The goal of this clinical trial is to learn evaluate the safety and efficacy of reduced surgical resection margins in patients with local advanced upper rectal or rectosigmoid junction tumors who met the ycT≤3N0M0 regression following neoadjuvant therapy. The main questions it aims to answer are: Does reduced surgical resection margins (3 cm of distal margin and 5 cm of proximal margin) meet the radical resection criteria, including the rate of negative resection margin, the number of lymph node harvested? How is the surgical safety of reduced surgical resection, including the surgical duration , bleeding, recovery time and postoperative complications? Is reduced surgical margins resection (3 cm of distal margin and 5 cm of proximal margin) inferior to conventional surgical margins resection (5 cm of distal margin and 10 cm of proximal margin) in terms of oncology safety?
This study will be a prospective, multicenter, randomized phase III controlled trial conducted in collaboration with Sun Yat-sen University Sixth Affiliated Hospital and multiple domestic colorectal cancer centers. It will involve patients with upper rectal or rectosigmoid junction tumors at a clinical stage of cT3-4N+M0. The trial will compare conventional resection margins (distal 5 cm + proximal 10 cm) with reduced margins (distal 3 cm + proximal 5 cm) in patients who have met the ycT ≤3N0M0 regression criteria following neoadjuvant therapy or total neoadjuvant therapy (TNT). The aim is to evaluate the safety and efficacy of reduced surgical resection margins. The primary research objective is 3-year disease-free survival (DFS). The secondary research objectives includes radical surgery outcomes (R0 resection rate and number of lymph nodes dissected), surgical safety metrics (Operation time, intraoperative blood loss, incidence of anastomotic complications, etc.) and other survival outcomes (1-year disease-free survival and overall survival).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
874
Laparoscopic resection of bowel and corresponding mesentery.
Neoadjuvant Therapy aims to downstage the tumor including different chemotherapy, targeted therapy and immunotherapy.
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
3 years DFS
3 years Disease Free Survival Rate
Time frame: 3 year
R0 resection rate
R0 resection rate in participants
Time frame: 1 year
Number of lymph node harvested
Number of lymph node harvested in participants
Time frame: 1 year
Surgical duration
Operative time in participants
Time frame: 1 year
Intraoperative blood loss
Blood loss during the operation
Time frame: 1 year
Anastomotic leakage
Post-operative leakage in anastomotic site
Time frame: 1 year
1 year DFS
1 year Disease Free Survival Rate
Time frame: 1 year
3 years OS
3 years Overall Survival Rate
Time frame: 3 year
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