Actively Recruiting
Selective Total Mesorectal Excision Based on Intra-Operative Frozen Section From Local Excision in Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy: A Prospective, Single-arm, Phase II Superiority Trial
Led by Sun Yat-sen University · Updated on 2026-01-13
27
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a selective organ-preserving approach for adults with low rectal cancer located 5 cm or less from the anus who have a near clinical complete response or partial response after radiation therapy. This prospective, single-arm, phase II trial aims to see if using immediate intra-operative frozen-section results during local excision can achieve good 2-year local control while reducing surgery complications and long-term functional problems such as anorectal and urogenital issues. The study focuses on patients who have undergone neoadjuvant radiotherapy and have residual tumors smaller than 2 cm. All participants receive trans-anal full-thickness local excision under general anesthesia. The removed tissue is examined immediately using frozen-section pathology during surgery. If the frozen section shows ypT0-1 stage, the procedure ends and the patient enters a watch-and-wait monitoring phase. If the frozen section shows ypT2-3 stage or positive margins (R1), an immediate completion total mesorectal excision (TME) is performed. If the frozen section shows ypT1-2 but the final paraffin section upgrades the tumor to ypT2-3 or R1, an elective TME is done within 8 weeks. During the study, participants will be monitored for local recurrence, surgical complications within 30 days, and long-term functional outcomes including anal incontinence, sexual dysfunction, and permanent stoma rates over 2 years. Researchers will also compare frozen-section pathology with final pathology results and assess disease-free and overall survival at 3 years. The study enrolls about 27 adults aged 18 to 75 years and includes assessments of quality of life and recovery after surgery.
CONDITIONS
Brief Title
Selective Total Mesorectal Excision Based on Intra-Operative Frozen Section From Local Excision in Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed rectal adenocarcinoma.
- Completed neoadjuvant radiotherapy with evaluation at least 8 weeks later showing near clinical complete response or partial response with residual tumor less than 2 cm.
- Tumor located 5 cm or less from the anal verge.
- Age between 18 and 75 years.
- No synchronous multiple primary cancers.
- No contraindications to pre-operative radiotherapy or chemotherapy.
- Adequate heart, liver, kidney, and blood function.
- Ability to understand the study and provide informed consent.
You will not qualify if you...
- Age under 18 or over 75 years.
- Other malignancy within past 5 years except certain skin or cervical cancers.
- Emergency surgery required for bowel obstruction, perforation, or bleeding.
- Prior colorectal surgery that may affect intestinal reconstruction.
- Need for multivisceral en-bloc resection.
- ASA physical status IV or V.
- Pregnant or breastfeeding women.
- Women of childbearing potential with positive pregnancy test or no pregnancy testing; postmenopausal women not amenorrheic for at least 12 months.
- Men or women unwilling to use effective contraception during study.
- Severe psychiatric illness preventing informed consent or compliance.
- Severe lung or heart disease making surgery unsafe.
- Ongoing systemic corticosteroid treatment within 1 month before enrollment.
- Contraindications to laparoscopic surgery.
- Inability to understand study conditions and objectives.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single surgical procedure with possible additional surgery within 8 weeks
Participants undergo trans-anal full-thickness local excision under general anesthesia. The excised tissue is analyzed during surgery using intra-operative frozen section. Based on the results, participants either conclude the procedure and enter watch-and-wait, receive immediate completion total mesorectal excision (TME), or have elective TME within 8 weeks if indicated by final pathology.
1 surgery visit and possible additional surgery visit within 8 weeks
Duration - Up to 2 years
Participants are monitored for up to 2 years to assess local recurrence, surgical complications, functional impairment, and quality of life.
Regular follow-up visits during 2 years
Trial Site Locations
Total: 1 location
1
Dept. of Colorectal Surgery, Sun Yat-sen University Cancer Center. Yuexiu District, Dongfeng East Road 651
Guangzhou, Guanggong, China, 510060
Actively Recruiting
Research Team
W
Wei-Jian Mei
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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