NCT06043999Recruiting
Salvage Chemotherapy Versus Total Mesorectal Resection for Local Resection Rectal Cancer Patients
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
Source: ClinicalTrials.gov · Last updated 21 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 392 (estimated)
- First submitted
- 24 Aug 2023
- Start date
- 1 Sept 2023
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT06043999
What you commit to
- Study type: Interventional
- Planned participants: 392
- From 1 Sept 2023 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- not suitable for subsequent chemoradiotherapy or surgery;
Other illness
- complicated with other malignant tumors or a previous history of malignant tumors;
- a history of inflammatory bowl disease (IBD) or familial adenomatous polyposis (FAP);
- recently diagnosed with other malignant tumors;
- 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;
Lab values
- Patients with other clinical or laboratory conditions were not considered to be eligible for the study
Other
- ASA physical status ≥ IV and/or ECOG performance status \> 2 points;
- pregnant or lactating women;
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gastrointestinal Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.