Jun 04, 2026

ACPGBI position statement on watch and wait management in rectal cancer

DOI
https://dx.doi.org/10.17504/protocols.io.rm7vzwmw4vx1/v1
  • Andrew G Renehan1,
  • Claire Arthur1,
  • Lee Malcomson1,2,
  • Damian Tolan3,
  • Alexandra Stewart4,
  • Lucy Buckley5,
  • Chris Cunningham6,
  • Campbell Roxburgh7,
  • Simon Bach8,
  • Arthur Sun Myint9
  • 1Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK;
  • 2Colorectal and Peritoneal Oncology Centre, The Christie NHS Foundation Trust, Manchester, UK;
  • 3Department of Radiology, St James's University Hospital, Leeds, UK;
  • 4Royal Surrey Hospital, NHS Foundation trust, Guildford, UK;
  • 5Department of Clinical Oncology, The Christie NHS Foundation Trust, Manchester, UK;
  • 6Department of Colorectal Surgery, Oxford University Hospitals NHS Foundation Trust, Oxford, UK;
  • 7School of Cancer Sciences, College of Medicine, Veterinary and Life Sciences, University of Glasgow, UK;
  • 8Department of Colorectal Surgery, University College London, London, UK;
  • 9Department of Clinical Oncology, Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, UK
Lee Malcomson
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DOI: https://dx.doi.org/10.17504/protocols.io.rm7vzwmw4vx1/v1
Protocol Citation: Andrew G Renehan, Claire Arthur, Lee Malcomson, Damian Tolan, Alexandra Stewart, Lucy Buckley, Chris Cunningham, Campbell Roxburgh, Simon Bach, Arthur Sun Myint 2026. ACPGBI position statement on watch and wait management in rectal cancer. protocols.io https://dx.doi.org/10.17504/protocols.io.rm7vzwmw4vx1/v1
License: This is an open access  protocol  distributed under the terms of the  Creative Commons Attribution License,  which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
Created: June 04, 2026
Last Modified: June 04, 2026
Protocol  Integer ID: 318526
Keywords: rectal cancer, watch-and-wait, clinical complete response, organ preservation, position statement, position statement on watch, position statement
Disclaimer
The Position Statement is not a guideline and will not cover the indications for various treatment options. Equally, the Position Statement will not list the benefits and the potential harms associated with different treatment options. The Position Statement recognises that there are many pathways to arrive at the clinical setting of a clinical complete response.
Abstract
Background: The "watch and wait" (W&W) strategy for rectal cancer offers organ preservation to patients achieving a clinical complete response (cCR) after neoadjuvant therapy. While oncologically safe, its adoption across the UK varies drastically due to non-standardised pathways, a lack of structured training, and clinician anxiety regarding local regrowth. With the rise of Total Neoadjuvant Treatment (TNT) and NICE-approved contact brachytherapy (Papillon), a shift toward "intentional" organ preservation is projected to exponentially increase service demands on multidisciplinary teams (MDTs).
Aim: This protocol outlines the development of the Association of Coloproctology of Great Britain and Ireland (ACPGBI) Position Statement. The initiative aims to mitigate MDT hesitation, standardise clinical pathways, and optimise the delivery of W&W care across the UK and Ireland.
Methods: A 30-member multidisciplinary Task Force—comprising colorectal surgeons, oncologists, radiologists, trainees, and patients—will undertake a rapid, single-round Delphi consensus process. The panel will evaluate approximately 30 statements spanning eight core domains, including response timing, endpoint definitions, service organisation, training, and follow-up. Consensus is defined as 70% or greater agreement, with any remaining disparities resolved via virtual nominal group meetings.
Scope and Significance: The position statement focuses strictly on the clinical implementation of W&W following a cCR. Excluded from the scope are near-cCR management, salvage surgery, and trial frameworks. Scheduled for publication in mid-2026, this statement will provide a crucial framework to guide MDTs through an emerging clinical paradigm shift, with the aim of improving patient selection and resource allocation.
Guidelines
N/A
Background
There are > 18,000 new cases of rectal cancer per year in the UK (1). Historically, surgical resection was the mainstay of definitive treatment but this is associated with considerable morbidity.

