Summary of Recommendations

Document Overview

Design and created by Guideline Central in participation with the European Society for Medical Oncology.

Localised Rectal Cancer: Diagnosis, Treatment and Follow-Up

European Society for Medical Oncology

Publication Date: May 22, 2025

Page Last Updated: May 6, 2026

TNT

Decisions on the use of TNT should be made within an MDT using high-quality MRI and taking patient factors into account [V, A].
RT should be offered as long-course CRT (50-50.4 Gy in 25-28 fractions with concomitant capecitabine or infusional 5-FU) or SCRT (25 Gy in five fractions) [I, A].
Consolidation or induction ChT (CAPOX or FOLFOX) should be administered for 3-4.5 months [I, A].
If irinotecan is used, it should be administered in line with the protocol of the PRODIGE 23 trial [I, A].
For upper third tumours:
- TNT should be offered to patients with cT4 or involved or threatened MRF [I, A].
- CRT or SCRT should be considered if TNT is not feasible [I, A].
For lower or middle third tumours when surgery is intended:
- TNT should be offered to patients with high-risk criteria [I, A].
For lower or middle third tumours when organ preservation is intended:
- TNT is recommended for patients with high-risk criteria and patients with cT2 N+ or cT3 Nany tumours [I, A].
- Upfront CRT followed by consolidation ChT can be recommended to increase the likelihood of cCR [I, B].

Neoadjuvant ChT

When considering neoadjuvant ChT, the inclusion criteria of the PROSPECT study should be used (T2 N+, T3 Nany, distance to the CRM ≥3 mm, continence-preserving surgery possible) [I, A].
Neoadjuvant ChT should comprise 3 months of CAPOX or FOLFOX [I, A]. Neoadjuvant FOLFIRINOX or mAbs cannot be recommended [V, D].
For upper third tumours:
- Neoadjuvant ChT is recommended for patients with cT2 N+ or cT3 Nany disease [I, A].
- Neoadjuvant ChT is recommended for patients with cT4 Nany disease [V, A].
For lower or middle third tumours when surgery is intended:
- Neoadjuvant ChT is recommended for patients with cT2 N+, cT3 N0 or cT3 N1 disease [I, A].
Neoadjuvant ChT cannot be recommended for dMMR and MSI-H tumours [V, D].
Salvage RT is recommended in case of intolerance to, or progression on, neoadjuvant ChT [I, A].
Watch and wait cannot be recommended in case of a cCR [I, D].

dMMR and MSI-H tumours

Patients with locally advanced dMMR or MSI-H tumours in the upper, middle or lower third of the rectum should receive dostarlimab for a planned treatment duration of 6 months [II, A; ESCAT score: I-B; not European Medicines Agency (EMA) or Food and Drug Administration (FDA) approved in this setting].
Follow-up procedures should be aligned with those for patients with pMMR tumours achieving a cCR after TNT (i.e. watch and wait) [II, A].
Salvage resection is recommended in case of tumour persistence or local recurrence [IV, A].
MTD discussion is recommended to consider adjuvant ChT or CRT, according to clinical risk assessment [III, A].

Restaging before surgery or organ preservation

Restaging should comprise MRI, endoscopy and DRE [I, A].
ERUS cannot be recommended for restaging [V, D].
In case of a cCR, biopsies cannot be recommended to determine a watch-and-wait approach, as their value in this setting is unclear [V, D].
The recommended timings for restaging are:
- For restaging with intended surgery:
  - 2-4 weeks after CRT with consolidation ChT [I, A].
  - 6-7 weeks after induction ChT and CRT [I, A].
  - 4-8 weeks after the start of SCRT when delayed surgery is planned [I, A].
  - 4-7 weeks after completion of neoadjuvant CRT [I, A].
  - 3-4 weeks after completion of neoadjuvant ChT [I, A].
- For restaging to determine cCR for a watch-and-wait approach:
  - 4-8 weeks after completion of consolidation ChT in TNT [I, A].
  - 12 weeks after the start of RT in SCRT or CRT; in case of near cCR, further restaging can be recommended after another 4-8 weeks [I, B].
  - 14 weeks after the start of RT in CRT–brachytherapy; in case of near cCR, further restaging can be recommended after another 6-10 weeks [I, B].
  - 12 weeks after initiation of dostarlimab in patients with dMMR or MSI-H tumours and a second restaging 24 weeks after initiation of immunotherapy [III, A].

Watch and wait

For lower or middle third tumours, a watch-and-wait strategy is recommended in patients with cCR when organ preservation is intended [I, A].
For all dMMR or MSI-H rectal tumours, a watch-and-wait strategy is recommended in patients with cCR after treatment with a PD-1 inhibitor [II, A].
Discussion with patients about the importance of adherence to strict follow-up investigations is mandatory [V, A].
Follow-up examinations should comprise MRI, endoscopy and DRE every 3 months for the first 2 years and every 6 months thereafter [I, A]. CT scans of the chest and abdomen should be carried out every 6 months for the first 2 years and annually thereafter [I, A].

