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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional resection margins group | Other | Conventional resection margins: Refers to the surgical resection region including 10 cm bowel proximal to the tumor, 5 cm bowel distal to the tumor, and lymph node dissection in the corresponding mesentery. |
|
| Reduced resection margins group | Experimental | Reduced resection margins: Refers to the surgical resection region including 5 cm bowel proximal to the tumor, 3 cm bowel distal to the tumor, and lymph node dissection in the corresponding mesentery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic resection | Procedure | Laparoscopic resection of bowel and corresponding mesentery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3 years DFS | 3 years Disease Free Survival Rate | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | R0 resection rate in participants | 1 year |
| Number of lymph node harvested | Number of lymph node harvested in participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Huang, PhD. | The Sixth Affiliated Hospital, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sixth Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China |
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| Neoadjuvant Therapy | Other | Neoadjuvant Therapy aims to downstage the tumor including different chemotherapy, targeted therapy and immunotherapy. |
|
| 1 year |
| Surgical duration | Operative time in participants | 1 year |
| Intraoperative blood loss | Blood loss during the operation | 1 year |
| Anastomotic leakage | Post-operative leakage in anastomotic site | 1 year |
| 1 year DFS | 1 year Disease Free Survival Rate | 1 year |
| 3 years OS | 3 years Overall Survival Rate | 3 year |
| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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