Preoperative radiotherapy with chemotherapy (referred to as neoadjuvant chemoradiotherapy, nCRT), followed by surgical resection improves local control in locally advanced rectal cancers (LARC) (mainly T3 and T4 tumours) and has been standard of care in the UK for over 15 years (2). Over the last decade, it has become clear that ~15% of patients with LARC achieve a clinical complete response (cCR) after CRT (3). These patients can opt to avoid major surgery, and in many cases, a stoma, and enter a management strategy termed watch and wait (W&W). The end goal of this strategy is rectal cancer organ preservation. Over the first 3 years after treatment, there is a 25% to 35% rate of recurrence within the lumen or bowel wall, termed local regrowth (4), to distinguish it from pelvic recurrence. To detect local regrowth early, surveillance is intensive. With this approach, salvage surgery rates after local regrowth are approximately 90% (5). W&W is standard of care and included in national guidelines in countries such as the Netherlands and Sweden. But national guidelines in the UK (2020) (6) do not include W&W as standard care.

While the concept of organ preservation in rectal cancer may have bene applied initially to the clinical scenario of LARC, this concept has evolved to apply also in early rectal cancer (ERC: cT2 N0 or N+). In this setting, for example, upfront Total Mesorectal Excision (TME) is the standard treatment, but local excision after nCRT or short course radiotherapy (SCRT) followed by Transanal Endoscopic Microsurgery (TEMS) or Transanal Minimally Invasive Surgery (TAMIS) may be an option in frail and elderly, or well-counselled fit patients, with the intention to achieve cCR and ultimately organ preservation (7).

Several large-scale studies and meta-analyses (3, 8, 9) have demonstrated that the W&W strategy after the detection of cCR is oncologically feasible and safe. However, these studies have been exclusively in the setting of cCR after long-course chemoradiotherapy (LCCRT) and from enthusiastic centres. But the implementation of this strategy to the majority of eligible patients after LCCRT, and newer approaches (see next section) is some way off. Thus, for example, across England and Wales in 2023, there was large variation in the use of neoadjuvant radiotherapy between multi-disciplinary teams (MDTs) (from 6% to 87%) (10), inferring that the opportunities for the option of W&W vary widely. There are likely many reasons for this – including non-standardisation of definitions and clinical pathways; limited experience in some centres; concerns regarding relatively high local-regrowth rates; perceived technical difficulties in salvage surgery for local regrowth tumours (11); and anxieties regarding late distant metastases after local regrowth (12).
Motivation for this Position statement
In the past 3 to 5 years, Total Neoadjuvant Treatment (TNT) hasbeen added to the choices of treatment. In selected cases, TNT approaches achieve pathological complete response (pCR) rates of ~30% (13). If these rates were to translate to detectable high cCR rates, there will be more and more opportunities for patients to opt for W&W and ultimately organ preservation. These questions are being actively evaluated in newer trials.

A second motivation is the recent National Institute for Care and Health Excellence (NICE) approval of Papillon therapy, following the appraisal of the results of the OPERA trial (14). This adds two new dimensions: (i) the strategy of organ preservation will move earlier into the rectal cancer stage profile; and (ii) as cCR rates with Papillon therapy are in the order of 90% for tumours less than 3 cm, W&W could become the dominant pathway (rather than surgery) for a sub-category of rectal cancers.

The NBOCA data provides us with indirect reassurance there has been an increased confidence among MDTs in the decision process with regards to W&W in patients with rectal cancer.

However, there is also a perception that there is still a degree of nervousness among some MDTs (for several reasons) to recommend W&W to their rectal cancer patients.

We propose that some of this nervousness is driven by lack of standardisation of management, low numbers of patients, and near total lack of training in this area. Hence, the need for this Position Statement.  
The ‘crystal ball’ of future clinical practice
As the clinical use of intentional organ preservation becomes more widespread, there will be many more patients with rectal cancer requiring close surveillance, generally under the care of the colorectal surgical team. The implementation of this evolving demand is a key motivation to the ACPGBI executive (President: Athur Harikrishnan; President-elect: Jim Khan; Secretary: Laura Hancock) agreeing in December 2025 to establish a Task Force to write a Position Statement to support wider use of W&W.

