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

NCT07337811 | Recruiting DMC

• 1 other identifier: 2025-FXY-237
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Cancer Patients

Keywords

Local Excision; Frozen Pathology; Chemoradiotherapy; Total Mesorectal Excision

Outcome Measures

Primary Outcomes (5)

• 2-year local recurrence rate

  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).

  2 years

• Rate of major surgical complications within 30 days post operation

  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).

  30 days

• Rate of permanent stoma at 2 years

  Participants alive at 24 months who still have an end-colostomy or ileostomy deemed permanent by the treating surgeon.

  2 years

• Rate of anal incontinence at 2 years

  Wexner score \> 10 points assessed by validated questionnaire.

  2 years

• Rate of sexual dysfunction at 2 years

  Sexual dysfunction assessed by the EORTC QLQ-C30/CR38 sexual function subscale; defined as score below reference value.

  2 years

Study Arms (1)

Experimental

EXPERIMENTAL

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

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

Interventions

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

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed rectal adenocarcinoma.
• Neoadjuvant therapy based on radiotherapy; post-radiotherapy evaluation ≥8 weeks later shows near clinical complete response (near-cCR) or partial response (PR) with residual tumor \<2 cm.
• Tumor distance from the anal verge ≤5 cm.
• Age 18-75 years.
• No synchronous multiple primary cancers.
• No contraindications to pre-operative radiotherapy or chemotherapy.
• Adequate organ function (cardiac, hepatic, renal, hematologic).
• Patient or legally authorized representative able to understand the study protocol, willing to participate, and provide written informed consent.

You may not qualify if:

• Age \<18 or \>75 years.
• Concurrent or previous malignancy within the past 5 years (except adequately treated basal-cell or squamous-cell skin carcinoma or carcinoma in situ of the cervix).
• Emergency surgery required for bowel obstruction, perforation, or bleeding.
• Prior colorectal surgery that may compromise intestinal reconstruction.
• Need for en-bloc multivisceral resection.
• ASA physical status IV or V.
• Pregnant or lactating women.
• a) Women of child-bearing potential with a positive serum pregnancy test at baseline or who have not undergone pregnancy testing; post-menopausal women must have been amenorrheic for ≥12 months.
• b) Men or women of reproductive potential unwilling to use effective contraception throughout the study period.
• Severe psychiatric illness precluding informed consent or compliance.
• Severe COPD, interstitial lung disease, or ischemic heart disease precluding safe surgery.
• Continuous systemic corticosteroid therapy within 1 month before enrolment.
• Contraindications to laparoscopic surgery.
• Patient or legally authorized representative unable to understand the study conditions and objectives.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Dept. of Colorectal Surgery, Sun Yat-sen University Cancer Center. Yuexiu District, Dongfeng East Road 651

Guangzhou, Guanggong, 510060, China

RECRUITING

Study Officials

• Pei-Rong Ding

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Jian Mei

CONTACT

+86-13824419341; meiwj@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Colorectal Surgery

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: January 13, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)