# INT-0116 (Macdonald trial)

Source: https://onco.cc/trials/int-0116/  
OnCo record `int-0116` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The Macdonald trial made postoperative chemoradiation the US standard for resected stomach cancer in 2001, though later trials with better surgery and chemotherapy have largely replaced it.

## Summary

INT-0116 randomised 556 patients after resection of stomach or junctional adenocarcinoma to observation or fluorouracil-leucovorin with 45 Gy radiotherapy. Median overall survival was 36 months with chemoradiation and 27 months with surgery alone (hazard ratio 0.74), and relapse-free survival improved (Macdonald and colleagues, New England Journal of Medicine 2001). Criticism centred on the limited lymph node surgery in most patients; with adequate D2 dissection (ARTIST, CRITICS) the added value of radiotherapy was not confirmed, and perioperative chemotherapy is now the usual approach.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Tags: radiation-wave4
- Phase: 3
- Setting: Resected gastric or gastro-oesophageal junction adenocarcinoma: postoperative fluorouracil-leucovorin with 45 Gy radiotherapy versus observation
- Sponsor: Southwest Oncology Group (US Intergroup)
- Enrolled: 556
- Result: Median overall survival 36 vs 27 months (hazard ratio 0.74).
- Outcomes: Median overall survival: Chemoradiation 36 months vs Surgery alone 27 months

## Sources

- NEJM 2001: https://doi.org/10.1056/NEJMoa010187

## Connected records

- cancers: [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/)
- technologies: [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/)
- drugs: [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [Leucovorin (folinic acid)](https://onco.cc/drugs/leucovorin/)
- terms: [Chemoradiation (chemoradiotherapy, CRT)](https://onco.cc/terms/chemoradiation/)

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