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Salvage Chemotherapy Versus Total Mesorectal Resection for Local Resection Rectal Cancer Patients

RecruitingNAAges 18 Years - 75 YearsAllSun Yat-sen University
NCT06043999 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. aged 18-75 years; 2. Local radical resection of rectal adenocarcinoma (TEM, TAMIS, TSPM, EMR, ESD or polypectomy) 3. 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; 4. The distance from the lower edge of the tumor to the anal verge was within 10cm on MRI at initial diagnosis; 5. clinical stage N0M0 at initial diagnosis; 6. no multiple colorectal cancer; 7. The heart, lung, liver and kidney function can tolerate surgery; 8. Patients and their families were able to understand and willing to participate in this study, and provided written informed consent Exclusion Criteria: 1. complicated with other malignant tumors or a previous history of malignant tumors; 2. not suitable for subsequent chemoradiotherapy or surgery; 3. a history of inflammatory bowl disease (IBD) or familial adenomatous polyposis (FAP); 4. recently diagnosed with other malignant tumors; 5. ASA physical status ≥ IV and/or ECOG performance status \> 2 points; 6. patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious underlying diseases can not tolerate surgery; 7. a history of severe mental illness; 8. pregnant or lactating women; 9. Patients with other clinical or laboratory conditions were not considered to be eligible for the study
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What it tests

  • Radical total mesorectal excision
  • Salavge Adjuvant Chemoradiotherapy
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Where

1 site
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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