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

Recruiting now · Not applicable

Conditions studied: Rectal Cancer Patients

In brief

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.

Key facts

Study ID

NCT07337811

Run by

Sun Yat-sen University

People needed

27

Starts

2025-08-01

Expected to finish

2028-07-31

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Dept. of Colorectal Surgery, Sun Yat-sen University Cancer Center. Yuexiu District, Dongfeng East Road 651 — Guangzhou, Guanggong, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.