The STAR-TREC trial compared long-course chemoradiotherapy (LCCRT: 50 Gy in 25 fractions + capecitabine) versus short-course radiotherapy (SCRT: 25 Gy in 5 fractions) for response-adapted organ preservation versus primary TME in patients with early-to-intermediate rectal cancer (mrT1–T3bN0, ≤40 mm) across 37 sites in 5 European countries; this report covers 12-month outcomes in 409 modified intention-to-treat participants.
At 12 months, TME-free survival was significantly higher with LCCRT than SCRT (78.5% vs 60.6%; HR 1.90, 95% CI 1.29–2.81). In phase 2, LCCRT showed a striking early benefit over SCRT (median TME-free survival not reached vs 7.6 months; HR 3.7, 95% CI 1.7–8.0). Grade 3–4 gastrointestinal events were low across all arms (2% LCCRT, 4% SCRT, 8% TME); one TME patient died from an anastomotic leak.
- This is a planned interim 12-month analysis; the prespecified primary endpoint is organ preservation at 30 months, so definitive conclusions cannot yet be drawn. - The trial shifted from a 3-arm RCT (phase 2) to a partially randomised patient-preference design (phase 3), which may introduce selection bias. - Functional and quality-of-life outcomes are not yet reported.
For patients with early-to-intermediate rectal cancer who want to avoid surgery, LCCRT-based organ preservation yields meaningfully higher TME-free survival at 12 months than SCRT. Clinicians should discuss organ-preservation pathways with eligible patients, while awaiting the 30-month definitive data before changing standard practice broadly.
Explore related topics