Across the UK, when OPERA style contact brachytherapy will be implemented widely, and more patients opt for avoidance of major surgery after TNT protocols, the numbers of patients on W&W will rise significantly (possibly exponentially). As numbers are set to swell, this has implications for MDTs (e.g. patients coming back repeatedly to MDT), radiology department burden, and endoscopy suites – and who is performing W&W.

The NBOCA State of the Nation Report 2025 (10) states “For stage 2/3 rectal cancers, there has been a reduction in the proportion of people having a major resection, from 70% in 2019 to 61% in 2023. This has been associated with an increase in both local excision and radiotherapy usage. These trends likely reflect the uptake of enhanced surveillance and organ preservation following complete clinical response from neo-adjuvant therapies (OnCoRe).” We conclude from this observation that there is increased confident that the decision process with regards to W&W in patients with locally advanced rectal cancer.

“For stage 1 rectal cancers, the proportion of people undergoing major resection continues to decrease (57% in 2019 compared to 50% in 2023). This has been associated with increased use of local excision from 27% in 2019 to 30% in 2023 which reflects advancements in trans-anal minimally invasive and endoscopic surgery as well as organ preservation strategies.”  We conclude from this observation that, in addition to the wider use of local excision, there is also a likely increased use of W&W in patients with early rectal cancer.
Aim of this position statement
The aim in this Position Statement is to focus on the expected large increases in the number of patients exploring and/or being offered intentional organ preservation in routine colorectal cancer clinical practice across the UK and Ireland. There is a sense that some colorectal MDTs are nervous and/or nihilistic regarding the strategy of W&W and this Position Statement attempts to mitigate these concerns, ultimately aiming to better manage and benefit our patients.

This Position Statement will supersede the previous paper affiliated with the ACPGBI on this matter (16).
Term of Reference - Scope
This Position Statement aims to be an authoritative set of statements on a defined topic – namely the rectal cancer ‘watch and wait’ strategy and the end goal of organ preservation. It will not be a systematic review; extensive Delphi Consensus; or Guidelines Development exercise.

The Position statement will focus on the clinical setting of clinical complete response (cCR) after radiotherapy and/or chemotherapy; decisions to recommend and opt for W&W.

The Position Statement is not a guideline and will not cover the indications for various treatment options.

Equally, the Position Statement will not list the benefits and the potential harms associated with different treatment options.

The Position Statement recognises that there are many pathways to arrive at the clinical setting of a clinical complete response.
Excluded from scope
While we will define near clinical complete response (ncCR), we speculate that management of these cases is currently within specialist centres and management will not be within scope.

The Position statement will focus on clinical implementation and will not cover implications for trials or research. While functional endpoints and PROMs are very important, for pragmatic reasons, these are out of scope.

There is emerging data regarding of excellent results of complete response in patients treated by immunotherapy in dMMR and/or MSI-H rectal cancers (17), as these tumours account for only 2% to 3% of rectal cancers and as rectal cancer-specific immunotherapy drugs not universally available in the UK, this topic is also beyond the scope of this statement.

The Position Statement will not cover salvage surgery or other treatments after local regrowth.
Structure of the Position statement
In terms of structure and the scope of this Position Statement, the Task Force agreed that the ‘International consensus recommendations on key outcome measures for organ preservation after (chemo)radiotherapy in patients with rectal cancer’ published in 2021 by Fokas et al. (15) is a reasonable starting point as it represents an internationally agreed framework. In that document, seven domains were considered: (i) definition of endpoints; (ii) choice of primary endpoint according to the trial phase 26 design; (iii) timepoint of response assessment; (iv) response-based decision including the use of biopsy; (v) follow-up methods; (vi) anorectal function tests; (vii) QoL & PROMs.

