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RECRUITING
NCT05984485
PHASE3

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

Sponsor: 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

Official title: TME vs TME+nCT in Low-risk LARC

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

766

Start Date

2022-07-05

Completion Date

2028-07

Last Updated

2023-08-09

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

neoadjuvant chemotherapy plus total mesorectal excision

Neoadjuvant chemotherapy regimen recommended FOLFOX6, XELON, FOLFOX, mFOLFOX for 4-6 courses, and TME surgical treatment after preoperative tumor restaging 1-2 weeks after neoadjuvant chemotherapy.

PROCEDURE

total mesorectal excision

Standard total mesorectal excision

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