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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)

  • Clinical Study Protocol
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International Journal of Colorectal Disease Aims and scope Submit manuscript

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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Acknowledgements

We thank all the members of the multidisciplinary committee for colorectal tumors at our hospital for their support. We are also grateful to Cristina Gomez Vigo for correcting the manuscript and Michael Maudsley for help with the English.

TAU-TEM study group

Hospital Parc Taulí: Xavier Serra-Aracil, Carles Pericay, Laura Mora, Sheila Serra, Eugeni Saigi, Emma Dotor, Aleidis Pisa, Ismael Macias, Anna Pallisera, Salvador Navarro. Hospital Clinic I Provincial: Antonio Lacy, Anna Otero. Hospital de Bellvitge: Sebastiano Biondo, Thomas Golda. Hospital de la Santa Creu i Sant Pau: Eduardo Tarragona, Pilar Hernández; Mª Carmen Martínez, Juan Carlos Pernas, Marta Martín, Dolores González, David Paez, Xavier Cussó, C. Balagué. Hospital General Universitari de Valencia: Mª José García Coret, Francisco Villalba Ferrer. Hospital Universitario La Paz: Beatriz Díaz San Andrés, Álvarez Gallego, Higuera, Prieto. Hospital Universitario de Getafe: Jose Luis Ramos, Javier Jiménez Miramó, Javier García Septiem, Francisco Angulo. Hospital Marqués de Valdecilla: Julio Castillo, Joaquín Alonso Martín, Isabel Seco, Carlos Manuel Palazuelo. Hospital Torrecárdenas de Almeria: Ángel Reina, Francisco A. Rubio Gil, Carmen Caro, Rubén Varela, Fco. Manuel Ramos, Ana Fernández, Ricardo Belda, Ramon Solbes, Begoña Medina, Piedad Reche. Hospital Universitari Vall d’Hebrón: Eloy Espín, Francesc Vallribera, Stefania Landolfini, Jaume Capdevila. Hospital del Mar: Marta Pascual, Silvia Salvans, Miguel Pera. Hospital Reina Sofía. Córdoba: César Díaz, Jose Gomez Barbadillo, Amalia Palacios, Carlos Villar Pastor, María Pleguezuelo, Francisco Triviño, José L. Martínez de Dueñas, Auxiliadora Gómez España y Elena Navarro Rodriguez. Hospital de Sagunto: Roberto Lozoya Trujillo, Andrés Frangi, Mª Dolores Ruiz Carmona, Rodolfo Rodríguez Carrillo, Mireia Gil, Vicente Miranda. Hospital de Cabueñes. Gijón: Carlos Álvarez Laso, Paola Lora. Hospital de Donosti: José Mª Enriquez Navascues, Carlos Placer, Dra. Nerea Borda, Adelaida La Casta, JL Elosegui, Yolanda Saralegui, Elena Guimón, JA Múgica. Hospital General Universitario de Elche: Javier Gallego Plazas, Antonio Arroyo. Hospital Universitari Juan XXIII: Aleidis Caro, Monica Millan.

Funding

Funding obtained by the principal investigator (PI): Xavier Serra-Aracil, Olga Torres Grant, Grant from the Ministry of Health and Social Policy, Independent Clinical Research grants Ayudas de Investigación Clínica Independiente, Parc Taulí Foundation grant, and Spanish Coloproctology Foundation grant.

Author information

Authors and Affiliations

  1. Coloproctology Unit, General and Digestive Surgery Department, Parc Tauli University Hospital, Universitat Autònoma de Barcelona, Parc Tauli s/n. 08208, Sabadell, Spain

    X. Serra-Aracil, L. Mora, S. Serra-Pla & J. C. Garcia-Pacheco

  2. Medical Oncology Department, Parc Tauli University Hospital, Universitat Autònoma de Barcelona, Sabadell, Spain

    C. Pericay

  3. Coloproctology Unit, General and Digestive Surgery Department, Bellvitge University Hospital, Barcelona, Spain

    T. Golda

  4. General and Digestive Surgery Department, Santa Creu and Sant Pau University Hospital, Barcelona, Spain

    E. Targarona

  5. General and Digestive Surgery Department, Clinic University Hospital, Barcelona, Spain

    S. Delgado

  6. Coloproctology Unit, General and Digestive Surgery Department, Torrecardenas University Hospital, Almeria, Spain

    A. Reina

  7. Coloproctology Unit, General and Digestive Surgery Department, Vall d’Hebron University Hospital, Barcelona, Spain

    F. Vallribera

  8. General and Digestive Surgery Department, Donostia University Hospital, Donostia, Spain

    J. M. Enriquez-Navascues

Authors
  1. X. Serra-Aracil
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  2. C. Pericay
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  3. T. Golda
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  4. L. Mora
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  5. E. Targarona
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  6. S. Delgado
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  7. A. Reina
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  8. F. Vallribera
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  9. J. M. Enriquez-Navascues
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  10. S. Serra-Pla
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  11. J. C. Garcia-Pacheco
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Consortia

On behalf of TAU-TEM study group

  • Eugeni Saigi
  • , Emma Dotor
  • , Aleidis Pisa
  • , Ismael Macias
  • , Anna Pallisera
  • , Salvador Navarro
  • , Antonio Lacy
  • , Anna Otero
  • , Sebastiano Biondo
  • , Thomas 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

Contributions

XSA, CP, and LM wrote and edited the paper. TG, AR, SD, and ET will contribute patients to the study and are active in the management of the protocol. All authors have reviewed the research protocol, revising it critically for intellectual content. Each author has participated sufficiently in the work of reviewing and approving the protocol as written. In addition, FV, JMEN, AA, MP, JC, CD, AC, and RL will contribute patients and have reviewed and approved the protocol. JCGP and SS are the clinical research managers of the trial.

Corresponding author

Correspondence to X. Serra-Aracil.

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The authors have no competing interests to declare.

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The study has been approved by the local ethics committees of the participating centers.

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Serra-Aracil, X., Pericay, C., Golda, T. et al. 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). Int J Colorectal Dis 33, 241–249 (2018). https://doi.org/10.1007/s00384-017-2942-1

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  • DOI: https://doi.org/10.1007/s00384-017-2942-1

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