Adjuvant therapy

Adjuvant treatment after surgery should be discussed by an MDT on a case-by-case basis, taking into account tolerability, response to treatment and patient preference [V, A].
For upper third tumours:
- Adjuvant ChT with a fluoropyrimidine and (potentially) oxaliplatin should be offered (according to clinical risk assessment) following PME or TME alone [I, A].
- In patients who did not receive preoperative RT, adjuvant CRT should be offered in case of CRM positivity, pT4b, pN2 with extracapsular spread close to the MRF or poor quality TME [III, A].
For lower or middle third tumours after surgery:
- Adjuvant therapy with a fluoropyrimidine and (potentially) oxaliplatin should be offered (according to clinical risk assessment) following TME alone [I, A] and can be considered after neoadjuvant CRT or SCRT [V, B].
- In patients who did not receive preoperative RT, adjuvant CRT should be offered in case of CRM positivity, pT4b, pN2 with extracapsular spread close to the MRF or poor quality TME [III, A].
For lower or middle third tumours with organ preservation:
- An adjuvant fluoropyrimidine–oxaliplatin combination can be offered on a case-by-case basis after RT or fluoropyrimidine-based CRT in patients achieving cCR with initial cN+ disease [I, B].
Post-neoadjuvant systemic treatment following TNT (irrespective of surgical or non-surgical local approach) cannot be generally recommended due to toxicity considerations [I, D]. This approach should be discussed individually within an MDT.
Adjuvant ChT may be considered after neoadjuvant ChT, but its clinical value has not been proven [V, C].
Post-operative ctDNA status cannot currently be recommended for use in adjuvant therapy decisions [II, D].

Levels of evidence and grades of recommendation

Levels of evidence	Description
I	Evidence from at least one large randomised, controlled trial of good methodological quality (low potential for bias) or meta-analyses of well-conducted randomised trials without heterogeneity
II	Small randomised trials or large randomised trials with a suspicion of bias (lower methodological quality) or meta-analyses of such trials or of trials demonstrated heterogeneity
III	Prospective cohort studies
IV	Retrospective cohort studies or case-control studies
V	Studies without control group, case reports, expert opinions
Grades of recommendation	Description
A	Strong evidence for efficacy with a substantial clinical benefit, strongly recommended
B	Strong or moderate evidence for efficacy but with a limited clinical benefit, generally recommended
C	Insufficient evidence for efficacy or benefit does not outweigh the risk or the disadvantages (adverse events, costs, etc.), optional
D	Moderate evidence against efficacy or for adverse outcome, generally not recommended
E	Strong evidence against efficacy or for adverse outcome, never recommended

Document Overview

Document Title: Localised Rectal Cancer: Diagnosis, Treatment and Follow-Up

Authoring Society: European Society for Medical Oncology

Document Publication Date: May 22, 2025

Page Last Reviewed/Updated: May 6, 2026

Document Type: Guideline

Country of Publication: European

Full Text Freely Available: Yes

Full Text Guideline: www.annalsofoncology.org/article/S0923-7534(25)00731-8/fulltext

Source Citation: Hofheinz RD, Fokas E, Benhaim L, Price TJ, Arnold D, Beets-Tan R, Guren MG, Hospers GAP, Lonardi S, Nagtegaal ID, Perez RO, Cervantes A, Martinelli E; ESMO Guidelines Committee. Localised rectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2025 May 20:S0923-7534(25)00731-8. doi: 10.1016/j.annonc.2025.05.528. Epub ahead of print. PMID: 40412553.

Document Scope, Criteria, and Use Cases

Document Objectives: This ESMO Clinical Practice Guideline provides key recommendations for managing localised rectal cancer. The guideline covers imaging and diagnosis, staging and risk assessment, treatment and follow-up. Algorithms for the management of local and locally advanced disease are provided. The authors comprise a multidisciplinary group of experts from different institutions and countries. Recommendations are based on available scientific data and the authors’ collective expert opinion.

Scope: Assessment and Screening, Diagnosis, Management, Treatment

Diseases/Conditions (MeSH)

D012004 - Rectal Neoplasms

Keywords: localized rectal cancer, rectal cancer

Target Patient Population: Patients with localized rectal cancer

Target Provider Population: Oncologists and allied clinicians caring for patients with localized rectal cancer

Inclusion Criteria: Male, Female, Adolescent, Adult, Child, Older Adult

Health Care Settings: Ambulatory, Operating and Recovery Room, Outpatient, Radiology Services

Intended Users: Nurse, Nurse Practitioner, Physician, Physician Assistant

Recommendation Development Processes & Methodology

Supplemental Methodology Resource: Data Supplement

Localised Rectal Cancer: Diagnosis, Treatment and Follow-Up

Summary of Recommendations

Diagnosis, Pathology, and Molecular Biology

Staging and Risk Assessment

Management of Localised Disease

RT and CRT

TNT

Surgery

Watch and wait

Follow-Up, Long-Term Implications, and Survivorship

Levels of evidence and grades of recommendation

Document Overview

Document Scope, Criteria, and Use Cases

Recommendation Development Processes & Methodology