Actively Recruiting
Total Mesorectal Excision(TME) With Lateral Lymph Node Dissection Versus TME After Neoadjuvant Chemo-radiotherapy
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2022-11-25
250
Participants Needed
1
Research Sites
596 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Treatment for Low rectal cancer, especially in patients with regional lymph node metastasis are quite different between Japanese guideline (JSCCR) and western countries' guideline (NCCN, ESMO). While Japanese scholars advocate total mesorectal excision (TME) plus lateral lymph node dissection (LLND), European and American scholars advocate TME alone after Neoadjuvant Chemo-radiotherapy (nCRT), without the need of LLND. Accordingly, this clinical trial is designed to directly compare the efficacy and safety of these two treatment strategies for low rectal cancer with regional lymph node metastasis. It will provide high-level clinical evidence for the treatment of low rectal cancer with suspected local lymph node metastasis
CONDITIONS
Official Title
Total Mesorectal Excision(TME) With Lateral Lymph Node Dissection Versus TME After Neoadjuvant Chemo-radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma located below the peritoneal reflection with clinical stage II
- Tumor suitable for radical resection
- No previous chemotherapy or pelvic radiation for other cancers
- Provided written informed consent
- Lower tumor margin confirmed below the peritoneal reflection
- Clinical stage T1-3 N1-2 M0 confirmed by a multidisciplinary team based on MRI and endorectal ultrasound
You will not qualify if you...
- Past history of other cancers
- Multiple primary colorectal cancers or familial adenomatous polyposis (FAP)
- Presence of inflammatory bowel disease (IBD)
- Recurrent tumor or tumor invading other organs
- Obstruction, perforation, or bleeding requiring emergency surgery
- Tumor invading the external sphincter, levator ani muscle, or adjacent organs
- Participation in other clinical trials within 4 weeks
- American Society of Anesthesiologists (ASA) score of 4 or higher and/or Eastern Cooperative Oncology Group (ECOG) score 2 or higher
- Pregnant or lactating patients
- Severe infection before operation
- Psychological disorder
- Severe organ dysfunction or other contraindications
- Cardiac infarction within six months
- Severe pulmonary emphysema or pulmonary fibrosis
- Tumor invading other organs found during surgery
- Lower tumor margin above the peritoneal reflection
- Doctor's decision for exclusion
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Sixth Affiliate Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
Y
Yanxin Luo
CONTACT
S
Shaoyong Peng
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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