A Barina1, A De Paoli2, P Delrio3, M Guerrieri4, A Muratore5, F Bianco6, D Vespa7, C Asteria8, E Morpurgo9, A Restivo10, C Coco11, U Pace3, C Belluco2, C Aschele12, S Lonardi13, V Valentini14, G Mantello15, I Maretto16, P Del Bianco17, A Perin16, S Pucciarelli16. 1. Department of Surgical, Gastroenterological and Oncological Sciences (DiSCOG), Clinica Chirurgica I, University of Padua, Padua, Italy. andreabarina1@gmail.com. 2. Department of Radiation Oncology, Centro di Riferimento Oncologico, National Cancer Institute, Aviano, Italy. 3. National Cancer Institute, IRCCS Fondazione "G.Pascale", Naples, Italy. 4. Surgery Clinic, Marche Polytechnic University, Ancona, Italy. 5. E. Agnelli Hospital, Pinerolo, TO, Italy. 6. Abdominal Surgical Oncology Unit, IRCCS Fondazione "G.Pascale", Naples, Italy. 7. General Surgery Unit, San Bortolo Hospital, Vicenza, Italy. 8. Department of Surgery and Orthopaedics, General Surgery Units of Asola, Mantua, Italy. 9. Department of Surgery, Regional Center for Laparoscopic and Robotic Surgery, Camposampiero Hospital, Padua, Italy. 10. Department of Surgery, Colorectal Surgery Center, University of Cagliari, Cagliari, Italy. 11. Department of Surgical Sciences, Catholic University of Rome, Rome, Italy. 12. Medical Oncology Unit, S. Andrea Hospital, La Spezia, Italy. 13. Medical Oncology Unit 1, Istituto Oncologico Veneto, IRCCS, Padua, Italy. 14. Institute of Radiotherapy, Catholic University of Rome, Rome, Italy. 15. Department of Radiotherapy, Ospedali Riuniti, Ancona, Italy. 16. Department of Surgical, Gastroenterological and Oncological Sciences (DiSCOG), Clinica Chirurgica I, University of Padua, Padua, Italy. 17. Istituto Oncologico Veneto, IRCSS, Padua, Italy.
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).
BACKGROUND: Rectum-sparing approaches appear to be appropriate in rectal cancerpatients 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).
Entities:
Keywords:
Local excision; Neoadjuvant therapy; Rectal cancer; Rectum-preserving approach; Watch and wait
Authors: E Kapiteijn; C A Marijnen; I D Nagtegaal; H Putter; W H Steup; T Wiggers; H J Rutten; L Pahlman; B Glimelius; J H van Krieken; J W Leer; C J van de Velde Journal: N Engl J Med Date: 2001-08-30 Impact factor: 91.245
Authors: S Pucciarelli; F Giandomenico; A De Paoli; T Gavaruzzi; L Lotto; G Mantello; C Barba; P Zotti; S Flora; P Del Bianco Journal: Br J Surg Date: 2016-10-05 Impact factor: 6.939
Authors: Ann M Hanly; Elizabeth M Ryan; Ailín C Rogers; Deborah A McNamara; Robert D Madoff; Desmond C Winter Journal: Ann Surg Date: 2014-04 Impact factor: 12.969
Authors: Matthew F Kalady; Luiz Felipe de Campos-Lobato; Luca Stocchi; Daniel P Geisler; David Dietz; Ian C Lavery; Victor W Fazio Journal: Ann Surg Date: 2009-10 Impact factor: 12.969
Authors: Milou H Martens; Monique Maas; Luc A Heijnen; Doenja M J Lambregts; Jeroen W A Leijtens; Laurents P S Stassen; Stephanie O Breukink; Christiaan Hoff; Eric J Belgers; Jarno Melenhorst; Rob Jansen; Jeroen Buijsen; Ton G M Hoofwijk; Regina G H Beets-Tan; Geerard L Beets Journal: J Natl Cancer Inst Date: 2016-08-10 Impact factor: 13.506
Authors: Julio Garcia-Aguilar; Lindsay A Renfro; Oliver S Chow; Qian Shi; Xiomara W Carrero; Patricio B Lynn; Charles R Thomas; Emily Chan; Peter A Cataldo; Jorge E Marcet; David S Medich; Craig S Johnson; Samuel C Oommen; Bruce G Wolff; Alessio Pigazzi; Shane M McNevin; Roger K Pons; Ronald Bleday Journal: Lancet Oncol Date: 2015-10-22 Impact factor: 41.316
Authors: M Bushati; S Pucciarelli; N Gennaro; I Maretto; P Toppan; A Perin; E D L Urso; A Bagatella; G Spolverato Journal: Int J Colorectal Dis Date: 2019-11-14 Impact factor: 2.571
Authors: Claudio Belluco; Marco Forlin; Paolo Delrio; Daniela Rega; Maurizio Degiuli; Silvia Sofia; Matteo Olivieri; Salvatore Pucciarelli; Matteo Zuin; Giovanni De Manzoni; Alberto Di Leo; Stefano Scabini; Luigi Zorcolo; Angelo Restivo Journal: BMC Cancer Date: 2018-11-12 Impact factor: 4.430
Authors: Seong Ho Park; Seung Hyun Cho; Sang Hyun Choi; Jong Keon Jang; Min Ju Kim; Seung Ho Kim; Joon Seok Lim; Sung Kyoung Moon; Ji Hoon Park; Nieun Seo Journal: Korean J Radiol Date: 2020-07 Impact factor: 3.500
Authors: F Crimì; R Stramare; G Spolverato; V Aldegheri; A Barison; L D'Alimonte; Q R Bao; A Spimpolo; L Albertoni; D Cecchin; C Campi; E Quaia; S Pucciarelli; P Zucchetta Journal: Tech Coloproctol Date: 2021-04-01 Impact factor: 3.781
Authors: G Gallo; M La Torre; R Pietroletti; F Bianco; D F Altomare; S Pucciarelli; G Gagliardi; R Perinotti Journal: Tech Coloproctol Date: 2020-04-14 Impact factor: 3.781