Status:
RECRUITING
Salvage Chemotherapy Versus Total Mesorectal Resection for Local Resection Rectal Cancer Patients
Lead Sponsor:
Sun Yat-sen University
Conditions:
Chemotherapy Effect
Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 ...
Detailed Description
In China, with the implementation of population-based early screening for colorectal cancer, more and more colorectal cancer are detected and diagnosed at an early stage. However, although operation m...
Eligibility Criteria
Inclusion
- 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
Exclusion
- complicated with other malignant tumors or a previous history of malignant tumors;
- not suitable for subsequent chemoradiotherapy or surgery;
- a history of inflammatory bowl disease (IBD) or familial adenomatous polyposis (FAP);
- recently diagnosed with other malignant tumors;
- ASA physical status ≥ IV and/or ECOG performance status \> 2 points;
- patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious underlying diseases can not tolerate surgery;
- a history of severe mental illness;
- pregnant or lactating women;
- Patients with other clinical or laboratory conditions were not considered to be eligible for the study
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
392 Patients enrolled
Trial Details
Trial ID
NCT06043999
Start Date
September 1 2023
End Date
December 31 2028
Last Update
September 21 2023
Active Locations (1)
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1
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655