Selective Total Mesorectal Excision Based on Intra-Operative Frozen Section From Local Excision i… (NCT07337811) | Clinical Trial Compass
RecruitingNot Applicable
Selective Total Mesorectal Excision Based on Intra-Operative Frozen Section From Local Excision in Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy
China27 participantsStarted 2025-08-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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.
Exclusion criteria
✕. 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).
What they're measuring
1
2-year local recurrence rate
Timeframe: 2 years
2
Rate of major surgical complications within 30 days post operation
✕. 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.