PROSPECT

Regimen

Experimental
Neoadjuvant FOLFOX × 6 cycles → TME (CRT added only if <20% tumor shrinkage after FOLFOX)
Control
Standard neoadjuvant long-course CRT (50.4 Gy + fluoropyrimidine) → TME

Population

cT2N+ or cT3N0/N+ rectal cancer eligible for sphincter-sparing surgery (lower-risk locally advanced rectal cancer), N=1,194.

Key finding

5-year DFS: FOLFOX 80.8% vs CRT 78.6% (HR 0.92, 90.2% CI 0.74-1.14; noninferiority P=0.005); OS and local recurrence similar. Only 9.1% of FOLFOX arm received salvage preoperative CRT. First trial showing that radiation can be selectively omitted for favorable-risk LARC without compromising DFS.

Source: PMID 37272534

Timeline

    Guideline citations

    • NCCN Colon (p.27)
    • NCCN Rectal (p.44)