Long-course chemoradiotherapy preserved the rectum more often than short-course radiotherapy

Design

International, open-label, randomised phase 2/3 trial with patient-preference component

Population

409 patients with early or intermediate-stage rectal cancer (≤40 mm, mrT1–T3bN0), 5 European countries

Primary outcome

TME-free survival at 12 months (interim); organ preservation at 30 months (final)

Effect

12-month TME-free survival 78.5% vs 60.6% (long-course vs short-course), HR 1.90 (95% CI 1.29–2.81)

STAR-TREC enrolled patients with early and intermediate-stage rectal cancer (up to 40 mm, mrT1–T3bN0) at 37 European sites. Those who chose organ preservation were randomised to long-course chemoradiotherapy (50 Gy with capecitabine) or short-course radiotherapy (25 Gy in 5 fractions), followed by response-adapted surveillance. The trial's primary endpoint is at 30 months; this is a 12-month analysis released on committee advice.

Twelve months after treatment, survival free of total mesorectal excision was 78.5% with long-course chemoradiotherapy and 60.6% with short-course radiotherapy. Serious gastrointestinal adverse events were less frequent with organ preservation than with primary surgery.

For patients with small, node-negative tumours who want to avoid a stoma or major surgery, organ preservation is now an evidence-supported conversation. Where it is chosen, long-course chemoradiotherapy appears the better route. This requires high-quality MRI and endoscopic surveillance, which limits where it can be offered safely.

• Discuss organ preservation with patients who have small, node-negative rectal cancers
• Prefer long-course chemoradiotherapy when organ preservation is the goal
• Offer it only where MRI and endoscopic surveillance can be delivered reliably
• Explain that 30-month and oncological outcomes are still awaited

Why it matters

Avoiding major rectal surgery is becoming a realistic, trial-supported goal for early rectal cancer.

Don't overread it

These are early 12-month results; recurrence, survival and function at 30 months have not yet been reported.

The statistics, in plain English

The HR of 1.90 (95% CI 1.29–2.81) is for needing TME with short-course compared with long-course treatment, so short-course carried about twice the rate. The comparison between the two radiotherapy schedules was randomised; the comparison with surgery was by patient choice and is not.

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