Actively Recruiting
The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer
Led by Sun Yat-sen University · Updated on 2023-08-09
766
Participants Needed
6
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed patients aged 18 to 75 years
- Pathologically confirmed rectal adenocarcinoma
- Tumor lower margin located less than 15 cm from the anal margin
- Low-risk locally advanced rectal cancer on high-resolution MRI: T1-3bN1-2, T3aN0, or T3bN0
- No involvement of the anal sphincter
- Negative mesorectal fascia (MRF) status
- Negative extramural vascular invasion (EMVI)
- No cancer nodules
- No distant metastases or local recurrence
- No synchronous colorectal multiple primary cancers
- Adequate cardiac, pulmonary, hepatic, and renal function to tolerate surgery and chemotherapy
- No difficulty in sphincter preservation as assessed by the study physician
- Willingness of patients and families to participate and provide written informed consent
You will not qualify if you...
- Presence of other concurrent malignancies or history of malignant tumors
- Intestinal obstruction, perforation, bleeding, or other emergency surgery conditions
- Tumor invasion into the external sphincter, levator ani muscles, or adjacent organs requiring combined organ resection
- Poor anal function or fecal incontinence before surgery
- History of inflammatory bowel disease or familial adenomatous polyposis
- Recent diagnosis of other malignancies
- ASA grade 4 or higher and/or ECOG performance status score greater than 2
- Severe liver or kidney dysfunction, major cardiopulmonary impairment, coagulation disorders, or other severe conditions preventing surgery
- History of severe mental illness
- Pregnant or lactating women
- Uncontrolled infections before surgery
- Other clinical or laboratory conditions deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Daping Hospital, Amy Medeical Univerisity
Chongqing, Chongqing Municipality, China, 400042
Actively Recruiting
2
Sun yat-sen University, the Sixth Affiliated Hospital
Guangzhou, Guangdong, China, 510655
Actively Recruiting
3
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China, 421001
Actively Recruiting
4
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
Actively Recruiting
5
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
6
The Affiliated Nanchong Central Hospital of North Sichuan Medical College
Nanchong, Sichuan, China, 637000
Actively Recruiting
Research Team
H
Huashan Liu, MD. PhD
CONTACT
Z
Ziwei Zeng, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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