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

Not Applicable

• Conditions: Circumferential Resection Margin; Disease-free Survival; Overal Survival; Intraoperative Perforation of Rectum; Local Recurrence of Malignant Tumor of Rectum
• Interventions: Other: neoadjuvant chemoradiotherapy

• Registration Number: NCT03504449
• Lead Sponsor: Beijing Chao Yang Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-12
• Study First Posted: 2018-04-20
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-08
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. Tumor within 12 cm of the anal verge
2. T3N1-2 as determined by preoperative MRI examination
3. negative circumferential resection margin determined by preoperative MRI examination
4. Absence of distant metastases
5. Absence of intestinal obstruction

Exclusion Criteria

1. With distant metastases
2. With intestinal obstruction
3. Pregnancy or lactation
4. With operation contraindication
5. With mental disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
surgery with neoadjuvant chemoradiotherapy	neoadjuvant chemoradiotherapy	For T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, recieve surgery following neoadjuvant chemoradiotherapy.
surgery without neoadjuvant chemoradiotherapy	neoadjuvant chemoradiotherapy	For T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, recieve surgery without neoadjuvant chemoradiotherapy.

Primary Outcome Measures

Name	Time	Method
circumferential resection margin	one week after operation
introperative perforation	During the operation

Secondary Outcome Measures

Name	Time	Method
local recurrece	3 years after operation
overal survival	3 years after operation
disease-free survival	3 years after operation
complications	30 days after operation

Trial Locations

Locations (1)

Beijing Chaoyang Hospital; 🇨🇳 Beijing, Beijing, China