Definitive / Organ Preservation · Phase II/III international randomized; 409 mITT early/intermediate rectal cancer. Long-course CRT vs short-course RT with response-adapted organ preservation; primary TME arm separate. Early 12-month results. · Among participants opting for organ preservation, 12-month TME-free survival 78.5% with LCCRT vs 60.6% with SCRT

STAR-TREC

Clinical question: For early/intermediate rectal cancer, does long-course chemoradiotherapy improve organ-preservation outcomes compared with short-course radiotherapy?

Among participants opting for organ preservation, 12-month TME-free survival 78.5% with LCCRT vs 60.6% with SCRT; HR 1.90 (95% CI 1.29–2.81); approximate NNT 6. Definitive 30-month endpoint pending. · Registry:

Design, population and treatment

Phase II/III international randomized; 409 mITT early/intermediate rectal cancer. Long-course CRT vs short-course RT with response-adapted organ preservation; primary TME arm separate. Early 12-month results.

Key efficacy outcome

78.5 · intervention

60.6

78.5 · comparator

NNT 6 for one additional patient TME-free at 12 months among organ-preservation participants; longer follow-up required.

Grade 3–4 serious GI AEs 2% LCCRT, 4% SCRT, 8% primary TME; one TME-group death after anastomotic leak.

Safety and absolute effect

12-month TME-free survival (%)

https://www.sciencedirect.com/science/article/pii/S1470204526002287

Interpretation and limitations

Current-practice context · 14 November 2026: Primary publication/abstract and trial identifier checked. Guideline-level current-practice mapping was not established in this publication-led batch; no NCCN citation provenance is claimed. Where detailed QoL, follow-up or toxicity data were not present in the retrieved abstract, they are not inferred.

Primary source

Primary publication · DOI: 10.1016/S1470-2045(26)00228-7