CAO-ARO-AIO-04

Regimen

Experimental
Oxaliplatin-intensified: preop RT + infusional 5-FU + oxaliplatin → TME → adjuvant FOLFOX
Control
Standard: preop RT + infusional 5-FU → TME → bolus 5-FU adjuvant

Population

Locally advanced rectal cancer (cT3–4 or cN1–2), N=1,236; intensified CRT plus adjuvant oxaliplatin.

Key finding

3-year DFS: oxaliplatin-intensified regimen 75.9% vs fluorouracil-only 71.2% (HR 0.79, 95% CI 0.64-0.98, P=0.03). Absolute DFS benefit 4.7% at 3 years. pCR rate also improved. Oxaliplatin added to CRT with modified schedule shows DFS benefit unlike ACCORD 12.

Source: PMID 26189067

Timeline

    Guideline citations

    • NCCN Rectal (p.44)