# Dutch TME trial

Source: https://onco.cc/trials/dutch-tme-trial/  
OnCo record `dutch-tme-trial` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The trial that proved a week of radiotherapy before rectal cancer surgery halves the chance of the cancer coming back in the pelvis, even when the operation is done properly.

## Summary

The Dutch TME trial randomised 1,861 patients with resectable rectal cancer to 5 x 5 Gy preoperative radiotherapy followed by total mesorectal excision, or to total mesorectal excision alone, with surgical quality controlled by training and pathology review. Among the 1,748 who had a macroscopically complete local resection, local recurrence at two years was 2.4 percent with radiotherapy against 8.2 percent without. Two-year overall survival was the same (82.0 against 81.8 percent). The trial settled two questions at once: total mesorectal excision is the operation, and radiotherapy reduces local recurrence without lengthening life, so its use is a trade against long-term bowel and sexual function.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-24
- Also known as: CKVO 95-04
- Phase: 3
- Setting: Resectable rectal cancer: short-course preoperative radiotherapy (5 x 5 Gy) plus total mesorectal excision against total mesorectal excision alone
- Sponsor: Dutch Colorectal Cancer Group
- Enrolled: 1861
- Result: Local recurrence at two years 2.4 against 8.2 percent; no survival difference.
- Outcomes: Local recurrence at 2 years: Radiotherapy plus TME 2.4 percent vs TME alone 8.2 percent

## Sources

- Dutch TME trial: preoperative radiotherapy combined with total mesorectal excision (New England Journal of Medicine 2001): https://doi.org/10.1056/NEJMoa010580

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/)
- terms: [Neoadjuvant / adjuvant / perioperative](https://onco.cc/terms/neoadjuvant-adjuvant/)
- trials: [CAO/ARO/AIO-94 (German Rectal Cancer Study)](https://onco.cc/trials/cao-aro-aio-94/), [PROSPECT (Alliance N1048)](https://onco.cc/trials/prospect/), [RAPIDO](https://onco.cc/trials/rapido/), [Stockholm III](https://onco.cc/trials/stockholm-iii/), [Swedish Rectal Cancer Trial](https://onco.cc/trials/swedish-rectal-cancer-trial/)

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