TME vs TME+nCT in Low-risk LARC

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Newly diagnosed patients, aged 18 to 75 years;

• Pathologically confirmed rectal adenocarcinoma;

• Distance of the lower margin of the rectal tumor lesion from the anal margin \<15cm;

• 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;

• Exclusion of patients with non-local recurrence or distant metastases;

• Absence of synchronous colorectal multiple primary cancers;

• Adequate physical condition to tolerate surgery and neoadjuvant chemotherapy, including cardiac, pulmonary, hepatic, and renal functions;

• The study physician assessed no difficulty in sphincter preservation;

• patients and their families will be willing to participate in this study and provide written informed consent.

Locations
Other Locations
China
Daping Hospital, Amy Medeical Univerisity
RECRUITING
Chongqing
Sun yat-sen University, the Sixth Affiliated Hospital
RECRUITING
Guangzhou
The First Affiliated Hospital of University of South China
RECRUITING
Hengyang
The Affiliated Nanchong Central Hospital of North Sichuan Medical College
RECRUITING
Nanchong
Shengjing Hospital of China Medical University
RECRUITING
Shenyang
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
Contact Information
Primary
Huashan Liu, MD. PhD
liuhshan@mail2.sysu.edu.cn
+8613560309975
Backup
Ziwei Zeng, MD,PhD
zengzw@mail2.sysu.edu.cn
+8615521161750
Time Frame
Start Date: 2022-07-05
Estimated Completion Date: 2028-07
Participants
Target number of participants: 766
Treatments
Experimental: Primary total mesorectal excision
Patients with low-risk locally advanced rectal cancer received total mesorectal excision alone.
Active_comparator: Neoadjuvant chemotherapy plus TME
Patients with low-risk locally advanced rectal cancer received neoadjuvant chemotherapy and total mesorectal excision.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov