Is Transanal Local Excision Oncologically Safe After Chemoradiotherapy? A Multicenter Phase II Study in ycT0-1 Rectal Cancer
In brief
Transanal local excision after chemoradiotherapy yields 85% three-year disease-free survival
In a multicenter phase II trial of 80 rectal cancer patients downstaged to ycT0-1 after neoadjuvant chemoradiotherapy, full-thickness transanal excision achieved an 84.8% three-year disease-free survival, meeting the non-inferiority benchmark. Local recurrence was only 5% and serious postoperative complications occurred in 3.8%, supporting organ preservation in carefully selected responders, provided vigilant follow-up.
- Journal
- Cancer research and treatment (Q1)
- Published
- 16 September 2026
- Study design
- Non-randomized / quasi-experimental trial
- Evidence level
- Level 2, Moderate (CEBM 2b)
- Authors
- Min Jung Kim, Kiho You, Jungnam Joo, Sung Chan Park, Dae Kyung Sohn, Hee Jin Chang, et al.
- PMID
- 42755060
- DOI
- 10.4143/crt.2026.0512
Why clinicians should know about it
- Picked for Surgical Oncology (paper of the day, 21 September 2026): Phase II study, organ-preserving surgery after CRT
Abstract
PURPOSE: To evaluate the feasibility of local excision (LE) as an organ-preserving approach in patients with locally advanced rectal cancer showing a good response to neoadjuvant chemoradiotherapy (CRT). MATERIALS AND METHODS: This prospective, multicenter, single-arm phase II study enrolled patients with cT2-3N0-2M0 rectal adenocarcinoma downstaged to ycT0-1N0M0 after CRT. All patients underwent full-thickness LE. Patients with ypT0-1 were observed without completion total mesorectal excision (TME), whereas completion TME was recommended for those with ypT2-3 or positive margins. The primary endpoint was 3-year disease-free survival (DFS), with noninferiority defined as the lower bound of the one-sided 90% confidence interval (CI) exceeding 77.5%. The full analysis set (FAS) included all patients who underwent LE. RESULTS: Eighty patients were included [median follow-up, 74.2 months (Q1-Q3, 63.4-94.2)]. Pathology showed ypT0-1 in 62.5% and ypT2-3 in 37.5%. The 3-year DFS was 84.8% (lower 90% CI, 78.8%) in the FAS and 86.3% (lower 90% CI, 79.3%) in the per-protocol population. In the FAS, 5-year overall survival was 94.7%, and cumulative incidences of local recurrence (LR) and distant metastasis (DM) were 5.0%, and 8.9%, respectively. In subgroup analysis, 5-year DFS was 83.2% for ypT0-1, 88.9% for ypT2-3 with completion TME, and 75.3% for ypT2-3 without completion TME. The 30-day postoperative complications after transanal LE after CRT were 21.3%, and ≥ Clavien-Dindo grade 3 was 3.8%. CONCLUSION: LE met the prespecified non-inferiority criterion for 3-year DFS with excellent local control in patients with ycT0-1 after neoadjuvant CRT. Transanal LE can be considered as an alternative organ-preserving strategy in selected patients with major response after CRT with acceptable postoperative complications, provided that appropriate surveillance is ensured.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.