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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.
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.
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 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Median overall survivalprimary | Chemoradiation | 281 | 36 months | - | - | - |
| Surgery alone | 275 | 27 months |
Shares Chemoradiation (chemoradiotherapy, CRT), Fluorouracil (5-FU), IMRT / IGRT (modern external beam) and the tag radiation-wave4.
Shares Chemoradiation (chemoradiotherapy, CRT), Fluorouracil (5-FU), IMRT / IGRT (modern external beam) and the tag radiation-wave4.
Shares Chemoradiation (chemoradiotherapy, CRT), Fluorouracil (5-FU), IMRT / IGRT (modern external beam) and the tag radiation-wave4.
Shares Chemoradiation (chemoradiotherapy, CRT), Fluorouracil (5-FU), IMRT / IGRT (modern external beam) and the tag radiation-wave4.
Shares Chemoradiation (chemoradiotherapy, CRT), IMRT / IGRT (modern external beam) and the tag radiation-wave4.
Shares Chemoradiation (chemoradiotherapy, CRT), IMRT / IGRT (modern external beam) and the tag radiation-wave4.
Shares Chemoradiation (chemoradiotherapy, CRT), IMRT / IGRT (modern external beam) and the tag radiation-wave4.
Shares Chemoradiation (chemoradiotherapy, CRT), IMRT / IGRT (modern external beam) and the tag radiation-wave4.