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

Condition(s) studied

Investigational drug(s) / intervention(s)

Selective Total Mesorectal Excision Based on Intra-Operative Frozen Section From Local Excision: All participants undergo trans-anal full-thickness local excision under general anesthesia. The specimen is sent for intra-operative frozen-section pathology. 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• 2-year local recurrence rate — 2 years
  2-year local recurrence rate: defined as any clinical, radiologic, or pathologic evidence of tumor regrowth within the pelvis detected by digital rectal examination, endoscopy, CT/MR or PET-CT imaging, and biopsy (if indicated).
• Rate of major surgical complications within 30 days post operation — 30 days
  Surgical complications graded ≥ III by the Clavien-Dindo classification (III = requiring surgical, endoscopic or radiologic intervention; IV = life-threatening complication requiring IC/ICU admission; V = death attributable to the complication).
• Rate of permanent stoma at 2 years — 2 years
  Participants alive at 24 months who still have an end-colostomy or ileostomy deemed permanent by the treating surgeon.
• Rate of anal incontinence at 2 years — 2 years
  Wexner score \> 10 points assessed by validated questionnaire.
• Rate of sexual dysfunction at 2 years — 2 years
  Sexual dysfunction assessed by the EORTC QLQ-C30/CR38 sexual function subscale; defined as score below reference value.

Trial sites (1)

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