Comparing chemotherapy and surgery for rectal cancer after local resection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Gastrointestinal Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Liang Huang, phD
• Email: huangl75@mail.sysu.edu.cn
• Phone: 15989101216

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.