Selective completion total mesorectal excision guided by intra-operative frozen pathology after local excision for low rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm phase II trial enrolling adults with primary rectal adenocarcinoma located ≤5 cm from the anal verge who show a near clinical complete response or a residual tumor <2 cm after neoadjuvant radiotherapy. All participants undergo local excision and the specimen is evaluated by intra-operative frozen section; if the frozen section shows ypT0-1 the procedure is concluded and the patient enters a watch-and-wait pathway, while ypT2-3 or positive margins prompt immediate completion total mesorectal excision (TME). The main goal is to test whether this selective organ-preserving strategy achieves favorable 2-year local control while reducing morbidity compared with routine upfront TME. The trial is conducted at Sun Yat-sen University Cancer Center in Guangzhou, China.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Pei-Rong Ding — Sun Yat-sen University
• Study coordinator: Wei-Jian Mei
• Email: meiwj@sysucc.org.cn
• Phone: +86-13824419341

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.