Surgery Without Neoadjuvant Chemoradiotherapy Compared With Neoadjuvant Chemoradiotherapy for Rectal Cancer With Negative Circumferential Resection Margin Based on MRI Assessment, a Perspective Multicenter Randomized Controlled Trial

Study Overview
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Brief Summary
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For now, neoadjuvant chemoradiotherapy is routinely performed for T3N1-2M0 rectal cancer. However, there are lots of complications following neoadjuvant chemoradiotherapy, such as Wound-related complications, anastomotic leakage, anastomotic stenosis, sexual dysfunction, testicular or ovary failure. Patients undergoing resection for rectal cancer had low rates of local recurrence and long disease-free survival regardless of whether an APR, CAA or low AR was performed. The main purpose of preoperative radiotherapy is to lower the local recurrence. For the T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, we suppose might not necessary to receive neoadjuvant chemoradiotherapy, for operation can achieve the negative circumferential resection margin.

Conditions
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Circumferential Resection Margin, Intraoperative Perforation of Rectum, Local Recurrence of Malignant Tumor of Rectum, Disease-free Survival, Overal Survival

Intervention / Treatment
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* Other: neoadjuvant chemoradiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Tumor within 12 cm of the anal verge T3N1-2 as determined by preoperative MRI examination negative circumferential resection margin determined by preoperative MRI examination Absence of distant metastases Absence of intestinal obstruction Exclusion Criteria: With distant metastases With intestinal obstruction Pregnancy or lactation With operation contraindication With mental disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: surgery without neoadjuvant chemoradiotherapy<br>For T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, recieve surgery without neoadjuvant chemoradiotherapy. | Other: neoadjuvant chemoradiotherapy<br> <br> |
| Experimental: surgery with neoadjuvant chemoradiotherapy<br>For T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, recieve surgery following neoadjuvant chemoradiotherapy. | Other: neoadjuvant chemoradiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| circumferential resection margin |  | one week after operation | 
| introperative perforation |  | During the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local recurrece |  | 3 years after operation | 
| overal survival |  | 3 years after operation | 
| disease-free survival |  | 3 years after operation | 
| complications |  | 30 days after operation |