Actively Recruiting
Salvage Chemotherapy Versus Total Mesorectal Resection for Local Resection Rectal Cancer Patients
Led by Sun Yat-sen University · Updated on 2023-09-21
392
Participants Needed
1
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Salvage Chemotherapy Versus Total Mesorectal Resection for Local Resection Rectal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years
- Local radical resection of rectal adenocarcinoma performed (including TEM, TAMIS, TSPM, EMR, ESD or polypectomy)
- Tumor stage pT1 with diameter 3-5 cm, or diameter ≤ 3 cm with poor differentiation and/or lymphovascular invasion and/or perineural invasion and/or SM3
- Distance from lower edge of tumor to anal verge within 10 cm on MRI at initial diagnosis
- Clinical stage N0M0 at initial diagnosis
- No multiple colorectal cancers
- Adequate heart, lung, liver, and kidney function to tolerate surgery
- Able and willing to provide written informed consent with understanding of the study
You will not qualify if you...
- Presence or history of other malignant tumors
- Not suitable for chemoradiotherapy or surgery
- History of inflammatory bowel disease (IBD) or familial adenomatous polyposis (FAP)
- Recently diagnosed with other malignant tumors
- ASA physical status ≥ IV and/or ECOG performance status > 2
- Severe liver, kidney, cardiopulmonary dysfunction, coagulation disorders, or serious underlying diseases preventing surgery
- History of severe mental illness
- Pregnant or breastfeeding women
- Other clinical or laboratory conditions making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Actively Recruiting
Research Team
L
Liang Huang, phD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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