# Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer (Dutch TME trial)

Source: https://onco.cc/key-papers/paper-kapiteijn-dutch-tme-preoperative-radiotherapy-nejm-2001/  
OnCo record `paper-kapiteijn-dutch-tme-preoperative-radiotherapy-nejm-2001` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The trial that asked whether radiotherapy still helps once the surgery is done properly. It does for local control, cutting two-year pelvic recurrence from 8.2 to 2.4 percent, but it did not lengthen life.

## Summary

Kapiteijn, Marijnen, Nagtegaal and colleagues randomly assigned 1,861 patients with resectable rectal cancer to preoperative radiotherapy (5 Gy on each of five days) followed by total mesorectal excision, or to total mesorectal excision alone, with standardisation and quality control of the radiotherapy, the surgery and the pathological assessment. Of these, 1,805 were eligible and 1,748 underwent a macroscopically complete local resection.

The overall two-year survival was identical in the two groups, and the trial therefore separated local control from survival in rectal cancer for the first time.

## Fields

- Kind: Key paper
- Last checked: 2026-09-24
- Tags: colorectal-evidence
- Journal: New England Journal of Medicine
- Year: 2001
- DOI: 10.1056/NEJMoa010580
- Authors: Kapiteijn E, Marijnen CA, Nagtegaal ID, et al.
- Findings: Two-year survival 82.0 percent with radiotherapy plus surgery against 81.8 percent with surgery alone (p=0.84).; Overall two-year local recurrence after macroscopically complete resection 5.3 percent.; Local recurrence at two years 2.4 percent with radiotherapy against 8.2 percent with surgery alone (p<0.001).; Radiotherapy, surgery and pathology were standardised and quality-controlled across the trial.
- What it means: The modern basis for offering short-course radiotherapy selectively: it buys local control, not survival, so the decision turns on the predicted recurrence risk from MRI against the long-term bowel and sexual morbidity of pelvic irradiation.
- Caveats: Two-year outcomes in the primary report; the long-term follow-up showed the local control benefit persists without a survival difference.; The trial cannot say whether radiotherapy is needed in the MRI-defined low-risk tumours that would now be operated on directly.; Late toxicity, particularly faecal incontinence and sexual dysfunction, is the cost the primary report does not quantify.

## Sources

- N Engl J Med 2001: https://doi.org/10.1056/NEJMoa010580
- PubMed: https://pubmed.ncbi.nlm.nih.gov/11547717/

## Connected records

- key papers: [Improved survival with preoperative radiotherapy in resectable rectal cancer (Swedish Rectal Cancer Trial)](https://onco.cc/key-papers/paper-swedish-rectal-cancer-trial-preoperative-radiotherapy-nejm-1997/), [Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016)](https://onco.cc/key-papers/paper-sebag-montefiore-cr07-preoperative-radiotherapy-lancet-2009/), [Sauer 2004: chemoradiotherapy before rather than after surgery for rectal cancer (CAO/ARO/AIO-94)](https://onco.cc/key-papers/paper-sauer-preoperative-chemoradiotherapy-rectal-nejm-2004/), [The mesorectum in rectal cancer surgery: the clue to pelvic recurrence?](https://onco.cc/key-papers/paper-heald-mesorectum-rectal-cancer-surgery-br-j-surg-1982/)
- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- fronts: [Radiation Therapy](https://onco.cc/fronts/radiation/), [Surgery & Interventional](https://onco.cc/fronts/surgery/)
- terms: [Neoadjuvant / adjuvant / perioperative](https://onco.cc/terms/neoadjuvant-adjuvant/), [Radiotherapy](https://onco.cc/terms/radiotherapy/), [Total mesorectal excision (TME)](https://onco.cc/terms/total-mesorectal-excision/)
- technologies: [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/), [MRI](https://onco.cc/technologies/mri/)
- institutions: [Erasmus MC Cancer Institute](https://onco.cc/institutions/erasmus-mc/)
- people: [Cornelis J. H. van de Velde](https://onco.cc/people/cornelis-van-de-velde/)
- bottlenecks: [Surgery and radiotherapy cure most, get least](https://onco.cc/bottlenecks/b-surgery-radiation-innovation/), [Toxicity and quality of life are undervalued](https://onco.cc/bottlenecks/b-toxicity-qol/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)
- roadmaps: [Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation](https://onco.cc/roadmaps/colorectal-roadmap/)

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