - Trujillo, Roberto Lozoya

AU - Frangi, Andrés

AU - Carmona, Mª Dolores Ruiz

AU - Carrillo, Rodolfo Rodríguez

AU - Gil, Mireia

AU - Miranda, Vicente

AU - Laso, Carlos Álvarez

AU - Lora, Paola

AU - Navascues, José Mª Enriquez

AU - Placer, Carlos

AU - Borda, Nerea

AU - La Casta, Adelaida

AU - Elosegui, Jl

AU - Saralegui, Yolanda

AU - Guimón, Elena

AU - Múgica, Ja

AU - Plazas, Javier Gallego

AU - Arroyo, Antonio

AU - Caro, Aleidis

AU - Millan, Monica

PY - 2018/2/1

Y1 - 2018/2/1

N2 - © 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.

AB - © 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.

KW - Local excision and rectal cancer

KW - Neoadjuvant treatment and rectal cancer

KW - Rectal cancer

KW - Total mesorectal excision (TME)

KW - Transanal endoscopic microsurgery (TEM)

U2 - 10.1007/s00384-017-2942-1

DO - 10.1007/s00384-017-2942-1

M3 - Article

C2 - 29234923

VL - 33

SP - 241

EP - 249

IS - 2

ER -

Serra-Aracil X, Pericay C, Golda T, Mora L, Targarona E, Delgado S et al. 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). International Journal of Colorectal Disease. 2018 Feb 1;33(2):241-249. doi: 10.1007/s00384-017-2942-1