Comparing chemotherapy and surgery for rectal cancer after local resection

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

This study is testing whether chemotherapy or surgery works better for people with intermediate-risk rectal cancer who have already had part of their tumor removed.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 392 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06043999 on ClinicalTrials.gov

What this trial studies

This study investigates whether salvage chemotherapy or total mesorectal excision (TME) is more effective for patients with intermediate-risk T1 rectal cancer who have undergone local resection. It aims to address the controversy surrounding the best treatment approach by comparing outcomes such as overall survival and disease-free survival between the two interventions. The study will include patients aged 18-75 who meet specific criteria related to tumor characteristics and health status. The goal is to determine the optimal treatment strategy that minimizes complications while effectively managing cancer recurrence.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with specific characteristics of T1 rectal adenocarcinoma who have undergone local radical resection.

Not a fit: Patients with other malignant tumors, inflammatory bowel disease, or those unsuitable for chemotherapy or surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for rectal cancer patients, potentially improving their quality of life and reducing surgical complications.

How similar studies have performed: Previous studies have shown no significant difference in survival outcomes between salvage chemotherapy and TME, indicating that this approach is based on existing evidence but may still be novel in its specific application.

Eligibility criteria

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

Where this trial is running

Guangzhou, Guangdong

• Gastrointestinal Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Liang Huang, phD

Conditions: Chemotherapy Effect, Rectal Cancer