INT-0116 (Macdonald trial)
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.
Overview
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.
- Median 36 vs 27 months with Chemoradiation compared with Surgery alone; about 9 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Resected gastric or gastro-oesophageal junction adenocarcinoma: postoperative fluorouracil-leucovorin with 45 Gy radiotherapy versus observation. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
556 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Median overall survivalprimary | Chemoradiation | 281 | 36 months | - | - | - |
| Surgery alone | 275 | 27 months |
Similar pages
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