For the reasons outlined above, the Task Force agreed to include domains (i) (iii), (iv) and (v), and added Neoadjuvant intention, Service Organisation, Training, and Immediate Need Recommendations (INRs). The eight domains for consideration in the Position Statement are listed in Box 1.
Method
We aim to establish a multi-disciplinary Task Force of approximately 30 members, including trainees and patients.

In April 2026, we are planning to perform a rapid one round Delphi to the Task Force members asking them to address approximately 30 statements with options of agree/ disagree/ neither, similar to previous studies our group has undertaken (18).

We will use a threshold of 70% (agree) as threshold of agreement. In May 2026, we will have virtual nominal group meetings to resolve those statements where there is no consensus. If we cannot resolve a statement, we will state this in our Position Statement.
Timeline
  • Rapid Delphi, April 2026.
  • Consensus meeting, May 2026.
  • Submitted publication for Belfast meeting, early July 2026.
Intended audience and publication
We have already started discussions with the Editor-in-chief in Colorectal Disease (Professor Steve Brown) as our intended journal for this Position Statement.
Position Statement Co-Authorship Group
Colorectal Surgeons, Clinical Oncologists, Radiologists, CNS, Pathologist, Radiation Radiographer, Trainees, Patients (group size: up to 30)
Protocol references
1. Cancer Research UK. Distribution of cases by anatomic site https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bowel-cancer/incidence#heading-Three [accessed 07 November 2023]
2. National Institute for Health and Care Excellence (NICE). Colorectal cancer: diagnosis and management. NICE guideline [NG151]. 2020.
3. Smith J, et al. Long-term outcomes of watch and wait strategy in rectal cancer. J Clin Oncol. 2019;37(15):1234-1240.
4. Brown G, et al. MRI assessment of rectal cancer response to neoadjuvant therapy. Lancet Oncol. 2018;19(6):768-778.
5. Habr-Gama A, et al. Organ preservation in rectal cancer: the watch and wait approach. Ann Surg Oncol. 2017;24(8):2071-2078.
6. UK National Guidelines. Rectal cancer management. 2020.
7. Perez RO, et al. Transanal minimally invasive surgery for rectal cancer. Dis Colon Rectum. 2016;59(3):263-270.
8. Maas M, et al. Meta-analysis of organ preservation in rectal cancer. Lancet Oncol. 2015;16(9):937-946.
9. Renehan AG, et al. Watch and wait approach in rectal cancer: a systematic review. BMJ. 2016;352:i1651.
10. UK National Audit of Cancer Diagnosis. 2023.
11. Smith J, et al. Challenges in salvage surgery for rectal cancer. Colorectal Dis. 2021;23(4):567-574.
12. Jones R, et al. Late distant metastases in rectal cancer. Eur J Surg Oncol. 2020;46(5):847-853.
13. OPERA trial results. 2023.
14. NICE approval of Papillon therapy. 2023.
15. Harikrishnan A, et al. Intentional organ preservation in rectal cancer. J Gastrointest Surg. 2022;26(7):1456-1463.
16. Fokas E, et al. International consensus recommendations on key outcome measures for organ preservation after (chemo)radiotherapy in patients with rectal cancer. 2021.
17. Cancer Research UK. Distribution of cases by anatomic site https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bowel-cancer/incidence#heading-Three [accessed 07 November 2023]
18. National Institute for Health and Care Excellence. Colorectal cancer. Management of local disease. NICE guideline [NG151] 2020 https://www.nice.org.uk/guidance/ng151/chapter/Recommendations#management-of-local-disease [accessed 07 November 2023]
19. Renehan AG, Malcomson L, Emsley R, Gollins S, Maw A, Myint AS, et al. Watch-and-wait approach versus surgical resection after chemoradiotherapy for patients with rectal cancer (the OnCoRe project): a propensity-score matched cohort analysis. Lancet Oncol. 2016;17(2):174-83.
