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Reducing the Resection Range After Neoadjuvant Therapy for Locally Advanced Upper Rectal and Rectosigmoid Junction Cancers
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Summary
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?
Official title: Reducing the Resection Range After Neoadjuvant Therapy for Locally Advanced Upper Rectal and Rectosigmoid Junction Cancers: A Prospective, Multicenter, Randomized Controlled Phase 3 Study
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
874
Start Date
2025-07-01
Completion Date
2028-06-20
Last Updated
2025-12-18
Healthy Volunteers
No
Conditions
Interventions
Laparoscopic resection
Laparoscopic resection of bowel and corresponding mesentery.
Neoadjuvant Therapy
Neoadjuvant Therapy aims to downstage the tumor including different chemotherapy, targeted therapy and immunotherapy.
Locations (1)
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China