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

A. Barina, A. De Paoli, P. Delrio, M. Guerrieri, A. Muratore, F. Bianco, D. Vespa, C. Asteria, E. Morpurgo, A. Restivo, C. Coco, U. Pace, C. Belluco, C. Aschele, S. Lonardi, V. Valentini, G. Mantello, I. Maretto, P. Del Bianco, A. PerinS. Pucciarelli

Research output: Contribution to journalArticlepeer-review

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). © 2017, Springer International Publishing AG.
Original languageEnglish
Pages (from-to)633-640
Number of pages8
JournalTechniques in Coloproctology
Volume21
Issue number8
DOIs
Publication statusPublished - 2017

Keywords

  • Local excision
  • Neoadjuvant therapy
  • Rectal cancer
  • Rectum-preserving approach
  • Watch and wait
  • Article
  • cancer chemotherapy
  • cancer patient
  • cancer staging
  • cancer surgery
  • cancer survival
  • clinical effectiveness
  • disease free survival
  • endoscopy
  • human
  • local recurrence free survival
  • major clinical study
  • multicenter study
  • neoadjuvant therapy
  • nuclear magnetic resonance imaging
  • observational study
  • overall survival
  • pathophysiology
  • preoperative radiotherapy
  • prospective study
  • rectum carcinoma
  • rectum sparing approach
  • study design
  • surgical approach
  • total mesorectal excision
  • treatment response
  • tumor volume

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