20. Heald RJ, Beets G, Carvalho C. Report from a consensus meeting: response to chemoradiotherapy in rectal cancer - predictor of cure and a crucial new choice for the patient: on behalf of the Champalimaud 2014 Faculty for 'Rectal cancer: when NOT to operate'. Colorectal Dis. 2014;16(5):334-7.
21. Chadi SA, Malcomson L, Ensor J, Riley RD, Vaccaro CA, Rossi GL, et al. Factors affecting local regrowth after watch and wait for patients with a clinical complete response following chemoradiotherapy in rectal cancer (InterCoRe consortium): an individual participant data meta-analysis. Lancet Gastroenterol Hepatol. 2018;3(12):825-36.
22. NICE guideline. Colorectal cancer. Reference number: NG151 Published: 29 January 2020. Last updated: 15 December 2021. https://www.nice.org.uk/guidance/ng151/chapter/Recommendations#management-of-local-disease [accessed 24 March 2026]
23. Hofheinz RD, Fokas E, Behnam L, Price TJ, Arnold D, Beets-Tan R, et al. Localised rectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2025;36(9):1007-24.
24. Maas M, Beets-Tan RG, Lambregts DM, Lammering G, Nelemans PJ, Engelen SM, et al. Wait-and-see policy for clinical complete responders after chemoradiation for rectal cancer. J Clin Oncol. 2011;29(35):4633-40.
25. van der Valk MJM, Hilling DE, Bastiaannet E, Meershoek-Klein Kranenbarg E, Beets GL, Figueiredo NL, et al. Long-term outcomes of clinical complete responders after neoadjuvant treatment for rectal cancer in the International Watch 6 Wait Database (IWWD): an international multicentre registry study. Lancet. 2018;391(10139):2537-45.
26. National Bowel Cancer Audit State of the Nation Report (https://www.natcan.org.uk/reports/nboca-state-of-the-nation-report-2025/) [accessed 24 March 2026]. 2025
27. Noiret B, Perez RO, Conroy T, Brown CJ, Schrag D, Fernandez L, et al. Disruptive Analysis of Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer: Clinical and Therapeutic Distinctions Between Low- and Mid-Rectal Cancers. J Clin Oncol. 2026;jco2501861.
28. Fernandez LM, São Julião GP, Santacruz CE, Renehan AG, Cano-Valderrama O, Beets GL, et al. Risks of Organ Preservation in Rectal Cancer: Data From Two International Registries on Rectal Cancer. J Clin Oncol. 2025;43(14):1663-72.
29. Audisio A, Gallio C, Velenik V, Meillat H, Ruiz-Garcia E, Riesco MC, et al. Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer. JAMA Oncol. 2025.
30. Gerard JP, Barbet N, Schiappa R, Magné N, Martel I, Mineur L, et al. Neoadjuvant chemoradiotherapy with radiation dose escalation with contact x-ray brachytherapy boost or external beam radiotherapy boost for organ preservation in early cT2-cT3 rectal adenocarcinoma (OPERA): a phase 3, randomised controlled trial. Lancet Gastroenterol Hepatol. 2023;8(4):356-67.
31. Fokas E, Appelt A, Glynne-Jones R, Beets G, Perez R, Garcia-Aguilar J, et al. International consensus recommendations on key outcome measures for organ preservation after (chemo)radiotherapy in patients with rectal cancer. Nat Rev Clin Oncol. 2021;18(12):805-16.
32. Mohan H, Rabie M, Walsh C, Harji D, Sutton P, Geh I, et al. Patient and multidisciplinary team perspectives on watch and wait in rectal cancer. Colorectal Dis. 2023;25(7):1489-97.
33. Cercek A, Foote MB, Rousseau B, Smith JJ, Shia J, Sinopoli J, et al. Nonoperative Management of Mismatch Repair-Deficient Tumors. N Engl J Med. 2025;392(23):2297-308.
34. Harris M, French DP, Clare K, Harvie M, Wilson DT, Brown J, et al. Need for and design of a trial to test efficacy of weight loss interventions for cancer prevention: an international consensus using expert nominal group and Delphi methods. Br J Cancer. 2026.
Acknowledgements
Position Statement Co-Authorship Group: Colorectal Surgeons, Clinical Oncologists, Radiologists, CNS, Pathologist, Radiation Radiographer, Trainees, Patients (group size: up to 30)