A Prospective, Multicenter, Randomized, Open, Parallel Controlled, Non-inferiority Clinical Trial of Salvage Chemoradiotherapy Versus Radical Total Mesorectal Excision in the Treatment of Intermediate-risk Early Middle-low Rectal Cancer After Local Resection

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Whether to perform radical TME or salvage chemoradiotherapy after local resection of intermediate-risk T1 rectal cancer is still controversial. A study based on the National Cancer Data Center showed that, because of the need for organ preservation, rescue chemoradiotherapy after local resection of rectal cancer was used in 10% of patients with T1N0 tumors and in 40% of patients with T2N0 tumors. However, the local recurrence caused by non-TME surgery is still the focus of concern for clinicians and patients. Previous retrospective studies have shown that there is no significant difference in overall survival and disease free survival between salvage CRT group and salvage TME group for patients with early rectal cancer after local resection. Pathological pT2 after local resection is the only independent risk factor for disease-free survival. However, limited to a single center and small sample size, the recurrence caused by salvage radiotherapy and chemotherapy should still be alert. Given these concerns, there is an urgent need to identify a better treatment regimen that can ensure reliable oncologic outcomes after local resection. Therefore, with TME as the control group and salvage chemoradiotherapy as the experimental group, we conducted a prospective, randomized, multicenter, non-inferiority clinical trial of the treatment effect of patients with intermediate-risk T1 and clinical stage N0M0 rectal cancer after local resection, to provide high-level evidence-based medical evidence for the final choice of these two salvage treatment methods.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• aged 18-75 years;

• Local radical resection of rectal adenocarcinoma (TEM, TAMIS, TSPM, EMR, ESD or polypectomy)

• pT1 with a diameter of 3-5 cm, or a maximum diameter of 3 cm, and at least poor differentiation and/or lymphovascular invasion and/or perineural invasion and/or SM3;

• The distance from the lower edge of the tumor to the anal verge was within 10cm on MRI at initial diagnosis;

• clinical stage N0M0 at initial diagnosis;

• no multiple colorectal cancer;

• The heart, lung, liver and kidney function can tolerate surgery;

• Patients and their families were able to understand and willing to participate in this study, and provided written informed consent

Locations
Other Locations
China
Gastrointestinal Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Liang Huang, phD
huangl75@mail.sysu.edu.cn
15989101216
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 392
Treatments
Experimental: Salvage adjuvant chemoradiotherapy group
Patitents under local radical resection of rectal adenocarcinoma received:~1. Concurrent adjuvant chemotherapy~2. Adjuvant radiotherapy: long-course radiotherapy was planned in this study.
Active_comparator: Radical TME group
Patitents under local radical resection of rectal adenocarcinoma received:~Standard TME surgery was performed 3-4 weeks after local resection.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov