NCT07337811 Selective Total Mesorectal Excision Based on Intra-Operative Frozen Section From Local Excision in Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy

Eligibility & Interventions

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This trial targets 27 participants in total. It began in 2025-08-01 with a primary completion date of 2028-07-31.

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.

Eligibility Criteria

Inclusion Criteria: 1. Pathologically confirmed rectal adenocarcinoma. 2. 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. 3. Tumor distance from the anal verge ≤5 cm. 4. Age 18-75 years. 5. No synchronous multiple primary cancers. 6. No contraindications to pre-operative radiotherapy or chemotherapy. 7. Adequate organ function (cardiac, hepatic, renal, hematologic). 8. Patient or legally authorized representative able to understand the study protocol, willing to participate, and provide written informed consent. Exclusion Criteria: 1. Age \<18 or \>75 years. 2. 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). 3. Emergency surgery required for bowel obstruction, perforation, or bleeding. 4. Prior colorectal surgery that may compromise intestinal reconstruction. 5. Need for en-bloc multivisceral resection. 6. ASA physical status IV or V. 7. Pregnant or lactating women. 8. 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. 9. b) Men or women of reproductive potential unwilling to use effective contraception throughout the study period. 10. Severe psychiatric illness precluding informed consent or compliance. 11. Severe COPD, interstitial lung disease, or ischemic heart disease precluding safe surgery. 12. Continuous systemic corticosteroid therapy within 1 month before enrolment. 13. Contraindications to laparoscopic surgery. 14. Patient or legally authorized representative unable to understand the study conditions and objectives.

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