International consensus recommendations on key outcome measures for organ preservation after (chemo)radiotherapy in patients with rectal cancer

Research output: Contribution to journalReview articlepeer-review


  • Emmanouil Fokas
  • Ane Appelt
  • Robert Glynne-Jones
  • Geerard Beets
  • Rodrigo Perez
  • Julio Garcia-Aguilar
  • Eric Rullier
  • J. Joshua Smith
  • Corrie Marijnen
  • Femke P. Peters
  • Maxine van der Valk
  • Regina Beets-Tan
  • Arthur S. Myint
  • Jean Pierre Gerard
  • Michael Ghadimi
  • Ralf D. Hofheinz
  • Krzysztof Bujko
  • Cihan Gani
  • Karin Haustermans
  • Bruce D. Minsky
  • Ethan Ludmir
  • Nicholas P. West
  • Maria A. Gambacorta
  • Vincenzo Valentini
  • Marc Buyse
  • Andrew G. Renehan
  • Alexandra Gilbert
  • David Sebag-Montefiore
  • Claus Rödel

Colleges, School and Institutes

External organisations

  • Goethe-Universität Frankfurt Am Main
  • DKFZ (German Cancer Research Centre)
  • German Cancer Consortium (DKTK)
  • Frankfurt Cancer Institute (FCI)
  • University of Leeds
  • Lister Hospital, East and North Hertfordshire NHS Trust
  • Maastricht University
  • The Netherlands Cancer Institute
  • Angelita & Joaquim Institute
  • Memorial Sloan Kettering Cancer Center
  • Centre Hospitalier Universitaire (CHU) Bordeaux
  • Royal Liverpool University Hospital
  • Centre Antoine-Lacassagne
  • Academic Department of Surgery
  • University of Göttingen
  • Heidelberg University
  • Institute of Oncology, Warsaw
  • University of Tübingen
  • Leuven Cancer Institute
  • The University of Texas MD Anderson Cancer Center
  • Università Cattolica del Sacro Cuore
  • I-Minds
  • International Drug Development Institute
  • University of Manchester
  • Christie Hospital NHS Foundation Trust


Multimodal treatment strategies for patients with rectal cancer are increasingly including the possibility of organ preservation, through nonoperative management or local excision. Organ preservation strategies can enable patients with a complete response or near-complete clinical responses after radiotherapy with or without concomitant chemotherapy to safely avoid the morbidities associated with radical surgery, and thus to maintain anorectal function and quality of life. However, standardization of the key outcome measures of organ preservation strategies is currently lacking; this includes a lack of consensus of the optimal definitions and selection of primary end points according to the trial phase and design; the optimal time points for response assessment; response-based decision-making; follow-up schedules; use of specific anorectal function tests; and quality of life and patient-reported outcomes. Thus, a consensus statement on outcome measures is necessary to ensure consistency and facilitate more accurate comparisons of data from ongoing and future trials. Here, we have convened an international group of experts with extensive experience in the management of patients with rectal cancer, including organ preservation approaches, and used a Delphi process to establish the first international consensus recommendations for key outcome measures of organ preservation, in an attempt to standardize the reporting of data from both trials and routine practice in this emerging area.

Bibliographic note

Funding Information: The work of A.A. is supported by Yorkshire Cancer Research Academic Fellowship funding (grant L389AA). The work of N.P.W. was supported by grants from Yorkshire Cancer Research while the study was conducted. The work of A.G. is funded by a Cancer Research UK clinical trials fellowship (CRUK/28301). Publisher Copyright: © 2021, Springer Nature Limited.


Original languageEnglish
JournalNature Reviews Clinical Oncology
Early online date4 Aug 2021
Publication statusE-pub ahead of print - 4 Aug 2021

ASJC Scopus subject areas

Sustainable Development Goals