Chemoradiation Enables Organ Preservation in Early-Stage Rectal Cancer: Study

A new study published in the journal of The Lancet Oncology showed that following chemoradiation treatment, over 80% of patients with early-stage rectal cancer avoided surgery for at least a year.

The majority of early-stage and intermediate-stage rectal cancers are treated with total mesorectal excision (TME), which can result in significant perioperative morbidity, functional impairment, and a worse quality of life. This study evaluated whether short-course radiotherapy (SCRT) or long-course chemoradiotherapy (LCCRT) may improve organ preservation while lowering risks associated with surgery, toxicity, and quality of life without sacrificing oncological results.

A multicenter, open-label, randomized phase 2/3 experiment called STAR-TREC was carried out in 5 European nations. Patients with rectal adenocarcinoma (≤40 mm; mrT1–T3bN0), ECOG performance class 0–1, and ages ≥16 (UK) or ≥18 (other countries) were eligible. Phase 2 involved a 1:1:1 randomization of patients to either primary complete mesorectal excision (TME), long-course chemoradiotherapy-based organ preservation (LCCRT-OP; 50 Gy/25 fractions with capecitabine), or short-course radiotherapy-based organ preservation (SCRT-OP; 25 Gy/5 fractions). Recruitment rates at 12 and 24 months were used to assess feasibility.

A patient-preference design was adopted in Phase 3, which permitted organ preservation or TME. Organ-preservation patients were randomly assigned 1:1 to either LCCRT-OP or SCRT-OP after being stratified by country and MRI T stage (≤T3a vs. T3b). At 30 months, organ preservation—defined as the absence of TME, stoma, or local recurrence—was the main outcome. For patients enrolled prior to August 8, 2023, a 12-month modified intention-to-treat study of implementation outcomes was advised after interim phase 2 analysis.

In 37 locations, 503 people were enrolled between June 2017 and April 2024. According to interim analysis, LCCRT considerably outperformed SCRT in terms of TME-free survival (HR 3.7; >99.5% likelihood of superiority).

The 12-month TME-free survival rate for the 409 individuals in the modified intention-to-treat group who chose organ preservation was **78.5% with LCCRT versus 60.6% with SCRT** (HR 1.90). Procedural problems and gastrointestinal illnesses were the most prevalent grade 3–4 major adverse events. Anastomotic leaking after initial TME resulted in one fatality.

Overall, these preliminary findings indicate that standardized methods for response-adapted organ preservation may be successful in treating rectal cancer in both early and intermediate stages, with high success rates at 12 months.

Source:

Bach, S. P., Sebag-Montefiore, D., Homer, V., Gilbert, A., Appelt, A., Geh, I., Beets, G. L., Burger, J., Angenete, E., Baatrup, G., Spindler, K.-L. G., Haustermans, K., Holman, F., Kerkhof, E. M., Lam, E., Korsgen, S., Martling, A., Wolthuis, A., Al-Najami, I., … STAR-TREC Collaborative. (2026). Chemoradiotherapy versus short-course radiotherapy for response-adapted organ preservation in early-stage and intermediate-stage rectal cancer (STAR-TREC): 12-month results of an international, multicentre, open-label, parallel-group, randomised, phase 2/3 trial. The Lancet Oncology, 27(9), 1120–1132. https://doi.org/10.1016/S1470-2045(26)00228-7