NCT07337811

Selective Total Mesorectal Excision Based on Intra-Operative Frozen Section From Local Excision in Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy

Recruiting now NA Last updated 13 January 2026

What this trial tests

NA trial testing Selective Total Mesorectal Excision Based on Intra-Operative Frozen Section From Local Excision in Rectal Cancer Patients in 27 participants. Currently enrolling.

Timeline

1 August 2025

Primary endpoint
31 July 2028

31 July 2028

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	1 August 2025
Primary completion	31 July 2028
Estimated completion	31 July 2028
Sites	1 location across China

Drugs / interventions tested

• Selective Total Mesorectal Excision Based on Intra-Operative Frozen Section From Local Excision

Conditions studied

• Rectal Cancer Patients — all drugs for Rectal Cancer Patients →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 75, any sex, with Rectal Cancer Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a prospective, single-arm, phase II superiority trial to determine whether a selective organ-preserving strategy based on immediate intra-operative frozen-section results can achieve favorable 2-year local control while lowering morbidity in patients with low rectal cancer (tumor ≤5 cm from the anus) who have a near clinical complete response (near-cCR) or partial response (residual tumor \<2 cm) after radiation therapy.

Population: Adults with primary rectal adenocarcinoma located ≤5 cm from the anal verge who, after neoadjuvant radiotherapy, are judged to have near-cCR or partial response (residual tumor \<2 cm).

Intervention: All participants undergo local excision under general anesthesia. The specimen is sent for intra-operative frozen section.

ypT0-1 on frozen section → procedure concluded; patient enters watch-and-wait. ypT2-3 or R1 on frozen section → immediate completion total mesorectal excision (TME).

Frozen-section ypT1-2 but final paraffin section up-staged to ypT2-3 or R1 → elective TME within 8 weeks.

Primary Endpoint: a composite outcome of 2-year local recurrence rate, surgical complications (≤30 days), and long-term functional impairment (anorectal, urogenital, and quality-of-life scales).

Secondary Endpoints: Agreement between intra-operative frozen-section pathology and final paraffin-section pathology, 3-year disease-free survival (DFS), 3-year overall survival (OS), surgery-sparing rate, post-operative recovery metrics, Quality-of-life scores.

Estimated Enrollment: 27 participants.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.