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

Disease-free Survival Clinical Trial

— SCRM-01  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03504449
• Other study ID #: SCRM-01
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2021
• Source: Beijing Chao Yang Hospital
• Contact: Jiagang Han, MD
• Phone: +861085231604
• Email: wzhj611[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• neoadjuvant chemoradiotherapy

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	circumferential resection margin		one week after operation
Primary	introperative perforation		During the operation
Secondary	local recurrece		3 years after operation
Secondary	overal survival		3 years after operation
Secondary	disease-free survival		3 years after operation
Secondary	complications		30 days after operation