NCT05984485

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 766 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-07-05
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2023-08-09
• Last updated: 2023-08-09

Locations

6 sites across 1 country: China