The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
neoadjuvant chemotherapy plus total mesorectal excision: Neoadjuvant chemotherapy regimen recommended FOLFOX6, XELON, FOLFOX, mFOLFOX for 4-6 courses, and TME surgical treatment after preoperative tumor restaging 1-2 weeks after neoadjuvant chemotherapy.
total mesorectal excision: Standard total mesorectal excision
Study summary
Comparative analysis of the clinical efficacy between primary Total Mesorectal Excision (TME) surgery and neoadjuvant chemotherapy combined with TME surgery for low-risk locally advanced rectal cancer. Randomly enrolling eligible patients into either the control group receiving neoadjuvant chemotherapy combined with TME surgery or the experimental group receiving primary TME surgery, and subsequently comparing the clinical outcomes of the two groups
Eligibility
Primary outcome measure(s)
- 3-year Disease Free Survival — 3 years after surgery
Defined as the proportion of patients who did not experience any of the following events from the beginning of the randomized subgroup to the end of the third year, which included disease progression, local recurrence, distant metastasis, or second primary colorectal cancer, or death from any cause.
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| Daping Hospital, Amy Medeical Univerisity | Chongqing | Chongqing Municipality | Recruiting |
| Sun yat-sen University, the Sixth Affiliated Hospital | Guangzhou | Guangdong | Recruiting |
| The First Affiliated Hospital of University of South China | Hengyang | Hunan | Recruiting |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | Recruiting |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | Recruiting |
| The Affiliated Nanchong Central Hospital of North Sichuan Medical College | Nanchong | Sichuan | Recruiting |
More Sun Yat-sen University trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05984485 on ClinicalTrials.gov ↗ ← All trials in China