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Rectal sparing approach after preoperative radio- and/or chemotherapy (RESARCH) in patients with rectal cancer: a multicentre observational study

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Abstract

Background

Rectum-sparing approaches appear to be appropriate in rectal cancer patients with a major (mCR) or complete clinical response (cCR) after neoadjuvant therapy. The aim of the present study is to evaluate the effectiveness of rectum-sparing approaches at 2 years after the completion of neoadjuvant treatment.

Study design

Patients with rectal adenocarcinoma eligible to receive neoadjuvant therapy will be prospectively enrolled. Patients will be restaged 7–8 weeks after the completion of neoadjuvant therapy and those with mCR (defined as absence of mass, small mucosal irregularity no more than 2 cm in diameter at endoscopy and no metastatic nodes at MRI) or cCR will be enrolled in the trial. Patients with mCR will undergo local excision, while patients with cCR will either undergo local excision or watch and wait policy. The main end point of the study is to determine the percentage of rectum preservation at 2 years in the enrolled patients.

Conclusion

This protocol is the first prospective trial that investigates the role of both local excision and watch and wait approaches in patients treated with neoadjuvant therapy for rectal cancer. The trial is registered at clinicaltrials.gov (NCT02710812).

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Acknowledgements

This work was partially supported by the Italian Ministry of Health (Progetti ordinari di Ricerca Finalizzata N. RF-2011-02349645) and by the University of Padua (Progetti di Ateneo, PRAT 2015). The authors thank Ms. Mariasole Bigon who helped in the creation and development of this study. The authors are extremely grateful to Ms. Christina Drace (Language Revision Service, Veneto Institute of Oncology IOV IRCCS, Padova, Italy) for the English revision of the manuscript. Ms. Christina Drace is a native English speaker.

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Authors and Affiliations

  1. Department of Surgical, Gastroenterological and Oncological Sciences (DiSCOG), Clinica Chirurgica I, University of Padua, Padua, Italy

    A. Barina, I. Maretto, A. Perin & S. Pucciarelli

  2. Department of Radiation Oncology, Centro di Riferimento Oncologico, National Cancer Institute, Aviano, Italy

    A. De Paoli & C. Belluco

  3. National Cancer Institute, IRCCS Fondazione “G.Pascale”, Naples, Italy

    P. Delrio & U. Pace

  4. Surgery Clinic, Marche Polytechnic University, Ancona, Italy

    M. Guerrieri

  5. E. Agnelli Hospital, Pinerolo, TO, Italy

    A. Muratore

  6. Abdominal Surgical Oncology Unit, IRCCS Fondazione “G.Pascale”, Naples, Italy

    F. Bianco

  7. General Surgery Unit, San Bortolo Hospital, Vicenza, Italy

    D. Vespa

  8. Department of Surgery and Orthopaedics, General Surgery Units of Asola, Mantua, Italy

    C. Asteria

  9. Department of Surgery, Regional Center for Laparoscopic and Robotic Surgery, Camposampiero Hospital, Padua, Italy

    E. Morpurgo

  10. Department of Surgery, Colorectal Surgery Center, University of Cagliari, Cagliari, Italy

    A. Restivo

  11. Department of Surgical Sciences, Catholic University of Rome, Rome, Italy

    C. Coco

  12. Medical Oncology Unit, S. Andrea Hospital, La Spezia, Italy

    C. Aschele

  13. Medical Oncology Unit 1, Istituto Oncologico Veneto, IRCCS, Padua, Italy

    S. Lonardi

  14. Institute of Radiotherapy, Catholic University of Rome, Rome, Italy

    V. Valentini

  15. Department of Radiotherapy, Ospedali Riuniti, Ancona, Italy

    G. Mantello

  16. Istituto Oncologico Veneto, IRCSS, Padua, Italy

    P. Del Bianco

Authors
  1. A. Barina
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  2. A. De Paoli
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  3. P. Delrio
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  4. M. Guerrieri
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  5. A. Muratore
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  6. F. Bianco
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  7. D. Vespa
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  8. C. Asteria
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  9. E. Morpurgo
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  10. A. Restivo
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  11. C. Coco
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  12. U. Pace
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  13. C. Belluco
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  14. C. Aschele
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  15. S. Lonardi
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  16. V. Valentini
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  17. G. Mantello
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  18. I. Maretto
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  19. P. Del Bianco
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  20. A. Perin
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  21. S. Pucciarelli
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Corresponding author

Correspondence to A. Barina.

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The authors declare that they have no conflict of interest.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from the patient included in the case report.

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Barina, A., De Paoli, A., Delrio, P. et al. Rectal sparing approach after preoperative radio- and/or chemotherapy (RESARCH) in patients with rectal cancer: a multicentre observational study. Tech Coloproctol 21, 633–640 (2017). https://doi.org/10.1007/s10151-017-1665-1

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  • DOI: https://doi.org/10.1007/s10151-017-1665-1

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