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The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE3

The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer

TME vs TME+nCT in Low-risk LARC

NCT05984485•Sun Yat-sen University

View on ClinicalTrials.gov

Summary

Comparative analysis of the clinical efficacy between primary Total Mesorectal Excision (TME) surgery and neoadjuvant chemotherapy combined with TME surgery for low-risk locally advanced rectal cancer. Randomly enrolling eligible patients into either the control group receiving neoadjuvant chemotherapy combined with TME surgery or the experimental group receiving primary TME surgery, and subsequently comparing the clinical outcomes of the two groups

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Newly diagnosed patients, aged 18 to 75 years;
•2. Pathologically confirmed rectal adenocarcinoma;
•3. Distance of the lower margin of the rectal tumor lesion from the anal margin \<15cm;
•4. High-resolution MRI indicates low-risk locally advanced rectal cancer: T1-3bN1-2 or T3aN0 or T3bN0; no involvement of the anal sphincter; negative mesorectal fascia (MRF) status; negative extramural vascular invasion (EMVI); no cancer nodules;
•5. Exclusion of patients with non-local recurrence or distant metastases;
•6. Absence of synchronous colorectal multiple primary cancers;
•7. Adequate physical condition to tolerate surgery and neoadjuvant chemotherapy, including cardiac, pulmonary, hepatic, and renal functions;
•8. The study physician assessed no difficulty in sphincter preservation;
•9. patients and their families will be willing to participate in this study and provide written informed consent.

Exclusion Criteria

•1. Patients with concurrent other malignancies or a history of malignant tumors in the past;
•2. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, or other conditions requiring emergency surgery;
•3. Patients with tumor invasion into the external sphincter or levator ani muscles, or involvement of adjacent organs necessitating combined organ resection;
•4. Patients with poor anal function or fecal incontinence before surgery;
•5. Patients with a history of inflammatory bowel disease or familial adenomatous polyposis;
•6. Patients recently diagnosed with other malignancies;
•7. Patients with ASA grade ≥ IV and/or ECOG performance status score \> 2;
•8. Patients with severe liver or kidney dysfunction, significant cardiopulmonary impairment, coagulation disorders, or those with extreme underlying conditions unable to tolerate surgery;
•9. Patients with a history of severe mental illness;
•10. Pregnant or lactating women;
+2 more criteria

Locations (6)

Daping Hospital, Amy Medeical Univerisity

Chongqing, Chongqing Municipality, China

Sun yat-sen University, the Sixth Affiliated Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

The Affiliated Nanchong Central Hospital of North Sichuan Medical College

Nanchong, Sichuan, China

Key Dates

Start Date

July 5, 2022

Primary Completion Date

July 1, 2028

Completion Date

July 1, 2028

Last Updated

August 9, 2023

Enrollment

766

ESTIMATED participants

Conditions

Rectal Cancer

Interventions

neoadjuvant chemotherapy plus total mesorectal excision

PROCEDURE

total mesorectal excision

PROCEDURE

Contacts

Huashan Liu, MD. PhD

CONTACT

+8613560309975 liuhshan@mail2.sysu.edu.cn

Ziwei Zeng, MD,PhD

CONTACT

+8615521161750 zengzw@mail2.sysu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 9, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer

Inclusion Criteria

Exclusion Criteria

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